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LRB095 10560 RAS 30780 b |
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| (b) The following Acts are repealed on December 31, 2008: |
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| The Medical Practice Act of 1987. |
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| The Environmental Health Practitioner Licensing Act.
|
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| (Source: P.A. 94-754, eff. 5-10-06; 94-1075, eff. 12-29-06; |
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| 94-1085, eff. 1-19-07; revised 1-22-07.)
|
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| (5 ILCS 80/4.28 new) |
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| Sec. 4.28. Act repealed on January 1, 2018. The following |
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| Act is repealed on January 1, 2018: |
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| The Pharmacy Practice Act. |
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| Section 10. The Illinois Act on the Aging is amended by |
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| changing Section 4.01 as follows:
|
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| (20 ILCS 105/4.01) (from Ch. 23, par. 6104.01)
|
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| Sec. 4.01. Additional powers and duties of the Department. |
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| In addition
to powers and duties otherwise provided by law, the |
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| Department shall have the
following powers and duties:
|
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| (1) To evaluate all programs, services, and facilities for |
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| the aged
and for minority senior citizens within the State and |
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| determine the extent
to which present public or private |
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| programs, services and facilities meet the
needs of the aged.
|
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| (2) To coordinate and evaluate all programs, services, and |
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| facilities
for the Aging and for minority senior citizens |
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| presently furnished by State
agencies and make appropriate |
23 |
| recommendations regarding such services, programs
and |
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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| facilities to the Governor and/or the General Assembly.
|
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| (3) To function as the sole State agency to develop a |
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| comprehensive
plan to meet the needs of the State's senior |
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| citizens and the State's
minority senior citizens.
|
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| (4) To receive and disburse State and federal funds made |
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| available
directly to the Department including those funds made |
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| available under the
Older Americans Act and the Senior |
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| Community Service Employment Program for
providing services |
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| for senior citizens and minority senior citizens or for
|
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| purposes related thereto, and shall develop and administer any |
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| State Plan
for the Aging required by federal law.
|
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| (5) To solicit, accept, hold, and administer in behalf of |
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| the State
any grants or legacies of money, securities, or |
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| property to the State of
Illinois for services to senior |
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| citizens and minority senior citizens or
purposes related |
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| thereto.
|
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| (6) To provide consultation and assistance to communities, |
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| area agencies
on aging, and groups developing local services |
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| for senior citizens and
minority senior citizens.
|
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| (7) To promote community education regarding the problems |
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| of senior
citizens and minority senior citizens through |
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| institutes, publications,
radio, television and the local |
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| press.
|
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| (8) To cooperate with agencies of the federal government in |
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| studies
and conferences designed to examine the needs of senior |
26 |
| citizens and minority
senior citizens and to prepare programs |
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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| and facilities to meet those needs.
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| (9) To establish and maintain information and referral |
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| sources
throughout the State when not provided by other |
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| agencies.
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| (10) To provide the staff support as may reasonably be |
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| required
by the Council and the Coordinating Committee of State |
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| Agencies Serving Older
Persons.
|
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| (11) To make and enforce rules and regulations necessary |
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| and proper
to the performance of its duties.
|
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| (12) To establish and fund programs or projects or |
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| experimental facilities
that are specially designed as |
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| alternatives to institutional care.
|
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| (13) To develop a training program to train the counselors |
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| presently
employed by the Department's aging network to provide |
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| Medicare
beneficiaries with counseling and advocacy in |
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| Medicare, private health
insurance, and related health care |
17 |
| coverage plans. The Department shall
report to the General |
18 |
| Assembly on the implementation of the training
program on or |
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| before December 1, 1986.
|
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| (14) To make a grant to an institution of higher learning |
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| to study the
feasibility of establishing and implementing an |
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| affirmative action
employment plan for the recruitment, |
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| hiring, training and retraining of
persons 60 or more years old |
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| for jobs for which their employment would not
be precluded by |
25 |
| law.
|
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| (15) To present one award annually in each of the |
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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| categories of community
service, education, the performance |
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| and graphic arts, and the labor force
to outstanding Illinois |
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| senior citizens and minority senior citizens in
recognition of |
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| their individual contributions to either community service,
|
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| education, the performance and graphic arts, or the labor |
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| force. The awards
shall be presented to four senior citizens |
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| and minority senior citizens
selected from a list of 44 |
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| nominees compiled annually by
the Department. Nominations |
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| shall be solicited from senior citizens'
service providers, |
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| area agencies on aging, senior citizens'
centers, and senior |
11 |
| citizens' organizations. The Department shall consult
with the |
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| Coordinating Committee of State Agencies Serving Older Persons |
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| to
determine which of the nominees shall be the recipient in |
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| each category of
community service. The Department shall |
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| establish a central location within
the State to be designated |
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| as the Senior Illinoisans Hall of Fame for the
public display |
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| of all the annual awards, or replicas thereof.
|
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| (16) To establish multipurpose senior centers through area |
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| agencies on
aging and to fund those new and existing |
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| multipurpose senior centers
through area agencies on aging, the |
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| establishment and funding to begin in
such areas of the State |
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| as the Department shall designate by rule and as
specifically |
23 |
| appropriated funds become available.
|
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| (17) To develop the content and format of the |
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| acknowledgment regarding
non-recourse reverse mortgage loans |
26 |
| under Section 6.1 of the Illinois
Banking Act; to provide |
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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| independent consumer information on reverse
mortgages and |
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| alternatives; and to refer consumers to independent
counseling |
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| services with expertise in reverse mortgages.
|
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| (18) To develop a pamphlet in English and Spanish which may |
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| be used by
physicians licensed to practice medicine in all of |
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| its branches pursuant
to the Medical Practice Act of 1987, |
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| pharmacists licensed pursuant to the
Pharmacy Practice Act of |
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| 1987 , and Illinois residents 65 years of age or
older for the |
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| purpose of assisting physicians, pharmacists, and patients in
|
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| monitoring prescriptions provided by various physicians and to |
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| aid persons
65 years of age or older in complying with |
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| directions for proper use of
pharmaceutical prescriptions. The |
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| pamphlet may provide space for recording
information including |
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| but not limited to the following:
|
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| (a) name and telephone number of the patient;
|
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| (b) name and telephone number of the prescribing |
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| physician;
|
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| (c) date of prescription;
|
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| (d) name of drug prescribed;
|
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| (e) directions for patient compliance; and
|
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| (f) name and telephone number of dispensing pharmacy.
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| In developing the pamphlet, the Department shall consult |
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| with the
Illinois State Medical Society, the Center for |
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| Minority Health Services,
the Illinois Pharmacists Association |
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| and
senior citizens organizations. The Department shall |
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| distribute the
pamphlets to physicians, pharmacists and |
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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| persons 65 years of age or older
or various senior citizen |
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| organizations throughout the State.
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| (19) To conduct a study by April 1, 1994 of the feasibility |
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| of
implementing the Senior Companion Program throughout the |
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| State for the fiscal
year beginning July 1, 1994.
|
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| (20) With respect to contracts in effect on July 1, 1994, |
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| the Department
shall increase the grant amounts so that the |
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| reimbursement rates paid through
the community care program for |
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| chore housekeeping services and homemakers are
at the same |
10 |
| rate, which shall be the higher of the 2 rates currently paid.
|
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| With respect to all contracts entered into, renewed, or |
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| extended on or after
July 1, 1994, the reimbursement rates paid |
13 |
| through the community care program
for chore housekeeping |
14 |
| services and homemakers shall be the same.
|
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| (21) From funds appropriated to the Department from the |
16 |
| Meals on Wheels
Fund, a special fund in the State treasury that |
17 |
| is hereby created, and in
accordance with State and federal |
18 |
| guidelines and the intrastate funding
formula, to make grants |
19 |
| to area agencies on aging, designated by the
Department, for |
20 |
| the sole purpose of delivering meals to homebound persons 60
|
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| years of age and older.
|
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| (22) To distribute, through its area agencies on aging, |
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| information
alerting seniors on safety issues regarding |
24 |
| emergency weather
conditions, including extreme heat and cold, |
25 |
| flooding, tornadoes, electrical
storms, and other severe storm |
26 |
| weather. The information shall include all
necessary |
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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| instructions for safety and all emergency telephone numbers of
|
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| organizations that will provide additional information and |
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| assistance.
|
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| (23) To develop guidelines for the organization and |
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| implementation of
Volunteer Services Credit Programs to be |
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| administered by Area Agencies on
Aging or community based |
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| senior service organizations. The Department shall
hold public |
8 |
| hearings on the proposed guidelines for public comment, |
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| suggestion,
and determination of public interest. The |
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| guidelines shall be based on the
findings of other states and |
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| of community organizations in Illinois that are
currently |
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| operating volunteer services credit programs or demonstration
|
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| volunteer services credit programs. The Department shall offer |
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| guidelines for
all aspects of the programs including, but not |
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| limited to, the following:
|
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| (a) types of services to be offered by volunteers;
|
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| (b) types of services to be received upon the |
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| redemption of service
credits;
|
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| (c) issues of liability for the volunteers and the |
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| administering
organizations;
|
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| (d) methods of tracking service credits earned and |
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| service credits
redeemed;
|
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| (e) issues of time limits for redemption of service |
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| credits;
|
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| (f) methods of recruitment of volunteers;
|
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| (g) utilization of community volunteers, community |
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LRB095 10560 RAS 30780 b |
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| service groups, and
other resources for delivering |
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| services to be received by service credit
program clients;
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| (h) accountability and assurance that services will be |
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| available to
individuals who have earned service credits; |
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| and
|
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| (i) volunteer screening and qualifications.
|
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| The Department shall submit a written copy of the guidelines to |
8 |
| the General
Assembly by July 1, 1998.
|
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| (Source: P.A. 92-651, eff. 7-11-02.)
|
10 |
| Section 15. The Mental Health and Developmental |
11 |
| Disabilities Administrative Act is amended by changing Section |
12 |
| 56 as follows:
|
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| (20 ILCS 1705/56) (from Ch. 91 1/2, par. 100-56)
|
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| Sec. 56. The Secretary, upon making a determination based
|
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| upon information in the possession of the Department, that
|
16 |
| continuation in practice of a licensed health care professional |
17 |
| would
constitute an immediate danger to the public, shall |
18 |
| submit a written
communication to the Director of Professional |
19 |
| Regulation indicating such
determination and additionally |
20 |
| providing a complete summary of the
information upon which such |
21 |
| determination is based, and recommending that
the Director of |
22 |
| Professional Regulation immediately suspend such person's
|
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| license. All relevant evidence, or copies thereof, in the |
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| Department's
possession may also be submitted in conjunction |
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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| with the written
communication. A copy of such written |
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| communication, which is exempt from
the copying and inspection |
3 |
| provisions of the Freedom of Information Act,
shall at the time |
4 |
| of submittal to the Director of Professional Regulation
be |
5 |
| simultaneously mailed to the last known business address of |
6 |
| such
licensed health care professional by certified or |
7 |
| registered postage,
United States Mail, return receipt |
8 |
| requested. Any evidence, or copies
thereof, which is submitted |
9 |
| in conjunction with the written communication
is also exempt |
10 |
| from the copying and inspection provisions of the Freedom of
|
11 |
| Information Act.
|
12 |
| For the purposes of this Section, "licensed health care |
13 |
| professional"
means any person licensed under the Illinois |
14 |
| Dental Practice Act, the Nursing
and Advanced Practice Nursing |
15 |
| Act, the Medical Practice Act of 1987, the
Pharmacy Practice |
16 |
| Act of 1987 , the Podiatric Medical Practice Act of
1987, and |
17 |
| the Illinois Optometric Practice Act of 1987.
|
18 |
| (Source: P.A. 89-507, eff. 7-1-97; 90-742, eff. 8-13-98.)
|
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| Section 20. The Department of Professional Regulation Law |
20 |
| of the
Civil Administrative Code of Illinois is amended by |
21 |
| changing Section 2105-400 as follows: |
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| (20 ILCS 2105/2105-400)
|
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| Sec. 2105-400. Emergency Powers. |
24 |
| (a) Upon proclamation of a disaster by the Governor, as |
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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| provided for in the Illinois Emergency Management Agency Act, |
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| the Secretary of Financial and Professional Regulation shall |
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| have the following powers, which shall be exercised only in |
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| coordination with the Illinois Emergency Management Agency and |
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| the Department of Public Health:
|
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| (1) The power to suspend the requirements for permanent |
7 |
| or temporary licensure of persons who are licensed in |
8 |
| another state and are working under the direction of the |
9 |
| Illinois Emergency Management Agency and the Department of |
10 |
| Public Health pursuant to a declared disaster. |
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| (2) The power to modify the scope of practice |
12 |
| restrictions under any licensing act administered by the |
13 |
| Department for any person working under the direction of |
14 |
| the Illinois Emergency Management Agency and the Illinois |
15 |
| Department of Public Health pursuant to the declared |
16 |
| disaster. |
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| (3) The power to expand the exemption in Section 4(a) |
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| of the Pharmacy Practice Act of 1987 to those licensed |
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| professionals whose scope of practice has been modified, |
20 |
| under paragraph (2) of subsection (a) of this Section, to |
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| include any element of the practice of pharmacy as defined |
22 |
| in the Pharmacy Practice Act of 1987 for any person working |
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| under the direction of the Illinois Emergency Management |
24 |
| Agency and the Illinois Department of Public Health |
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| pursuant to the declared disaster. |
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| (b) Persons exempt from licensure under paragraph (1) of |
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LRB095 10560 RAS 30780 b |
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| subsection (a) of this Section and persons operating under |
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| modified scope of practice provisions under paragraph (2) of |
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| subsection (a) of this Section shall be exempt from licensure |
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| or be subject to modified scope of practice only until the |
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| declared disaster has ended as provided by law. For purposes of |
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| this Section, persons working under the direction of an |
7 |
| emergency services and disaster agency accredited by the |
8 |
| Illinois Emergency Management Agency and a local public health |
9 |
| department, pursuant to a declared disaster, shall be deemed to |
10 |
| be working under the direction of the Illinois Emergency |
11 |
| Management Agency and the Department of Public Health.
|
12 |
| (c) The Director shall exercise these powers by way of |
13 |
| proclamation.
|
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| (Source: P.A. 93-829, eff. 7-28-04; 94-733, eff. 4-27-06.) |
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| Section 25. The Department of Public Health Powers and |
16 |
| Duties Law of the
Civil Administrative Code of Illinois is |
17 |
| amended by changing Section 2310-140 as follows:
|
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| (20 ILCS 2310/2310-140) (was 20 ILCS 2310/55.37a)
|
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| Sec. 2310-140. Recommending suspension of licensed health |
20 |
| care
professional. The Director, upon making a
determination |
21 |
| based upon information in the possession of the Department
that |
22 |
| continuation in practice of a licensed health care professional |
23 |
| would
constitute an immediate danger to the public, shall |
24 |
| submit a written
communication to the Director of
Professional |
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LRB095 10560 RAS 30780 b |
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| Regulation indicating that determination and
additionally
(i) |
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| providing a complete summary of the information upon which the
|
3 |
| determination is based and (ii) recommending that the Director |
4 |
| of
Professional
Regulation immediately suspend the person's |
5 |
| license. All relevant
evidence, or copies thereof, in the |
6 |
| Department's possession may also be
submitted in conjunction |
7 |
| with the written communication. A copy of the
written |
8 |
| communication, which is exempt from the copying and inspection
|
9 |
| provisions of the Freedom of Information Act, shall at the time |
10 |
| of
submittal to the Director of
Professional Regulation be |
11 |
| simultaneously mailed to the last known
business address of the |
12 |
| licensed health care professional by
certified or
registered |
13 |
| postage, United States Mail, return receipt requested. Any
|
14 |
| evidence, or copies thereof, that is submitted in conjunction
|
15 |
| with the
written communication is also exempt from the copying |
16 |
| and
inspection
provisions of the Freedom of Information Act.
|
17 |
| For the purposes of this Section, "licensed health care |
18 |
| professional"
means any person licensed under the Illinois |
19 |
| Dental Practice Act, the Nursing
and Advanced Practice Nursing |
20 |
| Act, the Medical Practice Act of 1987, the
Pharmacy Practice |
21 |
| Act of 1987 , the Podiatric Medical Practice Act of
1987, or the |
22 |
| Illinois Optometric Practice Act of 1987.
|
23 |
| (Source: P.A. 90-742, eff. 8-13-98; 91-239, eff. 1-1-00.)
|
24 |
| Section 30. The Illinois Municipal Code is amended by |
25 |
| changing Section 11-22-1 as follows:
|
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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| (65 ILCS 5/11-22-1) (from Ch. 24, par. 11-22-1)
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2 |
| Sec. 11-22-1. The corporate authorities of each |
3 |
| municipality may erect,
establish, and maintain hospitals, |
4 |
| nursing homes and
medical dispensaries, all on a nonprofit |
5 |
| basis, and
may locate and regulate hospitals, medical |
6 |
| dispensaries, sanitariums, and
undertaking establishments; |
7 |
| provided that the corporate authorities of any
municipality |
8 |
| shall not regulate any pharmacy or drugstore registered under
|
9 |
| the Pharmacy Practice Act of 1987 . Any hospital maintained |
10 |
| under this
Section is authorized to provide any service and |
11 |
| enter into any contract or
other arrangement not prohibited by |
12 |
| a hospital licensed under the Hospital
Licensing Act, |
13 |
| incorporated under the General Not-For-Profit Corporation
Act, |
14 |
| and exempt from taxation under paragraph (3) of subsection (c) |
15 |
| of
Section 501 of the Internal Revenue Code.
|
16 |
| For purposes of erecting, establishing and maintaining a |
17 |
| nursing home
on a nonprofit basis pursuant to this Section, the |
18 |
| corporate authorities of
each municipality shall have the power |
19 |
| to borrow money; execute a
promissory note or notes, execute a |
20 |
| mortgage or trust deed to secure
payment of such notes or |
21 |
| deeds, or execute such other security instrument
or document as |
22 |
| needed, and pledge real and personal nursing home property
as |
23 |
| security for any such promissory note, mortgage or trust deed; |
24 |
| and issue
revenue or general obligation bonds.
|
25 |
| (Source: P.A. 86-739.)
|
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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|
1 |
| Section 35. The School Employee Benefit Act is amended by |
2 |
| changing Section 25 as follows: |
3 |
| (105 ILCS 55/25)
|
4 |
| Sec. 25. Pharmacy providers. |
5 |
| (a) The Department or its contractor may enter into a |
6 |
| contract with a pharmacy registered or licensed under Section |
7 |
| 16a of the Pharmacy Practice Act of 1987 . |
8 |
| (b) Before entering into an agreement with other pharmacy |
9 |
| providers, pursuant to Sections 15 and 20 of this Act, the |
10 |
| Department or its contractor must by rule or contract establish |
11 |
| terms or conditions that must be met by pharmacy providers |
12 |
| desiring to contract with the Department or its contractor. If |
13 |
| a pharmacy licensed under Section 15 of the Pharmacy Practice |
14 |
| Act of 1987 rejects the terms and conditions established, the |
15 |
| Department or its contractor may offer other terms and |
16 |
| conditions necessary to comply with the network adequacy |
17 |
| requirements. |
18 |
| (c) Notwithstanding the provisions of subsection (a) of |
19 |
| this Section, the Department or its contractor may not refuse |
20 |
| to contract with a pharmacy licensed under Section 15 of the |
21 |
| Pharmacy Practice Act of 1987 that meets the terms and |
22 |
| conditions established by the Department or its contractor |
23 |
| under subsection (a) or (b) of this Section.
|
24 |
| (Source: P.A. 93-1036, eff. 9-14-04.) |
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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|
1 |
| Section 40. The Illinois Insurance Code is amended by |
2 |
| changing Section 512-7 as follows:
|
3 |
| (215 ILCS 5/512-7) (from Ch. 73, par. 1065.59-7)
|
4 |
| Sec. 512-7. Contractual provisions.
|
5 |
| (a) Any agreement or contract entered into in this State |
6 |
| between the
administrator of a program and a pharmacy shall |
7 |
| include a statement of the
method and amount of reimbursement |
8 |
| to the pharmacy for services rendered to
persons enrolled in |
9 |
| the program, the frequency of payment by the program
|
10 |
| administrator to the pharmacy for those services, and a method |
11 |
| for the
adjudication of complaints and the settlement of |
12 |
| disputes between the
contracting parties.
|
13 |
| (b)(1) A program shall provide an annual period of at least |
14 |
| 30 days
during which any pharmacy licensed under the |
15 |
| Pharmacy Practice Act of 1987
may elect to participate in |
16 |
| the program under the program terms for at
least one year.
|
17 |
| (2) If compliance with the requirements of this |
18 |
| subsection (b) would
impair any provision of a contract |
19 |
| between a program and any other person,
and if the contract |
20 |
| provision was in existence before January 1, 1990,
then |
21 |
| immediately after the expiration of those contract |
22 |
| provisions the
program shall comply with the requirements |
23 |
| of this subsection (b).
|
24 |
| (3) This subsection (b) does not apply if:
|
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SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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|
1 |
| (A) the program administrator is a licensed health |
2 |
| maintenance
organization that owns or controls a |
3 |
| pharmacy and that enters into an
agreement or contract |
4 |
| with that pharmacy in accordance with subsection (a); |
5 |
| or
|
6 |
| (B) the program administrator is a licensed health |
7 |
| maintenance
organization that is owned or controlled |
8 |
| by another entity that also owns
or controls a |
9 |
| pharmacy, and the administrator enters into an |
10 |
| agreement or
contract with that pharmacy in accordance |
11 |
| with subsection (a).
|
12 |
| (4) This subsection (b) shall be inoperative after |
13 |
| October 31,
1992.
|
14 |
| (c) The program administrator shall cause to be issued an |
15 |
| identification
card to each person enrolled in the program. The |
16 |
| identification card
shall include:
|
17 |
| (1) the name of the individual enrolled in the program; |
18 |
| and
|
19 |
| (2) an expiration date if required under the |
20 |
| contractual arrangement or
agreement between a provider of |
21 |
| pharmaceutical services and prescription
drug products and |
22 |
| the third party prescription program administrator.
|
23 |
| (Source: P.A. 86-473; 87-254.)
|
24 |
| Section 45. The Health Maintenance Organization Act is |
25 |
| amended by changing Section 2-3.1 as follows:
|
|
|
|
SB0509 Enrolled |
- 18 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (215 ILCS 125/2-3.1) (from Ch. 111 1/2, par. 1405.1)
|
2 |
| Sec. 2-3.1. (a) No health maintenance organization shall |
3 |
| cause to be
dispensed any drug other than that prescribed by a |
4 |
| physician. Nothing
herein shall prohibit drug product |
5 |
| selection under Section 3.14 of the
"Illinois Food, Drug
and |
6 |
| Cosmetic Act", approved June 29, 1967, as amended, and in |
7 |
| accordance
with the requirements of Section 25 of the "Pharmacy |
8 |
| Practice Act of 1987 ",
approved September 24, 1987, as amended.
|
9 |
| (b) No health maintenance organization shall include in any |
10 |
| contract
with any physician providing for health care services |
11 |
| any provision
requiring such physician to prescribe any |
12 |
| particular drug product to any
enrollee unless the enrollee is |
13 |
| a hospital in-patient where such drug product
may be permitted |
14 |
| pursuant
to written guidelines or procedures previously |
15 |
| established by a
pharmaceutical or therapeutics committee of a |
16 |
| hospital, approved by the
medical staff of such hospital and |
17 |
| specifically approved, in writing, by
the prescribing |
18 |
| physician for his or her patients in such hospital, and
unless |
19 |
| it is compounded, dispensed or sold by a
pharmacy located in a |
20 |
| hospital, as defined in Section 3 of the Hospital
Licensing Act |
21 |
| or a hospital organized under "An Act in relation to the
|
22 |
| founding and operation of the University of Illinois Hospital |
23 |
| and the
conduct of University of Illinois health care |
24 |
| programs", approved July 3,
1931, as amended.
|
25 |
| (Source: P.A. 85-1246.)
|
|
|
|
SB0509 Enrolled |
- 19 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| Section 50. The Illinois Dental Practice Act is amended by |
2 |
| changing Section 51 as follows:
|
3 |
| (225 ILCS 25/51) (from Ch. 111, par. 2351)
|
4 |
| (Section scheduled to be repealed on January 1, 2016)
|
5 |
| Sec. 51. Dispensing Drugs or Medicine. Any dentist who |
6 |
| dispenses any drug
or medicine shall dispense such drug or |
7 |
| medicine in good faith and shall
affix to the box, bottle, |
8 |
| vessel or package containing the same a label
indicating:
|
9 |
| (a) the date on which such drug or medicine is dispensed;
|
10 |
| (b) the name of the patient;
|
11 |
| (c) the last name of the person dispensing such drug or |
12 |
| medicine;
|
13 |
| (d) the directions for use thereof; and
|
14 |
| (e) the proprietary name or names or the established
name |
15 |
| or names of the drug or medicine, the dosage and quantity, |
16 |
| except as
otherwise authorized by regulation of the Department.
|
17 |
| This Section shall not apply to drugs and medicines in a |
18 |
| package
which bears a label of the manufacturer containing |
19 |
| information describing
its contents which is in compliance with |
20 |
| requirements of the Federal Food,
Drug, and Cosmetic Act and |
21 |
| the Illinois Food, Drug, and Cosmetic Act and
which is |
22 |
| dispensed without consideration by a dentist.
"Drug" and |
23 |
| "medicine" have the meanings ascribed to them in the Pharmacy
|
24 |
| Practice Act of 1987 , as now or hereafter amended;
"good faith" |
|
|
|
SB0509 Enrolled |
- 20 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| has the meaning ascribed to it in subsection (v) of Section
102 |
2 |
| of the "Illinois Controlled Substances Act", as amended.
|
3 |
| (Source: P.A. 85-1209 .)
|
4 |
| Section 55. The Health Care Worker Self-Referral Act is |
5 |
| amended by changing Section 15 as follows:
|
6 |
| (225 ILCS 47/15)
|
7 |
| Sec. 15. Definitions. In this Act:
|
8 |
| (a) "Board" means the Health Facilities Planning Board.
|
9 |
| (b) "Entity" means any individual, partnership, firm, |
10 |
| corporation, or
other business that provides health services |
11 |
| but does not include an
individual who is a health care worker |
12 |
| who provides professional services
to an individual.
|
13 |
| (c) "Group practice" means a group of 2 or more health care |
14 |
| workers
legally organized as a partnership, professional |
15 |
| corporation,
not-for-profit corporation, faculty
practice plan |
16 |
| or a similar association in which:
|
17 |
| (1) each health care worker who is a member or employee |
18 |
| or an
independent contractor of the group provides
|
19 |
| substantially the full range of services that the health |
20 |
| care worker
routinely provides, including consultation, |
21 |
| diagnosis, or treatment,
through the use of office space, |
22 |
| facilities, equipment, or personnel of the
group;
|
23 |
| (2) the services of the health care workers
are |
24 |
| provided through the group, and payments received for |
|
|
|
SB0509 Enrolled |
- 21 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| health
services are treated as receipts of the group; and
|
2 |
| (3) the overhead expenses and the income from the |
3 |
| practice are
distributed by methods previously determined |
4 |
| by the group.
|
5 |
| (d) "Health care worker" means any individual licensed |
6 |
| under the laws of
this State to provide health services, |
7 |
| including but not limited to:
dentists licensed under the |
8 |
| Illinois Dental Practice Act; dental hygienists
licensed under |
9 |
| the Illinois Dental Practice Act; nurses and advanced practice
|
10 |
| nurses licensed under the Nursing and Advanced Practice Nursing |
11 |
| Act;
occupational therapists licensed under
the
Illinois |
12 |
| Occupational Therapy Practice Act; optometrists licensed under |
13 |
| the
Illinois Optometric Practice Act of 1987; pharmacists |
14 |
| licensed under the
Pharmacy Practice Act of 1987 ; physical |
15 |
| therapists licensed under the
Illinois Physical Therapy Act; |
16 |
| physicians licensed under the Medical
Practice Act of 1987; |
17 |
| physician assistants licensed under the Physician
Assistant |
18 |
| Practice Act of 1987; podiatrists licensed under the Podiatric
|
19 |
| Medical Practice Act of 1987; clinical psychologists licensed |
20 |
| under the
Clinical Psychologist Licensing Act; clinical social |
21 |
| workers licensed under
the Clinical Social Work and Social Work |
22 |
| Practice Act; speech-language
pathologists and audiologists |
23 |
| licensed under the Illinois Speech-Language
Pathology and |
24 |
| Audiology Practice Act; or hearing instrument
dispensers |
25 |
| licensed
under the Hearing Instrument Consumer Protection Act, |
26 |
| or any of
their successor Acts.
|
|
|
|
SB0509 Enrolled |
- 22 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (e) "Health services" means health care procedures and |
2 |
| services
provided by or through a health care worker.
|
3 |
| (f) "Immediate family member" means a health care worker's |
4 |
| spouse,
child, child's spouse, or a parent.
|
5 |
| (g) "Investment interest" means an equity or debt security |
6 |
| issued by an
entity, including, without limitation, shares of |
7 |
| stock in a corporation,
units or other interests in a |
8 |
| partnership, bonds, debentures, notes, or
other equity |
9 |
| interests or debt instruments except that investment interest
|
10 |
| for purposes of Section 20 does not include interest in a |
11 |
| hospital licensed
under the laws of the State of Illinois.
|
12 |
| (h) "Investor" means an individual or entity directly or |
13 |
| indirectly
owning a legal or beneficial ownership or investment |
14 |
| interest, (such as
through an immediate family member, trust, |
15 |
| or another entity related to the investor).
|
16 |
| (i) "Office practice" includes the facility or facilities |
17 |
| at which a health
care worker, on an ongoing basis, provides or |
18 |
| supervises the provision of
professional health services to |
19 |
| individuals.
|
20 |
| (j) "Referral" means any referral of a patient for health |
21 |
| services,
including, without limitation:
|
22 |
| (1) The forwarding of a patient by one health care |
23 |
| worker to another
health care worker or to an entity |
24 |
| outside the health care worker's office
practice or group |
25 |
| practice that provides health services.
|
26 |
| (2) The request or establishment by a health care
|
|
|
|
SB0509 Enrolled |
- 23 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| worker of a plan of care outside the health care worker's |
2 |
| office practice
or group practice
that includes the |
3 |
| provision of any health services.
|
4 |
| (Source: P.A. 89-72, eff. 12-31-95; 90-742, eff. 8-13-98.)
|
5 |
| Section 60. The Medical Practice Act of 1987 is amended by |
6 |
| changing Section 33 as follows:
|
7 |
| (225 ILCS 60/33) (from Ch. 111, par. 4400-33)
|
8 |
| (Section scheduled to be repealed on December 31, 2008)
|
9 |
| Sec. 33. Any person licensed under this Act to practice |
10 |
| medicine in all
of its branches shall be authorized to purchase |
11 |
| legend drugs requiring an
order of a person authorized to |
12 |
| prescribe drugs, and to dispense such legend
drugs in the |
13 |
| regular course of practicing medicine. The dispensing of such
|
14 |
| legend drugs shall be the personal act of the person licensed |
15 |
| under this
Act and may not be delegated to any other person not |
16 |
| licensed under this
Act or the Pharmacy Practice Act of 1987
|
17 |
| unless such delegated
dispensing functions are under the direct |
18 |
| supervision of the physician
authorized to dispense legend |
19 |
| drugs. Except when dispensing manufacturers'
samples or other |
20 |
| legend drugs in a maximum 72 hour supply, persons licensed
|
21 |
| under this Act shall maintain a book or file of prescriptions |
22 |
| as required
in the Pharmacy Practice Act of 1987 . Any person |
23 |
| licensed under this
Act who dispenses any drug or medicine |
24 |
| shall dispense such drug or
medicine in good faith and shall |
|
|
|
SB0509 Enrolled |
- 24 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| affix to the box, bottle,
vessel or package containing the same |
2 |
| a label indicating (a)
the date on which such drug or medicine |
3 |
| is dispensed; (b)
the name of the patient; (c) the last name of |
4 |
| the person
dispensing such drug or medicine; (d) the directions |
5 |
| for use
thereof; and (e) the proprietary name or names or, if |
6 |
| there
are none, the established name or names of the drug or
|
7 |
| medicine, the dosage and quantity, except as otherwise
|
8 |
| authorized by regulation of the Department of Professional |
9 |
| Regulation.
The foregoing labeling requirements shall
not |
10 |
| apply to drugs or medicines in a package which bears a label of |
11 |
| the
manufacturer containing information describing its |
12 |
| contents
which is in compliance with requirements of the |
13 |
| Federal
Food, Drug, and Cosmetic Act and the Illinois Food, |
14 |
| Drug, and Cosmetic Act.
"Drug" and "medicine" have the meaning |
15 |
| ascribed to them in the Pharmacy Practice
Act of 1987 , as now |
16 |
| or hereafter amended; "good faith" has the meaning
ascribed to |
17 |
| it in subsection (v) of Section 102 of the "Illinois Controlled
|
18 |
| Substances Act", approved August 16, 1971, as amended.
|
19 |
| Prior to dispensing a prescription to a patient, the |
20 |
| physician shall
offer a written prescription to the patient |
21 |
| which the patient may elect to
have filled by the physician or |
22 |
| any licensed pharmacy.
|
23 |
| A violation of any provision of this Section shall |
24 |
| constitute a violation
of this Act and shall be grounds for |
25 |
| disciplinary action provided for in
this Act.
|
26 |
| (Source: P.A. 85-1209 .)
|
|
|
|
SB0509 Enrolled |
- 25 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| Section 65. The Illinois Optometric Practice Act of 1987 is |
2 |
| amended by changing Section 3 as follows:
|
3 |
| (225 ILCS 80/3) (from Ch. 111, par. 3903)
|
4 |
| (Section scheduled to be repealed on January 1, 2017)
|
5 |
| Sec. 3. Practice of optometry defined; referrals; |
6 |
| manufacture of lenses
and prisms.
|
7 |
| (a) The practice of optometry is defined as the employment |
8 |
| of any
and all means for the examination, diagnosis, and |
9 |
| treatment of the human
visual system, the human eye, and its |
10 |
| appendages without the use of
surgery, including but not |
11 |
| limited to: the appropriate
use of ocular
pharmaceutical |
12 |
| agents; refraction and other determinants of visual function;
|
13 |
| prescribing corrective lenses or prisms; prescribing, |
14 |
| dispensing, or management
of contact lenses; vision therapy; |
15 |
| visual rehabilitation; or any other
procedures taught in |
16 |
| schools and colleges of optometry approved by the
Department, |
17 |
| and not specifically restricted in this Act, subject to
|
18 |
| demonstrated competency and training as required by the Board, |
19 |
| and pursuant
to rule or regulation approved by the Board and |
20 |
| adopted by
the Department.
|
21 |
| A person shall be deemed to be practicing optometry within |
22 |
| the meaning of
this Act who:
|
23 |
| (1) In any way presents himself or herself to be |
24 |
| qualified to
practice optometry.
|
|
|
|
SB0509 Enrolled |
- 26 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (2) Performs refractions or employs any other |
2 |
| determinants of
visual function.
|
3 |
| (3) Employs any means for the adaptation of lenses or |
4 |
| prisms.
|
5 |
| (4) Prescribes corrective lenses, prisms, vision |
6 |
| therapy,
visual rehabilitation, or ocular pharmaceutical |
7 |
| agents.
|
8 |
| (5) Prescribes or manages contact lenses for |
9 |
| refractive,
cosmetic, or therapeutic purposes.
|
10 |
| (6) Evaluates the need for, or prescribes, low vision |
11 |
| aids to
partially sighted persons.
|
12 |
| (7) Diagnoses or treats any ocular abnormality, |
13 |
| disease, or
visual or muscular anomaly of the human eye or |
14 |
| visual system.
|
15 |
| (8) Practices, or offers or attempts to practice, |
16 |
| optometry as defined in
this Act either on his or her own |
17 |
| behalf or as an employee
of a person, firm,
or corporation, |
18 |
| whether under the supervision of his or her employer or |
19 |
| not.
|
20 |
| Nothing in this Section shall be interpreted (i) to prevent |
21 |
| a person from
functioning as an assistant under the direct |
22 |
| supervision of a person licensed
by the State of Illinois to |
23 |
| practice optometry or medicine in all of its
branches or (ii) |
24 |
| to prohibit visual screening programs that
are conducted |
25 |
| without a fee (other than voluntary donations), by
charitable |
26 |
| organizations
acting in the public welfare under
the |
|
|
|
SB0509 Enrolled |
- 27 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| supervision of a committee composed of persons licensed by the |
2 |
| State of
Illinois to practice optometry or persons licensed by |
3 |
| the State of Illinois
to practice medicine in all of its |
4 |
| branches.
|
5 |
| (b) When, in the course of providing optometric services to |
6 |
| any person,
an optometrist licensed under this Act finds an |
7 |
| indication of a disease or
condition of the eye which in his or |
8 |
| her professional judgment requires
professional service |
9 |
| outside the scope of practice as defined in this Act,
he or she |
10 |
| shall refer such person to a physician licensed to practice |
11 |
| medicine
in all of its branches, or other appropriate health |
12 |
| care practitioner.
Nothing in this Act shall preclude an |
13 |
| optometrist from rendering appropriate nonsurgical
emergency |
14 |
| care.
|
15 |
| (c) Nothing contained in this Section shall prohibit a |
16 |
| person from
manufacturing ophthalmic lenses and prisms or the |
17 |
| fabrication
of contact lenses according to the specifications |
18 |
| prescribed by an optometrist
or a physician licensed to |
19 |
| practice medicine in all of its branches, but shall
|
20 |
| specifically prohibit the sale or delivery of ophthalmic
|
21 |
| lenses, prisms, and contact lenses without a prescription |
22 |
| signed by an
optometrist or a physician licensed to practice |
23 |
| medicine in all of its
branches.
|
24 |
| (d) Nothing in this Act shall restrict the filling of a |
25 |
| prescription by a
pharmacist licensed under the Pharmacy |
26 |
| Practice Act of 1987 .
|
|
|
|
SB0509 Enrolled |
- 28 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (Source: P.A. 94-787, eff. 5-19-06.)
|
2 |
| Section 70. The Pharmacy Practice Act of 1987 is amended by |
3 |
| changing Sections 2, 3, 5, 6, 7, 7.5, 8, 9, 10, 11, 12, 13, 15, |
4 |
| 16, 16a, 17, 17.1, 18, 19, 20, 22, 22a, 25, 26, 27, 30, 35.1, |
5 |
| 35.2, 35.5, 35.7, 35.10, 35.12, 35.16, and 35.19 and by adding |
6 |
| Sections 2.5, 9.5, 14.1, 16b, 22b, 25.5, 25.10, 25.15, and |
7 |
| 25.20 as follows:
|
8 |
| (225 ILCS 85/2) (from Ch. 111, par. 4122)
|
9 |
| (Section scheduled to be repealed on January 1, 2008)
|
10 |
| Sec. 2. This Act shall be known as the " Pharmacy Practice |
11 |
| Act of 1987" . |
12 |
| (Source: P.A. 85-796.)
|
13 |
| (225 ILCS 85/2.5 new)
|
14 |
| Sec. 2.5. References to Department or Director of |
15 |
| Professional Regulation. References in this Act (i) to the |
16 |
| Department of Professional Regulation are deemed, in |
17 |
| appropriate contexts, to be references to the Department of |
18 |
| Financial and Professional Regulation and (ii) to the Director |
19 |
| of Professional Regulation are deemed, in appropriate |
20 |
| contexts, to be references to the Secretary of Financial and |
21 |
| Professional Regulation.
|
22 |
| (225 ILCS 85/3) (from Ch. 111, par. 4123)
|
|
|
|
SB0509 Enrolled |
- 29 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (Section scheduled to be repealed on January 1, 2008)
|
2 |
| Sec. 3. Definitions. For the purpose of this Act, except |
3 |
| where otherwise
limited therein:
|
4 |
| (a) "Pharmacy" or "drugstore" means and includes every |
5 |
| store, shop,
pharmacy department, or other place where |
6 |
| pharmacist
pharmaceutical care is
provided
by a pharmacist (1) |
7 |
| where drugs, medicines, or poisons are
dispensed, sold or
|
8 |
| offered for sale at retail, or displayed for sale at retail; or
|
9 |
| (2)
where
prescriptions of physicians, dentists, advanced |
10 |
| practice nurses, physician assistants, veterinarians, |
11 |
| podiatrists, or
therapeutically certified optometrists, within |
12 |
| the limits of their
licenses, are
compounded, filled, or |
13 |
| dispensed; or (3) which has upon it or
displayed within
it, or |
14 |
| affixed to or used in connection with it, a sign bearing the |
15 |
| word or
words "Pharmacist", "Druggist", "Pharmacy", |
16 |
| "Pharmaceutical
Care", "Apothecary", "Drugstore",
"Medicine |
17 |
| Store", "Prescriptions", "Drugs", "Dispensary", "Medicines", |
18 |
| or any word
or words of similar or like import, either in the |
19 |
| English language
or any other language; or (4) where the |
20 |
| characteristic prescription
sign (Rx) or similar design is |
21 |
| exhibited; or (5) any store, or
shop,
or other place with |
22 |
| respect to which any of the above words, objects,
signs or |
23 |
| designs are used in any advertisement.
|
24 |
| (b) "Drugs" means and includes (l) articles recognized
in |
25 |
| the official United States Pharmacopoeia/National Formulary |
26 |
| (USP/NF),
or any supplement thereto and being intended for and |
|
|
|
SB0509 Enrolled |
- 30 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| having for their
main use the diagnosis, cure, mitigation, |
2 |
| treatment or prevention of
disease in man or other animals, as |
3 |
| approved by the United States Food and
Drug Administration, but |
4 |
| does not include devices or their components, parts,
or |
5 |
| accessories; and (2) all other articles intended
for and having |
6 |
| for their main use the diagnosis, cure, mitigation,
treatment |
7 |
| or prevention of disease in man or other animals, as approved
|
8 |
| by the United States Food and Drug Administration, but does not |
9 |
| include
devices or their components, parts, or accessories; and |
10 |
| (3) articles
(other than food) having for their main use and |
11 |
| intended
to affect the structure or any function of the body of |
12 |
| man or other
animals; and (4) articles having for their main |
13 |
| use and intended
for use as a component or any articles |
14 |
| specified in clause (l), (2)
or (3); but does not include |
15 |
| devices or their components, parts or
accessories.
|
16 |
| (c) "Medicines" means and includes all drugs intended for
|
17 |
| human or veterinary use approved by the United States Food and |
18 |
| Drug
Administration.
|
19 |
| (d) "Practice of pharmacy" means (1) the interpretation and |
20 |
| the provision of assistance in the monitoring, evaluation, and |
21 |
| implementation of prescription drug orders; (2) the dispensing |
22 |
| of prescription drug orders; (3) participation in drug and |
23 |
| device selection; (4) drug administration limited to the |
24 |
| administration of oral, topical, injectable, and inhalation as |
25 |
| follows: in the context of patient education on the proper use |
26 |
| or delivery of medications; vaccination of patients 14 years of |
|
|
|
SB0509 Enrolled |
- 31 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| age and older pursuant to a valid prescription or standing |
2 |
| order, by a physician licensed to practice medicine in all its |
3 |
| branches, upon completion of appropriate training, including |
4 |
| how to address contraindications and adverse reactions set |
5 |
| forth by rule, with notification to the patient's physician and |
6 |
| appropriate record retention, or pursuant to hospital pharmacy |
7 |
| and therapeutics committee policies and procedures; (5) drug |
8 |
| regimen review; (6) drug or drug-related research; (7) the |
9 |
| provision of patient counseling; (8) the practice of |
10 |
| telepharmacy; (9) the provision of those acts or services |
11 |
| necessary to provide pharmacist care; (10) medication therapy |
12 |
| management; and (11) the responsibility for compounding and |
13 |
| labeling of drugs and devices (except labeling by a |
14 |
| manufacturer, repackager, or distributor of non-prescription |
15 |
| drugs and commercially packaged legend drugs and devices), |
16 |
| proper and safe storage of drugs and devices, and maintenance |
17 |
| of required records. A pharmacist who performs any of the acts |
18 |
| defined as the practice of pharmacy in this State must be |
19 |
| actively licensed as a pharmacist under this Act.
means the |
20 |
| provision of pharmaceutical care to
patients as determined by |
21 |
| the pharmacist's professional judgment in the
following areas,
|
22 |
| which may include but are not limited to (1) patient
|
23 |
| counseling, (2)
interpretation and assisting in the monitoring |
24 |
| of appropriate drug use and
prospective drug utilization |
25 |
| review, (3) providing information on the
therapeutic values, |
26 |
| reactions, drug interactions, side effects, uses, selection
of |
|
|
|
SB0509 Enrolled |
- 32 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| medications and medical devices, and outcome of drug therapy, |
2 |
| (4)
participation in drug selection, drug monitoring, drug |
3 |
| utilization review,
evaluation, administration, |
4 |
| interpretation, application of
pharmacokinetic and
laboratory |
5 |
| data to design safe and effective drug
regimens, (5) drug |
6 |
| research
(clinical and scientific), and (6) compounding and |
7 |
| dispensing of drugs and medical
devices.
|
8 |
| (e) "Prescription" means and includes any written, oral, |
9 |
| facsimile, or
electronically transmitted order for drugs
or |
10 |
| medical devices, issued by a physician licensed to practice |
11 |
| medicine in
all its branches, dentist, veterinarian, or |
12 |
| podiatrist, or therapeutically
certified
optometrist, within |
13 |
| the
limits of their licenses, by a physician assistant in |
14 |
| accordance with
subsection (f) of Section 4, or by an advanced |
15 |
| practice nurse in
accordance with subsection (g) of Section 4, |
16 |
| containing the
following: (l) name
of the patient; (2) date |
17 |
| when prescription was issued; (3) name
and strength of drug or |
18 |
| description of the medical device prescribed;
and (4) quantity, |
19 |
| (5) directions for use, (6) prescriber's name,
address
and |
20 |
| signature, and (7) DEA number where required, for controlled
|
21 |
| substances.
DEA numbers shall not be required on inpatient drug |
22 |
| orders.
|
23 |
| (f) "Person" means and includes a natural person, |
24 |
| copartnership,
association, corporation, government entity, or |
25 |
| any other legal
entity.
|
26 |
| (g) "Department" means the Department of Financial and
|
|
|
|
SB0509 Enrolled |
- 33 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| Professional Regulation.
|
2 |
| (h) "Board of Pharmacy" or "Board" means the State Board
of |
3 |
| Pharmacy of the Department of Financial and Professional |
4 |
| Regulation.
|
5 |
| (i) "Secretary"
"Director" means the Secretary
Director of |
6 |
| Financial and Professional Regulation.
|
7 |
| (j) "Drug product selection" means the interchange for a
|
8 |
| prescribed pharmaceutical product in accordance with Section |
9 |
| 25 of
this Act and Section 3.14 of the Illinois Food, Drug and |
10 |
| Cosmetic Act.
|
11 |
| (k) "Inpatient drug order" means an order issued by an |
12 |
| authorized
prescriber for a resident or patient of a facility |
13 |
| licensed under the
Nursing Home Care Act or the Hospital |
14 |
| Licensing Act, or "An Act in relation to
the founding and |
15 |
| operation of the University of Illinois Hospital and the
|
16 |
| conduct of University of Illinois health care programs", |
17 |
| approved July 3, 1931,
as amended, or a facility which is |
18 |
| operated by the Department of Human
Services (as successor to |
19 |
| the Department of Mental Health
and Developmental |
20 |
| Disabilities) or the Department of Corrections.
|
21 |
| (k-5) "Pharmacist" means an individual health care |
22 |
| professional and
provider currently licensed by this State to |
23 |
| engage in the practice of
pharmacy.
|
24 |
| (l) "Pharmacist in charge" means the licensed pharmacist |
25 |
| whose name appears
on a pharmacy license and who is responsible |
26 |
| for all aspects of the
operation related to the practice of |
|
|
|
SB0509 Enrolled |
- 34 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| pharmacy.
|
2 |
| (m) "Dispense" or "dispensing" means the interpretation, |
3 |
| evaluation, and implementation of a prescription drug order, |
4 |
| including the preparation and delivery of a drug or device to a |
5 |
| patient or patient's agent in a suitable container |
6 |
| appropriately labeled for subsequent administration to or use |
7 |
| by a patient in accordance with applicable State and federal |
8 |
| laws and regulations.
delivery of drugs and medical devices, in
|
9 |
| accordance with applicable State and federal laws and |
10 |
| regulations, to the
patient or the patient's representative |
11 |
| authorized to receive these products,
including the |
12 |
| preparation, compounding, packaging, and labeling necessary |
13 |
| for delivery, computer entry, and verification of medication |
14 |
| orders and prescriptions, and
any recommending or advising |
15 |
| concerning the contents and therapeutic values and
uses |
16 |
| thereof. "Dispense" or "dispensing" does not mean the physical |
17 |
| delivery to a patient or a
patient's representative in a home |
18 |
| or institution by a designee of a pharmacist
or by common |
19 |
| carrier. "Dispense" or "dispensing" also does not mean the |
20 |
| physical delivery
of a drug or medical device to a patient or |
21 |
| patient's representative by a
pharmacist's designee within a |
22 |
| pharmacy or drugstore while the pharmacist is
on duty and the |
23 |
| pharmacy is open.
|
24 |
| (n) "Nonresident pharmacy"
"Mail-order pharmacy" means a |
25 |
| pharmacy that is located in a state , commonwealth, or territory
|
26 |
| of the United States, other than Illinois, that delivers, |
|
|
|
SB0509 Enrolled |
- 35 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| dispenses , or
distributes, through the United States Postal |
2 |
| Service , commercially acceptable parcel delivery service, or |
3 |
| other common
carrier, to Illinois residents, any substance |
4 |
| which requires a prescription.
|
5 |
| (o) "Compounding" means the preparation and mixing of |
6 |
| components, excluding flavorings, (1) as the result of a |
7 |
| prescriber's prescription drug order or initiative based on the |
8 |
| prescriber-patient-pharmacist relationship in the course of |
9 |
| professional practice or (2) for the purpose of, or incident |
10 |
| to, research, teaching, or chemical analysis and not for sale |
11 |
| or dispensing. "Compounding" includes the preparation of drugs |
12 |
| or devices in anticipation of receiving prescription drug |
13 |
| orders based on routine, regularly observed dispensing |
14 |
| patterns. Commercially available products may be compounded |
15 |
| for dispensing to individual patients only if all of the |
16 |
| following conditions are met: (i) the commercial product is not |
17 |
| reasonably available from normal distribution channels in a |
18 |
| timely manner to meet the patient's needs and (ii) the |
19 |
| prescribing practitioner has requested that the drug be |
20 |
| compounded. , mixing, assembling,
packaging, or labeling of a |
21 |
| drug or medical device: (1) as the result of a
practitioner's |
22 |
| prescription drug order or initiative that is dispensed |
23 |
| pursuant
to a prescription in the course of professional |
24 |
| practice; or (2) for the
purpose of, or incident to, research, |
25 |
| teaching, or chemical analysis; or (3) in anticipation of |
26 |
| prescription drug orders
based on routine, regularly observed |
|
|
|
SB0509 Enrolled |
- 36 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| prescribing patterns.
|
2 |
| (p) (Blank).
"Confidential information" means information,
|
3 |
| maintained by the
pharmacist in the patient's records, released |
4 |
| only (i) to the patient or,
as the patient directs, to other |
5 |
| practitioners and other pharmacists or (ii)
to any other person |
6 |
| authorized by law to receive the
information.
|
7 |
| (q) (Blank).
"Prospective drug review" or "drug |
8 |
| utilization evaluation" means a
screening for potential drug |
9 |
| therapy problems due to
therapeutic duplication, drug-disease |
10 |
| contraindications, drug-drug
interactions (including serious |
11 |
| interactions with nonprescription or
over-the-counter drugs), |
12 |
| drug-food interactions, incorrect drug dosage
or duration of |
13 |
| drug
treatment, drug-allergy interactions, and clinical abuse |
14 |
| or misuse.
|
15 |
| (r) "Patient counseling" means the communication between a |
16 |
| pharmacist or a pharmacy intern under the supervision of a |
17 |
| pharmacist and a patient or the patient's representative about |
18 |
| the patient's medication or device for the purpose of |
19 |
| optimizing proper use of prescription medications or devices. |
20 |
| "Patient counseling" may include without limitation (1) |
21 |
| obtaining a medication history; (2) acquiring a patient's |
22 |
| allergies and health conditions; (3) facilitation of the |
23 |
| patient's understanding of the intended use of the medication; |
24 |
| (4) proper directions for use; (5) significant potential |
25 |
| adverse events; (6) potential food-drug interactions; and (7) |
26 |
| the need to be compliant with the medication therapy. A |
|
|
|
SB0509 Enrolled |
- 37 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| pharmacy technician may only participate in the following |
2 |
| aspects of patient counseling under the supervision of a |
3 |
| pharmacist: (1) obtaining medication history; (2) providing |
4 |
| the offer for counseling by a pharmacist or intern; and (3) |
5 |
| acquiring a patient's allergies and health conditions.
or
a |
6 |
| student pharmacist under the direct supervision of a pharmacist |
7 |
| and a
patient or the patient's representative about the |
8 |
| patient's medication or
device for the purpose of optimizing |
9 |
| proper use of prescription medications
or devices. The offer to |
10 |
| counsel by the pharmacist or the pharmacist's
designee, and |
11 |
| subsequent patient counseling by the pharmacist or student
|
12 |
| pharmacist, shall be made in a face-to-face communication with |
13 |
| the patient
or patient's representative unless, in the |
14 |
| professional judgment of the
pharmacist, a face-to-face |
15 |
| communication is deemed inappropriate or
unnecessary. In that |
16 |
| instance, the offer to counsel or patient counseling may
be |
17 |
| made in a written communication, by telephone, or in a manner |
18 |
| determined by
the pharmacist to be appropriate.
|
19 |
| (s) "Patient profiles" or "patient drug therapy record" |
20 |
| means the
obtaining, recording, and maintenance of patient |
21 |
| prescription
information, including prescriptions for |
22 |
| controlled substances, and
personal information.
|
23 |
| (t) (Blank).
"Pharmaceutical care" includes, but is not |
24 |
| limited to, the act of
monitoring drug use and other patient |
25 |
| care services intended to achieve
outcomes that improve the |
26 |
| patient's quality of life but shall not include
the sale of |
|
|
|
SB0509 Enrolled |
- 38 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| over-the-counter drugs by a seller of goods and services who
|
2 |
| does not dispense prescription drugs.
|
3 |
| (u) "Medical device" means an instrument, apparatus, |
4 |
| implement, machine,
contrivance, implant, in vitro reagent, or |
5 |
| other similar or related article,
including any component part |
6 |
| or accessory, required under federal law to
bear the label |
7 |
| "Caution: Federal law requires dispensing by or on the order
of |
8 |
| a physician". A seller of goods and services who, only for the |
9 |
| purpose of
retail sales, compounds, sells, rents, or leases |
10 |
| medical devices shall not,
by reasons thereof, be required to |
11 |
| be a licensed pharmacy.
|
12 |
| (v) "Unique identifier" means an electronic signature, |
13 |
| handwritten
signature or initials, thumb print, or other |
14 |
| acceptable individual biometric
or electronic identification |
15 |
| process as approved by the Department.
|
16 |
| (w) "Current usual and customary retail price" means the |
17 |
| actual price that a pharmacy charges to a non-third-party payor
|
18 |
| a retail purchaser .
|
19 |
| (x) "Automated pharmacy system" means a mechanical system |
20 |
| located within the confines of the pharmacy or remote location |
21 |
| that performs operations or activities, other than compounding |
22 |
| or administration, relative to storage, packaging, dispensing, |
23 |
| or distribution of medication, and which collects, controls, |
24 |
| and maintains all transaction information. |
25 |
| (y) "Drug regimen review" means and includes the evaluation |
26 |
| of prescription drug orders and patient records for (1)
known |
|
|
|
SB0509 Enrolled |
- 39 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| allergies; (2) drug or potential therapy contraindications;
|
2 |
| (3) reasonable dose, duration of use, and route of |
3 |
| administration, taking into consideration factors such as age, |
4 |
| gender, and contraindications; (4) reasonable directions for |
5 |
| use; (5) potential or actual adverse drug reactions; (6) |
6 |
| drug-drug interactions; (7) drug-food interactions; (8) |
7 |
| drug-disease contraindications; (9) therapeutic duplication; |
8 |
| (10) patient laboratory values when authorized and available; |
9 |
| (11) proper utilization (including over or under utilization) |
10 |
| and optimum therapeutic outcomes; and (12) abuse and misuse.
|
11 |
| (z) "Electronic transmission prescription" means any |
12 |
| prescription order for which a facsimile or electronic image of |
13 |
| the order is electronically transmitted from a licensed |
14 |
| prescriber to a pharmacy. "Electronic transmission |
15 |
| prescription" includes both data and image prescriptions.
|
16 |
| (aa) "Medication therapy management services" means a |
17 |
| distinct service or group of services offered by licensed |
18 |
| pharmacists, physicians licensed to practice medicine in all |
19 |
| its branches, advanced practice nurses authorized in a written |
20 |
| agreement with a physician licensed to practice medicine in all |
21 |
| its branches, or physician assistants authorized in guidelines |
22 |
| by a supervising physician that optimize therapeutic outcomes |
23 |
| for individual patients through improved medication use. In a |
24 |
| retail or other non-hospital pharmacy, medication therapy |
25 |
| management services shall consist of the evaluation of |
26 |
| prescription drug orders and patient medication records to |
|
|
|
SB0509 Enrolled |
- 40 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| resolve conflicts with the following: |
2 |
| (1) known allergies; |
3 |
| (2) drug or potential therapy contraindications; |
4 |
| (3) reasonable dose, duration of use, and route of |
5 |
| administration, taking into consideration factors such as |
6 |
| age, gender, and contraindications; |
7 |
| (4) reasonable directions for use; |
8 |
| (5) potential or actual adverse drug reactions; |
9 |
| (6) drug-drug interactions; |
10 |
| (7) drug-food interactions; |
11 |
| (8) drug-disease contraindications; |
12 |
| (9) identification of therapeutic duplication; |
13 |
| (10) patient laboratory values when authorized and |
14 |
| available; |
15 |
| (11) proper utilization (including over or under |
16 |
| utilization) and optimum therapeutic outcomes; and |
17 |
| (12) drug abuse and misuse. |
18 |
| "Medication therapy management services" includes the |
19 |
| following: |
20 |
| (1) documenting the services delivered and |
21 |
| communicating the information provided to patients' |
22 |
| prescribers within an appropriate time frame, not to exceed |
23 |
| 48 hours; |
24 |
| (2) providing patient counseling designed to enhance a |
25 |
| patient's understanding and the appropriate use of his or |
26 |
| her medications; and |
|
|
|
SB0509 Enrolled |
- 41 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (3) providing information, support services, and |
2 |
| resources designed to enhance a patient's adherence with |
3 |
| his or her prescribed therapeutic regimens.
|
4 |
| "Medication therapy management services" may also include |
5 |
| patient care functions authorized by a physician licensed to |
6 |
| practice medicine in all its branches for his or her identified |
7 |
| patient or groups of patients under specified conditions or |
8 |
| limitations in a standing order from the physician. |
9 |
| "Medication therapy management services" in a licensed |
10 |
| hospital may also include the following: |
11 |
| (1) reviewing assessments of the patient's health |
12 |
| status; and |
13 |
| (2) following protocols of a hospital pharmacy and |
14 |
| therapeutics committee with respect to the fulfillment of |
15 |
| medication orders.
|
16 |
| (bb) "Pharmacist care" means the provision by a pharmacist |
17 |
| of medication therapy management services, with or without the |
18 |
| dispensing of drugs or devices, intended to achieve outcomes |
19 |
| that improve patient health, quality of life, and comfort and |
20 |
| enhance patient safety.
|
21 |
| (cc) "Protected health information" means individually |
22 |
| identifiable health information that, except as otherwise |
23 |
| provided, is:
|
24 |
| (1) transmitted by electronic media; |
25 |
| (2) maintained in any medium set forth in the |
26 |
| definition of "electronic media" in the federal Health |
|
|
|
SB0509 Enrolled |
- 42 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| Insurance Portability and Accountability Act; or |
2 |
| (3) transmitted or maintained in any other form or |
3 |
| medium. |
4 |
| "Protected health information" does not include individually |
5 |
| identifiable health information found in: |
6 |
| (1) education records covered by the federal |
7 |
| Family Educational Right and Privacy Act; or |
8 |
| (2) employment records held by a licensee in its |
9 |
| role as an employer. |
10 |
| (dd) "Standing order" means a specific order for a patient |
11 |
| or group of patients issued by a physician licensed to practice |
12 |
| medicine in all its branches in Illinois. |
13 |
| (ee) "Address of record" means the address recorded by the |
14 |
| Department in the applicant's or licensee's application file or |
15 |
| license file, as maintained by the Department's licensure |
16 |
| maintenance unit. |
17 |
| (ff) "Home pharmacy" means the location of a pharmacy's |
18 |
| primary operations.
|
19 |
| (Source: P.A. 93-571, eff. 8-20-03; 93-1075, eff. 1-18-05; |
20 |
| 94-459, eff. 1-1-06.)
|
21 |
| (225 ILCS 85/5) (from Ch. 111, par. 4125)
|
22 |
| (Section scheduled to be repealed on January 1, 2008)
|
23 |
| Sec. 5. Application of Act.
|
24 |
| (a) It shall be unlawful for any person to engage in the
|
25 |
| practice of pharmacy in this State and it shall be unlawful for |
|
|
|
SB0509 Enrolled |
- 43 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| any
employer to allow any person in his or her employ to engage |
2 |
| in the practice
of pharmacy in this State, unless such person |
3 |
| who shall engage in the
practice of pharmacy in this State |
4 |
| shall be first authorized to do
so under the provisions of this |
5 |
| Act.
|
6 |
| (b) Nothing contained in this Act shall be construed to |
7 |
| invalidate
any existing valid and unexpired certificate of |
8 |
| registration, nor any
existing rights or privileges |
9 |
| thereunder, of any registered pharmacist,
registered assistant |
10 |
| pharmacist, local registered pharmacist, or registered
|
11 |
| pharmacy apprentice, in force on January 1, 1956 and issued |
12 |
| under any
prior Act of this State also in force on January 1, |
13 |
| 1956. Every person
holding such a certificate of registration |
14 |
| shall have the authority
to practice under this Act, but shall |
15 |
| be subject to the same limitations
and restrictions as were |
16 |
| applicable to him or her in the Act under
which his or her |
17 |
| certificate of registration was issued. Each such
certificate |
18 |
| may be renewed as provided in Section 12.
|
19 |
| (c) It shall be unlawful for any person to take, use or |
20 |
| exhibit any
word, object, sign or design described in |
21 |
| subsection (a) of Section
3 in connection with any drug store, |
22 |
| shop or other place or in any
other manner to advertise or hold |
23 |
| himself out as operating or conducting
a drug store unless such |
24 |
| drug store, shop, pharmacy department or other
place shall be |
25 |
| operated and conducted in compliance with the provisions
of |
26 |
| this Act.
|
|
|
|
SB0509 Enrolled |
- 44 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (d) Nothing in this Act shall be construed to authorize a |
2 |
| pharmacist to prescribe or perform medical diagnosis of human |
3 |
| ailments or conditions.
|
4 |
| (Source: P.A. 90-253, eff. 7-29-97.)
|
5 |
| (225 ILCS 85/6) (from Ch. 111, par. 4126)
|
6 |
| (Section scheduled to be repealed on January 1, 2008)
|
7 |
| Sec. 6. Each individual seeking
licensure as a registered |
8 |
| pharmacist shall make application to the
Department and shall |
9 |
| provide evidence of the following:
|
10 |
| 1. that he or she is a United States citizen or legally |
11 |
| admitted alien;
|
12 |
| 2. that he or she has not engaged in conduct or behavior |
13 |
| determined to be
grounds for discipline under this Act;
|
14 |
| 3. that he or she is a graduate of a first professional |
15 |
| degree program in
pharmacy of a university recognized and |
16 |
| approved by the Department;
|
17 |
| 4. that he or she has successfully completed a program of |
18 |
| practice experience
under the direct supervision of a |
19 |
| registered pharmacist in a pharmacy
in this State, or in any |
20 |
| other State; and
|
21 |
| 5. that he or she has passed an examination recommended by |
22 |
| the Board of Pharmacy
and authorized by the Department.
|
23 |
| The program of practice experience referred to in paragraph |
24 |
| (4) of
this Section shall be fulfilled by the successful |
25 |
| completion of a practice
course offered by a school or college |
|
|
|
SB0509 Enrolled |
- 45 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| of pharmacy or department of
pharmacy recognized and approved |
2 |
| by the Department, which shall be
a minimum of one academic |
3 |
| quarter in length.
|
4 |
| Any person applying for a license as a registered |
5 |
| pharmacist in this
State who has graduated from a first |
6 |
| professional degree program in
pharmacy of at least 5 academic |
7 |
| years from a school or college of pharmacy,
which at the time |
8 |
| of such graduation was not recognized and approved
as reputable |
9 |
| and in good standing by the Department, shall be required,
in |
10 |
| order to qualify for admittance to take the Department's |
11 |
| examination
for licensure as a registered pharmacist, to pass a |
12 |
| preliminary diagnostic
examination recommended by the Board |
13 |
| and authorized by the Department,
covering proficiency in the |
14 |
| English language and such academic areas
as the Board may deem |
15 |
| essential to a satisfactory pharmacy curriculum
and by rule |
16 |
| prescribe. Any applicant who submits to and fails to pass
the |
17 |
| preliminary diagnostic examination may be required to satisfy |
18 |
| the
Board that he has taken additional remedial work previously |
19 |
| approved
by the Board to correct deficiencies in his |
20 |
| pharmaceutical education
indicated by the results of the last |
21 |
| preliminary diagnostic examination
prior to taking the |
22 |
| preliminary diagnostic examination again.
|
23 |
| Any applicant who has graduated from a first professional |
24 |
| degree program
in pharmacy of at least 5 academic years from a |
25 |
| school or college of
pharmacy, which at the time of such |
26 |
| graduation was not recognized and
approved as reputable and in |
|
|
|
SB0509 Enrolled |
- 46 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| good standing by the Department, shall
complete a clinical |
2 |
| program previously approved by the Board on the
basis of its |
3 |
| equivalence to programs that are components of first |
4 |
| professional
degree programs in pharmacy approved by the |
5 |
| Department.
|
6 |
| Any person required by Section 6 to submit to a preliminary |
7 |
| diagnostic
examination in advance of admittance to an |
8 |
| examination for registration
as a registered pharmacist under |
9 |
| this Act shall be permitted to take
such preliminary diagnostic |
10 |
| examination, provided that he is not less
than 21 years of age |
11 |
| and furnishes the Department with satisfactory
evidence that he |
12 |
| has: successfully completed a program of preprofessional
|
13 |
| education (postsecondary school) consisting of course work |
14 |
| equivalent
to that generally required for admission to U.S. |
15 |
| colleges of pharmacy
recognized and approved as reputable and |
16 |
| in good standing by the Department;
and has received a degree |
17 |
| in pharmacy as required in this Section.
|
18 |
| The Department shall issue a license as a registered |
19 |
| pharmacist to
any applicant who has qualified as aforesaid and |
20 |
| who has filed the
required applications and paid the required |
21 |
| fees in connection therewith;
and such registrant shall have |
22 |
| the authority to practice the profession
of pharmacy in this |
23 |
| State.
|
24 |
| (Source: P.A. 85-796.)
|
25 |
| (225 ILCS 85/7) (from Ch. 111, par. 4127)
|
|
|
|
SB0509 Enrolled |
- 47 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (Section scheduled to be repealed on January 1, 2008)
|
2 |
| Sec. 7. Application; examination. Applications for |
3 |
| original licenses
shall be made to the Department
in writing on |
4 |
| forms prescribed by the Department and shall be accompanied by
|
5 |
| the required fee, which shall not be refundable. Any such |
6 |
| application shall
require such information as in the judgment |
7 |
| of the Department will enable the
Board and Department to pass |
8 |
| on the qualifications of the applicant for a
license.
|
9 |
| The Department shall authorize examinations of applicants |
10 |
| as pharmacists not
less than 3 times per year at such times and |
11 |
| places as it may
determine.
The
examination of applicants shall |
12 |
| be of a character to give a fair test of the
qualifications of |
13 |
| the applicant to practice pharmacy.
|
14 |
| Applicants for examination as pharmacists shall be |
15 |
| required to pay,
either to the Department or the designated |
16 |
| testing service, a fee covering
the cost of providing the |
17 |
| examination. Failure to appear for the examination
on the |
18 |
| scheduled date, at the time and place specified, after the |
19 |
| applicant's
application for examination has been received and |
20 |
| acknowledged by the
Department or the designated testing |
21 |
| service, shall result in the forfeiture
of the examination fee. |
22 |
| The examination shall be developed and provided by the
National |
23 |
| Association of Boards of Pharmacy.
|
24 |
| If an applicant neglects, fails or refuses to take an |
25 |
| examination or
fails to pass an examination for a license under |
26 |
| this Act within 3
years after filing his application, the |
|
|
|
SB0509 Enrolled |
- 48 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| application is denied. However,
such applicant may thereafter |
2 |
| make a new application accompanied by
the required fee and show |
3 |
| evidence of meeting the requirements in force
at the time of |
4 |
| the new application.
|
5 |
| The Department shall notify applicants taking the |
6 |
| examination of their
results within 7 weeks of the examination |
7 |
| date. Further, the Department
shall have the authority to |
8 |
| immediately authorize such applicants who
successfully pass |
9 |
| the examination to engage in the practice of pharmacy.
|
10 |
| An applicant shall have one year from the date of |
11 |
| notification of successful
completion of the examination to |
12 |
| apply to the Department for a license.
If an applicant fails to |
13 |
| make such application within one year the
applicant shall be |
14 |
| required to again take and pass the examination. |
15 |
| An applicant who has graduated with a professional degree |
16 |
| from a school of pharmacy located outside of the United States |
17 |
| must do the following: |
18 |
| (1) obtain a Foreign Pharmacy Graduate Examination |
19 |
| Committee (FPGEC) Certificate; |
20 |
| (2) complete 1,200 hours of clinical training and |
21 |
| experience, as defined by rule, in the United States or its |
22 |
| territories; and |
23 |
| (3) successfully complete the licensing requirements |
24 |
| set forth in Section 6 of this Act, as well as those |
25 |
| adopted by the Department by rule.
|
26 |
| The Department may employ consultants for the purpose of |
|
|
|
SB0509 Enrolled |
- 49 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| preparing
and conducting examinations.
|
2 |
| (Source: P.A. 90-253, eff. 7-29-97.)
|
3 |
| (225 ILCS 85/7.5)
|
4 |
| (Section scheduled to be repealed on January 1, 2008)
|
5 |
| Sec. 7.5. Social Security Number or unique identifying |
6 |
| number on license application. In addition
to any other |
7 |
| information required to be contained in the application, every
|
8 |
| application for an original, renewal, or restored license under |
9 |
| this Act shall
include the applicant's Social Security Number |
10 |
| or other unique identifying number deemed appropriate by the |
11 |
| Department .
|
12 |
| (Source: P.A. 90-144, eff. 7-23-97.)
|
13 |
| (225 ILCS 85/8) (from Ch. 111, par. 4128)
|
14 |
| (Section scheduled to be repealed on January 1, 2008)
|
15 |
| Sec. 8. Licensure by endorsement; emergency licensure.
The |
16 |
| Department may, in its discretion, license
as a pharmacist, |
17 |
| without examination, on payment of the required fee,
an |
18 |
| applicant who is so licensed under the laws of another U.S. |
19 |
| jurisdiction
or another country, if the requirements for |
20 |
| licensure in the other
jurisdiction in which the applicant was |
21 |
| licensed, were, at the date
of his or her licensure deemed by |
22 |
| the Board to be substantially equivalent
to the requirements |
23 |
| then in force in this State.
|
24 |
| A person holding an active, unencumbered license in good
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| standing in another jurisdiction who applies for a license
|
2 |
| pursuant to Section 7 of this Act due to a natural disaster or
|
3 |
| catastrophic event in another jurisdiction may be temporarily
|
4 |
| authorized by the Secretary to practice pharmacy pending the
|
5 |
| issuance of the license. This temporary authorization shall |
6 |
| expire upon issuance of the license or upon notification that |
7 |
| the Department has denied licensure.
|
8 |
| Upon a declared Executive Order due to an emergency caused |
9 |
| by a natural or manmade disaster or any other exceptional |
10 |
| situation that causes an extraordinary demand for pharmacist |
11 |
| services, the Department may issue a pharmacist who holds a |
12 |
| license to practice pharmacy in another state an emergency |
13 |
| license to practice in this State.
|
14 |
| (Source: P.A. 85-796.)
|
15 |
| (225 ILCS 85/9) (from Ch. 111, par. 4129)
|
16 |
| (Section scheduled to be repealed on January 1, 2008)
|
17 |
| Sec. 9. Registration as pharmacy technician. Any person |
18 |
| shall be entitled
to registration as a registered pharmacy |
19 |
| technician who is of the age of 16
or over, has not engaged in |
20 |
| conduct or behavior determined to be grounds for
discipline |
21 |
| under this Act, is of temperate habits, is attending or has
|
22 |
| graduated from an accredited high school or comparable school |
23 |
| or educational
institution or received a GED , and has filed a |
24 |
| written application for registration on a form
to be prescribed |
25 |
| and furnished by the Department for that purpose. The
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| Department shall issue a certificate of
registration as a |
2 |
| registered pharmacy technician to any applicant who has
|
3 |
| qualified as aforesaid, and such registration shall be the sole |
4 |
| authority
required to assist licensed pharmacists in the |
5 |
| practice of pharmacy, under
the personal supervision of a |
6 |
| licensed pharmacist. A registered pharmacy technician may, |
7 |
| under the supervision of a pharmacist, assist in the practice |
8 |
| of pharmacy and perform such functions as assisting in the |
9 |
| dispensing process, offering counseling, receiving new verbal |
10 |
| prescription orders, and having prescriber contact concerning |
11 |
| prescription drug order clarification. A registered pharmacy |
12 |
| technician may not engage in patient counseling, drug regimen |
13 |
| review, or clinical conflict resolution. |
14 |
| Beginning on January 1, 2010, within 2 years after being |
15 |
| employed as a registered technician, a pharmacy technician must |
16 |
| become certified by successfully passing the Pharmacy |
17 |
| Technician Certification Board (PTCB) examination or another |
18 |
| Board-approved pharmacy technician examination in order to |
19 |
| continue to perform pharmacy technician's duties. This |
20 |
| requirement does not apply to pharmacy technicians hired prior |
21 |
| to January 1, 2008.
|
22 |
| Any person registered
as a pharmacy technician who is also |
23 |
| enrolled in a first professional
degree program in pharmacy in |
24 |
| a school or college of pharmacy or a
department of pharmacy of |
25 |
| a university approved by the Department shall be
considered a |
26 |
| "pharmacy intern"
"student pharmacist" and entitled to use the |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| title "pharmacy intern". A pharmacy intern must meet all of the |
2 |
| requirements for registration as a pharmacy technician set |
3 |
| forth in this Section and pay the required pharmacy technician |
4 |
| registration fees
"student
pharmacist" . |
5 |
| The Department, upon the recommendation of the Board, may
|
6 |
| take any action set forth in Section 30 of this Act with regard |
7 |
| to
certificates pursuant to this Section.
|
8 |
| Any person who is enrolled in a non-traditional Pharm.D.
|
9 |
| program at an ACPE accredited college of pharmacy and is a |
10 |
| licensed pharmacist
under the laws of another United States |
11 |
| jurisdiction shall be permitted to
engage in the program of |
12 |
| practice experience required in the academic program
by virtue |
13 |
| of such license. Such person shall be exempt from the |
14 |
| requirement
of registration as a registered pharmacy |
15 |
| technician while engaged in the
program of practice experience |
16 |
| required in the academic program.
|
17 |
| An applicant for registration as a pharmacy technician may |
18 |
| assist a
registered pharmacist in the practice of pharmacy for |
19 |
| a period of up to
60 days prior to the issuance of a |
20 |
| certificate of registration if the
applicant has submitted the |
21 |
| required fee and an application for registration
to the |
22 |
| Department. The applicant shall keep a copy of the submitted
|
23 |
| application on the premises where the applicant is assisting in |
24 |
| the
practice of pharmacy. The Department shall forward |
25 |
| confirmation of receipt of the application with start and |
26 |
| expiration dates of practice pending registration.
|
|
|
|
SB0509 Enrolled |
- 53 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (Source: P.A. 92-16, eff. 6-28-01.)
|
2 |
| (225 ILCS 85/9.5 new)
|
3 |
| Sec. 9.5. Certified pharmacy technician. |
4 |
| (a) An individual registered as a pharmacy technician under |
5 |
| this Act may receive certification as a certified pharmacy |
6 |
| technician, if he or she meets all of the following |
7 |
| requirements: |
8 |
| (1) He or she has submitted a written application in |
9 |
| the form and manner prescribed by the Board. |
10 |
| (2) He or she has attained the age of 18. |
11 |
| (3) He or she is of good moral character, as determined |
12 |
| by the Department. |
13 |
| (4) He or she has (i) graduated from pharmacy |
14 |
| technician training meeting the requirements set forth in |
15 |
| subsection (a) of Section 17.1 of this Act or (ii) obtained |
16 |
| documentation from the pharmacist-in-charge of the |
17 |
| pharmacy where the applicant is employed verifying that he |
18 |
| or she has successfully completed a training program and |
19 |
| has successfully completed an objective assessment |
20 |
| mechanism prepared in accordance with rules established by |
21 |
| the Board. |
22 |
| (5) He or she has successfully passed an examination |
23 |
| accredited by the National Organization of Certifying |
24 |
| Agencies, as approved and required by the Board. |
25 |
| (6) He or she has paid the required certification fees. |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| (b) No pharmacist whose license has been denied, revoked, |
2 |
| suspended, or restricted for disciplinary purposes may be |
3 |
| eligible to be registered as a certified pharmacy technician. |
4 |
| (c) The Board may, by rule, establish any additional |
5 |
| requirements for certification under this Section.
|
6 |
| (225 ILCS 85/10) (from Ch. 111, par. 4130)
|
7 |
| (Section scheduled to be repealed on January 1, 2008)
|
8 |
| Sec. 10. State Board of Pharmacy. There is created in the |
9 |
| Department the
State Board of Pharmacy.
It shall consist of 9 |
10 |
| members, 7 of whom shall be licensed pharmacists.
Each of those |
11 |
| 7 members must be a licensed pharmacist in good standing
in |
12 |
| this State, a graduate of an accredited college of pharmacy or |
13 |
| hold
a Bachelor of Science degree in Pharmacy and have at least |
14 |
| 5 years'
practical experience in the practice of pharmacy |
15 |
| subsequent to the
date of his licensure as a licensed |
16 |
| pharmacist in the State of Illinois.
There shall be 2 public |
17 |
| members, who shall be voting members, who
shall not be licensed |
18 |
| pharmacists in this State or any other state.
|
19 |
| Each member shall be appointed by the Governor.
|
20 |
| Members
The terms of all members serving as of March 31, |
21 |
| 1999 shall expire on that
date. The Governor shall appoint 3 |
22 |
| persons to serve one-year terms, 3 persons
to serve 3-year |
23 |
| terms, and 3 persons to serve 5-year terms to begin April 1,
|
24 |
| 1999. Otherwise, members shall be appointed to 5 year terms. |
25 |
| The Governor shall fill any vacancy for the remainder of the |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| unexpired term. Partial terms over 3 years in length shall be |
2 |
| considered full terms. A member may be reappointed for a |
3 |
| successive term, but no member shall serve more than 2 full |
4 |
| terms in his or her lifetime.
No member shall
be eligible to |
5 |
| serve more than 12 consecutive years.
|
6 |
| In making the appointment of members on the Board, the |
7 |
| Governor shall
give due consideration to recommendations by the |
8 |
| members of the profession
of pharmacy and by pharmacy
|
9 |
| pharmaceutical organizations therein. The Governor
shall |
10 |
| notify the pharmacy
pharmaceutical organizations promptly of |
11 |
| any vacancy
of members on the Board and in appointing members |
12 |
| shall give consideration
to individuals engaged in all types |
13 |
| and settings of pharmacy practice.
|
14 |
| The Governor may remove any member of the Board for |
15 |
| misconduct, incapacity
or neglect of duty and he shall be the |
16 |
| sole judge of the sufficiency of the
cause for removal.
|
17 |
| Every person appointed a member of the Board shall take and |
18 |
| subscribe
the constitutional oath of office and file it with |
19 |
| the Secretary of
State. Each member of the Board shall be |
20 |
| reimbursed for such actual
and legitimate expenses as he may |
21 |
| incur in going to and from the place
of meeting and remaining |
22 |
| thereat during sessions of the Board. In
addition, each member |
23 |
| of the Board may
shall receive a per diem payment
in an amount |
24 |
| determined from time to time by the Director for attendance
at |
25 |
| meetings of the Board and conducting other official business of
|
26 |
| the Board.
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| The Board shall hold quarterly meetings and an annual |
2 |
| meeting in January
of each year and such other meetings at such |
3 |
| times and places and upon
such notice as the Department
Board
|
4 |
| may determine and as its business may require.
A majority of |
5 |
| the Board members currently appointed shall constitute a |
6 |
| quorum. A vacancy in the membership of the Board shall not |
7 |
| impair the right of a quorum to exercise all the rights and |
8 |
| perform all the duties of the Board.
Five members of the Board |
9 |
| shall constitute a quorum for the transaction
of business. The |
10 |
| Director shall appoint a pharmacy coordinator, who shall be
|
11 |
| someone other than a member of the Board. The pharmacy |
12 |
| coordinator shall be a
registered pharmacist in good standing |
13 |
| in this State, shall be a graduate of
an accredited college of |
14 |
| pharmacy, or hold at a minimum a Bachelor of Science
degree in |
15 |
| Pharmacy and shall have at least 5 years' experience in the |
16 |
| practice
of pharmacy immediately prior to his appointment. The |
17 |
| pharmacy coordinator
shall be the executive administrator and |
18 |
| the chief enforcement officer of the
Pharmacy Practice Act of |
19 |
| 1987.
|
20 |
| The Board shall exercise the rights, powers and duties |
21 |
| which have been
vested in the Board under this Act, and any |
22 |
| other duties conferred
upon the Board by law.
|
23 |
| The Director shall, in conformity with the Personnel Code, |
24 |
| employ not
less than 7 pharmacy investigators and 2 pharmacy |
25 |
| supervisors. Each pharmacy
investigator and each supervisor |
26 |
| shall be a registered pharmacist in good
standing in this |
|
|
|
SB0509 Enrolled |
- 57 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| State, and shall be a graduate of an accredited college of
|
2 |
| pharmacy and have at least 5 years of experience in the |
3 |
| practice of pharmacy.
The Department shall also employ at least |
4 |
| one attorney who is a pharmacist
to prosecute violations of |
5 |
| this Act and its rules. The Department may, in
conformity with |
6 |
| the Personnel Code, employ such clerical and other employees
as |
7 |
| are necessary to carry out the duties of the Board.
|
8 |
| The duly authorized pharmacy investigators of the |
9 |
| Department shall have the
right to enter and inspect during |
10 |
| business hours any pharmacy or any other
place in the State of |
11 |
| Illinois holding itself out to be a pharmacy where
medicines or |
12 |
| drugs or drug products or proprietary medicines are sold, |
13 |
| offered
for sale, exposed for sale, or kept for sale. The |
14 |
| pharmacy investigators shall
be the only Department |
15 |
| investigators authorized to inspect, investigate, and
monitor |
16 |
| probation compliance of pharmacists, pharmacies, and
pharmacy |
17 |
| technicians.
|
18 |
| (Source: P.A. 91-827, eff. 6-13-00; 92-651, eff. 7-11-02; |
19 |
| 92-880, eff. 1-1-04.)
|
20 |
| (225 ILCS 85/11) (from Ch. 111, par. 4131)
|
21 |
| (Section scheduled to be repealed on January 1, 2008)
|
22 |
| Sec. 11. Duties of the Department. The Department shall |
23 |
| exercise the
powers and duties prescribed by
the Civil |
24 |
| Administrative Code of Illinois for the administration of |
25 |
| Licensing
Acts and shall exercise such other powers and duties |
|
|
|
SB0509 Enrolled |
- 58 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| necessary for effectuating
the purpose of this Act. However, |
2 |
| the following powers and duties shall be
exercised only upon |
3 |
| review
action and report in writing of a majority of the Board |
4 |
| of
Pharmacy to take such action:
|
5 |
| (a) Formulate such rules, not inconsistent with law and |
6 |
| subject to
the Illinois Administrative Procedure Act, as may be |
7 |
| necessary to carry
out the purposes and enforce the provisions |
8 |
| of this Act. The Director
may grant variances from any such |
9 |
| rules as provided for in this Section;
|
10 |
| (b) The suspension, revocation, placing on probationary
|
11 |
| status, reprimand, and refusing to issue or restore any license |
12 |
| or
certificate of registration issued under the provisions of |
13 |
| this Act
for the reasons set forth in Section 30 of this Act.
|
14 |
| (c) The issuance, renewal, restoration or reissuance of any |
15 |
| license
or certificate which has been previously refused to be |
16 |
| issued or renewed,
or has been revoked, suspended or placed on |
17 |
| probationary status.
|
18 |
| The granting of variances from rules promulgated pursuant |
19 |
| to this Section in
individual cases where there is a finding |
20 |
| that:
|
21 |
| (1) the provision from which the variance is granted is |
22 |
| not statutorily
mandated;
|
23 |
| (2) no party will be injured by the granting of the |
24 |
| variance; and
|
25 |
| (3) the rule from which the variance is granted would, |
26 |
| in the particular
case, be unreasonable or unnecessarily |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| burdensome.
|
2 |
| The Director shall notify the State Board of Pharmacy of |
3 |
| the granting
of such variance and the reasons therefor, at the |
4 |
| next meeting of the Board.
|
5 |
| (d) The Secretary shall appoint a chief pharmacy |
6 |
| coordinator and at least 2 deputy pharmacy coordinators, all of |
7 |
| whom shall be registered pharmacists in good standing in this |
8 |
| State, shall be graduates of an accredited college of pharmacy |
9 |
| or hold, at a minimum, a bachelor of science degree in |
10 |
| pharmacy, and shall have at least 5 years of experience in the |
11 |
| practice of pharmacy immediately prior to his or her |
12 |
| appointment. The chief pharmacy coordinator shall be the |
13 |
| executive administrator and the chief enforcement officer of |
14 |
| this Act. The deputy pharmacy coordinators shall report to the |
15 |
| chief pharmacy coordinator. The Secretary shall assign at least |
16 |
| one deputy pharmacy coordinator to a region composed of Cook |
17 |
| County and such other counties as the Secretary may deem |
18 |
| appropriate, and such deputy pharmacy coordinator shall have |
19 |
| his or her primary office in Chicago. The Secretary shall |
20 |
| assign at least one deputy pharmacy coordinator to a region |
21 |
| composed of the balance of counties in the State, and such |
22 |
| deputy pharmacy coordinator shall have his or her primary |
23 |
| office in Springfield. |
24 |
| (e) The Secretary shall, in conformity with the Personnel |
25 |
| Code, employ not less than 4 pharmacy investigators who shall |
26 |
| report to the pharmacy coordinator or a deputy pharmacy |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| coordinator. Each pharmacy investigator shall be a graduate of |
2 |
| a 4-year college or university and shall (i) have at least 2 |
3 |
| years of investigative experience; (ii) have 2 years of |
4 |
| responsible pharmacy experience; or (iii) be a licensed |
5 |
| pharmacist. The Department shall also employ at least one |
6 |
| attorney to prosecute violations of this Act and its rules. The |
7 |
| Department may, in conformity with the Personnel Code, employ |
8 |
| such clerical and other employees as are necessary to carry out |
9 |
| the duties of the Board and Department. |
10 |
| The duly authorized pharmacy investigators of the |
11 |
| Department shall have the right to enter and inspect, during |
12 |
| business hours, any pharmacy or any other place in this State |
13 |
| holding itself out to be a pharmacy where medicines, drugs or |
14 |
| drug products, or proprietary medicines are sold, offered for |
15 |
| sale, exposed for sale, or kept for sale.
|
16 |
| (Source: P.A. 90-253, eff. 7-29-97.)
|
17 |
| (225 ILCS 85/12) (from Ch. 111, par. 4132)
|
18 |
| (Section scheduled to be repealed on January 1, 2008)
|
19 |
| Sec. 12. Expiration of license; renewal. The expiration |
20 |
| date and renewal
period for
each license and certificate of |
21 |
| registration issued under this Act
shall be set by rule.
|
22 |
| As a condition for the renewal of a certificate of |
23 |
| registration as
a registered pharmacist, the registrant shall |
24 |
| provide evidence to the
Department of completion of a total of |
25 |
| 30 hours of pharmacy continuing
education during the 24 months
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| 2 calendar years preceding the expiration date
of the |
2 |
| certificate. Such continuing education shall be approved by
the |
3 |
| Accreditation Council on Pharmacy
American Council on |
4 |
| Pharmaceutical Education.
|
5 |
| The Department shall establish by rule a means for the |
6 |
| verification
of completion of the continuing education |
7 |
| required by this Section.
This verification may be accomplished |
8 |
| through audits of records maintained
by registrants, by |
9 |
| requiring the filing of continuing education certificates
with |
10 |
| the Department or a qualified organization selected by the |
11 |
| Department
to maintain such records or by other means |
12 |
| established by the Department.
|
13 |
| Rules developed under this Section may provide for a |
14 |
| reasonable biennial
fee, not to exceed $20, to fund the cost of |
15 |
| such recordkeeping.
The Department shall, by rule, further |
16 |
| provide an orderly process
for the reinstatement of licenses |
17 |
| which have not been renewed due to
the failure to meet the |
18 |
| continuing education requirements of this Section.
The |
19 |
| requirements of continuing education may be waived, in whole or
|
20 |
| in part, in cases of extreme hardship as defined by rule of the |
21 |
| Department.
Such waivers shall be granted for not more than one |
22 |
| of any 3 consecutive
renewal periods.
|
23 |
| Any pharmacist who has permitted his license to expire or |
24 |
| who has had
his license on inactive status may have his license |
25 |
| restored by making
application to the Department and filing |
26 |
| proof acceptable to the Department
of his fitness to have his |
|
|
|
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LRB095 10560 RAS 30780 b |
|
|
1 |
| license restored, and by paying the required
restoration fee.
|
2 |
| The Department shall determine, by an evaluation program |
3 |
| established
by rule his fitness for restoration of his license |
4 |
| and shall establish
procedures and requirements for such |
5 |
| restoration. However, any pharmacist
who demonstrates that he |
6 |
| has continuously maintained active practice
in another |
7 |
| jurisdiction pursuant to a license in good standing, and
who |
8 |
| has substantially complied with the continuing education |
9 |
| requirements
of this Section shall not be subject to further |
10 |
| evaluation for purposes
of this Section.
|
11 |
| Any licensee who shall engage in the practice for which his |
12 |
| or her
license
was issued while the license is expired or on |
13 |
| inactive status
shall
be considered to be practicing without a |
14 |
| license which, shall be grounds
for discipline under Section 30 |
15 |
| of this Act.
|
16 |
| Any pharmacy operating on an expired license is engaged in
|
17 |
| the unlawful
practice of pharmacy and is subject to discipline |
18 |
| under Section 30 of this
Act. A pharmacy whose license has been |
19 |
| expired for one year or
more may not
have its license restored |
20 |
| but must apply for a new license and meet all
requirements for |
21 |
| licensure. Any pharmacy whose license has been expired for
less |
22 |
| than one year may apply for restoration of its license and |
23 |
| shall have
its license restored.
|
24 |
| However, any pharmacist whose license expired while he was |
25 |
| (l) in
Federal Service on active duty with the Armed Forces of |
26 |
| the United
States, or the State Militia called into service or |
|
|
|
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|
|
1 |
| training, or (2)
in training or education under the supervision |
2 |
| of the United States
preliminary to induction into the military |
3 |
| service, may have his license
or certificate restored without |
4 |
| paying any lapsed renewal fees, if
within 2 years after |
5 |
| honorable termination of such service, training
or education he |
6 |
| furnishes the Department with satisfactory evidence
to the |
7 |
| effect that he has been so engaged and that his service, |
8 |
| training
or education has been so terminated.
|
9 |
| (Source: P.A. 90-253, eff. 7-29-97.)
|
10 |
| (225 ILCS 85/13) (from Ch. 111, par. 4133)
|
11 |
| (Section scheduled to be repealed on January 1, 2008)
|
12 |
| Sec. 13. Inactive status. Any pharmacist or pharmacy |
13 |
| technician who notifies the Department,
in writing on forms |
14 |
| prescribed by the Department, may elect to place
his or her
|
15 |
| license on an inactive status and shall be excused from payment
|
16 |
| of renewal fees and completion of continuing education |
17 |
| requirements
until he or she notifies the Department in writing |
18 |
| of his or her intent to restore
his license.
|
19 |
| Any pharmacist or pharmacist technician requesting |
20 |
| restoration from inactive status shall be
required to pay the |
21 |
| current renewal fee and shall be required to restore
his or her |
22 |
| license or certificate, as provided by rule of the Department.
|
23 |
| Any pharmacist or pharmacist technician whose license is in |
24 |
| inactive status shall not practice
in the State of Illinois.
|
25 |
| A
Neither a pharmacy license nor a pharmacy technician |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| license may not be
placed on inactive status.
|
2 |
| Continued practice on a license which has lapsed or been |
3 |
| placed on
inactive status shall be considered to be practicing |
4 |
| without a license.
|
5 |
| (Source: P.A. 90-253, eff. 7-29-97.)
|
6 |
| (225 ILCS 85/14.1 new)
|
7 |
| Sec. 14.1. Structural and equipment requirements. The |
8 |
| Department shall establish structural and equipment |
9 |
| requirements for a pharmacy by rule.
|
10 |
| (225 ILCS 85/15) (from Ch. 111, par. 4135)
|
11 |
| (Section scheduled to be repealed on January 1, 2008)
|
12 |
| Sec. 15. Pharmacy requirements. It shall be unlawful
for |
13 |
| the owner of any pharmacy, as defined in this Act, to operate |
14 |
| or conduct
the same, or to allow the same to be
operated or |
15 |
| conducted, unless:
|
16 |
| (a) It has a licensed pharmacist, authorized to practice |
17 |
| pharmacy
in this State under the provisions of this Act, on |
18 |
| duty whenever the
practice of pharmacy is conducted;
|
19 |
| (b) Security provisions for all drugs and devices, as |
20 |
| determined by
rule of the Department, are provided during the |
21 |
| absence from the licensed
pharmacy of all licensed pharmacists. |
22 |
| Maintenance of security provisions
is the responsibility of the |
23 |
| licensed registered pharmacist in charge;
and
|
24 |
| (c) The pharmacy is licensed under this Act to conduct the |
|
|
|
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|
|
1 |
| practice of pharmacy in any and all forms from the physical |
2 |
| address of the pharmacy's primary inventory where U.S. mail is |
3 |
| delivered. If a facility, company, or organization operates |
4 |
| multiple pharmacies from multiple physical addresses, a |
5 |
| separate pharmacy license is required for each different |
6 |
| physical address
to do business .
|
7 |
| (d) The Department may allow a pharmacy that is not located |
8 |
| at the same location as its home pharmacy and at which pharmacy |
9 |
| services are provided during an emergency situation, as defined |
10 |
| by rule, to be operated as an emergency remote pharmacy. An |
11 |
| emergency remote pharmacy operating under this subsection (d) |
12 |
| shall operate under the license of the home pharmacy.
|
13 |
| The Department shall, by rule, provide requirements for |
14 |
| each division
of pharmacy license and shall, as well provide |
15 |
| guidelines for the designation
of a registered pharmacist in |
16 |
| charge for each division.
|
17 |
| Division I. Retail Licenses for pharmacies which are open |
18 |
| to, or offer
pharmacy services to, the general public.
|
19 |
| Division II. Licenses for pharmacies whose primary |
20 |
| pharmacy service
is provided to patients or residents of |
21 |
| facilities licensed under the
Nursing Home Care Act or the |
22 |
| Hospital Licensing Act,
or "An Act in relation to the
founding |
23 |
| and operation of the University of Illinois Hospital and the
|
24 |
| conduct of University of Illinois health care programs", |
25 |
| approved July 3,
1931, as amended,
and which are not located in |
26 |
| the facilities they serve.
|
|
|
|
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LRB095 10560 RAS 30780 b |
|
|
1 |
| Division III. Licenses for pharmacies which are located in |
2 |
| a facility
licensed under the Nursing Home Care Act or the |
3 |
| Hospital
Licensing Act,
or "An Act in relation to the
founding |
4 |
| and operation of the University of Illinois Hospital and the
|
5 |
| conduct of University of Illinois health care programs", |
6 |
| approved July 3,
1931, as amended,
or a facility which is |
7 |
| operated by the Department of Human
Services (as successor to |
8 |
| the Department of Mental Health
and Developmental |
9 |
| Disabilities) or the Department of Corrections,
and which |
10 |
| provide pharmacy services to residents or patients of the
|
11 |
| facility, as well as employees, prescribers and students of the |
12 |
| facility.
|
13 |
| Division IV. Licenses for pharmacies which provide or offer |
14 |
| for sale
radioactive materials.
|
15 |
| Division V. Licenses for pharmacies which hold licenses in |
16 |
| Division
II or Division III which also provide pharmacy |
17 |
| services to the general
public, or pharmacies which are located |
18 |
| in or whose primary pharmacy
service is to ambulatory care |
19 |
| facilities or schools of veterinary medicine
or other such |
20 |
| institution or facility.
|
21 |
| Division VI. Licenses for pharmacies that provide pharmacy |
22 |
| services to patients of institutions serviced by pharmacies |
23 |
| with a Division II or Division III license, without using their |
24 |
| own supply of drugs. Division VI pharmacies may provide |
25 |
| pharmacy services only in cooperation with an institution's |
26 |
| pharmacy or pharmacy provider. Nothing in this paragraph shall |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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|
1 |
| constitute a change to the practice of pharmacy as defined in |
2 |
| Section 3 of this Act. Nothing in this amendatory Act of the |
3 |
| 94th General Assembly shall in any way alter the definition or |
4 |
| operation of any other division of pharmacy as provided in this |
5 |
| Act.
|
6 |
| The Director may waive the requirement for a pharmacist to |
7 |
| be on duty
at all times for State facilities not treating human |
8 |
| ailments.
|
9 |
| It shall be unlawful for any person, who is not a licensed |
10 |
| pharmacy
or health care facility, to purport to be such or to |
11 |
| use in name, title,
or sign designating, or in connection with |
12 |
| that place of business,
any of the words: "pharmacy", |
13 |
| "pharmacist", "pharmacy department",
"apothecary", "druggist", |
14 |
| "drug", "drugs", "medicines", "medicine store",
"drug |
15 |
| sundries", "prescriptions filled", or any list of words |
16 |
| indicating
that drugs are compounded or sold to the lay public, |
17 |
| or prescriptions
are dispensed therein. Each day during which, |
18 |
| or a part which, such
representation is made or appears or such |
19 |
| a sign is allowed to remain
upon or in such a place of business |
20 |
| shall constitute a separate offense
under this Act.
|
21 |
| The holder of any license or certificate of registration |
22 |
| shall conspicuously
display it in the pharmacy in which he is |
23 |
| engaged in the practice of
pharmacy. The registered pharmacist |
24 |
| in charge shall conspicuously
display his name in such |
25 |
| pharmacy. The pharmacy license shall also
be conspicuously |
26 |
| displayed.
|
|
|
|
SB0509 Enrolled |
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|
|
1 |
| (Source: P.A. 94-84, eff. 6-28-05.)
|
2 |
| (225 ILCS 85/16) (from Ch. 111, par. 4136)
|
3 |
| (Section scheduled to be repealed on January 1, 2008)
|
4 |
| Sec. 16. The Department shall require
and provide for the |
5 |
| licensure of every pharmacy doing business in this
State. Such |
6 |
| licensure shall expire 30
10 days after the pharmacist in
|
7 |
| charge dies or leaves the place where the pharmacy is licensed |
8 |
| or after
such pharmacist's license has been suspended or |
9 |
| revoked.
|
10 |
| In the event the designated pharmacist in charge dies or |
11 |
| otherwise
ceases to function in that capacity, or when the |
12 |
| license of the pharmacist
in charge has been suspended or |
13 |
| revoked, the owner of the pharmacy
shall be required to notify |
14 |
| the Department, on forms provided by the
Department, of the |
15 |
| identity of the new pharmacist in charge.
|
16 |
| It is the duty of every pharmacist in charge who ceases to |
17 |
| function
in that capacity to report to the Department within 30
|
18 |
| 10 days of the
date on which he ceased such functions for such |
19 |
| pharmacy. It is the
duty of every owner of a pharmacy licensed |
20 |
| under this Act to report
to the Department within 30
10 days of |
21 |
| the date on which the pharmacist
in charge died or ceased to |
22 |
| function in that capacity. Failure to
provide such notification |
23 |
| to the Department shall be grounds for disciplinary
action.
|
24 |
| No license shall be issued to any pharmacy unless such |
25 |
| pharmacy has
a pharmacist in charge and each such pharmacy |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| license shall indicate
on the face thereof the pharmacist in |
2 |
| charge.
|
3 |
| (Source: P.A. 85-796.)
|
4 |
| (225 ILCS 85/16a) (from Ch. 111, par. 4136a)
|
5 |
| (Section scheduled to be repealed on January 1, 2008)
|
6 |
| Sec. 16a. (a) The Department shall establish rules and |
7 |
| regulations,
consistent with the provisions of this Act, |
8 |
| governing nonresident
mail-order pharmacies,
including |
9 |
| pharmacies providing services via the Internet,
which sell, or |
10 |
| offer for sale, drugs, medicines, or other pharmaceutical
|
11 |
| services in this State.
|
12 |
| (b) The Board shall require and provide for an annual |
13 |
| nonresident
special pharmacy registration for all pharmacies |
14 |
| located outside of this
State that dispense medications for |
15 |
| Illinois residents and mail, ship, or
deliver prescription |
16 |
| medications into this State. Nonresident special
pharmacy |
17 |
| registration shall be granted by the Board upon the disclosure |
18 |
| and
certification by a pharmacy:
|
19 |
| (1) that it is licensed in the state in which the |
20 |
| dispensing facility
is located and from which the drugs are |
21 |
| dispensed;
|
22 |
| (2) of the location, names, and titles of all principal |
23 |
| corporate
officers and all pharmacists who are dispensing |
24 |
| drugs to residents of this
State;
|
25 |
| (3) that it complies with all lawful directions and |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| requests for
information from the board of pharmacy of each |
2 |
| state in which it is
licensed or registered, except that it |
3 |
| shall respond directly to all
communications from the Board |
4 |
| concerning emergency circumstances arising
from the |
5 |
| dispensing of drugs to residents of this State;
|
6 |
| (4) that it maintains its records of drugs dispensed to |
7 |
| residents of
this State so that the records are readily |
8 |
| retrievable from the records of
other drugs dispensed;
|
9 |
| (5) that it cooperates with the Board in providing |
10 |
| information to the
board of pharmacy of the state in which |
11 |
| it is licensed concerning matters
related to the dispensing |
12 |
| of drugs to residents of this State; and
|
13 |
| (6) that during its regular hours of operation, but not |
14 |
| less than 6
days per week, for a minimum of 40 hours per |
15 |
| week, a toll-free telephone
service is provided to |
16 |
| facilitate communication between patients in this
State |
17 |
| and a pharmacist at the pharmacy who has access to the |
18 |
| patients'
records. The toll-free number must be disclosed |
19 |
| on the label affixed to
each container of drugs dispensed |
20 |
| to residents of this State.
|
21 |
| (Source: P.A. 91-438, eff. 1-1-00.)
|
22 |
| (225 ILCS 85/16b new)
|
23 |
| Sec. 16b. Prescription pick up and drop off. Nothing |
24 |
| contained in this Act shall prohibit a pharmacist or pharmacy, |
25 |
| by means of its employee or by use of a common carrier or the |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| U.S. mail, at the request of the patient, from picking up |
2 |
| prescription orders from the prescriber or delivering |
3 |
| prescription drugs to the patient or the patient's agent at the |
4 |
| residence or place of employment of the person for whom the |
5 |
| prescription was issued or at the hospital or medical care |
6 |
| facility in which the patient is confined. Conversely, the |
7 |
| patient or patient's agent may drop off prescriptions at a |
8 |
| designated area.
|
9 |
| (225 ILCS 85/17) (from Ch. 111, par. 4137)
|
10 |
| (Section scheduled to be repealed on January 1, 2008)
|
11 |
| Sec. 17. Disposition of legend drugs on cessation of |
12 |
| pharmacy operations.
|
13 |
| (a) The pharmacist in charge of a pharmacy which has
its |
14 |
| pharmacy license revoked or otherwise ceases operation shall |
15 |
| notify
the Department and forward to the Department a copy of |
16 |
| the closing
inventory of controlled substances and a statement |
17 |
| indicating the intended
manner of disposition of all legend |
18 |
| drugs and prescription files within
30
10 days of such |
19 |
| revocation or cessation of operation.
|
20 |
| (b) The Department shall approve the intended manner of |
21 |
| disposition
of all legend drugs prior to disposition of such |
22 |
| drugs by the pharmacist
in charge.
|
23 |
| (1) The Department shall notify the pharmacist in |
24 |
| charge of approval
of the manner of disposition of all |
25 |
| legend drugs, or disapproval accompanied
by reasons for |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| such disapproval, within 30
10 days of receipt of the |
2 |
| statement
from the pharmacist in charge. In the event that |
3 |
| the manner of disposition
is not approved, the pharmacist |
4 |
| in charge shall notify the Department
of an alternative |
5 |
| manner of disposition within 30
10 days of the receipt
of |
6 |
| disapproval.
|
7 |
| (2) If disposition of all legend drugs does not occur |
8 |
| within 30
10 days
after approval is received from the |
9 |
| Department, or if no alternative
method of disposition is |
10 |
| submitted to the Department within 30
10 days
of the |
11 |
| Department's disapproval, the Director shall notify the |
12 |
| pharmacist
in charge by mail at the address of the closing |
13 |
| pharmacy, of the Department's
intent to confiscate all |
14 |
| legend drugs. The Notice of Intent to Confiscate
shall be |
15 |
| the final administrative decision of the Department, as |
16 |
| that
term is defined in the Administrative Review Law, and |
17 |
| the confiscation of all
prescription drugs shall be |
18 |
| effected.
|
19 |
| (b-5) In the event that the pharmacist in charge has died |
20 |
| or is otherwise
physically incompetent to perform the duties of |
21 |
| this Section, the owner of a
pharmacy that has its license |
22 |
| revoked or otherwise ceases operation shall be
required to |
23 |
| fulfill the duties otherwise imposed upon the pharmacist in
|
24 |
| charge.
|
25 |
| (c) The pharmacist in charge of a pharmacy which acquires |
26 |
| prescription
files from a pharmacy which ceases operation shall |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| be responsible for
the preservation of such acquired |
2 |
| prescriptions for the remainder of
the term that such |
3 |
| prescriptions are required to be preserved by this
Act.
|
4 |
| (d) Failure to comply with this Section shall be grounds |
5 |
| for denying
an application or renewal application for a |
6 |
| pharmacy license or for
disciplinary action against a |
7 |
| registration.
|
8 |
| (e) Compliance with the provisions of the Illinois |
9 |
| Controlled Substances
Act concerning the disposition of |
10 |
| controlled substances shall be deemed
compliance with this |
11 |
| Section with respect to legend drugs which are
controlled |
12 |
| substances.
|
13 |
| (Source: P.A. 90-253, eff. 7-29-97.)
|
14 |
| (225 ILCS 85/17.1)
|
15 |
| (Section scheduled to be repealed on January 1, 2008)
|
16 |
| Sec. 17.1. Pharmacy technician training.
|
17 |
| (a) Beginning January 1, 2004, it shall be the joint |
18 |
| responsibility of a
pharmacy
and its pharmacist in charge to |
19 |
| have trained all of its pharmacy technicians
or obtain
proof of |
20 |
| prior training in all of the following topics as they relate to |
21 |
| the
practice site:
|
22 |
| (1) The duties and responsibilities of the technicians |
23 |
| and pharmacists.
|
24 |
| (2) Tasks and technical skills, policies, and |
25 |
| procedures.
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| (3) Compounding, packaging, labeling, and storage.
|
2 |
| (4) Pharmaceutical and medical terminology.
|
3 |
| (5) Record keeping requirements.
|
4 |
| (6) The ability to perform and apply arithmetic |
5 |
| calculations.
|
6 |
| (b) Within 6 months after initial employment or changing |
7 |
| the duties and
responsibilities of a pharmacy technician, it
|
8 |
| shall be
the joint responsibility of the pharmacy and the |
9 |
| pharmacist in charge to
train the
pharmacy technician or obtain |
10 |
| proof of prior training in the areas listed in
subsection (a)
|
11 |
| of this Section as they relate to the practice site or to |
12 |
| document that the pharmacy technician is making appropriate |
13 |
| progress .
|
14 |
| (c) All divisions of pharmacies shall maintain an |
15 |
| up-to-date training
program
describing the duties and |
16 |
| responsibilities of a pharmacy technician.
|
17 |
| (d) All divisions of pharmacies shall create and maintain |
18 |
| retrievable
records
of
training or proof of training as |
19 |
| required in this Section.
|
20 |
| (Source: P.A. 92-880, eff. 1-1-04.)
|
21 |
| (225 ILCS 85/18) (from Ch. 111, par. 4138)
|
22 |
| (Section scheduled to be repealed on January 1, 2008)
|
23 |
| Sec. 18. Record retention. (a) Except as provided in |
24 |
| subsection (b), there shall be kept in every drugstore or
|
25 |
| pharmacy a suitable
book, file, or electronic record keeping |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| system in which shall be preserved
for a period of not less |
2 |
| than 5 years the original , or an exact, unalterable image, of |
3 |
| every written
prescription and the original transcript or copy |
4 |
| of every verbal prescription
filled, compounded, or dispensed, |
5 |
| in such pharmacy; and such book or
file of prescriptions shall |
6 |
| at all reasonable times be open to inspection
to the pharmacy |
7 |
| coordinator and the duly authorized agents or
employees of the |
8 |
| Department.
|
9 |
| Every prescription filled or refilled shall contain the
|
10 |
| unique identifiers
identifier of the persons
person authorized |
11 |
| to practice
pharmacy under the provision of this Act who fills |
12 |
| or refills the
prescription.
|
13 |
| Records kept pursuant to this Section may be maintained in |
14 |
| an alternative
data retention system, such as a direct digital |
15 |
| imaging system, provided that:
|
16 |
| (1) the records maintained in the alternative data |
17 |
| retention system
contain all of the information required in |
18 |
| a manual record;
|
19 |
| (2) the data processing system is capable of producing |
20 |
| a hard copy of the
electronic record on the request of the |
21 |
| Board, its representative, or other
authorized local, |
22 |
| State, or federal law enforcement or regulatory agency; and
|
23 |
| (3) the digital images are recorded and stored only by |
24 |
| means of a
technology that does not allow subsequent |
25 |
| revision or replacement of the
images ; and .
|
26 |
| (4) the prescriptions may be retained in written form |
|
|
|
SB0509 Enrolled |
- 76 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| or recorded in a data processing system, provided that such |
2 |
| order can be produced in printed form upon lawful request.
|
3 |
| As used in this Section, "digital imaging system" means a |
4 |
| system, including
people, machines, methods of organization, |
5 |
| and procedures, that provides input,
storage, processing, |
6 |
| communications, output, and control functions for
digitized
|
7 |
| representations of original prescription records.
|
8 |
| Inpatient drug orders may be maintained
within an |
9 |
| institution in a manner approved by the Department.
|
10 |
| (b) The record retention requirements for a Division VI |
11 |
| pharmacy shall be set by rule. |
12 |
| (Source: P.A. 94-84, eff. 6-28-05.)
|
13 |
| (225 ILCS 85/19) (from Ch. 111, par. 4139)
|
14 |
| (Section scheduled to be repealed on January 1, 2008)
|
15 |
| Sec. 19. Nothing contained in this Act shall be construed |
16 |
| to prohibit
a pharmacist licensed in this State from filling or |
17 |
| refilling a valid
prescription for prescription drugs which is |
18 |
| on file in a pharmacy licensed in
any state and has been |
19 |
| transferred from one pharmacy to another by any means,
|
20 |
| including by way of electronic data processing equipment upon |
21 |
| the following
conditions and exceptions:
|
22 |
| (1) Prior to dispensing pursuant to any such prescription, |
23 |
| the dispensing
pharmacist shall:
|
24 |
| (a) Advise the patient that the prescription on file at |
25 |
| such other
pharmacy must be canceled before he or she will |
|
|
|
SB0509 Enrolled |
- 77 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| be able to fill or refill it.
|
2 |
| (b) Determine that the prescription is valid and on |
3 |
| file at such other
pharmacy and that such prescription may |
4 |
| be filled or refilled, as requested,
in accordance with the |
5 |
| prescriber's intent expressed on such prescription.
|
6 |
| (c) Notify the pharmacy where the prescription is on |
7 |
| file that the
prescription must be canceled.
|
8 |
| (d) Record in writing the prescription order, the name |
9 |
| of the pharmacy
at which the prescription was on file, the |
10 |
| prescription number, the
name of the drug and the original |
11 |
| amount dispensed, the date of original
dispensing, and the |
12 |
| number of remaining authorized refills.
|
13 |
| (e) Obtain the consent of the prescriber to the |
14 |
| refilling of the
prescription when the prescription, in the |
15 |
| professional judgment of the
dispensing pharmacist, so |
16 |
| requires.
|
17 |
| (2) Upon receipt of a request for prescription information |
18 |
| set forth
in subparagraph (d) of paragraph (1) of this Section, |
19 |
| if the requested
pharmacist is satisfied in his professional |
20 |
| judgment that such request
is valid and legal, the requested |
21 |
| pharmacist shall:
|
22 |
| (a) Provide such information accurately and |
23 |
| completely.
|
24 |
| (b) Record electronically or, if in writing, on the |
25 |
| face of the prescription , the name of the requesting
|
26 |
| pharmacy and pharmacist and the date of request.
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| (c) Cancel the prescription on file by writing the word |
2 |
| "void" on
its face or the electronic equivalent, if not in |
3 |
| written format . No further prescription information shall |
4 |
| be given or medication
dispensed pursuant to such original |
5 |
| prescription.
|
6 |
| (3) In the event that, after the information set forth in |
7 |
| subparagraph
(d) of paragraph (1) of this Section has been |
8 |
| provided, a prescription
is not dispensed by the requesting |
9 |
| pharmacist, then such pharmacist
shall provide notice of this |
10 |
| fact to the pharmacy from which such information
was obtained; |
11 |
| such notice shall then cancel the prescription in the
same |
12 |
| manner as set forth in subparagraph (c) of paragraph (2) of |
13 |
| this
Section.
|
14 |
| (4) When filling or refilling a valid prescription on file |
15 |
| in another
state, the dispensing pharmacist shall be required |
16 |
| to follow all the
requirements of Illinois law which apply to |
17 |
| the dispensing of prescription
drugs. If anything in Illinois |
18 |
| law prevents the filling or refilling of
the original |
19 |
| prescription it shall be unlawful to dispense pursuant to this
|
20 |
| Section.
|
21 |
| (5) Prescriptions for drugs in Schedules III, IV, and V of |
22 |
| the Illinois
Controlled Substances Act may be transferred only |
23 |
| once and may not be further
transferred. However, pharmacies |
24 |
| electronically sharing a real-time, online database may |
25 |
| transfer up to the maximum refills permitted by the law and the |
26 |
| prescriber's authorization.
|
|
|
|
SB0509 Enrolled |
- 79 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (Source: P.A. 92-880, eff. 1-1-04.)
|
2 |
| (225 ILCS 85/20) (from Ch. 111, par. 4140)
|
3 |
| (Section scheduled to be repealed on January 1, 2008)
|
4 |
| Sec. 20. Two or more pharmacies may establish and use a |
5 |
| common
electronic file to maintain required dispensing |
6 |
| information.
|
7 |
| Pharmacies using such a common electronic file are not |
8 |
| required to
physically transfer prescriptions or information |
9 |
| for dispensing purposes
between or among pharmacies |
10 |
| participating in the same common prescription
file; provided, |
11 |
| however any such common file must contain complete
and adequate |
12 |
| records of such prescription and refill dispensed as stated
in |
13 |
| Section 18.
|
14 |
| The Department and Board may formulate such rules and |
15 |
| regulations,
not inconsistent with law, as may be necessary to |
16 |
| carry out the purposes
of and to enforce the provisions of this |
17 |
| Section within the following
exception: The Department and |
18 |
| Board shall not impose greater requirements
on either common |
19 |
| electronic files or a hard copy record system.
|
20 |
| Drugs shall in no event be dispensed more frequently or in |
21 |
| larger amounts
than the prescriber ordered without direct |
22 |
| prescriber authorization
by way of a new prescription order.
|
23 |
| The dispensing by a pharmacist licensed in this State or |
24 |
| another state of a prescription contained in a common database |
25 |
| shall not constitute a transfer, provided that (i) all |
|
|
|
SB0509 Enrolled |
- 80 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| pharmacies involved in the transactions pursuant to which the |
2 |
| prescription is dispensed and all pharmacists engaging in |
3 |
| dispensing functions are properly licensed, permitted, or |
4 |
| registered in this State or another jurisdiction, (ii) a policy |
5 |
| and procedures manual that governs all participating |
6 |
| pharmacies and pharmacists is available to the Department upon |
7 |
| request and includes the procedure for maintaining appropriate |
8 |
| records for regulatory oversight for tracking a prescription |
9 |
| during each stage of the filling and dispensing process, and |
10 |
| (iii) the pharmacists involved in filling and dispensing the |
11 |
| prescription and counseling the patient are identified. A |
12 |
| pharmacist shall be accountable only for the specific tasks |
13 |
| performed. |
14 |
| Nothing in this Section shall prohibit a pharmacist who is |
15 |
| exercising his or her professional judgment from dispensing |
16 |
| additional quantities of medication up to the total number of |
17 |
| dosage units authorized by the prescriber on the original |
18 |
| prescription and any refills. |
19 |
| (Source: P.A. 85-796.)
|
20 |
| (225 ILCS 85/22) (from Ch. 111, par. 4142)
|
21 |
| (Section scheduled to be repealed on January 1, 2008)
|
22 |
| Sec. 22. Except only in the case of a drug, medicine or |
23 |
| poison
which is lawfully sold or dispensed, at retail, in the |
24 |
| original and
unbroken package of the manufacturer, packer, or |
25 |
| distributor thereof,
and which package bears the original label |
|
|
|
SB0509 Enrolled |
- 81 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| thereon showing the name
and address of the manufacturer, |
2 |
| packer, or distributor thereof, and
the name of the drug, |
3 |
| medicine, or poison therein contained, and the
directions for |
4 |
| its use, no person shall sell or dispense, at retail,
any drug, |
5 |
| medicine, or poison, without affixing to the box, bottle,
|
6 |
| vessel, or package containing the same, a label bearing the |
7 |
| name of
the article distinctly shown, and the directions for |
8 |
| its use, with
the name and address of the pharmacy wherein the |
9 |
| same is sold or dispensed.
However, in the case of a drug, |
10 |
| medicine, or poison which is sold or
dispensed pursuant to a |
11 |
| prescription of a physician licensed to practice
medicine in |
12 |
| all of its branches, licensed dentist, licensed veterinarian,
|
13 |
| licensed podiatrist, or therapeutically or diagnostically |
14 |
| certified
optometrist authorized by law to prescribe drugs or |
15 |
| medicines or poisons,
the label affixed to the box, bottle, |
16 |
| vessel, or package containing the
same shall show: (a) the name |
17 |
| and address of the pharmacy
wherein the same is sold or |
18 |
| dispensed; (b) the name or initials of
the person, authorized |
19 |
| to practice pharmacy under the provisions of
this Act, selling |
20 |
| or dispensing the same, (c) the date on which such
prescription |
21 |
| was filled; (d) the name of the patient; (e) the serial
number |
22 |
| of such prescription as filed in the prescription files; (f)
|
23 |
| the last name of the practitioner who prescribed such |
24 |
| prescriptions;
(g) the directions for use thereof as contained |
25 |
| in such prescription;
and (h) the proprietary name or names or |
26 |
| the established name or
names of the drugs, the dosage and |
|
|
|
SB0509 Enrolled |
- 82 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| quantity, except as otherwise authorized
by regulation of the |
2 |
| Department.
The Department shall establish rules governing |
3 |
| labeling in Division II and
Division III pharmacies.
|
4 |
| (Source: P.A. 92-880, eff. 1-1-04.)
|
5 |
| (225 ILCS 85/22a)
|
6 |
| (Section scheduled to be repealed on January 1, 2008)
|
7 |
| Sec. 22a. Automated dispensing and storage systems. The |
8 |
| Department shall
establish rules
governing the use of automated |
9 |
| dispensing and storage systems by Division I
through V |
10 |
| pharmacies .
|
11 |
| (Source: P.A. 90-253, eff. 7-29-97.)
|
12 |
| (225 ILCS 85/22b new)
|
13 |
| Sec. 22b. Automated pharmacy systems; remote dispensing.
|
14 |
| (a) Automated pharmacy systems must have adequate security |
15 |
| and procedures to comply with federal and State laws and |
16 |
| regulations and maintain patient confidentiality, as defined |
17 |
| by rule. |
18 |
| (b) Access to and dispensing from an automated pharmacy |
19 |
| system shall be limited to pharmacists or personnel who are |
20 |
| designated in writing by the pharmacist-in-charge and have |
21 |
| completed documented training concerning their duties |
22 |
| associated with the automated pharmacy system. |
23 |
| (c) All drugs stored in relation to an automated pharmacy |
24 |
| system must be stored in compliance with this Act and the rules |
|
|
|
SB0509 Enrolled |
- 83 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| adopted under this Act, including the requirements for |
2 |
| temperature, proper storage containers, handling of outdated |
3 |
| drugs, prescription dispensing, and delivery. |
4 |
| (d) An automated pharmacy system operated from a remote |
5 |
| site shall be under the continuous supervision of a home |
6 |
| pharmacy pharmacist. To qualify as continuous supervision, the |
7 |
| pharmacist is not required to be physically present at the site |
8 |
| of the automated pharmacy system if the system is supervised |
9 |
| electronically by a pharmacist, as defined by rule. |
10 |
| (e) Drugs may only be dispensed at a remote site through an |
11 |
| automated pharmacy system after receipt of an original |
12 |
| prescription drug order by a pharmacist at the home pharmacy. A |
13 |
| pharmacist at the home pharmacy must control all operations of |
14 |
| the automated pharmacy system and approve the release of the |
15 |
| initial dose of a prescription drug order. Refills from an |
16 |
| approved prescription drug order may be removed from the |
17 |
| automated medication system after this initial approval. Any |
18 |
| change made in the prescription drug order shall require a new |
19 |
| approval by a pharmacist to release the drug. |
20 |
| (f) If an automated pharmacy system uses removable |
21 |
| cartridges or containers to store a drug, the stocking or |
22 |
| restocking of the cartridges or containers may occur at a |
23 |
| licensed wholesale drug distributor and be sent to the home |
24 |
| pharmacy to be loaded after pharmacist verification by |
25 |
| personnel designated by the pharmacist, provided that the |
26 |
| individual cartridge or container is transported to the home |
|
|
|
SB0509 Enrolled |
- 84 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| pharmacy in a secure, tamper evident container. An automated |
2 |
| pharmacy system must use a bar code verification or weight |
3 |
| verification or electronic verification or similar process to |
4 |
| ensure that the cartridge or container is accurately loaded |
5 |
| into the automated pharmacy system. The pharmacist verifying |
6 |
| the filling and labeling shall be responsible for ensuring that |
7 |
| the cartridge or container is stocked or restocked correctly by |
8 |
| personnel designated to load the cartridges or containers. An |
9 |
| automated pharmacy system must use a bar code verification, |
10 |
| electronic, or similar process, as defined by rule, to ensure |
11 |
| that the proper medication is dispensed from the automated |
12 |
| system. A record of each transaction with the automated |
13 |
| pharmacy system must be maintained for 5 years. A prescription |
14 |
| dispensed from an automated pharmacy system shall be deemed to |
15 |
| have been approved by the pharmacist. No automated pharmacy |
16 |
| system shall be operated prior to inspection and approval by |
17 |
| the Department.
|
18 |
| (225 ILCS 85/25) (from Ch. 111, par. 4145)
|
19 |
| (Section scheduled to be repealed on January 1, 2008)
|
20 |
| Sec. 25. No person shall compound, or sell or offer for |
21 |
| sale, or
cause to be compounded, sold or offered for sale any |
22 |
| medicine or preparation
under or by a name recognized in the |
23 |
| United States Pharmacopoeia
National Formulary, for internal |
24 |
| or external use, which differs from
the standard of strength, |
25 |
| quality or purity as determined by the test
laid down in the |
|
|
|
SB0509 Enrolled |
- 85 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| United States Pharmacopoeia National Formulary official at
the |
2 |
| time
of
such compounding, sale or offering for sale. Nor shall |
3 |
| any person
compound, sell or offer for sale, or cause to be |
4 |
| compounded, sold,
or offered for sale, any drug, medicine, |
5 |
| poison, chemical or pharmaceutical
preparation, the strength |
6 |
| or purity of which shall fall below the professed
standard of |
7 |
| strength or purity under which it is sold. Except as set forth |
8 |
| in Section 26 of this Act, if the physician
or other authorized |
9 |
| prescriber, when transmitting an oral or written
prescription, |
10 |
| does not prohibit drug product selection, a different
brand |
11 |
| name or nonbrand name drug product of the same generic name may
|
12 |
| be dispensed by the pharmacist, provided that the selected drug
|
13 |
| has
a unit price less than the drug product specified in the |
14 |
| prescription.
A generic drug determined to be therapeutically |
15 |
| equivalent by the
United States Food and Drug Administration |
16 |
| (FDA) shall be
available for substitution in Illinois in |
17 |
| accordance with this
Act and the Illinois Food, Drug and |
18 |
| Cosmetic Act, provided that
each manufacturer submits to the |
19 |
| Director of the Department of Public Health a notification |
20 |
| containing product
technical bioequivalence information as a |
21 |
| prerequisite to product
substitution when they have completed |
22 |
| all required testing to
support FDA product approval and, in |
23 |
| any event, the information
shall be submitted no later than 60 |
24 |
| days prior to product
substitution in the State.
On the |
25 |
| prescription forms of prescribers,
shall be placed a signature |
26 |
| line and the words "may substitute" and
"may not substitute". |
|
|
|
SB0509 Enrolled |
- 86 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| The prescriber, in his or her own handwriting,
shall place a |
2 |
| mark beside either the "may substitute" or "may not substitute"
|
3 |
| alternatives to direct
guide the pharmacist in the dispensing |
4 |
| of the prescription.
A prescriber placing a mark beside the |
5 |
| "may substitute" alternative
or failing in his or her own |
6 |
| handwriting to place a mark beside either
alternative |
7 |
| authorizes drug product selection in accordance with this
Act.
|
8 |
| Preprinted or rubber stamped marks, or other deviations from
|
9 |
| the above prescription format shall not be permitted. The |
10 |
| prescriber
shall sign the form in his or her own handwriting to |
11 |
| authorize the
issuance of the prescription. When a person |
12 |
| presents a prescription
to be dispensed, the pharmacist to whom |
13 |
| it is presented may inform
the person if the pharmacy has |
14 |
| available a different brand name or
nonbrand name of the same |
15 |
| generic drug prescribed and the price of
the different brand |
16 |
| name or nonbrand name of the drug
product. If
the person |
17 |
| presenting the prescription is the one to whom the drug
is to |
18 |
| be administered, the pharmacist may dispense the prescription
|
19 |
| with the brand prescribed or a different brand name or nonbrand |
20 |
| name
product of the same generic name, if the drug is of lesser |
21 |
| unit cost and the
patient
is informed and agrees to the |
22 |
| selection and the pharmacist shall enter
such information into |
23 |
| the pharmacy record. If the person
presenting
the prescription |
24 |
| is someone other than the one to whom the drug is
to be |
25 |
| administered the pharmacist shall not dispense the |
26 |
| prescription
with a brand other than the one specified in the |
|
|
|
SB0509 Enrolled |
- 87 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| prescription unless
the pharmacist has the written or oral |
2 |
| authorization to select brands
from the person to whom the drug |
3 |
| is to be administered or a parent,
legal guardian or spouse of |
4 |
| that person.
|
5 |
| In every case in which a selection is made as permitted by |
6 |
| the Illinois
Food, Drug and Cosmetic Act, the pharmacist shall |
7 |
| indicate on the pharmacy
record of the filled prescription the |
8 |
| name or other identification
of the manufacturer of the drug |
9 |
| which has been dispensed.
|
10 |
| The selection of any drug product by a pharmacist shall not |
11 |
| constitute
evidence of negligence if the selected nonlegend |
12 |
| drug product was of
the same dosage form and each of its active |
13 |
| ingredients did not vary
by more than 1 percent from the active |
14 |
| ingredients of the prescribed,
brand name, nonlegend drug |
15 |
| product. Failure of a prescribing
physician to specify that |
16 |
| drug product selection is prohibited does not
constitute |
17 |
| evidence of negligence
unless that practitioner has reasonable |
18 |
| cause to believe that the health
condition of the patient for |
19 |
| whom the physician is prescribing warrants
the use of the brand |
20 |
| name drug product and not another.
|
21 |
| The Department is authorized to employ an analyst or |
22 |
| chemist of recognized
or approved standing whose duty it shall |
23 |
| be to examine into any claimed
adulteration, illegal |
24 |
| substitution, improper selection, alteration,
or other |
25 |
| violation hereof, and report the result of his investigation,
|
26 |
| and if such report justify such action the Department shall |
|
|
|
SB0509 Enrolled |
- 88 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| cause the
offender to be prosecuted.
|
2 |
| (Source: P.A. 93-841, eff. 7-30-04; 94-936, eff. 6-26-06.)
|
3 |
| (225 ILCS 85/25.5 new)
|
4 |
| Sec. 25.5. Centralized prescription filling. |
5 |
| (a) In this Section, "centralized prescription filling" |
6 |
| means the filling of a prescription by one pharmacy upon |
7 |
| request by another pharmacy to fill or refill the prescription. |
8 |
| "Centralized prescription filling" includes the performance by |
9 |
| one pharmacy for another pharmacy of other pharmacy duties such |
10 |
| as drug utilization review, therapeutic drug utilization |
11 |
| review, claims adjudication, and the obtaining of refill |
12 |
| authorizations. |
13 |
| (b) A pharmacy licensed under this Act may perform |
14 |
| centralized prescription filling for another pharmacy, |
15 |
| provided that both pharmacies have the same owner or have a |
16 |
| written contract specifying (i) the services to be provided by |
17 |
| each pharmacy, (ii) the responsibilities of each pharmacy, and |
18 |
| (iii) the manner in which the pharmacies shall comply with |
19 |
| federal and State laws, rules, and regulations. |
20 |
| (225 ILCS 85/25.10 new)
|
21 |
| Sec. 25.10. Remote prescription processing. |
22 |
| (a) In this Section, "remote prescription processing" |
23 |
| means and includes the outsourcing of certain prescription |
24 |
| functions to another pharmacy or licensed non-resident |
|
|
|
SB0509 Enrolled |
- 89 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| pharmacy, including the dispensing of drugs. "Remote |
2 |
| prescription processing" includes any of the following |
3 |
| activities related to the dispensing process: |
4 |
| (1) Receiving, interpreting, evaluating, or clarifying |
5 |
| prescriptions. |
6 |
| (2) Entering prescription and patient data into a data |
7 |
| processing system. |
8 |
| (3) Transferring prescription information. |
9 |
| (4) Performing a drug regimen review. |
10 |
| (5) Obtaining refill or substitution authorizations or |
11 |
| otherwise communicating with the prescriber concerning a |
12 |
| patient's prescription. |
13 |
| (6) Evaluating clinical data for prior authorization |
14 |
| for dispensing. |
15 |
| (7) Discussing therapeutic interventions with |
16 |
| prescribers. |
17 |
| (8) Providing drug information or counseling |
18 |
| concerning a patient's prescription to the patient or |
19 |
| patient's agent, as defined in this Act. |
20 |
| (b) A pharmacy may engage in remote prescription processing |
21 |
| under the following conditions: |
22 |
| (1) The pharmacies shall either have the same owner or |
23 |
| have a written contract describing the scope of services to |
24 |
| be provided and the responsibilities and accountabilities |
25 |
| of each pharmacy in compliance with all federal and State |
26 |
| laws and regulations related to the practice of pharmacy. |
|
|
|
SB0509 Enrolled |
- 90 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (2) The pharmacies shall share a common electronic file |
2 |
| or have technology that allows sufficient information |
3 |
| necessary to process a non-dispensing function. |
4 |
| (3) The records may be maintained separately by each |
5 |
| pharmacy or in common electronic file shared by both |
6 |
| pharmacies, provided that the system can produce a record |
7 |
| at either location showing each processing task, the |
8 |
| identity of the person performing each task, and the |
9 |
| location where each task was performed. |
10 |
| (c) Nothing in this Section shall prohibit an individual |
11 |
| employee licensed as a pharmacist from accessing the employer |
12 |
| pharmacy's database from a pharmacist's home or other remote |
13 |
| location or home verification for the purpose of performing |
14 |
| certain prescription processing functions, provided that the |
15 |
| pharmacy establishes controls to protect the privacy and |
16 |
| security of confidential records. |
17 |
| (225 ILCS 85/25.15 new)
|
18 |
| Sec. 25.15. Telepharmacy.
|
19 |
| (a) In this Section, "telepharmacy" means the provision of |
20 |
| pharmacist care by a pharmacist that is accomplished through
|
21 |
| the use of telecommunications or other technologies to patients
|
22 |
| or their agents who are at a distance and are located within |
23 |
| the
United States, and which follows all federal and State |
24 |
| laws, rules,
and regulations with regard to privacy and |
25 |
| security. |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| (b) Any pharmacy engaged in the practice of telepharmacy |
2 |
| must meet all of the following conditions:
|
3 |
| (1) All events involving the contents of an
automated |
4 |
| pharmacy system must be stored in a secure location
and may |
5 |
| be recorded electronically. |
6 |
| (2) An automated pharmacy or prescription dispensing |
7 |
| machine system may be used in
conjunction with the |
8 |
| pharmacy's practice of telepharmacy after inspection and |
9 |
| approval by the Department. |
10 |
| (3) The pharmacist in charge shall: |
11 |
| (A) be responsible for the practice of |
12 |
| telepharmacy
performed at a remote pharmacy, including |
13 |
| the supervision of any
prescription dispensing machine |
14 |
| or automated medication system; |
15 |
| (B) ensure that the home pharmacy has
sufficient |
16 |
| pharmacists on duty for the safe operation and
|
17 |
| supervision of all remote pharmacies; |
18 |
| (C) ensure, through the use of a video and auditory
|
19 |
| communication system, that a certified pharmacy |
20 |
| technician at the remote
pharmacy has accurately and |
21 |
| correctly prepared any prescription for
dispensing |
22 |
| according to the prescription; |
23 |
| (D) be responsible for the supervision and |
24 |
| training of
certified pharmacy technicians at remote |
25 |
| pharmacies who shall be subject to
all rules and |
26 |
| regulations; and |
|
|
|
SB0509 Enrolled |
- 92 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (E) ensure that patient counseling at the remote |
2 |
| pharmacy is
performed by a pharmacist or pharmacist |
3 |
| intern. |
4 |
| (225 ILCS 85/25.20 new)
|
5 |
| Sec. 25.20. Electronic visual image prescriptions. If a |
6 |
| pharmacy's computer system can capture an unalterable |
7 |
| electronic visual image of the prescription drug order, the |
8 |
| electronic image shall constitute the original prescription |
9 |
| and a hard copy of the prescription drug order is not required. |
10 |
| The computer system must be capable of maintaining, printing, |
11 |
| and providing, upon a request by the Department, the |
12 |
| Department's compliance officers, and other authorized agents, |
13 |
| all of the prescription information required by State law and |
14 |
| regulations of the Department within 72 hours of the request. |
15 |
| (225 ILCS 85/26)
|
16 |
| (Section scheduled to be repealed on January 1, 2008) |
17 |
| Sec. 26. Anti-epileptic drug product selection prohibited.
|
18 |
| (a) The General Assembly finds that this Section is |
19 |
| necessary for the immediate preservation of the public peace, |
20 |
| health, and safety. |
21 |
| (b) In this Section: |
22 |
| "Anti-epileptic drug means (i) any drug prescribed for the |
23 |
| treatment of epilepsy or (ii) a drug used to treat or prevent |
24 |
| seizures. |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| "Epilepsy" means a neurological condition characterized by |
2 |
| recurrent seizures. |
3 |
| "Seizure" means a brief disturbance in the electrical |
4 |
| activity of the brain. |
5 |
| (c) When the prescribing physician has indicated on the |
6 |
| original prescription "dispense as written" or "may not |
7 |
| substitute", a pharmacist may not interchange an |
8 |
| anti-epileptic drug or formulation of an anti-epileptic drug |
9 |
| for the treatment of epilepsy without notification and the |
10 |
| documented consent of the prescribing physician and the patient |
11 |
| or the patient's parent, legal guardian, or spouse.
This |
12 |
| Section does not apply to medication orders issued for |
13 |
| anti-epileptic drugs for any in-patient care in a licensed |
14 |
| hospital.
|
15 |
| (Source: P.A. 94-936, eff. 6-26-06.)
|
16 |
| (225 ILCS 85/27) (from Ch. 111, par. 4147)
|
17 |
| (Section scheduled to be repealed on January 1, 2008)
|
18 |
| Sec. 27. Fees. |
19 |
| (a) The Department shall, by rule, provide for a schedule |
20 |
| of fees to be paid for licenses and certificates. These fees |
21 |
| shall be for the administration and enforcement of this Act, |
22 |
| including without limitation original licensure and renewal |
23 |
| and restoration of licensure. All fees are nonrefundable. |
24 |
| (b) Applicants
The following fees are not refundable. (A) |
25 |
| Certificate of pharmacy technician.
(1) The fee for application |
|
|
|
SB0509 Enrolled |
- 94 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| for a certificate of registration as a
pharmacy technician is |
2 |
| $40.
(2) The fee for the renewal of a certificate of |
3 |
| registration as a
pharmacy technician shall be calculated at |
4 |
| the rate of $25 per year. (B) License as a pharmacist.
(1) The |
5 |
| fee for application for a license is $75.
(2) In addition, |
6 |
| applicants for any examination as a registered pharmacist
shall |
7 |
| be required to pay, either to the Department or to the |
8 |
| designated
testing service, a fee covering the cost of |
9 |
| determining an applicant's
eligibility and providing the |
10 |
| examination. Failure to appear for the
examination on the |
11 |
| scheduled date, at the time and place specified,
after the |
12 |
| applicant's application for examination has been received
and |
13 |
| acknowledged by the Department or the designated testing |
14 |
| service,
shall result in the forfeiture of the examination fee.
|
15 |
| (3) The fee for a license as a registered pharmacist |
16 |
| registered or
licensed under the laws of another state or |
17 |
| territory of the United
States is $200.
|
18 |
| (4) The fee upon the renewal of a license shall be |
19 |
| calculated at the
rate of $75 per year.
|
20 |
| (5) The fee for the restoration of a certificate other |
21 |
| than from inactive
status is $10 plus all lapsed renewal |
22 |
| fees.
|
23 |
| (c)
(6) Applicants for the preliminary diagnostic |
24 |
| examination shall be
required to pay, either to the Department |
25 |
| or to the designated testing
service, a fee covering the cost |
26 |
| of determining an applicant's eligibility
and providing the |
|
|
|
SB0509 Enrolled |
- 95 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| examination. Failure to appear for the examination
on the |
2 |
| scheduled date, at the time and place specified, after the |
3 |
| application
for examination has been received and acknowledged |
4 |
| by the Department
or the designated testing service, shall |
5 |
| result in the forfeiture of
the examination fee.
|
6 |
| (7) The fee to have the scoring of an examination |
7 |
| authorized by the
Department reviewed and verified is $20 |
8 |
| plus any fee charged by the
applicable testing service.
|
9 |
| (C) License as a pharmacy.
|
10 |
| (1) The fee for application for a license for a |
11 |
| pharmacy under this
Act is $100.
|
12 |
| (2) The fee for the renewal of a license for a pharmacy |
13 |
| under this
Act shall be calculated at the rate of $100 per |
14 |
| year.
|
15 |
| (3) The fee for the change of a pharmacist-in-charge is |
16 |
| $25.
|
17 |
| (D) General Fees.
|
18 |
| (1) The fee for the issuance of a duplicate license, |
19 |
| for the issuance
of a replacement license for a license |
20 |
| that has been lost or destroyed
or for the issuance of a |
21 |
| license with a change of name or address other
than during |
22 |
| the renewal period is $20. No fee is required for name
and |
23 |
| address changes on Department records when no duplicate |
24 |
| certification
is issued .
|
25 |
| (2) The fee for a certification of a registrant's |
26 |
| record for any purpose
is $20.
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| (3) The fee to have the scoring of an examination |
2 |
| administered by
the Department reviewed and verified is |
3 |
| $20.
|
4 |
| (4) The fee for a wall certificate showing licensure or |
5 |
| registration
shall be the actual cost of producing the |
6 |
| certificate.
|
7 |
| (5) The fee for a roster of persons registered as |
8 |
| pharmacists or
registered pharmacies in this State shall be |
9 |
| the actual cost of producing
the roster.
|
10 |
| (6) The fee for pharmacy licensing, disciplinary or |
11 |
| investigative
records obtained pursuant to a subpoena is $1 |
12 |
| per page.
|
13 |
| (d) All fees, fines, or penalties
(E) Except as provided in |
14 |
| subsection (F), all moneys received by the
Department under |
15 |
| this Act shall be deposited in the Illinois State Pharmacy
|
16 |
| Disciplinary Fund hereby created in the State Treasury and |
17 |
| shall be used
by the Department in the exercise of its powers |
18 |
| and performance of its duties under this Act, including, but |
19 |
| not limited to, the provision for evidence in pharmacy |
20 |
| investigations.
only for the following purposes: (a) by the |
21 |
| State Board of Pharmacy in the
exercise of its powers and |
22 |
| performance of its duties, as such use is made
by the |
23 |
| Department upon the recommendations of the State Board of |
24 |
| Pharmacy,
(b) for costs directly related to license renewal of |
25 |
| persons licensed
under this Act, and (c) for direct and |
26 |
| allocable indirect costs related to
the public purposes of the |
|
|
|
SB0509 Enrolled |
- 97 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| Department of Professional Regulation.
|
2 |
| Moneys in the Fund may be transferred to the Professions |
3 |
| Indirect Cost Fund
as authorized under Section 2105-300 of the |
4 |
| Department of
Professional Regulation Law (20 ILCS |
5 |
| 2105/2105-300).
|
6 |
| The moneys deposited in the Illinois State Pharmacy
|
7 |
| Disciplinary Fund shall be invested to earn interest which |
8 |
| shall accrue to
the Fund. The Department shall present to the |
9 |
| Board for its review and
comment all appropriation requests |
10 |
| from the Illinois State Pharmacy
Disciplinary Fund. The |
11 |
| Department shall give due consideration to any
comments of the |
12 |
| Board in making appropriation requests.
|
13 |
| (e)
(F) From the money received for license renewal fees, |
14 |
| $5 from each
pharmacist fee, and $2.50 from each pharmacy |
15 |
| technician fee, shall be set aside
within the Illinois State |
16 |
| Pharmacy Disciplinary
Fund for the purpose of supporting a |
17 |
| substance abuse program for
pharmacists and pharmacy |
18 |
| technicians. |
19 |
| (f) A pharmacy, manufacturer of controlled substances, or |
20 |
| wholesale distributor of controlled substances that is |
21 |
| licensed under this Act and owned and operated by the State is |
22 |
| exempt from licensure, registration, renewal, and other fees |
23 |
| required under this Act. |
24 |
| Pharmacists and pharmacy technicians working in facilities |
25 |
| owned and operated by the State are not exempt from the payment |
26 |
| of fees required by this Act and any rules adopted under this |
|
|
|
SB0509 Enrolled |
- 98 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| Act. |
2 |
| Nothing in this subsection (f) shall be construed to |
3 |
| prohibit the Department from imposing any fine or other penalty |
4 |
| allowed under this Act.
The State Board of Pharmacy shall,
|
5 |
| pursuant to all provisions of the Illinois Procurement Code, |
6 |
| determine how
and to whom
the money set aside under this |
7 |
| subsection is disbursed.
|
8 |
| (G) (Blank).
|
9 |
| (Source: P.A. 91-239, eff. 1-1-00; 92-880, eff. 1-1-04.)
|
10 |
| (225 ILCS 85/30) (from Ch. 111, par. 4150)
|
11 |
| (Section scheduled to be repealed on January 1, 2008)
|
12 |
| Sec. 30. (a) In accordance with Section 11 of this Act, the |
13 |
| Department
may refuse to issue, restore, or renew, or may |
14 |
| revoke, suspend, place on
probation, or reprimand or take other |
15 |
| disciplinary action as the Department
may deem proper with |
16 |
| regard to any license or certificate of registration
or may |
17 |
| impose a fine upon a licensee or registrant not to exceed |
18 |
| $10,000 per violation for any one or combination of the |
19 |
| following causes:
|
20 |
| 1. Material misstatement in furnishing information to |
21 |
| the Department.
|
22 |
| 2. Violations of this Act, or the rules promulgated |
23 |
| hereunder.
|
24 |
| 3. Making any misrepresentation for the purpose of |
25 |
| obtaining licenses.
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| 4. A pattern of conduct which demonstrates |
2 |
| incompetence or unfitness
to practice.
|
3 |
| 5. Aiding or assisting another person in violating any |
4 |
| provision of
this Act or rules.
|
5 |
| 6. Failing, within 60 days, to respond to a written |
6 |
| request made by
the Department for information.
|
7 |
| 7. Engaging in dishonorable or , unethical or |
8 |
| unprofessional conduct of
a character likely to deceive, |
9 |
| defraud or harm the public.
|
10 |
| 8. Discipline by another U.S. jurisdiction or foreign |
11 |
| nation, if at
least one of the grounds for the discipline |
12 |
| is the same or substantially
equivalent to those set forth |
13 |
| herein.
|
14 |
| 9. Directly or indirectly giving to or receiving from |
15 |
| any person, firm,
corporation, partnership or association |
16 |
| any fee, commission, rebate
or other form of compensation |
17 |
| for any professional services not actually
or personally |
18 |
| rendered.
|
19 |
| 10. A finding by the Department that the licensee, |
20 |
| after having his
license placed on probationary status has |
21 |
| violated the terms of probation.
|
22 |
| 11. Selling or engaging in the sale of drug samples |
23 |
| provided at no
cost by drug manufacturers.
|
24 |
| 12. Physical illness, including but not limited to, |
25 |
| deterioration through
the aging process, or loss of motor |
26 |
| skill which results in the inability
to practice the |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| profession with reasonable judgment, skill or safety.
|
2 |
| 13. A finding that licensure or registration has been |
3 |
| applied for or
obtained by fraudulent means.
|
4 |
| 14. The applicant , or licensee has been convicted in |
5 |
| state or federal
court of or entered a plea of guilty, nolo |
6 |
| contendere, or the equivalent in a state or federal court |
7 |
| to any crime which is a felony or any misdemeanor related |
8 |
| to
the practice of pharmacy, of which an essential element |
9 |
| is dishonesty.
|
10 |
| 15. Habitual or excessive use or addiction to alcohol, |
11 |
| narcotics, stimulants
or any other chemical agent or drug |
12 |
| which results in the inability
to practice with reasonable |
13 |
| judgment, skill or safety.
|
14 |
| 16. Willfully making or filing false records or reports |
15 |
| in the practice
of pharmacy, including, but not limited to |
16 |
| false records to support
claims against the medical |
17 |
| assistance program of the Department of Healthcare and |
18 |
| Family Services (formerly Department of
Public Aid ) under |
19 |
| the Public Aid Code.
|
20 |
| 17. Gross and willful overcharging for professional |
21 |
| services including
filing false statements for collection |
22 |
| of fees for which services are
not rendered, including, but |
23 |
| not limited to, filing false statements
for collection of |
24 |
| monies for services not rendered from the medical
|
25 |
| assistance program of the Department of Healthcare and |
26 |
| Family Services (formerly Department of Public Aid ) under |
|
|
|
SB0509 Enrolled |
- 101 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| the Public Aid Code.
|
2 |
| 18. Repetitiously dispensing prescription drugs |
3 |
| without receiving a
written or oral prescription.
|
4 |
| 19. Upon a finding of a substantial discrepancy in a |
5 |
| Department audit
of a prescription drug, including |
6 |
| controlled substances, as that term
is defined in this Act |
7 |
| or in the Illinois Controlled Substances Act.
|
8 |
| 20. Physical or mental illness or any other impairment |
9 |
| or disability, including without limitation deterioration |
10 |
| through the aging process or loss of motor skills that
|
11 |
| which results in the inability to practice with
reasonable |
12 |
| judgment, skill or safety, or mental incompetence,
|
13 |
| incompetency as declared
by a court of competent |
14 |
| jurisdiction.
|
15 |
| 21. Violation of the Health Care Worker Self-Referral |
16 |
| Act.
|
17 |
| 22. Failing to sell or dispense any drug, medicine, or |
18 |
| poison in good
faith. "Good faith", for the purposes of |
19 |
| this Section, has the meaning
ascribed
to it in subsection |
20 |
| (u) of Section 102 of the Illinois Controlled Substances
|
21 |
| Act.
|
22 |
| 23. Interfering with the professional judgment of a |
23 |
| pharmacist by
any registrant under this Act, or his or her |
24 |
| agents or employees.
|
25 |
| 24. Failing to report within 60 days to the Department
|
26 |
| any adverse final action taken against a pharmacist, |
|
|
|
SB0509 Enrolled |
- 102 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| pharmacist technician, or certified pharmacist technician |
2 |
| by another licensing jurisdiction in any other state or any |
3 |
| territory of the United States or any foreign jurisdiction, |
4 |
| any governmental agency, any law enforcement agency, or any |
5 |
| court for acts or conduct similar to acts or conduct that |
6 |
| would constitute grounds for discipline as defined in this |
7 |
| Section. |
8 |
| 25. Failing to comply with a subpoena issued in |
9 |
| accordance with Section 35.5 of this Act.
|
10 |
| (b) The Department may refuse to issue or may suspend the |
11 |
| license or
registration of any person who fails to file a |
12 |
| return, or to pay the tax,
penalty or interest shown in a filed |
13 |
| return, or to pay any final assessment
of tax, penalty or |
14 |
| interest, as required by any tax Act administered by the
|
15 |
| Illinois Department of Revenue, until such time as the |
16 |
| requirements of any
such tax Act are satisfied.
|
17 |
| (c) The Department shall revoke the license or certificate |
18 |
| of
registration issued under the provisions of this Act or any |
19 |
| prior Act of
this State of any person who has been convicted a |
20 |
| second time of committing
any felony under the Illinois |
21 |
| Controlled Substances Act, or who
has been convicted a second |
22 |
| time of committing a Class 1 felony under
Sections 8A-3 and |
23 |
| 8A-6 of the Illinois Public Aid Code. A
person whose license or |
24 |
| certificate of registration issued under the
provisions of this |
25 |
| Act or any prior Act of this State is revoked under this
|
26 |
| subsection (c) shall be prohibited from engaging in the |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| practice of
pharmacy in this State.
|
2 |
| (d) The Department may adopt rules for the imposition of |
3 |
| fines in disciplinary cases, not to exceed $10,000 for each |
4 |
| violation of this Act. Fines may be imposed in conjunction with |
5 |
| other forms of disciplinary action, but shall not be the |
6 |
| exclusive disposition of any disciplinary action arising out of |
7 |
| conduct resulting in death or injury to a patient. Any funds |
8 |
| collected from such fines shall be deposited in the Illinois |
9 |
| State Pharmacy Disciplinary Fund.
In any order issued in |
10 |
| resolution of a disciplinary proceeding,
the Board may request |
11 |
| any licensee found guilty of a charge involving a
significant |
12 |
| violation of subsection (a) of Section 5, or paragraph 19 of
|
13 |
| Section 30 as it pertains to controlled substances, to pay to |
14 |
| the
Department a fine not to exceed $2,000.
|
15 |
| (e) The entry of an order or judgment by any circuit court |
16 |
| establishing that any person holding a license or certificate |
17 |
| under this Act is a person in need of mental treatment operates |
18 |
| as a suspension of that license. A licensee may resume his or |
19 |
| her practice only upon the entry of an order of the Department |
20 |
| based upon a finding by the Board that he or she has been |
21 |
| determined to be recovered from mental illness by the court and |
22 |
| upon the Board's recommendation that the licensee be permitted |
23 |
| to resume his or her practice.
In any order issued in |
24 |
| resolution of a disciplinary proceeding, in
addition to any |
25 |
| other disciplinary action, the Board may request any
licensee |
26 |
| found guilty of noncompliance with the continuing education
|
|
|
|
SB0509 Enrolled |
- 104 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| requirements of Section 12 to pay the Department a fine not to |
2 |
| exceed $1000.
|
3 |
| (f) The Department shall issue quarterly to the Board a |
4 |
| status of all
complaints related to the profession received by |
5 |
| the Department.
|
6 |
| (g) In enforcing this Section, the Board or the Department, |
7 |
| upon a showing of a possible violation, may compel any licensee |
8 |
| or applicant for licensure under this Act to submit to a mental |
9 |
| or physical examination or both, as required by and at the |
10 |
| expense of the Department. The examining physician shall be |
11 |
| those specifically designated by the Department. The Board or |
12 |
| the Department may order the examining physician to present |
13 |
| testimony concerning this mental or physical examination of the |
14 |
| licensee or applicant. No information shall be excluded by |
15 |
| reason of any common law or statutory privilege relating to |
16 |
| communication between the licensee or applicant and the |
17 |
| examining physician. The individual to be examined may have, at |
18 |
| his or her own expense, another physician of his or her choice |
19 |
| present during all aspects of the examination. Failure of any |
20 |
| individual to submit to a mental or physical examination when |
21 |
| directed shall be grounds for suspension of his or her license |
22 |
| until such time as the individual submits to the examination if |
23 |
| the Board finds, after notice and hearing, that the refusal to |
24 |
| submit to the examination was without reasonable cause. If the |
25 |
| Board finds a pharmacist or pharmacy technician unable to |
26 |
| practice because of the reasons set forth in this Section, the |
|
|
|
SB0509 Enrolled |
- 105 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| Board shall require such pharmacist or pharmacy technician to |
2 |
| submit to care, counseling, or treatment by physicians approved |
3 |
| or designated by the Board as a condition for continued, |
4 |
| reinstated, or renewed licensure to practice. Any pharmacist or |
5 |
| pharmacy technician whose license was granted, continued, |
6 |
| reinstated, renewed, disciplined, or supervised, subject to |
7 |
| such terms, conditions, or restrictions, and who fails to |
8 |
| comply with such terms, conditions, or restrictions or to |
9 |
| complete a required program of care, counseling, or treatment, |
10 |
| as determined by the chief pharmacy coordinator or a deputy |
11 |
| pharmacy coordinator, shall be referred to the Secretary for a |
12 |
| determination as to whether the licensee shall have his or her |
13 |
| license suspended immediately, pending a hearing by the Board. |
14 |
| In instances in which the Secretary immediately suspends a |
15 |
| license under this subsection (g), a hearing upon such person's |
16 |
| license must be convened by the Board within 15 days after such |
17 |
| suspension and completed without appreciable delay. The Board |
18 |
| shall have the authority to review the subject pharmacist's or |
19 |
| pharmacy technician's record of treatment and counseling |
20 |
| regarding the impairment.
|
21 |
| (Source: P.A. 92-880, eff. 1-1-04; revised 12-15-05.)
|
22 |
| (225 ILCS 85/35.1) (from Ch. 111, par. 4155.1)
|
23 |
| (Section scheduled to be repealed on January 1, 2008)
|
24 |
| Sec. 35.1. (a) If any person violates the provision of this |
25 |
| Act,
the
Director may, in the name of the People of the State |
|
|
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|
1 |
| of Illinois, through the
Attorney General of the State of |
2 |
| Illinois, or the State's Attorney
of any county in which the |
3 |
| action is brought, petition, for an order
enjoining such |
4 |
| violation or for an order enforcing compliance with
this Act. |
5 |
| Upon the filing of a verified petition in such court, the
court |
6 |
| may issue a temporary restraining order, without notice or |
7 |
| bond,
and may preliminarily and permanently enjoin such |
8 |
| violation, and if
it is established that such person has |
9 |
| violated or is violating the
injunction, the Court may punish |
10 |
| the offender for contempt of court.
Proceedings under this |
11 |
| Section shall be in addition to, and not in
lieu of, all other |
12 |
| remedies and penalties provided by this Act.
|
13 |
| (b) If any person shall practice as a pharmacist or hold |
14 |
| himself
out
as a pharmacist or operate a pharmacy or drugstore, |
15 |
| including a nonresident
mail-order
pharmacy under Section 16a, |
16 |
| without being licensed under the provisions of
this
Act, then |
17 |
| any licensed pharmacist, any interested party or any person
|
18 |
| injured thereby may, in addition to the Director, petition for |
19 |
| relief
as provided in subsection (a) of this Section.
|
20 |
| Whoever knowingly practices or offers to practice in this |
21 |
| State without
being appropriately licensed or registered under |
22 |
| this Act shall be guilty
of a Class A misdemeanor and for each |
23 |
| subsequent conviction, shall
be guilty of a Class 4 felony.
|
24 |
| (c) Whenever in the opinion of the Department any person |
25 |
| not
licensed
in good standing under this Act violates any |
26 |
| provision of this Act,
the Department may issue a rule to show |
|
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|
1 |
| cause why an order to cease
and desist should not be entered |
2 |
| against him. The rule shall clearly
set forth the grounds |
3 |
| relied upon by the Department and shall provide
a period of 7 |
4 |
| days from the date of the rule to file an answer to the
|
5 |
| satisfaction of the Department. Failure to answer to the |
6 |
| satisfaction
of the Department shall cause an order to cease |
7 |
| and desist to be issued
forthwith.
|
8 |
| (Source: P.A. 92-678, eff. 7-16-02.)
|
9 |
| (225 ILCS 85/35.2) (from Ch. 111, par. 4155.2)
|
10 |
| (Section scheduled to be repealed on January 1, 2008)
|
11 |
| Sec. 35.2. The Department's pharmacy investigators
may |
12 |
| investigate the actions of any applicant or of any person or |
13 |
| persons
holding or claiming to hold a license or registration. |
14 |
| The Department
shall, before suspending, revoking, placing on |
15 |
| probationary status,
or taking any other disciplinary action as |
16 |
| the Department may deem
proper with regard to any license or |
17 |
| certificate, at least 30 days
prior to the date set for the |
18 |
| hearing, notify the accused in writing
of any charges made and |
19 |
| the time and place for a hearing of the charges
before the |
20 |
| Board, direct him or her to file his or her written answer |
21 |
| thereto to
the Board under oath within 20 days after the |
22 |
| service on him or her of such
notice and inform him or her that |
23 |
| if he or she fails to file such answer default
will be taken |
24 |
| against him or her and his or her license or certificate may be |
25 |
| suspended,
revoked, placed on probationary status, or have |
|
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| other disciplinary
action, including limiting the scope, |
2 |
| nature or extent of his or her practice,
provided for herein. |
3 |
| Such written notice may be served by personal
delivery or |
4 |
| certified or registered mail to the respondent at his or her
|
5 |
| the address
of record
his last notification to the Department . |
6 |
| At the time and place
fixed in the notice, the Board shall |
7 |
| proceed to hear the charges and
the parties or their counsel |
8 |
| shall be accorded ample opportunity to
present such statements, |
9 |
| testimony, evidence and argument as may be
pertinent to the |
10 |
| charges or to the defense thereto. Such hearing may
be |
11 |
| continued from time to time. In case the accused person, after
|
12 |
| receiving notice, fails to file an answer, his or her license |
13 |
| or certificate
may in the discretion of the Director, having |
14 |
| received first the recommendation
of the Board, be suspended, |
15 |
| revoked, placed on probationary status,
or the Director may |
16 |
| take whatever disciplinary action as he or she may deem
proper |
17 |
| as provided herein, including limiting the scope, nature, or
|
18 |
| extent of said person's practice, without a hearing, if the act |
19 |
| or
acts charged constitute sufficient grounds for such action |
20 |
| under this
Act.
|
21 |
| (Source: P.A. 88-428.)
|
22 |
| (225 ILCS 85/35.5) (from Ch. 111, par. 4155.5)
|
23 |
| (Section scheduled to be repealed on January 1, 2008)
|
24 |
| Sec. 35.5. The Department shall have power to subpoena
and |
25 |
| bring before it any person in this State and to take testimony,
|
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| either orally or by deposition or both, with the same fees and |
2 |
| mileage
and in the same manner as prescribed by law in judicial |
3 |
| proceedings
in civil cases in circuit courts of this State. The |
4 |
| Department may subpoena and compel the production of documents, |
5 |
| papers, files, books, and records in connection with any |
6 |
| hearing or investigation.
|
7 |
| The Director, and any member of the Board, shall each have |
8 |
| power to
administer oaths to witnesses at any hearing which the |
9 |
| Department is
authorized to conduct under this Act, and any |
10 |
| other oaths required
or authorized to be administered by the |
11 |
| Department hereunder.
|
12 |
| (Source: P.A. 85-796.)
|
13 |
| (225 ILCS 85/35.7) (from Ch. 111, par. 4155.7)
|
14 |
| (Section scheduled to be repealed on January 1, 2008)
|
15 |
| Sec. 35.7. Notwithstanding
the provisions of Section 35.6 |
16 |
| of this Act, the Director shall have
the authority to appoint |
17 |
| any attorney duly licensed to practice law
in the State of |
18 |
| Illinois to serve as the hearing officer in any action
before |
19 |
| the Board for refusal to issue, renew, or discipline of a |
20 |
| license
or certificate. The Director shall notify the Board of |
21 |
| any such appointment.
The hearing officer shall have full |
22 |
| authority to conduct the hearing.
There shall be present at |
23 |
| least one member of the Board at any such
hearing. The hearing |
24 |
| officer shall report his findings of fact, conclusions
of law |
25 |
| and recommendations to the Board and the Director. The Board
|
|
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| shall have 60 days from receipt of the report to review the |
2 |
| report
of the hearing officer and present their findings of |
3 |
| fact, conclusions
of law, and recommendations to the Director. |
4 |
| If the Board fails to
present its report within the 60 day |
5 |
| period, the respondent may request in writing a direct appeal |
6 |
| to the Secretary, in which case the Secretary shall, within 7 |
7 |
| calendar days after the request, issue an order directing the |
8 |
| Board to issue its findings of fact, conclusions of law, and |
9 |
| recommendations to the Secretary within 30 calendar days after |
10 |
| such order. If the Board fails to issue its findings of fact, |
11 |
| conclusions of law, and recommendations within that time frame |
12 |
| to the Secretary after the entry of such order, the Secretary |
13 |
| shall, within 30 calendar days thereafter, issue an order based |
14 |
| upon the report of the hearing officer and the record of the |
15 |
| proceedings or issue an order remanding the matter back to the |
16 |
| hearing officer for additional proceedings in accordance with |
17 |
| the order. If (i) a direct appeal is requested, (ii) the Board |
18 |
| fails to issue its findings of fact, conclusions of law, and |
19 |
| recommendations within the 30-day mandate from the Secretary or |
20 |
| the Secretary fails to order the Board to do so, and (iii) the |
21 |
| Secretary fails to issue an order within 30 calendar days |
22 |
| thereafter, then the hearing officer's report is deemed |
23 |
| accepted and a final decision of the Secretary. Notwithstanding |
24 |
| any other provision of this Section, if the Secretary, upon |
25 |
| review, determines that substantial justice has not been done |
26 |
| in the revocation, suspension, or refusal to issue or renew a |
|
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| license or other disciplinary action taken as the result of the |
2 |
| entry of the hearing officer's report, the Secretary may order |
3 |
| a rehearing by the same or other examiners. If the Secretary |
4 |
| disagrees with the recommendation of the Board or the hearing |
5 |
| officer, the Secretary may issue an order in contravention of |
6 |
| the recommendation.
the Director may issue
an order based on |
7 |
| the report of the hearing officer. However, if the
Board does |
8 |
| present its report within the specified 60 days, the Director's
|
9 |
| order shall be based upon the report of the Board.
|
10 |
| (Source: P.A. 85-796.)
|
11 |
| (225 ILCS 85/35.10) (from Ch. 111, par. 4155.10)
|
12 |
| (Section scheduled to be repealed on January 1, 2008)
|
13 |
| Sec. 35.10. None of the disciplinary functions, powers and |
14 |
| duties
enumerated in this Act shall be exercised by the |
15 |
| Department except
upon the review
action and report in writing
|
16 |
| of the Board.
|
17 |
| In all instances, under this Act, in which the Board has |
18 |
| rendered a
recommendation to the Director with respect to a |
19 |
| particular license
or certificate, the Director shall, in the |
20 |
| event that he or she disagrees
with or takes action contrary to |
21 |
| the recommendation of the Board, file
with the Board and the |
22 |
| Secretary of State his or her specific written reasons
of |
23 |
| disagreement with the Board. Such reasons shall be filed within
|
24 |
| 30 days of the occurrence of the Director's contrary position |
25 |
| having
been taken.
|
|
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| The action and report in writing of a majority of the Board |
2 |
| designated
is sufficient authority upon which the Director may |
3 |
| act.
|
4 |
| (Source: P.A. 85-796.)
|
5 |
| (225 ILCS 85/35.12) (from Ch. 111, par. 4155.12)
|
6 |
| (Section scheduled to be repealed on January 1, 2008)
|
7 |
| Sec. 35.12. Notwithstanding the provisions herein |
8 |
| concerning the
conduct of hearings and recommendations for |
9 |
| disciplinary actions, the
Director shall have the authority to |
10 |
| negotiate agreements with licensees
and registrants resulting |
11 |
| in disciplinary consent orders provided a Board
member is |
12 |
| present and the discipline is recommended by the Board member.
|
13 |
| Such consent orders may provide for any of the forms of |
14 |
| discipline otherwise
provided herein. Such consent orders |
15 |
| shall provide that they were not entered
into as a result of |
16 |
| any coercion by the Department. The Director shall forward
|
17 |
| copies of all final consent orders to the Board within 30 days |
18 |
| of their entry.
|
19 |
| (Source: P.A. 88-428.)
|
20 |
| (225 ILCS 85/35.16) (from Ch. 111, par. 4155.16)
|
21 |
| (Section scheduled to be repealed on January 1, 2008)
|
22 |
| Sec. 35.16. The Director may
temporarily suspend the |
23 |
| license of a pharmacist, pharmacy technician
or registration as |
24 |
| a distributor, without a hearing, simultaneously
with the |
|
|
|
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|
|
1 |
| institution of proceedings for a hearing provided for in |
2 |
| Section
35.2 of this Act, if the Director finds that evidence |
3 |
| in his possession
indicates that a continuation in practice |
4 |
| would constitute an imminent
danger to the public. In the event |
5 |
| that the Director suspends, temporarily,
this license or |
6 |
| certificate without a hearing, a hearing by the Department
must |
7 |
| be held within 15
10 days after such suspension has occurred, |
8 |
| and
be concluded without appreciable delay.
|
9 |
| (Source: P.A. 85-796.)
|
10 |
| (225 ILCS 85/35.19) (from Ch. 111, par. 4155.19)
|
11 |
| (Section scheduled to be repealed on January 1, 2008)
|
12 |
| Sec. 35.19. Any person who is found to have violated any |
13 |
| provision of
this Act is guilty of a Class A misdemeanor. On |
14 |
| conviction of a second or
subsequent offense, the violator |
15 |
| shall be guilty of a Class 4 felony. All
criminal fines, |
16 |
| monies, or other property collected or received by the
|
17 |
| Department under this Section or any other State or federal |
18 |
| statute,
including, but not limited to, property forfeited to |
19 |
| the Department under
Section 505 of The Illinois Controlled |
20 |
| Substances Act, shall be deposited
into the Illinois State |
21 |
| Pharmacy Disciplinary
Professional Regulation Evidence Fund.
|
22 |
| (Source: P.A. 86-685.)
|
23 |
| Section 75. The Veterinary Medicine and Surgery Practice |
24 |
| Act of 2004 is amended by changing Section 17 as follows:
|
|
|
|
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|
|
1 |
| (225 ILCS 115/17) (from Ch. 111, par. 7017)
|
2 |
| (Section scheduled to be repealed on January 1, 2014)
|
3 |
| Sec. 17. Any person licensed under this Act who dispenses |
4 |
| any drug
or medicine shall dispense such drug or medicine in |
5 |
| good faith and shall
affix to the container containing the same |
6 |
| a label indicating: (a) the date
on which such drug or medicine |
7 |
| is dispensed, (b) the name of the owner,
(c) the last name of |
8 |
| the person dispensing such drug or medicine, (d)
directions for |
9 |
| use thereof, including dosage and quantity, and (e) the
|
10 |
| proprietary or generic name of the drug or medicine, except as |
11 |
| otherwise
authorized by rules of the Department. This Section |
12 |
| shall not apply to
drugs and medicines that are in a container |
13 |
| which bears a label of the
manufacturer with information |
14 |
| describing its contents that are in
compliance with |
15 |
| requirements of the Federal Food, Drug, and Cosmetic Act or
the |
16 |
| Illinois Food, Drug and Cosmetic Act, approved June 29, 1967, |
17 |
| as
amended, and which are dispensed without consideration by a |
18 |
| practitioner
licensed under this Act. "Drug" and "medicine" |
19 |
| have the meanings ascribed
to them in the Pharmacy Practice Act |
20 |
| of 1987 , as amended, and "good faith"
has the meaning ascribed |
21 |
| to it in subsection (v) of Section 102 of the
"Illinois |
22 |
| Controlled Substances Act", approved August 16, 1971, as |
23 |
| amended.
|
24 |
| (Source: P.A. 85-1209 .)
|
|
|
|
SB0509 Enrolled |
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|
1 |
| Section 80. The Wholesale Drug Distribution Licensing Act |
2 |
| is amended by changing Sections 15, 20, 25, and 35 and by |
3 |
| adding Sections 3, 24, 55, 56, 57, 58, and 59 as follows: |
4 |
| (225 ILCS 120/3 new)
|
5 |
| (Section scheduled to be repealed on January 1, 2013) |
6 |
| Sec. 3. References to Department or Director of |
7 |
| Professional Regulation. References in this Act (i) to the |
8 |
| Department of Professional Regulation are
deemed, in |
9 |
| appropriate contexts, to be references to the Department of |
10 |
| Financial and Professional Regulation
and (ii) to the Director |
11 |
| of Professional Regulation are
deemed, in appropriate |
12 |
| contexts, to be references to the Secretary of Financial and |
13 |
| Professional Regulation.
|
14 |
| (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
|
15 |
| (Section scheduled to be repealed on January 1, 2013)
|
16 |
| Sec. 15. Definitions. As used in this Act:
|
17 |
| "Authentication" means the affirmative verification, |
18 |
| before any wholesale distribution of a prescription drug |
19 |
| occurs, that each transaction listed on the pedigree has |
20 |
| occurred. |
21 |
| "Authorized distributor of record" means a wholesale |
22 |
| distributor with whom a manufacturer has established an ongoing |
23 |
| relationship to distribute the manufacturer's prescription |
24 |
| drug. An ongoing relationship is deemed to exist between a |
|
|
|
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|
|
1 |
| wholesale distributor and a manufacturer when the wholesale |
2 |
| distributor, including any affiliated group of the wholesale |
3 |
| distributor, as defined in Section 1504 of the Internal Revenue |
4 |
| Code, complies with the following: |
5 |
| (1) The wholesale distributor has a written agreement |
6 |
| currently in effect with the manufacturer evidencing the |
7 |
| ongoing relationship; and |
8 |
| (2) The wholesale distributor is listed on the |
9 |
| manufacturer's current list of authorized distributors of |
10 |
| record, which is updated by the manufacturer on no less |
11 |
| than a monthly basis.
|
12 |
| "Blood" means whole blood collected from a single donor and |
13 |
| processed
either for transfusion or further manufacturing.
|
14 |
| "Blood component" means that part of blood separated by |
15 |
| physical or
mechanical means.
|
16 |
| "Board" means the State Board of Pharmacy of the Department |
17 |
| of
Professional Regulation.
|
18 |
| "Chain pharmacy warehouse" means a physical location for |
19 |
| prescription drugs that acts as a central warehouse and |
20 |
| performs intracompany sales or transfers of the drugs to a |
21 |
| group of chain or mail order pharmacies that have the same |
22 |
| common ownership and control. Notwithstanding any other |
23 |
| provision of this Act, a chain pharmacy warehouse shall be |
24 |
| considered part of the normal distribution channel. |
25 |
| "Co-licensed partner or product" means an instance where |
26 |
| one or more parties have the right to engage in the |
|
|
|
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|
1 |
| manufacturing or marketing of a prescription drug, consistent |
2 |
| with the FDA's implementation of the Prescription Drug |
3 |
| Marketing Act.
|
4 |
| "Department" means the Department of Financial and
|
5 |
| Professional Regulation.
|
6 |
| "Director" means the Director of Professional Regulation.
|
7 |
| "Drop shipment" means the sale of a prescription drug to a |
8 |
| wholesale distributor by the manufacturer of the prescription |
9 |
| drug or that manufacturer's co-licensed product partner, that |
10 |
| manufacturer's third party logistics provider, or that |
11 |
| manufacturer's exclusive distributor or by an authorized |
12 |
| distributor of record that purchased the product directly from |
13 |
| the manufacturer or one of these entities whereby the wholesale |
14 |
| distributor or chain pharmacy warehouse takes title but not |
15 |
| physical possession of such prescription drug and the wholesale |
16 |
| distributor invoices the pharmacy, chain pharmacy warehouse, |
17 |
| or other person authorized by law to dispense or administer |
18 |
| such drug to a patient and the pharmacy, chain pharmacy |
19 |
| warehouse, or other authorized person receives delivery of the |
20 |
| prescription drug directly from the manufacturer, that |
21 |
| manufacturer's third party logistics provider, or that |
22 |
| manufacturer's exclusive distributor or from an authorized |
23 |
| distributor of record that purchased the product directly from |
24 |
| the manufacturer or one of these entities.
|
25 |
| "Drug sample" means a unit of a prescription drug that is |
26 |
| not intended to
be sold and is intended to promote the sale of |
|
|
|
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|
|
1 |
| the drug.
|
2 |
| "Facility" means a facility of a wholesale distributor |
3 |
| where prescription drugs are stored, handled, repackaged, or |
4 |
| offered for sale. |
5 |
| "FDA" means the United States Food and Drug Administration.
|
6 |
| "Manufacturer" means a person licensed or approved by the |
7 |
| FDA to engage in the manufacture of drugs or devices, |
8 |
| consistent with the definition of "manufacturer" set forth in |
9 |
| the FDA's regulations and guidances implementing the |
10 |
| Prescription Drug Marketing Act. |
11 |
| "Manufacturer's exclusive distributor" means anyone who |
12 |
| contracts with a manufacturer to provide or coordinate |
13 |
| warehousing, distribution, or other services on behalf of a |
14 |
| manufacturer and who takes title to that manufacturer's |
15 |
| prescription drug, but who does not have general responsibility |
16 |
| to direct the sale or disposition of the manufacturer's |
17 |
| prescription drug. A manufacturer's exclusive distributor must |
18 |
| be licensed as a wholesale distributor under this Act and, in |
19 |
| order to be considered part of the normal distribution channel, |
20 |
| must also be an authorized distributor of record.
|
21 |
| "Normal distribution channel" means a chain of custody for |
22 |
| a prescription drug that goes, directly or by drop shipment, |
23 |
| from (i) a manufacturer of the prescription drug, (ii) that |
24 |
| manufacturer to that manufacturer's co-licensed partner, (iii) |
25 |
| that manufacturer to that manufacturer's third party logistics |
26 |
| provider, or (iv) that manufacturer to that manufacturer's |
|
|
|
SB0509 Enrolled |
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|
|
1 |
| exclusive distributor to: |
2 |
| (1) a pharmacy or to other designated persons |
3 |
| authorized by law to dispense or administer the drug to a |
4 |
| patient; |
5 |
| (2) a wholesale distributor to a pharmacy or other |
6 |
| designated persons authorized by law to dispense or |
7 |
| administer the drug to a patient; |
8 |
| (3) a wholesale distributor to a chain pharmacy |
9 |
| warehouse to that chain pharmacy warehouse's intracompany |
10 |
| pharmacy to a patient or other designated persons |
11 |
| authorized by law to dispense or administer the drug to a |
12 |
| patient; |
13 |
| (4) a chain pharmacy warehouse to the chain pharmacy |
14 |
| warehouse's intracompany pharmacy or other designated |
15 |
| persons authorized by law to dispense or administer the |
16 |
| drug to the patient; |
17 |
| (5) an authorized distributor of record to one other |
18 |
| authorized distributor of record to an office-based health |
19 |
| care practitioner authorized by law to dispense or |
20 |
| administer the drug to the patient; or |
21 |
| (6) an authorized distributor to a pharmacy or other |
22 |
| persons licensed to dispense or administer the drug. |
23 |
| "Pedigree" means a document or electronic file containing |
24 |
| information that records each wholesale distribution of any |
25 |
| given prescription drug from the point of origin to the final |
26 |
| wholesale distribution point of any given prescription drug.
|
|
|
|
SB0509 Enrolled |
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|
|
1 |
| "Manufacturer" means anyone who is engaged in the |
2 |
| manufacturing, preparing,
propagating, compounding, |
3 |
| processing, packaging, repackaging, or labeling
of a |
4 |
| prescription drug.
|
5 |
| "Person" means and includes a natural person, partnership, |
6 |
| association or
corporation.
|
7 |
| "Pharmacy distributor" means any pharmacy licensed in this |
8 |
| State or
hospital pharmacy that is engaged in the delivery or |
9 |
| distribution of
prescription drugs either to any other pharmacy |
10 |
| licensed in this State or
to any other person or entity |
11 |
| including, but not limited to, a wholesale
drug distributor |
12 |
| engaged in the delivery or distribution of prescription
drugs |
13 |
| who is involved in the actual, constructive, or attempted |
14 |
| transfer of
a drug in this State to other than the ultimate |
15 |
| consumer except as
otherwise provided for by law.
|
16 |
| "Prescription drug" means any human drug , including any |
17 |
| biological product (except for blood and blood components |
18 |
| intended for transfusion or biological products that are also |
19 |
| medical devices), required by federal law or
regulation to be |
20 |
| dispensed only by a prescription, including finished
dosage |
21 |
| forms and bulk drug substances
active ingredients subject to |
22 |
| subsection (b) of Section
503 of the Federal Food, Drug and |
23 |
| Cosmetic Act.
|
24 |
| "Repackage" means repackaging or otherwise changing the |
25 |
| container, wrapper, or labeling to further the distribution of |
26 |
| a prescription drug, excluding that completed by the pharmacist |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| responsible for dispensing the product to a patient. |
2 |
| "Secretary" means the Secretary of Financial and |
3 |
| Professional Regulation. |
4 |
| "Third party logistics provider" means anyone who |
5 |
| contracts with a prescription drug manufacturer to provide or |
6 |
| coordinate warehousing, distribution, or other services on |
7 |
| behalf of a manufacturer, but does not take title to the |
8 |
| prescription drug or have general responsibility to direct the |
9 |
| prescription drug's sale or disposition. A third party |
10 |
| logistics provider must be licensed as a wholesale distributor |
11 |
| under this Act and, in order to be considered part of the |
12 |
| normal distribution channel, must also be an authorized |
13 |
| distributor of record. |
14 |
| "Wholesale distribution" or "wholesale distributions"
|
15 |
| means the distribution
of prescription drugs to persons other |
16 |
| than a consumer or patient, but does
not include any of the |
17 |
| following:
|
18 |
| (1)
(a) Intracompany sales of prescription drugs, |
19 |
| meaning (i) , defined as any transaction or transfer
between |
20 |
| any division, subsidiary, parent, or affiliated or related |
21 |
| company
under the common ownership and control of a |
22 |
| corporate entity or (ii) any transaction or transfer |
23 |
| between co-licensees of a co-licensed product .
|
24 |
| (2) The sale, purchase, distribution, trade, or |
25 |
| transfer of a prescription drug or offer to sell, purchase, |
26 |
| distribute, trade, or transfer a prescription drug for |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| emergency medical reasons.
|
2 |
| (3) The distribution of prescription drug samples by |
3 |
| manufacturers' representatives. |
4 |
| (4) Drug returns, when conducted by a hospital, health |
5 |
| care entity, or charitable institution in accordance with |
6 |
| federal regulation. |
7 |
| (5) The sale of minimal quantities of prescription |
8 |
| drugs by retail pharmacies to licensed practitioners for |
9 |
| office use. |
10 |
| (6) The sale, purchase, or trade of a drug, an offer to |
11 |
| sell, purchase, or trade a drug, or the dispensing of a |
12 |
| drug pursuant to a prescription. |
13 |
| (7) The sale, transfer, merger, or consolidation of all |
14 |
| or part of the business of a pharmacy or pharmacies from or |
15 |
| with another pharmacy or pharmacies, whether accomplished |
16 |
| as a purchase and sale of stock or business assets. |
17 |
| (8) The sale, purchase, distribution, trade, or |
18 |
| transfer of a prescription drug from one authorized |
19 |
| distributor of record to one additional authorized |
20 |
| distributor of record when the manufacturer has stated in |
21 |
| writing to the receiving authorized distributor of record |
22 |
| that the manufacturer is unable to supply the prescription |
23 |
| drug and the supplying authorized distributor of record |
24 |
| states in writing that the prescription drug being supplied |
25 |
| had until that time been exclusively in the normal |
26 |
| distribution channel. |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| (9) The delivery of or the offer to deliver a |
2 |
| prescription drug by a common carrier solely in the common |
3 |
| carrier's usual course of business of transporting |
4 |
| prescription drugs when the common carrier does not store, |
5 |
| warehouse, or take legal ownership of the prescription |
6 |
| drug. |
7 |
| (10) The sale or transfer from a retail pharmacy, mail |
8 |
| order pharmacy, or chain pharmacy warehouse of expired, |
9 |
| damaged, returned, or recalled prescription drugs to the |
10 |
| original manufacturer, the originating wholesale |
11 |
| distributor, or a third party returns processor.
(b) The |
12 |
| purchase or other acquisition by a hospital or other health
|
13 |
| care entity that is a member of a group purchasing |
14 |
| organization of a drug
for its own use from the group |
15 |
| purchasing organization or from other
hospitals or health |
16 |
| care entities that are members of a group organization.
|
17 |
|
(c) The sale, purchase, or trade of a drug or an offer |
18 |
| to sell,
purchase, or trade a drug by a charitable |
19 |
| organization described in
subsection (c)(3) of Section 501 |
20 |
| of the U.S. Internal Revenue Code of 1954
to a nonprofit |
21 |
| affiliate of the organization to the extent otherwise
|
22 |
| permitted by law.
|
23 |
| (d) The sale, purchase, or trade of a drug or an offer |
24 |
| to sell,
purchase, or trade a drug among hospitals or other |
25 |
| health care entities
that are under common control. For |
26 |
| purposes of this Act, "common control"
means the power to |
|
|
|
SB0509 Enrolled |
- 124 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| direct or cause the direction of the management and
|
2 |
| policies of a person or an organization, whether by |
3 |
| ownership of stock,
voting rights, contract, or otherwise.
|
4 |
| (e) The sale, purchase, or trade of a drug or an offer |
5 |
| to sell,
purchase, or trade a drug for emergency medical |
6 |
| reasons. For purposes of
this Act, "emergency medical |
7 |
| reasons" include transfers of prescription
drugs by a |
8 |
| retail pharmacy to another retail pharmacy to alleviate a
|
9 |
| temporary shortage.
|
10 |
| (f) The sale, purchase, or trade of a drug, an offer to |
11 |
| sell, purchase,
or trade a drug, or the dispensing of a |
12 |
| drug pursuant to a prescription.
|
13 |
| (g) The distribution of drug samples by manufacturers' |
14 |
| representatives
or distributors' representatives.
|
15 |
| (h) The sale, purchase, or trade of blood and blood |
16 |
| components
intended for transfusion.
|
17 |
| "Wholesale drug distributor" means anyone
any person or |
18 |
| entity engaged in the
wholesale distribution of prescription |
19 |
| drugs, including without limitation , but not limited
to,
|
20 |
| manufacturers; repackers; own label distributors; jobbers; |
21 |
| private
label distributors; brokers; warehouses, including |
22 |
| manufacturers' and
distributors' warehouses ; manufacturer's |
23 |
| exclusive distributors; and authorized distributors of record; |
24 |
| drug wholesalers or distributors; independent wholesale drug |
25 |
| traders; specialty wholesale distributors; third party |
26 |
| logistics providers; and retail pharmacies that conduct |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| wholesale distribution; and chain pharmacy warehouses that |
2 |
| conduct wholesale distribution. In order to be considered part |
3 |
| of the normal distribution channel, a wholesale distributor |
4 |
| must also be an authorized distributor of record , chain drug |
5 |
| warehouses, and wholesale drug
warehouses; independent |
6 |
| wholesale drug traders; and retail
pharmacies that conduct |
7 |
| wholesale distributions, including, but
not limited to, any |
8 |
| pharmacy distributor as defined in this Section. A
wholesale |
9 |
| drug distributor shall not include any for hire carrier or |
10 |
| person
or entity hired solely to transport prescription drugs .
|
11 |
| (Source: P.A. 87-594.)
|
12 |
| (225 ILCS 120/24 new)
|
13 |
| (Section scheduled to be repealed on January 1, 2013) |
14 |
| Sec. 24. Bond required. The Department shall require every |
15 |
| wholesale distributor applying for licensure under this Act to |
16 |
| submit a bond not to exceed $100,000 or another equivalent |
17 |
| means of security acceptable to the Department, such as an |
18 |
| irrevocable letter of credit or a deposit in a trust account or |
19 |
| financial institution, payable to a fund established by the |
20 |
| Department. Chain pharmacy warehouses and warehouses that are |
21 |
| operated by agencies of this State that are not engaged in
|
22 |
| wholesale distribution are exempt from the bond requirement of |
23 |
| this Section. The purpose of the bond is to secure payment of |
24 |
| any fines or penalties imposed by the Department and any fees |
25 |
| and costs incurred by the Department regarding that license, |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| which are authorized under State law and which the licensee |
2 |
| fails to pay 30 days after the fines, penalties, or costs |
3 |
| become final. The Department may make a claim against the bond |
4 |
| or security until one year after the licensee's license ceases |
5 |
| to be valid. A single bond may suffice to cover all facilities |
6 |
| operated by an applicant or its affiliates licensed in this |
7 |
| State. |
8 |
| The Department shall establish a fund, separate from its |
9 |
| other accounts, in which to deposit the wholesale distributor |
10 |
| bonds required under this Section.
|
11 |
| (225 ILCS 120/25) (from Ch. 111, par. 8301-25)
|
12 |
| (Section scheduled to be repealed on January 1, 2013)
|
13 |
| Sec. 25. Wholesale drug distributor licensing |
14 |
| requirements. |
15 |
| All
wholesale distributors and pharmacy distributors, wherever |
16 |
| located, who
engage in wholesale distribution into, out of, or |
17 |
| within the State shall be
subject to the following |
18 |
| requirements:
|
19 |
| (a) Every resident wholesale distributor who engages in the |
20 |
| wholesale distribution of prescription drugs must be licensed |
21 |
| by the Department, and every non-resident wholesale |
22 |
| distributor must be licensed in this State if it ships |
23 |
| prescription drugs into this State, in accordance with this |
24 |
| Act, before engaging in wholesale distributions of wholesale |
25 |
| prescription drugs.
No person or distribution outlet shall act |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| as a wholesale drug
distributor without first obtaining a |
2 |
| license to do so from the Department
and paying any reasonable |
3 |
| fee required by the Department.
|
4 |
| (b) The Department shall require without limitation all of |
5 |
| the following information from each applicant for licensure |
6 |
| under this Act: |
7 |
| (1) The name, full business address, and telephone |
8 |
| number of the licensee. |
9 |
| (2) All trade or business names used by the licensee. |
10 |
| (3) Addresses, telephone numbers, and the names of |
11 |
| contact persons for all facilities used by the licensee for |
12 |
| the storage, handling, and distribution of prescription |
13 |
| drugs. |
14 |
| (4) The type of ownership or operation, such as a |
15 |
| partnership, corporation, or sole proprietorship. |
16 |
| (5) The name of the owner or operator of the wholesale |
17 |
| distributor, including: |
18 |
| (A) if a person, the name of the person; |
19 |
| (B) if a partnership, the name of each partner and |
20 |
| the name of the partnership; |
21 |
| (C) if a corporation, the name and title of each |
22 |
| corporate officer and director, the corporate names, |
23 |
| and the name of the state of incorporation; and |
24 |
| (D) if a sole proprietorship, the full name of the |
25 |
| sole proprietor and the name of the business entity. |
26 |
| (6) A list of all licenses and permits issued to the |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
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|
1 |
| applicant by any other state that authorizes the applicant |
2 |
| to purchase or possess prescription drugs. |
3 |
| (7) The name of the designated representative for the |
4 |
| wholesale distributor, together with the personal |
5 |
| information statement and fingerprints, as required under
|
6 |
| subsection (c) of this Section. |
7 |
| (8) Minimum liability insurance and other insurance as |
8 |
| defined by rule. |
9 |
| (9) Any additional information required by the |
10 |
| Department.
may grant a temporary
license when a wholesale |
11 |
| drug distributor first applies for a license to
operate |
12 |
| within this State. A temporary license shall only be |
13 |
| granted after the applicant meets the inspection |
14 |
| requirements for regular licensure and shall remain valid
|
15 |
| until the Department finds that the applicant
meets or |
16 |
| fails to meet the requirements for regular licensure. |
17 |
| Nevertheless,
no temporary license shall be valid for more |
18 |
| than 90 days from the
date of issuance. Any temporary |
19 |
| license issued under this subsection
shall be renewable for |
20 |
| a similar period of time not to exceed 90 days
under |
21 |
| policies and procedures prescribed by the Department.
|
22 |
| (c) Each wholesale distributor must designate an |
23 |
| individual representative who shall serve as the contact person |
24 |
| for the Department. This representative must provide the
|
25 |
| Department with all of the following information:
|
26 |
| (1) Information concerning whether the person has been |
|
|
|
SB0509 Enrolled |
- 129 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| enjoined, either temporarily or permanently, by a court of |
2 |
| competent jurisdiction from violating any federal or State |
3 |
| law regulating the possession, control, or distribution of |
4 |
| prescription drugs or criminal violations, together with |
5 |
| details concerning any such event. |
6 |
| (2) A description of any involvement by the person with |
7 |
| any business, including any investments, other than the |
8 |
| ownership of stock in a publicly traded company or mutual |
9 |
| fund which manufactured, administered, prescribed, |
10 |
| distributed, or stored pharmaceutical products and any |
11 |
| lawsuits in which such businesses were named as a party. |
12 |
| (3) A description of any misdemeanor or felony criminal |
13 |
| offense of which the person, as an adult, was found guilty, |
14 |
| regardless of whether adjudication of guilt was withheld or |
15 |
| whether the person pled guilty or nolo contendere. If the |
16 |
| person indicates that a criminal conviction is under appeal |
17 |
| and submits a copy of the notice of appeal of that criminal |
18 |
| offense, the applicant must, within 15 days after the |
19 |
| disposition of the appeal, submit to the Department a copy |
20 |
| of the final written order of disposition. |
21 |
| (4) The designated representative of an applicant for |
22 |
| licensure as a wholesale drug distributor shall have his or |
23 |
| her fingerprints submitted to the Department of State |
24 |
| Police in an electronic format that complies with the form |
25 |
| and manner for requesting and furnishing criminal history |
26 |
| record information as prescribed by the Department of State |
|
|
|
SB0509 Enrolled |
- 130 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| Police. These fingerprints shall be checked against the |
2 |
| Department of State Police and Federal Bureau of |
3 |
| Investigation criminal history record databases now and |
4 |
| hereafter filed. The Department of State Police shall |
5 |
| charge applicants a fee for conducting the criminal history |
6 |
| records check, which shall be deposited into the State |
7 |
| Police Services Fund and shall not exceed the actual cost |
8 |
| of the records check. The Department of State Police shall |
9 |
| furnish, pursuant to positive identification, records of |
10 |
| Illinois convictions to the Department. The Department may |
11 |
| require applicants to pay a separate fingerprinting fee, |
12 |
| either to the Department or to a vendor. The Department, in |
13 |
| its discretion, may allow an applicant who does not have |
14 |
| reasonable access to a designated vendor to provide his or |
15 |
| her fingerprints in an alternative manner. The Department |
16 |
| may adopt any rules necessary to implement this Section. |
17 |
| The designated representative of a licensee shall |
18 |
| receive and complete continuing training in applicable |
19 |
| federal and State laws governing the wholesale |
20 |
| distribution of prescription drugs.
No license shall be |
21 |
| issued or renewed for a wholesale drug
distributor to |
22 |
| operate unless the wholesale drug distributor shall |
23 |
| operate
in a manner prescribed by law and according to the |
24 |
| rules and regulations
promulgated by the Department.
|
25 |
| (d) The Department may not issue a wholesale distributor |
26 |
| license to an applicant, unless the Department first: |
|
|
|
SB0509 Enrolled |
- 131 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (1) ensures that a physical inspection of the facility |
2 |
| satisfactory to the Department has occurred at the address |
3 |
| provided by the applicant, as required under item (1) of |
4 |
| subsection (b) of this Section; and |
5 |
| (2) determines that the designated representative |
6 |
| meets each of the following qualifications: |
7 |
| (A) He or she is at least 21 years of age. |
8 |
| (B) He or she has been employed full-time for at |
9 |
| least 3 years in a pharmacy or with a wholesale |
10 |
| distributor in a capacity related to the dispensing and |
11 |
| distribution of, and recordkeeping relating to, |
12 |
| prescription drugs. |
13 |
| (C) He or she is employed by the applicant full |
14 |
| time in a managerial level position. |
15 |
| (D) He or she is actively involved in and aware of |
16 |
| the actual daily operation of the wholesale |
17 |
| distributor. |
18 |
| (E) He or she is physically present at the facility |
19 |
| of the applicant during regular business hours, except |
20 |
| when the absence of the designated representative is |
21 |
| authorized, including without limitation sick leave |
22 |
| and vacation leave. |
23 |
| (F) He or she is serving in the capacity of a |
24 |
| designated representative for only one applicant at a |
25 |
| time, except where more than one licensed wholesale |
26 |
| distributor is co-located in the same facility and such |
|
|
|
SB0509 Enrolled |
- 132 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| wholesale distributors are members of an affiliated |
2 |
| group, as defined in Section 1504 of the Internal |
3 |
| Revenue Code.
require a separate
license for each |
4 |
| facility directly or indirectly owned or operated by |
5 |
| the
same business entity within this State, or for a |
6 |
| parent entity with
divisions, subsidiaries, and |
7 |
| affiliate companies within this State when
operations |
8 |
| are conducted at more than one location and there |
9 |
| exists joint
ownership and control among all the |
10 |
| entities.
|
11 |
| (e) If a wholesale distributor distributes prescription |
12 |
| drugs from more than one facility, the wholesale distributor |
13 |
| shall obtain a license for each facility.
As a condition for |
14 |
| receiving and renewing any wholesale drug
distributor license |
15 |
| issued under this Act, each applicant shall satisfy the
|
16 |
| Department that it has and will continuously maintain:
|
17 |
| (1) acceptable storage and handling conditions plus |
18 |
| facilities standards;
|
19 |
| (2) minimum liability and other insurance as may be |
20 |
| required under
any applicable federal or State law;
|
21 |
| (3) a security system that includes after hours, |
22 |
| central alarm or
comparable entry detection capability; |
23 |
| restricted premises access; adequate
outside perimeter |
24 |
| lighting; comprehensive employment applicant screening;
|
25 |
| and safeguards against employee theft;
|
26 |
| (4) an electronic, manual, or any other reasonable |
|
|
|
SB0509 Enrolled |
- 133 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| system of
records, describing all wholesale distributor |
2 |
| activities governed by this
Act for the 2 year period |
3 |
| following disposition of each product and
reasonably |
4 |
| accessible during regular business hours as defined by the
|
5 |
| Department's rules in any inspection authorized by the |
6 |
| Department;
|
7 |
| (5) officers, directors, managers, and other persons |
8 |
| in charge of
wholesale drug distribution, storage, and |
9 |
| handling who must at all times
demonstrate and maintain |
10 |
| their capability of conducting business according
to sound |
11 |
| financial practices as well as State and federal law;
|
12 |
| (6) complete, updated information, to be provided the |
13 |
| Department
as a condition for obtaining and renewing a |
14 |
| license, about each wholesale
distributor to be licensed |
15 |
| under this Act, including all pertinent licensee
ownership |
16 |
| and other key personnel and facilities information deemed
|
17 |
| necessary for enforcement of this Act. Any changes in this |
18 |
| information
shall be submitted at the time of license |
19 |
| renewal or within 45 days from
the date of the change;
|
20 |
| (7) written policies and procedures that assure |
21 |
| reasonable
wholesale distributor preparation for, |
22 |
| protection against and handling of
any facility security or |
23 |
| operation problems, including, but not limited to,
those |
24 |
| caused by natural disaster or government emergency; |
25 |
| inventory
inaccuracies or product shipping and receiving; |
26 |
| outdated product or other
unauthorized product control; |
|
|
|
SB0509 Enrolled |
- 134 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| appropriate disposition of returned goods;
and product |
2 |
| recalls;
|
3 |
| (8) sufficient inspection procedures for all incoming |
4 |
| and outgoing
product shipments; and
|
5 |
| (9) operations in compliance with all federal legal |
6 |
| requirements
applicable to wholesale drug distribution.
|
7 |
| (f) The information provided under this Section may not be |
8 |
| disclosed to any person or entity other than the Department or |
9 |
| another government entity in need of such information for |
10 |
| licensing or monitoring purposes.
Department shall consider, |
11 |
| at a minimum, the following factors
in reviewing the |
12 |
| qualifications of persons who engage in wholesale
distribution |
13 |
| of prescription drugs in this State:
|
14 |
| (1) any conviction of the applicant under any federal, |
15 |
| State, or
local laws relating to drug samples, wholesale or |
16 |
| retail drug distribution,
or distribution of controlled |
17 |
| substances;
|
18 |
| (2) any felony convictions of the applicant under |
19 |
| federal, State,
or local laws;
|
20 |
| (3) the applicant's past experience in the manufacture |
21 |
| or
distribution of prescription drugs, including |
22 |
| controlled substances;
|
23 |
| (4) the furnishing by the applicant of false or |
24 |
| fraudulent material
in any application made in connection |
25 |
| with drug manufacturing or distribution;
|
26 |
| (5) suspension or revocation by federal, State, or |
|
|
|
SB0509 Enrolled |
- 135 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| local government
of any license currently or previously |
2 |
| held by the applicant for the
manufacture or distribution |
3 |
| of any drug, including controlled substances;
|
4 |
| (6) compliance with licensing requirements under |
5 |
| previously granted
licenses, if any;
|
6 |
| (7) compliance with requirements to maintain and make |
7 |
| available to
the Department or to federal, State, or local
|
8 |
| law enforcement officials those records required by this |
9 |
| Act; and
|
10 |
| (8) any other factors or qualifications the Department
|
11 |
| considers relevant to and consistent with the
public health |
12 |
| and safety, including whether the granting of the license
|
13 |
| would not be in the public interest.
|
14 |
| (9) All requirements set forth in this subsection shall |
15 |
| conform to
wholesale drug distributor licensing guidelines |
16 |
| formally adopted by the
U.S. Food and Drug Administration |
17 |
| (FDA). In case of conflict between
any wholesale drug |
18 |
| distributor licensing requirement imposed by the
|
19 |
| Department and any FDA wholesale drug distributor |
20 |
| licensing guideline, the
FDA guideline shall control.
|
21 |
| (g) An agent or employee of any licensed wholesale drug |
22 |
| distributor need
not seek licensure under this Section and may |
23 |
| lawfully possess
pharmaceutical drugs when the agent or |
24 |
| employee is acting in the usual
course of business or |
25 |
| employment.
|
26 |
| (h) The issuance of a license under this Act shall not |
|
|
|
SB0509 Enrolled |
- 136 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| change or
affect tax liability imposed by the State on any |
2 |
| wholesale drug distributor.
|
3 |
| (i) A license issued under this Act shall not be sold, |
4 |
| transferred, or
assigned in any manner.
|
5 |
| (Source: P.A. 94-942, eff. 1-1-07.)
|
6 |
| (225 ILCS 120/35) (from Ch. 111, par. 8301-35)
|
7 |
| (Section scheduled to be repealed on January 1, 2013)
|
8 |
| Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
|
9 |
| (a) The Department shall provide by rule for a schedule of |
10 |
| fees for the
administration and
enforcement of this Act, |
11 |
| including but not limited to original licensure,
renewal, and
|
12 |
| restoration. The fees shall be nonrefundable.
|
13 |
| (b) All fees collected under this Act shall be deposited |
14 |
| into the Illinois
State
Pharmacy
Disciplinary Fund and shall be |
15 |
| appropriated to the Department for the ordinary
and
contingent |
16 |
| expenses of the Department in the administration of this Act. |
17 |
| Moneys in the Fund may be transferred to the Professions
|
18 |
| Indirect Cost Fund as authorized by Section 2105-300 of the
|
19 |
| Department of Professional Regulation Law (20 ILCS |
20 |
| 2105/2105-300).
|
21 |
| The moneys deposited into the Illinois State Pharmacy |
22 |
| Disciplinary Fund shall
be invested to earn interest which |
23 |
| shall accrue to the Fund.
|
24 |
| The Department shall present to the Board for its review |
25 |
| and comment all
appropriation requests from the Illinois State |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| Pharmacy Disciplinary Fund. The
Department shall give due |
2 |
| consideration to any comments of the Board in making
|
3 |
| appropriation requests.
|
4 |
| (c) Any person who delivers a check or other payment to the |
5 |
| Department that
is returned to the Department unpaid by the |
6 |
| financial institution upon
which it is drawn shall pay to the |
7 |
| Department, in addition to the amount
already owed to the |
8 |
| Department, a fine of $50. The fines imposed by this Section |
9 |
| are in addition
to any other discipline provided under this Act |
10 |
| for unlicensed
practice or practice on a nonrenewed license. |
11 |
| The Department shall notify
the person that payment of fees and |
12 |
| fines shall be paid to the Department
by certified check or |
13 |
| money order within 30 calendar days of the
notification. If, |
14 |
| after the expiration of 30 days from the date of the
|
15 |
| notification, the person has failed to submit the necessary |
16 |
| remittance, the
Department shall automatically terminate the |
17 |
| license or certificate or deny
the application, without |
18 |
| hearing. If, after termination or denial, the
person seeks a |
19 |
| license or certificate, he or she shall apply to the
Department |
20 |
| for restoration or issuance of the license or certificate and
|
21 |
| pay all fees and fines due to the Department. The Department |
22 |
| may establish
a fee for the processing of an application for |
23 |
| restoration of a license or
certificate to pay all expenses of |
24 |
| processing this application. The Director
may waive the fines |
25 |
| due under this Section in individual cases where the
Director |
26 |
| finds that the fines would be unreasonable or unnecessarily
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| burdensome.
|
2 |
| (d) The Department shall maintain a roster of the names and |
3 |
| addresses of
all registrants and of all persons whose licenses |
4 |
| have been suspended or
revoked. This roster shall be available |
5 |
| upon written request and payment of
the required fee.
|
6 |
| (e) A manufacturer of controlled substances or wholesale |
7 |
| distributor of controlled substances that is licensed under |
8 |
| this Act and owned and operated by the State is exempt from |
9 |
| licensure, registration, renewal, and other fees required |
10 |
| under this Act. Nothing in this subsection (e) shall be |
11 |
| construed to prohibit the Department
from imposing any fine or |
12 |
| other penalty allowed under this Act.
|
13 |
| (Source: P.A. 91-239, eff. 1-1-00; 92-146, eff. 1-1-02; 92-586, |
14 |
| eff. 6-26-02.)
|
15 |
| (225 ILCS 120/55) (from Ch. 111, par. 8301-55)
|
16 |
| (Section scheduled to be repealed on January 1, 2013)
|
17 |
| Sec. 55. Discipline; grounds.
|
18 |
| (a) The Department may refuse to issue, restore, or renew, |
19 |
| or may revoke,
suspend, place on probation, reprimand or take |
20 |
| other disciplinary action as
the Department may deem proper for |
21 |
| any of the following reasons:
|
22 |
| (1) Violation of this Act or its rules.
|
23 |
| (2) Aiding or assisting another person in violating any |
24 |
| provision of
this Act or its rules.
|
25 |
| (3) Failing, within 60 days, to respond to a written |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| requirement made by
the Department for information.
|
2 |
| (4) Engaging in dishonorable, unethical, or |
3 |
| unprofessional conduct of a
character likely to deceive, |
4 |
| defraud, or harm the public. This includes
violations of |
5 |
| "good faith" as defined by the Illinois Controlled |
6 |
| Substances
Act and applies to all prescription drugs.
|
7 |
| (5) Discipline by another U.S. jurisdiction or foreign |
8 |
| nation, if at
least one of the grounds for the discipline |
9 |
| is the same or substantially
equivalent to those set forth |
10 |
| in this Act.
|
11 |
| (6) Selling or engaging in the sale of drug samples |
12 |
| provided at no cost
by drug manufacturers.
|
13 |
| (7) Conviction of or entry of a plea of guilty or nolo |
14 |
| contendere by the applicant or licensee, or any officer, |
15 |
| director,
manager or shareholder who owns more than 5% of |
16 |
| stock, to any crime under the laws of the United States or |
17 |
| any state or territory of the United States that is a |
18 |
| felony or a misdemeanor, of which an essential element is |
19 |
| dishonesty, or any crime that is directly related to the |
20 |
| practice of this profession
in State or federal
court of |
21 |
| any crime that is a felony .
|
22 |
| (8) Habitual or excessive use or addiction to alcohol, |
23 |
| narcotics,
stimulants, or any other chemical agent or drug |
24 |
| that results in the
inability to function with reasonable |
25 |
| judgment, skill, or safety.
|
26 |
| (b) The Department may refuse to issue, restore, or renew, |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| or may
revoke, suspend, place on probation, reprimand or take |
2 |
| other disciplinary
action as the Department may deem property |
3 |
| including fines not to exceed
$10,000 per offense
$1000 for any |
4 |
| of the following reasons:
|
5 |
| (1) Material misstatement in furnishing information to |
6 |
| the Department.
|
7 |
| (2) Making any misrepresentation for the purpose of |
8 |
| obtaining a license.
|
9 |
| (3) A finding by the Department that the licensee, |
10 |
| after having his
or her license placed on probationary |
11 |
| status, has violated the terms of
probation.
|
12 |
| (4) A finding that licensure or registration has been |
13 |
| applied for or
obtained by fraudulent means.
|
14 |
| (5) Willfully making or filing false records or |
15 |
| reports.
|
16 |
| (6) A finding of a substantial discrepancy in a |
17 |
| Department audit
of a prescription drug, including a |
18 |
| controlled substance as that term is
defined in this Act or |
19 |
| in the Illinois Controlled Substances Act.
|
20 |
| (c) The Department may refuse to issue or may suspend the |
21 |
| license or
registration of any person who fails to file a |
22 |
| return, or to pay the tax,
penalty or interest shown in a filed |
23 |
| return, or to pay any final assessment
of tax, penalty or |
24 |
| interest, as required by any tax Act administered by the
|
25 |
| Illinois Department of Revenue, until the time the requirements |
26 |
| of
the tax Act are satisfied.
|
|
|
|
SB0509 Enrolled |
- 141 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (d) The Department shall revoke the license or certificate |
2 |
| of
registration issued under this Act or any prior Act of
this |
3 |
| State of any person who has been convicted a second time of |
4 |
| committing
any felony under the Illinois Controlled Substances |
5 |
| Act or the Methamphetamine Control and Community Protection Act
|
6 |
| or who
has been convicted a second time of committing a Class 1 |
7 |
| felony under
Sections 8A-3 and 8A-6 of the Illinois Public Aid |
8 |
| Code. A
person whose license or certificate of registration |
9 |
| issued under
this Act or any prior Act of this State is revoked |
10 |
| under this
subsection (c) shall be prohibited from engaging in |
11 |
| the practice of
pharmacy in this State.
|
12 |
| (Source: P.A. 94-556, eff. 9-11-05.)
|
13 |
| (225 ILCS 120/56 new)
|
14 |
| (Section scheduled to be repealed on January 1, 2013) |
15 |
| Sec. 56. Restrictions on transactions. |
16 |
| (a) A licensee shall receive prescription drug returns or |
17 |
| exchanges from a pharmacy or other persons authorized to |
18 |
| administer or dispense drugs or a chain pharmacy warehouse |
19 |
| pursuant to the terms and conditions of the agreement between |
20 |
| the wholesale distributor and the pharmacy or chain pharmacy |
21 |
| warehouse. Returns of expired, damaged, recalled, or otherwise |
22 |
| non-saleable pharmaceutical products shall be distributed by |
23 |
| the receiving wholesale distributor only to either the original |
24 |
| manufacturer or a third party returns processor. Returns or |
25 |
| exchanges of prescription drugs, saleable or otherwise, |
|
|
|
SB0509 Enrolled |
- 142 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| including any redistribution by a receiving wholesaler, shall |
2 |
| not be subject to the pedigree requirements of Section 57 of |
3 |
| this Act, so long as they are exempt from the pedigree |
4 |
| requirement of the FDA's currently applicable Prescription |
5 |
| Drug Marketing Act guidance. Both licensees under this Act and |
6 |
| pharmacies or other persons authorized to administer or |
7 |
| dispense drugs shall be accountable for administering their |
8 |
| returns process and ensuring that the aspects of this operation |
9 |
| are secure and do not permit the entry of adulterated and |
10 |
| counterfeit product. |
11 |
| (b) A manufacturer or wholesale distributor licensed under |
12 |
| this Act may furnish prescription drugs only to a person |
13 |
| licensed by the appropriate state licensing authorities.
|
14 |
| Before furnishing prescription drugs to a person not known to |
15 |
| the manufacturer or wholesale distributor, the manufacturer or |
16 |
| wholesale distributor must affirmatively verify that the |
17 |
| person is legally authorized to receive the prescription drugs |
18 |
| by contacting the appropriate state licensing authorities. |
19 |
| (c) Prescription drugs furnished by a manufacturer or |
20 |
| wholesale distributor licensed under this Act may be delivered |
21 |
| only to the premises listed on the license, provided that the |
22 |
| manufacturer or wholesale distributor may furnish prescription |
23 |
| drugs to an authorized person or agent of that person at the |
24 |
| premises of the manufacturer or wholesale distributor if: |
25 |
| (1) the identity and authorization of the recipient is |
26 |
| properly established; and |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| (2) this method of receipt is employed only to meet the |
2 |
| immediate needs of a particular patient of the authorized |
3 |
| person. |
4 |
| (d) Prescription drugs may be furnished to a hospital |
5 |
| pharmacy receiving area, provided that a pharmacist or |
6 |
| authorized receiving personnel signs, at the time of delivery, |
7 |
| a receipt showing the type and quantity of the prescription |
8 |
| drug received. Any discrepancy between the receipt and the type |
9 |
| and quantity of the prescription drug actually received shall |
10 |
| be reported to the delivering manufacturer or wholesale |
11 |
| distributor by the next business day after the delivery to the |
12 |
| pharmacy receiving area. |
13 |
| (e) A manufacturer or wholesale distributor licensed under |
14 |
| this Act may not accept payment for, or allow the use of, a |
15 |
| person or entity's credit to establish an account for the |
16 |
| purchase of prescription drugs from any person other than the |
17 |
| owner of record, the chief executive officer, or the chief |
18 |
| financial officer listed on the license of a person or entity |
19 |
| legally authorized to receive the prescription drugs. Any |
20 |
| account established for the purchase of prescription drugs must |
21 |
| bear the name of the licensee. This subsection (e) shall not be |
22 |
| construed to prohibit a pharmacy or chain pharmacy warehouse |
23 |
| from receiving prescription drugs if payment for the |
24 |
| prescription drugs is processed through the pharmacy's or chain |
25 |
| pharmacy warehouse's contractual drug manufacturer or |
26 |
| wholesale distributor.
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| (225 ILCS 120/57 new)
|
2 |
| (Section scheduled to be repealed on January 1, 2013) |
3 |
| Sec. 57. Pedigree. |
4 |
| (a) Each person who is engaged in the wholesale |
5 |
| distribution of prescription drugs, including repackagers, but |
6 |
| excluding the original manufacturer of the finished form of the |
7 |
| prescription drug, that leave or have ever left the normal |
8 |
| distribution channel shall, before each wholesale distribution |
9 |
| of the drug, provide a pedigree to the person who receives the
|
10 |
| drug. A retail pharmacy, mail order pharmacy, or chain pharmacy |
11 |
| warehouse must comply with the requirements of this Section |
12 |
| only if the pharmacy or chain pharmacy warehouse engages in the |
13 |
| wholesale distribution of prescription drugs. On or before July |
14 |
| 1, 2009, the Department shall determine a targeted |
15 |
| implementation date for electronic track and trace pedigree |
16 |
| technology. This targeted implementation date shall not be |
17 |
| sooner than July 1, 2010. Beginning on the date established by |
18 |
| the Department, pedigrees may be implemented through an |
19 |
| approved and readily available system that electronically |
20 |
| tracks and traces the wholesale distribution of each |
21 |
| prescription drug starting with the sale by the manufacturer |
22 |
| through acquisition and sale by any wholesale distributor and |
23 |
| until final sale to a pharmacy or other authorized person |
24 |
| administering or dispensing the prescription drug. This |
25 |
| electronic tracking system shall be deemed to be readily |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| available only upon there being available a standardized system |
2 |
| originating with the manufacturers and capable of being used on |
3 |
| a wide scale across the entire pharmaceutical chain, including |
4 |
| manufacturers, wholesale distributors, and pharmacies. |
5 |
| Consideration must also be given to the large-scale |
6 |
| implementation of this technology across the supply chain and |
7 |
| the technology must be proven to have no negative impact on the |
8 |
| safety and efficacy of the pharmaceutical product. |
9 |
| (b) Each person who is engaged in the wholesale |
10 |
| distribution of a prescription drug who is provided a pedigree |
11 |
| for a prescription drug and attempts to further distribute that |
12 |
| prescription drug, including repackagers, but excluding the |
13 |
| original manufacturer of the finished form of the prescription |
14 |
| drug, must affirmatively verify before any distribution of a |
15 |
| prescription drug occurs that each transaction listed on the |
16 |
| pedigree has occurred. |
17 |
| (c) The pedigree must include all necessary identifying |
18 |
| information concerning each sale in the chain of distribution |
19 |
| of the product from the manufacturer or the manufacturer's |
20 |
| third party logistics provider, co-licensed product partner, |
21 |
| or exclusive distributor through acquisition and sale by any |
22 |
| wholesale distributor or repackager, until final sale to a |
23 |
| pharmacy or other person dispensing or administering the drug. |
24 |
| This necessary chain of distribution information shall |
25 |
| include, without limitation all of the following: |
26 |
| (1) The name, address, telephone number and, if |
|
|
|
SB0509 Enrolled |
- 146 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| available, the e-mail address of each owner of the |
2 |
| prescription drug and each wholesale distributor of the |
3 |
| prescription drug. |
4 |
| (2) The name and address of each location from which |
5 |
| the product was shipped, if different from the owner's. |
6 |
| (3) Transaction dates. |
7 |
| (4) Certification that each recipient has |
8 |
| authenticated the pedigree. |
9 |
| (d) The pedigree must also include without limitation all |
10 |
| of the following information concerning the prescription drug: |
11 |
| (1) The name and national drug code number of the |
12 |
| prescription drug. |
13 |
| (2) The dosage form and strength of the prescription |
14 |
| drug. |
15 |
| (3) The size of the container. |
16 |
| (4) The number of containers. |
17 |
| (5) The lot number of the prescription drug. |
18 |
| (6) The name of the manufacturer of the finished dosage |
19 |
| form. |
20 |
| (e) Each pedigree or electronic file shall be maintained by |
21 |
| the purchaser and the wholesale distributor for at least 3 |
22 |
| years from the date of sale or transfer and made available for |
23 |
| inspection or use within 5 business days upon a request of the |
24 |
| Department.
|
25 |
| (225 ILCS 120/58 new)
|
|
|
|
SB0509 Enrolled |
- 147 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (Section scheduled to be repealed on January 1, 2013) |
2 |
| Sec. 58. Prohibited acts. It is unlawful for a person to |
3 |
| perform or cause the performance of or aid and abet any of the |
4 |
| following acts: |
5 |
| (1) Failure to obtain a license in accordance with this |
6 |
| Act or operating without a valid license when a license is |
7 |
| required by this Act. |
8 |
| (2) If the requirements of subsection (a) of Section 56 |
9 |
| of this Act are applicable and are not met, the purchasing |
10 |
| or otherwise receiving of a prescription drug from a |
11 |
| pharmacy. |
12 |
| (3) If licensure is required pursuant to subsection (b) |
13 |
| of Section 56 of this Act, the sale, distribution, or |
14 |
| transfer of a prescription drug to a person that is not |
15 |
| authorized under the law of the jurisdiction in which the |
16 |
| person receives the prescription drug to receive the |
17 |
| prescription drug. |
18 |
| (4) Failure to deliver prescription drugs to specified |
19 |
| premises, as required by subsection (c) of Section 56 of |
20 |
| this Act. |
21 |
| (5) Accepting payment or credit for the sale of |
22 |
| prescription drugs in violation of subsection (e) of |
23 |
| Section 56 of this Act. |
24 |
| (6) Failure to maintain or provide pedigrees as |
25 |
| required by this Act. |
26 |
| (7) Failure to obtain, pass, or authenticate a pedigree |
|
|
|
SB0509 Enrolled |
- 148 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| as required by this Act. |
2 |
| (8) Providing the Department or any federal official |
3 |
| with false or fraudulent records or making false or |
4 |
| fraudulent statements regarding any matter within the |
5 |
| provisions of this Act. |
6 |
| (9) Obtaining or attempting to obtain a prescription |
7 |
| drug by fraud, deceit, or misrepresentation or engaging in |
8 |
| misrepresentation or fraud in the distribution of a |
9 |
| prescription drug. |
10 |
| (10) The manufacture, repacking, sale, transfer, |
11 |
| delivery, holding, or offering for sale of any prescription |
12 |
| drug that is adulterated, misbranded, counterfeit, |
13 |
| suspected of being counterfeit, or that has otherwise been |
14 |
| rendered unfit for distribution, except for the wholesale |
15 |
| distribution by manufacturers of a prescription drug that |
16 |
| has been delivered into commerce pursuant to an application |
17 |
| approved under federal law by the FDA. |
18 |
| (11) The adulteration, misbranding, or counterfeiting |
19 |
| of any prescription drug, except for the wholesale |
20 |
| distribution by manufacturers of a prescription drug that |
21 |
| has been delivered into commerce pursuant to an application |
22 |
| approved under federal law by the FDA. |
23 |
| (12) The receipt of any prescription drug that is |
24 |
| adulterated, misbranded, stolen, obtained by fraud or |
25 |
| deceit, counterfeit, or suspected of being counterfeit and |
26 |
| the delivery or proffered delivery of such drug for pay or |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| otherwise. |
2 |
| (13) The alteration, mutilation, destruction, |
3 |
| obliteration, or removal of the whole or any part of the |
4 |
| labeling of a prescription drug or the commission of any |
5 |
| other act with respect to a prescription drug that results |
6 |
| in the prescription drug being misbranded.
The acts |
7 |
| prohibited in this Section do not include the obtaining or |
8 |
| the attempt to obtain a prescription drug for the sole |
9 |
| purpose of testing the prescription drug for authenticity |
10 |
| performed by a prescription drug manufacturer or the agent |
11 |
| of a prescription drug manufacturer. |
12 |
| (225 ILCS 120/59 new)
|
13 |
| (Section scheduled to be repealed on January 1, 2013) |
14 |
| Sec. 59. Enforcement; order to cease distribution of a |
15 |
| drug. |
16 |
| (a) The Department shall issue an order requiring the |
17 |
| appropriate person, including the distributors or retailers of |
18 |
| a drug, to immediately cease distribution of the drug within |
19 |
| this State, if the Department finds that there is a reasonable |
20 |
| probability that: |
21 |
| (1) a wholesale distributor has (i) violated a |
22 |
| provision in this Act or (ii) falsified a pedigree or sold, |
23 |
| distributed, transferred, manufactured, repackaged, |
24 |
| handled, or held a counterfeit prescription drug intended |
25 |
| for human use; |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| (2) the prescription drug at issue, as a result of a |
2 |
| violation in paragraph (1) of this subsection (a), could |
3 |
| cause serious, adverse health consequences or death; and |
4 |
| (3) other procedures would result in unreasonable |
5 |
| delay. |
6 |
| (b) An order issued under this Section shall provide the |
7 |
| person subject to the order with an opportunity for an informal |
8 |
| hearing, to be held not later than 10 days after the date of |
9 |
| the issuance of the order, on the actions required by the |
10 |
| order. If, after providing an opportunity for a hearing, the |
11 |
| Department determines that inadequate grounds exist to support |
12 |
| the actions required by the order, the Department shall vacate |
13 |
| the order.
|
14 |
| Section 85. The Illinois Public Aid Code is amended by |
15 |
| changing Section 8A-7.1 as follows:
|
16 |
| (305 ILCS 5/8A-7.1) (from Ch. 23, par. 8A-7.1)
|
17 |
| Sec. 8A-7.1. The Director, upon making a
determination |
18 |
| based upon information in the possession of the Illinois
|
19 |
| Department, that continuation in practice of a licensed health |
20 |
| care
professional would constitute an immediate danger to the |
21 |
| public, shall submit
a written communication to the Director of |
22 |
| Professional Regulation indicating
such determination and
|
23 |
| additionally providing a complete summary of the information |
24 |
| upon which
such determination is based, and recommending that |
|
|
|
SB0509 Enrolled |
- 151 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| the Director of
Professional Regulation immediately suspend |
2 |
| such person's
license. All relevant evidence, or copies |
3 |
| thereof, in the Illinois
Department's possession may also be |
4 |
| submitted in conjunction with the written
communication. A copy |
5 |
| of such written communication, which is exempt from
the copying |
6 |
| and inspection provisions of the Freedom of Information Act,
|
7 |
| shall at the time of submittal to the Director
of Professional |
8 |
| Regulation
be simultaneously mailed to the last known business |
9 |
| address of such licensed
health care professional by certified |
10 |
| or registered postage, United States
Mail, return receipt |
11 |
| requested. Any evidence, or copies thereof, which is
submitted |
12 |
| in conjunction with the written communication is also exempt |
13 |
| from
the copying and inspection provisions of the Freedom of |
14 |
| Information Act.
|
15 |
| The Director, upon making a determination based upon |
16 |
| information in the
possession of the Illinois Department, that |
17 |
| a licensed health care
professional is willfully committing |
18 |
| fraud upon the Illinois Department's
medical assistance |
19 |
| program, shall submit a written communication to the
Director |
20 |
| of Professional Regulation indicating such
determination and |
21 |
| additionally providing a complete summary of the
information |
22 |
| upon which such determination is based. All relevant evidence,
|
23 |
| or copies thereof, in the Illinois Department's possession may |
24 |
| also be
submitted in conjunction with the written |
25 |
| communication.
|
26 |
| Upon receipt of such written communication, the Director of
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| Professional Regulation shall promptly investigate the
|
2 |
| allegations contained in such written communication. A copy of |
3 |
| such
written communication, which is exempt from the copying |
4 |
| and inspection
provisions of the Freedom of Information Act, |
5 |
| shall at the time of
submission to the Director of Professional |
6 |
| Regulation,
be simultaneously mailed to the last known address |
7 |
| of such licensed health
care professional by certified or |
8 |
| registered postage, United States Mail,
return receipt |
9 |
| requested. Any evidence, or copies thereof, which
is submitted |
10 |
| in conjunction with the written communication is also exempt
|
11 |
| from the copying and inspection provisions of the Freedom of |
12 |
| Information Act.
|
13 |
| For the purposes of this Section, "licensed health care |
14 |
| professional"
means any person licensed under the Illinois |
15 |
| Dental Practice Act, the Nursing
and Advanced Practice Nursing |
16 |
| Act, the Medical Practice Act of 1987, the
Pharmacy Practice |
17 |
| Act of 1987 , the Podiatric Medical Practice Act of 1987,
or the |
18 |
| Illinois Optometric Practice Act of 1987.
|
19 |
| (Source: P.A. 92-651, eff. 7-11-02.)
|
20 |
| Section 90. The Elder Abuse and Neglect Act is amended by |
21 |
| changing Section 2 as follows:
|
22 |
| (320 ILCS 20/2) (from Ch. 23, par. 6602)
|
23 |
| Sec. 2. Definitions. As used in this Act, unless the |
24 |
| context
requires otherwise:
|
|
|
|
SB0509 Enrolled |
- 153 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (a) "Abuse" means causing any physical, mental or sexual |
2 |
| injury to an
eligible adult, including exploitation of such |
3 |
| adult's financial resources.
|
4 |
| Nothing in this Act shall be construed to mean that an |
5 |
| eligible adult is a
victim of abuse, neglect, or self-neglect |
6 |
| for the sole reason that he or she is being
furnished with or |
7 |
| relies upon treatment by spiritual means through prayer
alone, |
8 |
| in accordance with the tenets and practices of a recognized |
9 |
| church
or religious denomination.
|
10 |
| Nothing in this Act shall be construed to mean that an |
11 |
| eligible adult is a
victim of abuse because of health care |
12 |
| services provided or not provided by
licensed health care |
13 |
| professionals.
|
14 |
| (a-5) "Abuser" means a person who abuses, neglects, or |
15 |
| financially
exploits an eligible adult.
|
16 |
| (a-7) "Caregiver" means a person who either as a result of |
17 |
| a family
relationship, voluntarily, or in exchange for |
18 |
| compensation has assumed
responsibility for all or a portion of |
19 |
| the care of an eligible adult who needs
assistance with |
20 |
| activities of daily
living.
|
21 |
| (b) "Department" means the Department on Aging of the State |
22 |
| of Illinois.
|
23 |
| (c) "Director" means the Director of the Department.
|
24 |
| (d) "Domestic living situation" means a residence where the |
25 |
| eligible
adult lives alone or with his or her family or a |
26 |
| caregiver, or others,
or a board and care home or other |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| community-based unlicensed facility, but
is not:
|
2 |
| (1) A licensed facility as defined in Section 1-113 of |
3 |
| the Nursing Home
Care Act;
|
4 |
| (2) A "life care facility" as defined in the Life Care |
5 |
| Facilities Act;
|
6 |
| (3) A home, institution, or other place operated by the |
7 |
| federal
government or agency thereof or by the State of |
8 |
| Illinois;
|
9 |
| (4) A hospital, sanitarium, or other institution, the |
10 |
| principal activity
or business of which is the diagnosis, |
11 |
| care, and treatment of human illness
through the |
12 |
| maintenance and operation of organized facilities |
13 |
| therefor,
which is required to be licensed under the |
14 |
| Hospital Licensing Act;
|
15 |
| (5) A "community living facility" as defined in the |
16 |
| Community Living
Facilities Licensing Act;
|
17 |
| (6) A "community residential alternative" as defined |
18 |
| in the Community
Residential Alternatives Licensing Act;
|
19 |
| (7) A "community-integrated living arrangement" as |
20 |
| defined in
the Community-Integrated Living Arrangements |
21 |
| Licensure and Certification Act;
|
22 |
| (8) An assisted living or shared housing establishment |
23 |
| as defined in the Assisted Living and Shared Housing Act; |
24 |
| or
|
25 |
| (9) A supportive living facility as described in |
26 |
| Section 5-5.01a of the Illinois Public Aid Code.
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| (e) "Eligible adult" means a person 60 years of age or |
2 |
| older who
resides in a domestic living situation and is, or is |
3 |
| alleged
to be, abused, neglected, or financially exploited by |
4 |
| another individual or who neglects himself or herself.
|
5 |
| (f) "Emergency" means a situation in which an eligible |
6 |
| adult is living
in conditions presenting a risk of death or |
7 |
| physical, mental or sexual
injury and the provider agency has |
8 |
| reason to believe the eligible adult is
unable to
consent to |
9 |
| services which would alleviate that risk.
|
10 |
| (f-5) "Mandated reporter" means any of the following |
11 |
| persons
while engaged in carrying out their professional |
12 |
| duties:
|
13 |
| (1) a professional or professional's delegate while |
14 |
| engaged in: (i) social
services, (ii) law enforcement, |
15 |
| (iii) education, (iv) the care of an eligible
adult or |
16 |
| eligible adults, or (v) any of the occupations required to |
17 |
| be licensed
under
the Clinical Psychologist Licensing Act, |
18 |
| the Clinical Social Work and Social
Work Practice Act, the |
19 |
| Illinois Dental Practice Act, the Dietetic and Nutrition
|
20 |
| Services Practice Act, the Marriage and Family Therapy |
21 |
| Licensing Act, the
Medical Practice Act of 1987, the |
22 |
| Naprapathic Practice Act, the
Nursing and Advanced |
23 |
| Practice Nursing Act, the Nursing Home
Administrators |
24 |
| Licensing and
Disciplinary Act, the Illinois Occupational |
25 |
| Therapy Practice Act, the Illinois
Optometric Practice Act |
26 |
| of 1987, the Pharmacy Practice Act of 1987 , the
Illinois |
|
|
|
SB0509 Enrolled |
- 156 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| Physical Therapy Act, the Physician Assistant Practice Act |
2 |
| of 1987,
the Podiatric Medical Practice Act of 1987, the |
3 |
| Respiratory Care Practice
Act,
the Professional Counselor |
4 |
| and
Clinical Professional Counselor Licensing Act, the |
5 |
| Illinois Speech-Language
Pathology and Audiology Practice |
6 |
| Act, the Veterinary Medicine and Surgery
Practice Act of |
7 |
| 2004, and the Illinois Public Accounting Act;
|
8 |
| (2) an employee of a vocational rehabilitation |
9 |
| facility prescribed or
supervised by the Department of |
10 |
| Human Services;
|
11 |
| (3) an administrator, employee, or person providing |
12 |
| services in or through
an unlicensed community based |
13 |
| facility;
|
14 |
| (4) any religious practitioner who provides treatment |
15 |
| by prayer or spiritual means alone in accordance with the |
16 |
| tenets and practices of a recognized church or religious |
17 |
| denomination, except as to information received in any |
18 |
| confession or sacred communication enjoined by the |
19 |
| discipline of the religious denomination to be held |
20 |
| confidential;
|
21 |
| (5) field personnel of the Department of Healthcare and |
22 |
| Family Services, Department of Public
Health, and |
23 |
| Department of Human Services, and any county or
municipal |
24 |
| health department;
|
25 |
| (6) personnel of the Department of Human Services, the |
26 |
| Guardianship and
Advocacy Commission, the State Fire |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| Marshal, local fire departments, the
Department on Aging |
2 |
| and its subsidiary Area Agencies on Aging and provider
|
3 |
| agencies, and the Office of State Long Term Care Ombudsman;
|
4 |
| (7) any employee of the State of Illinois not otherwise |
5 |
| specified herein
who is involved in providing services to |
6 |
| eligible adults, including
professionals providing medical |
7 |
| or rehabilitation services and all
other persons having |
8 |
| direct contact with eligible adults;
|
9 |
| (8) a person who performs the duties of a coroner
or |
10 |
| medical examiner; or
|
11 |
| (9) a person who performs the duties of a paramedic or |
12 |
| an emergency
medical
technician.
|
13 |
| (g) "Neglect" means
another individual's failure to |
14 |
| provide an eligible
adult with or willful withholding from an |
15 |
| eligible adult the necessities of
life including, but not |
16 |
| limited to, food, clothing, shelter or health care.
This |
17 |
| subsection does not create any new affirmative duty to provide |
18 |
| support to
eligible adults. Nothing in this Act shall be |
19 |
| construed to mean that an
eligible adult is a victim of neglect |
20 |
| because of health care services provided
or not provided by |
21 |
| licensed health care professionals.
|
22 |
| (h) "Provider agency" means any public or nonprofit agency |
23 |
| in a planning
and service area appointed by the regional |
24 |
| administrative agency with prior
approval by the Department on |
25 |
| Aging to receive and assess reports of
alleged or suspected |
26 |
| abuse, neglect, or financial exploitation.
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| (i) "Regional administrative agency" means any public or |
2 |
| nonprofit
agency in a planning and service area so designated |
3 |
| by the Department,
provided that the designated Area Agency on |
4 |
| Aging shall be designated the
regional administrative agency if |
5 |
| it so requests.
The Department shall assume the functions of |
6 |
| the regional administrative
agency for any planning and service |
7 |
| area where another agency is not so
designated.
|
8 |
| (i-5) "Self-neglect" means a condition that is the result |
9 |
| of an eligible adult's inability, due to physical or mental |
10 |
| impairments, or both, or a diminished capacity, to perform |
11 |
| essential self-care tasks that substantially threaten his or |
12 |
| her own health, including: providing essential food, clothing, |
13 |
| shelter, and health care; and obtaining goods and services |
14 |
| necessary to maintain physical health, mental health, |
15 |
| emotional well-being, and general safety.
|
16 |
| (j) "Substantiated case" means a reported case of alleged |
17 |
| or suspected
abuse, neglect, financial exploitation, or |
18 |
| self-neglect in which a provider agency,
after assessment, |
19 |
| determines that there is reason to believe abuse,
neglect, or |
20 |
| financial exploitation has occurred.
|
21 |
| (Source: P.A. 93-281 eff. 12-31-03; 93-300, eff. 1-1-04; |
22 |
| 94-1064, eff. 1-1-07.)
|
23 |
| Section 95. The Senior Citizens and Disabled Persons |
24 |
| Property Tax Relief and
Pharmaceutical Assistance Act is |
25 |
| amended by changing Section 3.17 as follows:
|
|
|
|
SB0509 Enrolled |
- 159 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (320 ILCS 25/3.17) (from Ch. 67 1/2, par. 403.17)
|
2 |
| Sec. 3.17. "Authorized pharmacy" means any pharmacy |
3 |
| registered
in this State under the Pharmacy Practice Act of |
4 |
| 1987 .
|
5 |
| (Source: P.A. 85-1209.)
|
6 |
| Section 100. The Illinois Prescription Drug Discount
|
7 |
| Program Act is amended by changing Section 15 as follows:
|
8 |
| (320 ILCS 55/15)
|
9 |
| Sec. 15. Definitions. As used in this Act:
|
10 |
| "Authorized pharmacy" means any pharmacy registered in |
11 |
| this State under the
Pharmacy Practice Act of 1987 or approved |
12 |
| by the Department of Financial and Professional Regulation and |
13 |
| approved by the Department or its program
administrator.
|
14 |
| "AWP" or "average wholesale price" means the amount |
15 |
| determined from the
latest publication of the Red Book, a |
16 |
| universally subscribed pharmacist
reference guide
annually |
17 |
| published by the Hearst Corporation. "AWP" or "average |
18 |
| wholesale
price"
may also be derived electronically from the |
19 |
| drug pricing database synonymous
with the
latest publication of |
20 |
| the Red Book and furnished in the National Drug Data File
|
21 |
| (NDDF)
by First Data Bank (FDB), a service of the Hearst |
22 |
| Corporation.
|
23 |
| "Covered medication" means any medication included in the |
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| Illinois Prescription Drug Discount Program.
|
2 |
| "Department" means the Department of Healthcare and Family |
3 |
| Services.
|
4 |
| "Director" means the Director of Healthcare and Family |
5 |
| Services.
|
6 |
| "Drug manufacturer" means any entity (1) that is located |
7 |
| within or outside
Illinois
that is engaged in (i) the |
8 |
| production, preparation, propagation, compounding,
conversion,
|
9 |
| or processing of prescription drug products covered under the |
10 |
| program, either
directly or
indirectly by extraction from |
11 |
| substances of natural origin, independently by
means of
|
12 |
| chemical synthesis, or by a combination of extraction and |
13 |
| chemical synthesis or
(ii) the
packaging, repackaging, |
14 |
| leveling, labeling, or distribution of prescription
drug |
15 |
| products
covered under the program and (2) that elects to |
16 |
| provide prescription drugs
either directly
or under contract |
17 |
| with any entity providing prescription drug services on
behalf |
18 |
| of the
State of Illinois. "Drug manufacturer", however, does |
19 |
| not include a wholesale
distributor
of drugs or a retail |
20 |
| pharmacy licensed under Illinois law.
|
21 |
| "Federal Poverty Limit" or "FPL" means the Federal Poverty |
22 |
| Income Guidelines published annually in the Federal Register.
|
23 |
| "Prescription drug" means any prescribed drug that may be |
24 |
| legally dispensed
by
an authorized pharmacy.
|
25 |
| "Program" means the Illinois Prescription Drug
Discount |
26 |
| Program created
under this Act.
|
|
|
|
SB0509 Enrolled |
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LRB095 10560 RAS 30780 b |
|
|
1 |
| "Program administrator" means the entity that is chosen by |
2 |
| the Department to
administer the program. The program |
3 |
| administrator may, in this case, be the
Director or
a Pharmacy |
4 |
| Benefits Manager (PBM) chosen to subcontract with the Director.
|
5 |
| "Rules" includes rules adopted and forms prescribed by the |
6 |
| Department.
|
7 |
| (Source: P.A. 93-18, eff. 7-1-03; 94-86, eff. 1-1-06.)
|
8 |
| Section 105. The Illinois Food, Drug and Cosmetic Act is |
9 |
| amended by changing Sections 2.22, 3.14 and 3.21 as follows:
|
10 |
| (410 ILCS 620/2.22) (from Ch. 56 1/2, par. 502.22)
|
11 |
| Sec. 2.22. "Drug product selection", as used in Section |
12 |
| 3.14 of
this Act, means the act of selecting the source of |
13 |
| supply of a drug product
in a specified dosage form in |
14 |
| accordance with Section 3.14 of this Act
and Section 25 of the |
15 |
| Pharmacy Practice Act of 1987 .
|
16 |
| (Source: P.A. 85-1209.)
|
17 |
| (410 ILCS 620/3.14) (from Ch. 56 1/2, par. 503.14)
|
18 |
| Sec. 3.14. Dispensing or causing to be dispensed a |
19 |
| different drug in
place of the drug or brand of drug ordered or |
20 |
| prescribed without the
express permission of the person |
21 |
| ordering or prescribing.
Except as set forth in Section 26 of |
22 |
| the Pharmacy Practice Act, this Section does not prohibit the |
23 |
| interchange of different brands
of the same generically |
|
|
|
SB0509 Enrolled |
- 162 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| equivalent drug product, when the drug
products
are not |
2 |
| required to bear the legend "Caution: Federal law prohibits |
3 |
| dispensing
without prescription", provided that the same |
4 |
| dosage form is dispensed and
there is no greater than 1% |
5 |
| variance in the stated amount of each active
ingredient of the |
6 |
| drug products.
A generic drug determined to be therapeutically |
7 |
| equivalent by the
United States Food and Drug Administration |
8 |
| (FDA) shall be available
for substitution in Illinois in |
9 |
| accordance with this Act and the
Pharmacy Practice Act of 1987 , |
10 |
| provided that each manufacturer
submits to the Director of the |
11 |
| Department of Public Health a notification containing product |
12 |
| technical
bioequivalence information as a prerequisite to |
13 |
| product
substitution when they have completed all required |
14 |
| testing to
support FDA product approval and, in any event, the |
15 |
| information
shall be submitted no later than 60 days prior to |
16 |
| product
substitution in the State.
|
17 |
| (Source: P.A. 93-841, eff. 7-30-04; 94-936, eff. 6-26-06.)
|
18 |
| (410 ILCS 620/3.21) (from Ch. 56 1/2, par. 503.21)
|
19 |
| Sec. 3.21. Except as authorized by this Act, the Controlled |
20 |
| Substances
Act, the Pharmacy Practice Act of 1987 , the Dental |
21 |
| Practice Act, the Medical
Practice Act of 1987, the Veterinary |
22 |
| Medicine and Surgery Practice Act of
2004, or the Podiatric |
23 |
| Medical Practice Act of 1987, to sell or dispense a
|
24 |
| prescription drug without a prescription.
|
25 |
| (Source: P.A. 93-281, eff. 12-31-03.)
|
|
|
|
SB0509 Enrolled |
- 163 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| Section 110. The Uniform Hazardous Substances Act of |
2 |
| Illinois is amended by changing Section 13 as follows:
|
3 |
| (430 ILCS 35/13) (from Ch. 111 1/2, par. 263)
|
4 |
| Sec. 13. This Act shall not apply to:
|
5 |
| (1) Any carrier, while lawfully engaged in transporting a |
6 |
| hazardous
substance within this State, if such carrier shall, |
7 |
| upon request, permit
the Director or his designated agent to |
8 |
| copy all records showing the
transactions in and movements of |
9 |
| the articles;
|
10 |
| (2) Public Officials of this State and of the federal |
11 |
| government engaged
in the performance of their official duties;
|
12 |
| (3) The manufacturer or shipper of a hazardous substance |
13 |
| for experimental use only:
|
14 |
| (a) By or under the supervision of an agency of this State |
15 |
| or of the federal
government authorized by law to conduct |
16 |
| research in the field of hazardous
substances; or
|
17 |
| (b) By others if the hazardous substance is not sold and if |
18 |
| the
container thereof is plainly and conspicuously marked "For |
19 |
| experimental use
only -- Not to be sold", together with the |
20 |
| manufacturer's name and address;
provided, however, that if a |
21 |
| written permit has been obtained from the
Director, hazardous |
22 |
| substances may be sold for experimental purposes
subject to |
23 |
| such restrictions and conditions as may be set forth in the |
24 |
| permit;
|
|
|
|
SB0509 Enrolled |
- 164 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (4) Any food, drug or cosmetic subject to the Federal Food, |
2 |
| Drug and
Cosmetic Act or to the Illinois Food, Drug and |
3 |
| Cosmetic Act, or to
preparations, drugs and chemicals which are |
4 |
| dispensed by pharmacists
authorized by and pursuant to the |
5 |
| Pharmacy Practice Act of 1987 ; provided
that this Act shall |
6 |
| apply to any pressurized container
containing a food, drug, |
7 |
| cosmetic, chemical or other preparation.
|
8 |
| (5) Any economic poison subject to the Federal Insecticide, |
9 |
| Fungicide
and Rodenticide Act, or to the "Illinois Pesticide |
10 |
| Act", approved
August 14, 1979, as amended, but shall
apply to |
11 |
| any article which is not itself an economic poison within the |
12 |
| meaning
of the Federal Insecticide, Fungicide and Rodenticide |
13 |
| Act or the Illinois
Pesticide Act, approved August 14, 1979, as |
14 |
| amended, but which
is a hazardous substance within the meaning |
15 |
| of Section
2-4 of this Act, by reason of bearing or containing |
16 |
| such an economic poison.
|
17 |
| (6) Fuel used primarily for cooking, heating or |
18 |
| refrigeration when stored
in containers and used in the |
19 |
| heating, cooking or refrigeration system of a household.
|
20 |
| (7) Any article of wearing apparel, bedding, fabric, doll |
21 |
| or toy which
is subject to the provisions of the Illinois |
22 |
| Flammable Fabrics and Toys
Act, by reason of its flammable |
23 |
| nature, but this Act shall apply to such
article if it bears or |
24 |
| contains a substance or mixture of substances which
is toxic, |
25 |
| corrosive, an irritant, strong sensitizer, or which generates
|
26 |
| pressure through decomposition, heat or other means and which |
|
|
|
SB0509 Enrolled |
- 165 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| may cause
substantial personal injury or illness during or as a |
2 |
| proximate result of
any customary or reasonably anticipated |
3 |
| handling or use including
reasonably foreseeable ingestion by |
4 |
| children.
|
5 |
| (8) Any source material, special nuclear material, or |
6 |
| by-product
material as defined in the Atomic Energy Act of |
7 |
| 1954, as amended, and
regulations issued pursuant thereto by |
8 |
| the Atomic Energy Commission.
|
9 |
| (9) The labeling of any equipment or facilities for the |
10 |
| use, storage,
transportation, or manufacture of any hazardous |
11 |
| material which is required
to be placarded by "An Act to |
12 |
| require labeling of equipment and facilities
for the use, |
13 |
| transportation, storage and manufacture of hazardous materials
|
14 |
| and to provide for a uniform response system to hazardous |
15 |
| materials
emergencies", approved August 26, 1976, as amended.
|
16 |
| The Director may exempt from the requirements established |
17 |
| by or pursuant
to this Act any hazardous substance or container |
18 |
| of a hazardous substance
with respect to which he finds |
19 |
| adequate requirements satisfying the
purposes of this Act have |
20 |
| been established by or pursuant to and in
compliance with any |
21 |
| other federal or state law.
|
22 |
| (Source: P.A. 85-1209.)
|
23 |
| Section 115. The Illinois Abortion Law of 1975 is amended |
24 |
| by changing Section 11 as follows:
|
|
|
|
SB0509 Enrolled |
- 166 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (720 ILCS 510/11) (from Ch. 38, par. 81-31)
|
2 |
| Sec. 11. (1) Any person who intentionally violates any |
3 |
| provision of this
Law commits a Class A misdemeanor unless a |
4 |
| specific penalty is otherwise
provided. Any person who |
5 |
| intentionally falsifies any writing required by
this Law |
6 |
| commits a Class A misdemeanor.
|
7 |
| Intentional, knowing, reckless, or negligent violations of |
8 |
| this Law shall
constitute unprofessional conduct which causes |
9 |
| public harm under Section
22 of the Medical Practice Act of |
10 |
| 1987, as amended; Sections
10-45 and 15-50 of
the
Nursing and |
11 |
| Advanced Practice Nursing Act, and
Section 21 of the Physician |
12 |
| Assistant
Practice Act of 1987, as amended.
|
13 |
| Intentional, knowing, reckless or negligent violations of |
14 |
| this Law will
constitute grounds for refusal, denial, |
15 |
| revocation,
suspension, or withdrawal of license, certificate, |
16 |
| or permit under Section
30 of the Pharmacy Practice Act of |
17 |
| 1987 , as amended; Section 7 of
the Ambulatory Surgical |
18 |
| Treatment Center
Act, effective July 19, 1973, as amended; and |
19 |
| Section 7 of the Hospital
Licensing Act.
|
20 |
| (2) Any hospital or licensed facility which, or any
|
21 |
| physician who intentionally, knowingly, or recklessly
fails to |
22 |
| submit a complete report to the Department in accordance with |
23 |
| the
provisions of Section 10 of this Law and any person who |
24 |
| intentionally,
knowingly, recklessly or negligently fails to |
25 |
| maintain the confidentiality
of any reports required under this |
26 |
| Law or reports required by
Sections 10.1 or 12 of this Law |
|
|
|
SB0509 Enrolled |
- 167 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| commits a Class B misdemeanor.
|
2 |
| (3) Any person who sells any drug, medicine, instrument or |
3 |
| other
substance which he knows to be an abortifacient and which |
4 |
| is in fact an
abortifacient, unless upon prescription of a |
5 |
| physician, is guilty of a
Class B misdemeanor. Any person who |
6 |
| prescribes or administers any instrument,
medicine, drug or |
7 |
| other substance or device, which he knows to be an
|
8 |
| abortifacient, and which is in fact an abortifacient, and |
9 |
| intentionally,
knowingly or recklessly fails to inform the |
10 |
| person for whom it is
prescribed or upon whom it is |
11 |
| administered that it is an abortifacient
commits a Class C |
12 |
| misdemeanor.
|
13 |
| (4) Any person who intentionally, knowingly or recklessly
|
14 |
| performs upon a woman what he represents to that woman to be an
|
15 |
| abortion when he knows or should know that she is not pregnant |
16 |
| commits
a Class 2 felony and shall be answerable in
civil |
17 |
| damages equal to 3 times the amount of proved damages.
|
18 |
| (Source: P.A. 90-742, eff. 8-13-98.)
|
19 |
| Section 120. The Illinois Controlled Substances Act is |
20 |
| amended by changing Sections 102, 103, 301, and 309 as follows: |
21 |
| (720 ILCS 570/102) (from Ch. 56 1/2, par. 1102) |
22 |
| Sec. 102. Definitions. As used in this Act, unless the |
23 |
| context
otherwise requires:
|
24 |
| (a) "Addict" means any person who habitually uses any drug, |
|
|
|
SB0509 Enrolled |
- 168 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| chemical,
substance or dangerous drug other than alcohol so as |
2 |
| to endanger the public
morals, health, safety or welfare or who |
3 |
| is so far addicted to the use of a
dangerous drug or controlled |
4 |
| substance other than alcohol as to have lost
the power of self |
5 |
| control with reference to his addiction.
|
6 |
| (b) "Administer" means the direct application of a |
7 |
| controlled
substance, whether by injection, inhalation, |
8 |
| ingestion, or any other
means, to the body of a patient, |
9 |
| research subject, or animal (as
defined by the Humane |
10 |
| Euthanasia in Animal Shelters Act) by:
|
11 |
| (1) a practitioner (or, in his presence, by his |
12 |
| authorized agent),
|
13 |
| (2) the patient or research subject at the lawful |
14 |
| direction of the
practitioner, or
|
15 |
| (3) a euthanasia technician as defined by the Humane |
16 |
| Euthanasia in
Animal Shelters Act.
|
17 |
| (c) "Agent" means an authorized person who acts on behalf |
18 |
| of or at
the direction of a manufacturer, distributor, or |
19 |
| dispenser. It does not
include a common or contract carrier, |
20 |
| public warehouseman or employee of
the carrier or warehouseman.
|
21 |
| (c-1) "Anabolic Steroids" means any drug or hormonal |
22 |
| substance,
chemically and pharmacologically related to |
23 |
| testosterone (other than
estrogens, progestins, and |
24 |
| corticosteroids) that promotes muscle growth,
and includes:
|
25 |
| (i) boldenone,
|
26 |
| (ii) chlorotestosterone,
|
|
|
|
SB0509 Enrolled |
- 170 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| substance described
or listed in this paragraph, if |
2 |
| that salt, ester, or isomer promotes muscle
growth.
|
3 |
| Any person who is otherwise lawfully in possession of an |
4 |
| anabolic
steroid, or who otherwise lawfully manufactures, |
5 |
| distributes, dispenses,
delivers, or possesses with intent to |
6 |
| deliver an anabolic steroid, which
anabolic steroid is |
7 |
| expressly intended for and lawfully allowed to be
administered |
8 |
| through implants to livestock or other nonhuman species, and
|
9 |
| which is approved by the Secretary of Health and Human Services |
10 |
| for such
administration, and which the person intends to |
11 |
| administer or have
administered through such implants, shall |
12 |
| not be considered to be in
unauthorized possession or to |
13 |
| unlawfully manufacture, distribute, dispense,
deliver, or |
14 |
| possess with intent to deliver such anabolic steroid for
|
15 |
| purposes of this Act.
|
16 |
| (d) "Administration" means the Drug Enforcement |
17 |
| Administration,
United States Department of Justice, or its |
18 |
| successor agency.
|
19 |
| (e) "Control" means to add a drug or other substance, or |
20 |
| immediate
precursor, to a Schedule under Article II of this Act |
21 |
| whether by
transfer from another Schedule or otherwise.
|
22 |
| (f) "Controlled Substance" means a drug, substance, or |
23 |
| immediate
precursor in the Schedules of Article II of this Act.
|
24 |
| (g) "Counterfeit substance" means a controlled substance, |
25 |
| which, or
the container or labeling of which, without |
26 |
| authorization bears the
trademark, trade name, or other |
|
|
|
SB0509 Enrolled |
- 171 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| identifying mark, imprint, number or
device, or any likeness |
2 |
| thereof, of a manufacturer, distributor, or
dispenser other |
3 |
| than the person who in fact manufactured, distributed,
or |
4 |
| dispensed the substance.
|
5 |
| (h) "Deliver" or "delivery" means the actual, constructive |
6 |
| or
attempted transfer of possession of a controlled substance, |
7 |
| with or
without consideration, whether or not there is an |
8 |
| agency relationship.
|
9 |
| (i) "Department" means the Illinois Department of Human |
10 |
| Services (as
successor to the Department of Alcoholism and |
11 |
| Substance Abuse) or its successor agency.
|
12 |
| (j) "Department of State Police" means the Department of |
13 |
| State
Police of the State of Illinois or its successor agency.
|
14 |
| (k) "Department of Corrections" means the Department of |
15 |
| Corrections
of the State of Illinois or its successor agency.
|
16 |
| (l) "Department of Professional Regulation" means the |
17 |
| Department
of Professional Regulation of the State of Illinois |
18 |
| or its successor agency.
|
19 |
| (m) "Depressant" or "stimulant substance" means:
|
20 |
| (1) a drug which contains any quantity of (i) |
21 |
| barbituric acid or
any of the salts of barbituric acid |
22 |
| which has been designated as habit
forming under section |
23 |
| 502 (d) of the Federal Food, Drug, and Cosmetic
Act (21 |
24 |
| U.S.C. 352 (d)); or
|
25 |
| (2) a drug which contains any quantity of (i) |
26 |
| amphetamine or
methamphetamine and any of their optical |
|
|
|
SB0509 Enrolled |
- 172 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| isomers; (ii) any salt of
amphetamine or methamphetamine or |
2 |
| any salt of an optical isomer of
amphetamine; or (iii) any |
3 |
| substance which the Department, after
investigation, has |
4 |
| found to be, and by rule designated as, habit forming
|
5 |
| because of its depressant or stimulant effect on the |
6 |
| central nervous
system; or
|
7 |
| (3) lysergic acid diethylamide; or
|
8 |
| (4) any drug which contains any quantity of a substance |
9 |
| which the
Department, after investigation, has found to |
10 |
| have, and by rule
designated as having, a potential for |
11 |
| abuse because of its depressant or
stimulant effect on the |
12 |
| central nervous system or its hallucinogenic
effect.
|
13 |
| (n) (Blank).
|
14 |
| (o) "Director" means the Director of the Department of |
15 |
| State Police or
the Department of Professional Regulation or |
16 |
| his designated agents.
|
17 |
| (p) "Dispense" means to deliver a controlled substance to |
18 |
| an
ultimate user or research subject by or pursuant to the |
19 |
| lawful order of
a prescriber, including the prescribing, |
20 |
| administering, packaging,
labeling, or compounding necessary |
21 |
| to prepare the substance for that
delivery.
|
22 |
| (q) "Dispenser" means a practitioner who dispenses.
|
23 |
| (r) "Distribute" means to deliver, other than by |
24 |
| administering or
dispensing, a controlled substance.
|
25 |
| (s) "Distributor" means a person who distributes.
|
26 |
| (t) "Drug" means (1) substances recognized as drugs in the |
|
|
|
SB0509 Enrolled |
- 173 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| official
United States Pharmacopoeia, Official Homeopathic |
2 |
| Pharmacopoeia of the
United States, or official National |
3 |
| Formulary, or any supplement to any
of them; (2) substances |
4 |
| intended for use in diagnosis, cure, mitigation,
treatment, or |
5 |
| prevention of disease in man or animals; (3) substances
(other |
6 |
| than food) intended to affect the structure of any function of
|
7 |
| the body of man or animals and (4) substances intended for use |
8 |
| as a
component of any article specified in clause (1), (2), or |
9 |
| (3) of this
subsection. It does not include devices or their |
10 |
| components, parts, or
accessories.
|
11 |
| (t-5) "Euthanasia agency" means
an entity certified by the |
12 |
| Department of Professional Regulation for the
purpose of animal |
13 |
| euthanasia that holds an animal control facility license or
|
14 |
| animal
shelter license under the Animal Welfare Act. A |
15 |
| euthanasia agency is
authorized to purchase, store, possess, |
16 |
| and utilize Schedule II nonnarcotic and
Schedule III |
17 |
| nonnarcotic drugs for the sole purpose of animal euthanasia.
|
18 |
| (t-10) "Euthanasia drugs" means Schedule II or Schedule III |
19 |
| substances
(nonnarcotic controlled substances) that are used |
20 |
| by a euthanasia agency for
the purpose of animal euthanasia.
|
21 |
| (u) "Good faith" means the prescribing or dispensing of a |
22 |
| controlled
substance by a practitioner in the regular course of |
23 |
| professional
treatment to or for any person who is under his |
24 |
| treatment for a
pathology or condition other than that |
25 |
| individual's physical or
psychological dependence upon or |
26 |
| addiction to a controlled substance,
except as provided herein: |
|
|
|
SB0509 Enrolled |
- 174 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| and application of the term to a pharmacist
shall mean the |
2 |
| dispensing of a controlled substance pursuant to the
|
3 |
| prescriber's order which in the professional judgment of the |
4 |
| pharmacist
is lawful. The pharmacist shall be guided by |
5 |
| accepted professional
standards including, but not limited to |
6 |
| the following, in making the
judgment:
|
7 |
| (1) lack of consistency of doctor-patient |
8 |
| relationship,
|
9 |
| (2) frequency of prescriptions for same drug by one |
10 |
| prescriber for
large numbers of patients,
|
11 |
| (3) quantities beyond those normally prescribed,
|
12 |
| (4) unusual dosages,
|
13 |
| (5) unusual geographic distances between patient, |
14 |
| pharmacist and
prescriber,
|
15 |
| (6) consistent prescribing of habit-forming drugs.
|
16 |
| (u-1) "Home infusion services" means services provided by a |
17 |
| pharmacy in
compounding solutions for direct administration to |
18 |
| a patient in a private
residence, long-term care facility, or |
19 |
| hospice setting by means of parenteral,
intravenous, |
20 |
| intramuscular, subcutaneous, or intraspinal infusion.
|
21 |
| (v) "Immediate precursor" means a substance:
|
22 |
| (1) which the Department has found to be and by rule |
23 |
| designated as
being a principal compound used, or produced |
24 |
| primarily for use, in the
manufacture of a controlled |
25 |
| substance;
|
26 |
| (2) which is an immediate chemical intermediary used or |
|
|
|
SB0509 Enrolled |
- 175 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| likely to
be used in the manufacture of such controlled |
2 |
| substance; and
|
3 |
| (3) the control of which is necessary to prevent, |
4 |
| curtail or limit
the manufacture of such controlled |
5 |
| substance.
|
6 |
| (w) "Instructional activities" means the acts of teaching, |
7 |
| educating
or instructing by practitioners using controlled |
8 |
| substances within
educational facilities approved by the State |
9 |
| Board of Education or
its successor agency.
|
10 |
| (x) "Local authorities" means a duly organized State, |
11 |
| County or
Municipal peace unit or police force.
|
12 |
| (y) "Look-alike substance" means a substance, other than a |
13 |
| controlled
substance which (1) by overall dosage unit |
14 |
| appearance, including shape,
color, size, markings or lack |
15 |
| thereof, taste, consistency, or any other
identifying physical |
16 |
| characteristic of the substance, would lead a reasonable
person |
17 |
| to believe that the substance is a controlled substance, or (2) |
18 |
| is
expressly or impliedly represented to be a controlled |
19 |
| substance or is
distributed under circumstances which would |
20 |
| lead a reasonable person to
believe that the substance is a |
21 |
| controlled substance. For the purpose of
determining whether |
22 |
| the representations made or the circumstances of the
|
23 |
| distribution would lead a reasonable person to believe the |
24 |
| substance to be
a controlled substance under this clause (2) of |
25 |
| subsection (y), the court or
other authority may consider the |
26 |
| following factors in addition to any other
factor that may be |
|
|
|
SB0509 Enrolled |
- 176 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| relevant:
|
2 |
| (a) statements made by the owner or person in control |
3 |
| of the substance
concerning its nature, use or effect;
|
4 |
| (b) statements made to the buyer or recipient that the |
5 |
| substance may
be resold for profit;
|
6 |
| (c) whether the substance is packaged in a manner |
7 |
| normally used for the
illegal distribution of controlled |
8 |
| substances;
|
9 |
| (d) whether the distribution or attempted distribution |
10 |
| included an
exchange of or demand for money or other |
11 |
| property as consideration, and
whether the amount of the |
12 |
| consideration was substantially greater than the
|
13 |
| reasonable retail market value of the substance.
|
14 |
| Clause (1) of this subsection (y) shall not apply to a |
15 |
| noncontrolled
substance in its finished dosage form that was |
16 |
| initially introduced into
commerce prior to the initial |
17 |
| introduction into commerce of a controlled
substance in its |
18 |
| finished dosage form which it may substantially resemble.
|
19 |
| Nothing in this subsection (y) prohibits the dispensing or |
20 |
| distributing
of noncontrolled substances by persons authorized |
21 |
| to dispense and
distribute controlled substances under this |
22 |
| Act, provided that such action
would be deemed to be carried |
23 |
| out in good faith under subsection (u) if the
substances |
24 |
| involved were controlled substances.
|
25 |
| Nothing in this subsection (y) or in this Act prohibits the |
26 |
| manufacture,
preparation, propagation, compounding, |
|
|
|
SB0509 Enrolled |
- 177 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| processing, packaging, advertising
or distribution of a drug or |
2 |
| drugs by any person registered pursuant to
Section 510 of the |
3 |
| Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
|
4 |
| (y-1) "Mail-order pharmacy" means a pharmacy that is |
5 |
| located in a state
of the United States, other than Illinois, |
6 |
| that delivers, dispenses or
distributes, through the United |
7 |
| States Postal Service or other common
carrier, to Illinois |
8 |
| residents, any substance which requires a prescription.
|
9 |
| (z) "Manufacture" means the production, preparation, |
10 |
| propagation,
compounding, conversion or processing of a |
11 |
| controlled substance other than methamphetamine, either
|
12 |
| directly or indirectly, by extraction from substances of |
13 |
| natural origin,
or independently by means of chemical |
14 |
| synthesis, or by a combination of
extraction and chemical |
15 |
| synthesis, and includes any packaging or
repackaging of the |
16 |
| substance or labeling of its container, except that
this term |
17 |
| does not include:
|
18 |
| (1) by an ultimate user, the preparation or compounding |
19 |
| of a
controlled substance for his own use; or
|
20 |
| (2) by a practitioner, or his authorized agent under |
21 |
| his
supervision, the preparation, compounding, packaging, |
22 |
| or labeling of a
controlled substance:
|
23 |
| (a) as an incident to his administering or |
24 |
| dispensing of a
controlled substance in the course of |
25 |
| his professional practice; or
|
26 |
| (b) as an incident to lawful research, teaching or |
|
|
|
SB0509 Enrolled |
- 178 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| chemical
analysis and not for sale.
|
2 |
| (z-1) (Blank).
|
3 |
| (aa) "Narcotic drug" means any of the following, whether |
4 |
| produced
directly or indirectly by extraction from substances |
5 |
| of natural origin,
or independently by means of chemical |
6 |
| synthesis, or by a combination of
extraction and chemical |
7 |
| synthesis:
|
8 |
| (1) opium and opiate, and any salt, compound, |
9 |
| derivative, or
preparation of opium or opiate;
|
10 |
| (2) any salt, compound, isomer, derivative, or |
11 |
| preparation thereof
which is chemically equivalent or |
12 |
| identical with any of the substances
referred to in clause |
13 |
| (1), but not including the isoquinoline alkaloids
of opium;
|
14 |
| (3) opium poppy and poppy straw;
|
15 |
| (4) coca leaves and any salts, compound, isomer, salt |
16 |
| of an isomer,
derivative, or preparation of coca leaves |
17 |
| including cocaine or ecgonine,
and any salt, compound, |
18 |
| isomer, derivative, or preparation thereof which is
|
19 |
| chemically equivalent or identical with any of these |
20 |
| substances, but not
including decocainized coca leaves or |
21 |
| extractions of coca leaves which do
not contain cocaine or |
22 |
| ecgonine (for the purpose of this paragraph, the
term |
23 |
| "isomer" includes optical, positional and geometric |
24 |
| isomers).
|
25 |
| (bb) "Nurse" means a registered nurse licensed under the
|
26 |
| Nursing and Advanced Practice Nursing Act.
|
|
|
|
SB0509 Enrolled |
- 179 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| (cc) (Blank).
|
2 |
| (dd) "Opiate" means any substance having an addiction |
3 |
| forming or
addiction sustaining liability similar to morphine |
4 |
| or being capable of
conversion into a drug having addiction |
5 |
| forming or addiction sustaining
liability.
|
6 |
| (ee) "Opium poppy" means the plant of the species Papaver
|
7 |
| somniferum L., except its seeds.
|
8 |
| (ff) "Parole and Pardon Board" means the Parole and Pardon |
9 |
| Board of
the State of Illinois or its successor agency.
|
10 |
| (gg) "Person" means any individual, corporation, |
11 |
| mail-order pharmacy,
government or governmental subdivision or |
12 |
| agency, business trust, estate,
trust, partnership or |
13 |
| association, or any other entity.
|
14 |
| (hh) "Pharmacist" means any person who holds a license or
|
15 |
| certificate of
registration as a registered pharmacist, a local |
16 |
| registered pharmacist
or a registered assistant pharmacist |
17 |
| under the Pharmacy Practice Act of 1987 .
|
18 |
| (ii) "Pharmacy" means any store, ship or other place in |
19 |
| which
pharmacy is authorized to be practiced under the Pharmacy |
20 |
| Practice Act of 1987 .
|
21 |
| (jj) "Poppy straw" means all parts, except the seeds, of |
22 |
| the opium
poppy, after mowing.
|
23 |
| (kk) "Practitioner" means a physician licensed to practice |
24 |
| medicine in all
its branches, dentist, podiatrist,
|
25 |
| veterinarian, scientific investigator, pharmacist, physician |
26 |
| assistant,
advanced practice nurse,
licensed practical
nurse, |
|
|
|
SB0509 Enrolled |
- 180 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| registered nurse, hospital, laboratory, or pharmacy, or other
|
2 |
| person licensed, registered, or otherwise lawfully permitted |
3 |
| by the
United States or this State to distribute, dispense, |
4 |
| conduct research
with respect to, administer or use in teaching |
5 |
| or chemical analysis, a
controlled substance in the course of |
6 |
| professional practice or research.
|
7 |
| (ll) "Pre-printed prescription" means a written |
8 |
| prescription upon which
the designated drug has been indicated |
9 |
| prior to the time of issuance.
|
10 |
| (mm) "Prescriber" means a physician licensed to practice |
11 |
| medicine in all
its branches, dentist, podiatrist or
|
12 |
| veterinarian who issues a prescription, a physician assistant |
13 |
| who
issues a
prescription for a Schedule III, IV, or V |
14 |
| controlled substance
in accordance
with Section 303.05 and the |
15 |
| written guidelines required under Section 7.5
of the
Physician |
16 |
| Assistant Practice Act of 1987, or an advanced practice
nurse |
17 |
| with prescriptive authority in accordance with Section 303.05
|
18 |
| and a written
collaborative agreement under Sections 15-15 and |
19 |
| 15-20 of
the Nursing and Advanced Practice Nursing Act.
|
20 |
| (nn) "Prescription" means a lawful written, facsimile, or |
21 |
| verbal order
of
a physician licensed to practice medicine in |
22 |
| all its branches,
dentist, podiatrist or veterinarian for any |
23 |
| controlled
substance, of a physician assistant for a Schedule |
24 |
| III, IV, or V
controlled substance
in accordance with Section |
25 |
| 303.05 and the written guidelines required under
Section 7.5 of |
26 |
| the
Physician Assistant Practice Act of 1987, or of an advanced |
|
|
|
SB0509 Enrolled |
- 181 - |
LRB095 10560 RAS 30780 b |
|
|
1 |
| practice
nurse who issues a prescription for a Schedule III, |
2 |
| IV, or V
controlled substance in accordance
with
Section 303.05 |
3 |
| and a written collaborative agreement under Sections 15-15
and
|
4 |
| 15-20 of the Nursing and Advanced Practice Nursing Act.
|
5 |
| (oo) "Production" or "produce" means manufacture, |
6 |
| planting,
cultivating, growing, or harvesting of a controlled |
7 |
| substance other than methamphetamine.
|
8 |
| (pp) "Registrant" means every person who is required to |
9 |
| register
under Section 302 of this Act.
|
10 |
| (qq) "Registry number" means the number assigned to each |
11 |
| person
authorized to handle controlled substances under the |
12 |
| laws of the United
States and of this State.
|
13 |
| (rr) "State" includes the State of Illinois and any state, |
14 |
| district,
commonwealth, territory, insular possession thereof, |
15 |
| and any area
subject to the legal authority of the United |
16 |
| States of America.
|
17 |
| (ss) "Ultimate user" means a person who lawfully possesses |
18 |
| a
controlled substance for his own use or for the use of a |
19 |
| member of his
household or for administering to an animal owned |
20 |
| by him or by a member
of his household.
|
21 |
| (Source: P.A. 93-596, eff. 8-26-03; 93-626, eff. 12-23-03; |
22 |
| 94-556, eff. 9-11-05.)
|
23 |
| (720 ILCS 570/103) (from Ch. 56 1/2, par. 1103)
|
24 |
| Sec. 103. Scope of Act. Nothing in this Act limits the |
25 |
| lawful authority
granted by the
Medical Practice Act of 1987, |
|
|
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| the Nursing and Advanced Practice
Nursing Act, or
the Pharmacy |
2 |
| Practice Act of 1987 .
|
3 |
| (Source: P.A. 90-742, eff. 8-13-98.)
|
4 |
| (720 ILCS 570/301) (from Ch. 56 1/2, par. 1301)
|
5 |
| Sec. 301. The Department of Professional Regulation shall |
6 |
| promulgate
rules and charge reasonable fees and fines relating |
7 |
| to the registration and
control of the manufacture, |
8 |
| distribution, and dispensing of controlled
substances within |
9 |
| this State. All moneys received by the Department of
|
10 |
| Professional Regulation under this Act shall be deposited into |
11 |
| the respective
professional dedicated funds in like manner as |
12 |
| the primary professional
licenses. |
13 |
| A pharmacy, manufacturer of controlled substances, or |
14 |
| wholesale distributor of controlled substances that is |
15 |
| regulated under this Act and owned and operated by the State is |
16 |
| exempt from fees required under this Act. Pharmacists and |
17 |
| pharmacy technicians working in facilities owned and operated |
18 |
| by the State are not exempt from the payment of fees required |
19 |
| by this Act and any rules adopted under this Act. Nothing in |
20 |
| this Section shall be construed to prohibit the Department from |
21 |
| imposing any fine or other penalty allowed under this Act.
|
22 |
| (Source: P.A. 89-204, eff. 1-1-96.)
|
23 |
| (720 ILCS 570/309) (from Ch. 56 1/2, par. 1309)
|
24 |
| Sec. 309. On or after April 1, 2000, no person shall issue |
|
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| a
prescription for a Schedule II
controlled substance, which is |
2 |
| a narcotic drug listed in Section 206 of
this Act; or which |
3 |
| contains any quantity of amphetamine or
methamphetamine, their |
4 |
| salts, optical isomers or salts of optical
isomers; |
5 |
| phenmetrazine and its salts; gluthethimide; and pentazocine, |
6 |
| other than on a written
prescription; provided
that in the case |
7 |
| of an emergency, epidemic or a
sudden or unforeseen accident or |
8 |
| calamity, the prescriber may issue a
lawful oral prescription |
9 |
| where failure to
issue such a prescription might result in
loss |
10 |
| of life or intense suffering, but such oral prescription shall
|
11 |
| include a statement by the prescriber concerning the accident
|
12 |
| or calamity, or circumstances constituting the emergency, the |
13 |
| cause for
which an oral prescription was used. Within
7 days |
14 |
| after issuing an
emergency prescription, the prescriber shall |
15 |
| cause a written prescription for
the emergency quantity |
16 |
| prescribed to be delivered to
the dispensing pharmacist. The |
17 |
| prescription shall have written on its face
"Authorization for |
18 |
| Emergency Dispensing", and the date of the emergency
|
19 |
| prescription. The written prescription
may be delivered to the |
20 |
| pharmacist in person, or by mail, but if delivered
by mail it |
21 |
| must be postmarked within the 7-day period. Upon
receipt, the
|
22 |
| dispensing pharmacist shall attach this prescription to the |
23 |
| emergency oral
prescription earlier received and
reduced to |
24 |
| writing. The dispensing pharmacist shall notify the Department |
25 |
| of
Human Services if the prescriber
fails to deliver the |
26 |
| authorization for emergency dispensing on the
prescription to |
|
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| him. Failure of the dispensing pharmacist to do so
shall void |
2 |
| the authority conferred by this paragraph to dispense without a
|
3 |
| written prescription of a
prescriber. All prescriptions issued |
4 |
| for Schedule II controlled substances
shall include both a |
5 |
| written and numerical notation of quantity on the face
of the |
6 |
| prescription. No prescription for a Schedule II controlled |
7 |
| substance
may
be refilled. The Department shall provide, at no |
8 |
| cost, audit reviews and necessary information to the Department |
9 |
| of Professional Regulation in conjunction with ongoing |
10 |
| investigations being conducted in whole or part by the |
11 |
| Department of Professional Regulation.
|
12 |
| (Source: P.A. 91-576, eff. 4-1-00; 91-714, eff. 6-2-00.)
|
13 |
| Section 130. The Methamphetamine Control and Community |
14 |
| Protection Act is amended by changing Section 110 as follows: |
15 |
| (720 ILCS 646/110)
|
16 |
| Sec. 110. Scope of Act. Nothing in this Act limits any |
17 |
| authority or activity authorized by the Illinois Controlled |
18 |
| Substances Act, the Medical Practice Act of 1987, the Nursing |
19 |
| and Advanced Practice Nursing Act, the Pharmacy Practice Act of |
20 |
| 1987 , the Illinois Dental Practice Act, the Podiatric Medical |
21 |
| Practice Act of 1987, or the Veterinary Medicine and Surgery |
22 |
| Practice Act of 2004. Nothing in this Act limits the authority |
23 |
| or activity of any law enforcement officer acting within the |
24 |
| scope of his or her employment.
|
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| (Source: P.A. 94-556, eff. 9-11-05.) |
2 |
| Section 135. The Methamphetamine Precursor Control Act is |
3 |
| amended by changing Sections 25 and 50 as follows: |
4 |
| (720 ILCS 648/25) |
5 |
| Sec. 25. Pharmacies. |
6 |
| (a) No targeted methamphetamine precursor may be knowingly |
7 |
| distributed through a pharmacy, including a pharmacy located |
8 |
| within, owned by, operated by, or associated with a retail |
9 |
| distributor unless all terms of this Section are satisfied. |
10 |
| (b) Any targeted methamphetamine precursor other than a |
11 |
| convenience package or a liquid, including but not limited to |
12 |
| any targeted methamphetamine precursor in liquid-filled |
13 |
| capsules, shall: be packaged in blister packs, with each |
14 |
| blister containing not more than 2 dosage units, or when the |
15 |
| use of blister packs is technically infeasible, in unit dose |
16 |
| packets. Each targeted package shall contain no more than 3,000 |
17 |
| milligrams of ephedrine or pseudoephedrine, their salts or |
18 |
| optical isomers, or salts of optical isomers.
|
19 |
| (c) The targeted methamphetamine precursor shall be stored |
20 |
| behind the pharmacy counter and distributed by a pharmacist or |
21 |
| pharmacy technician licensed under the Pharmacy Practice Act of |
22 |
| 1987 . |
23 |
| (d) Any retail distributor operating a pharmacy, and any |
24 |
| pharmacist or pharmacy technician involved in the transaction |
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| or transactions, shall ensure that any person purchasing, |
2 |
| receiving, or otherwise acquiring the targeted methamphetamine |
3 |
| precursor complies with subsection (a) of Section 20 of this |
4 |
| Act.
|
5 |
| (e) Any retail distributor operating a pharmacy, and any |
6 |
| pharmacist or pharmacy technician involved in the transaction |
7 |
| or transactions, shall verify that: |
8 |
| (1) The person purchasing, receiving, or otherwise |
9 |
| acquiring the targeted methamphetamine precursor is 18 |
10 |
| years of age or older and resembles the photograph of the |
11 |
| person on the government-issued identification presented |
12 |
| by the person; and
|
13 |
| (2) The name entered into the log referred to in |
14 |
| subsection (a) of Section 20 of this Act corresponds to the |
15 |
| name on the government-issued identification presented by |
16 |
| the person.
|
17 |
| (f) The logs referred to in subsection (a) of Section 20 of |
18 |
| this Act shall be kept confidential, maintained for not less |
19 |
| than 2 years, and made available for inspection and copying by |
20 |
| any law enforcement officer upon request of that officer.
These |
21 |
| logs may be kept in an electronic format if they include all |
22 |
| the information specified in subsection (a) of Section 20 of |
23 |
| this Act in a manner that is readily retrievable and |
24 |
| reproducible in hard-copy format. |
25 |
| (g) No retail distributor operating a pharmacy, and no |
26 |
| pharmacist or pharmacy technician, shall knowingly distribute |
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| any targeted methamphetamine precursor to any person under 18 |
2 |
| years of age. |
3 |
| (h) No retail distributor operating a pharmacy, and no |
4 |
| pharmacist or pharmacy technician, shall knowingly distribute |
5 |
| to a single person more than 2 targeted packages in a single |
6 |
| retail transaction. |
7 |
| (i) No retail distributor operating a pharmacy, and no |
8 |
| pharmacist or pharmacy technician, shall knowingly distribute |
9 |
| to a single person in any 30-day period products containing |
10 |
| more than a total of 7,500 milligrams of ephedrine or |
11 |
| pseudoephedrine, their salts or optical isomers, or salts of |
12 |
| optical isomers.
|
13 |
| (j) A pharmacist or pharmacy technician may distribute a |
14 |
| targeted methamphetamine precursor to a person who is without a |
15 |
| form of identification specified in paragraph (1) of subsection |
16 |
| (a) of Section 20 of this Act only if all other provisions of |
17 |
| this Act are followed and either: |
18 |
| (1) the person presents a driver's license issued |
19 |
| without a photograph by the State of Illinois pursuant to |
20 |
| the Illinois Administrative Code, Title 92, Section |
21 |
| 1030.90(b)(1) or 1030.90(b)(2); or |
22 |
| (2) the person is known to the pharmacist or pharmacy |
23 |
| technician, the person presents some form of |
24 |
| identification, and the pharmacist or pharmacy technician |
25 |
| reasonably believes that the targeted methamphetamine |
26 |
| precursor will be used for a legitimate medical purpose and |
|
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|
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|
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| not to manufacture methamphetamine.
|
2 |
| (k) When a pharmacist or pharmacy technician distributes a |
3 |
| targeted methamphetamine precursor to a person according to the |
4 |
| procedures set forth in this Act, and the pharmacist or |
5 |
| pharmacy technician does not have access to a working cash |
6 |
| register at the pharmacy counter, the pharmacist or pharmacy |
7 |
| technician may instruct the person to pay for the targeted |
8 |
| methamphetamine precursor at a cash register located elsewhere |
9 |
| in the retail establishment, whether that register is operated |
10 |
| by a pharmacist, pharmacy technician, or other employee or |
11 |
| agent of the retail establishment.
|
12 |
| (Source: P.A. 94-694, eff. 1-15-06; 94-830, eff. 6-5-06.) |
13 |
| (720 ILCS 648/50) |
14 |
| Sec. 50. Scope of Act. |
15 |
| (a) Nothing in this Act limits the scope, terms, or effect |
16 |
| of the Methamphetamine Control and Community Protection Act. |
17 |
| (b) Nothing in this Act limits the lawful authority granted |
18 |
| by the Medical Practice Act of 1987, the Nursing and Advanced |
19 |
| Practice Nursing Act, or the Pharmacy Practice Act of 1987 . |
20 |
| (c) Nothing in this Act limits the authority or activity of |
21 |
| any law enforcement officer acting within the scope of his or |
22 |
| her employment.
|
23 |
| (Source: P.A. 94-694, eff. 1-15-06.) |
24 |
| Section 140. The Parental Right of Recovery Act is amended |
|
|
|
SB0509 Enrolled |
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|
|
1 |
| by changing Section 2 as follows:
|
2 |
| (740 ILCS 120/2) (from Ch. 70, par. 602)
|
3 |
| Sec. 2. For the purpose of this Act, unless the context |
4 |
| clearly requires otherwise:
|
5 |
| (1) "Illegal drug" means (i) any substance as defined and |
6 |
| included in
the Schedules of Article II of the Illinois |
7 |
| Controlled Substances Act, (ii)
any cannabis as defined in |
8 |
| Section 3 of the Cannabis Control Act, or (iii) any
drug as |
9 |
| defined in paragraph (b) of Section 3 of the Pharmacy Practice |
10 |
| Act
of 1987 which is obtained without a prescription or |
11 |
| otherwise in violation
of the law.
|
12 |
| (2) "Minor" means a person who has not attained age 18.
|
13 |
| (3) "Legal guardian" means a person appointed guardian, or |
14 |
| given
custody, of a minor by a circuit court of this State, but |
15 |
| does not include
a person appointed guardian, or given custody, |
16 |
| of a minor under the
Juvenile Court Act or the Juvenile Court |
17 |
| Act of 1987.
|
18 |
| (4) "Parent" means any natural or adoptive parent of a |
19 |
| minor.
|
20 |
| (5) "Person" means any natural person, corporation, |
21 |
| association,
partnership or other organization.
|
22 |
| (6) "Prescription" means any order for drugs,
written or |
23 |
| verbal, by a physician, dentist, veterinarian or other person
|
24 |
| authorized to prescribe drugs within the limits of his
license, |
25 |
| containing the following: (1) Name of the patient; (2) date |
|
|
|
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|
|
1 |
| when
prescription was given; (3) name and strength of drug
|
2 |
| prescribed; (4) quantity, directions for use, prescriber's
|
3 |
| name, address and signature, and the United States Drug |
4 |
| Enforcement Agency
number where required, for controlled |
5 |
| substances.
|
6 |
| (7) "Sale or transfer" means the actual or constructive |
7 |
| transfer of
possession of an illegal drug, with or without |
8 |
| consideration, whether
directly or through an agent.
|
9 |
| (Source: P.A. 85-1209.)
|
10 |
| (225 ILCS 85/14 rep.)
|
11 |
| (225 ILCS 85/35.11 rep.)
|
12 |
| Section 145. The Pharmacy Practice Act of 1987 is amended |
13 |
| by repealing Sections 14 and 35.11.
|
14 |
| (225 ILCS 120/45 rep.)
|
15 |
| Section 150. The Wholesale Drug Distribution Licensing Act |
16 |
| is amended by repealing Section 45. |
17 |
| Section 999. Effective date. This Act takes effect upon |
18 |
| becoming law. |