SB0509 Enrolled LRB095 10560 RAS 30780 b

1     AN ACT concerning regulation.
 
2     Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
 
4     Section 5. The Regulatory Sunset Act is amended by changing
5 Section 4.18 and by adding Section 4.28 as follows:
 
6     (5 ILCS 80/4.18)
7     Sec. 4.18. Acts repealed January 1, 2008 and December 31,
8 2008.
9     (a) The following Acts are repealed on January 1, 2008:
10         The Acupuncture Practice Act.
11         The Clinical Social Work and Social Work Practice Act.
12         The Home Medical Equipment and Services Provider
13     License Act.
14         The Nursing and Advanced Practice Nursing Act.
15         The Illinois Speech-Language Pathology and Audiology
16     Practice Act.
17         The Marriage and Family Therapy Licensing Act.
18         The Nursing Home Administrators Licensing and
19     Disciplinary Act.
20         The Pharmacy Practice Act of 1987.
21         The Physician Assistant Practice Act of 1987.
22         The Podiatric Medical Practice Act of 1987.
23         The Structural Pest Control Act.

 

 

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1     (b) The following Acts are repealed on December 31, 2008:
2         The Medical Practice Act of 1987.
3         The Environmental Health Practitioner Licensing Act.
4 (Source: P.A. 94-754, eff. 5-10-06; 94-1075, eff. 12-29-06;
5 94-1085, eff. 1-19-07; revised 1-22-07.)
 
6     (5 ILCS 80/4.28 new)
7     Sec. 4.28. Act repealed on January 1, 2018. The following
8 Act is repealed on January 1, 2018:
9     The Pharmacy Practice Act.
 
10     Section 10. The Illinois Act on the Aging is amended by
11 changing Section 4.01 as follows:
 
12     (20 ILCS 105/4.01)  (from Ch. 23, par. 6104.01)
13     Sec. 4.01. Additional powers and duties of the Department.
14 In addition to powers and duties otherwise provided by law, the
15 Department shall have the following powers and duties:
16     (1) To evaluate all programs, services, and facilities for
17 the aged and for minority senior citizens within the State and
18 determine the extent to which present public or private
19 programs, services and facilities meet the needs of the aged.
20     (2) To coordinate and evaluate all programs, services, and
21 facilities for the Aging and for minority senior citizens
22 presently furnished by State agencies and make appropriate
23 recommendations regarding such services, programs and

 

 

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1 facilities to the Governor and/or the General Assembly.
2     (3) To function as the sole State agency to develop a
3 comprehensive plan to meet the needs of the State's senior
4 citizens and the State's minority senior citizens.
5     (4) To receive and disburse State and federal funds made
6 available directly to the Department including those funds made
7 available under the Older Americans Act and the Senior
8 Community Service Employment Program for providing services
9 for senior citizens and minority senior citizens or for
10 purposes related thereto, and shall develop and administer any
11 State Plan for the Aging required by federal law.
12     (5) To solicit, accept, hold, and administer in behalf of
13 the State any grants or legacies of money, securities, or
14 property to the State of Illinois for services to senior
15 citizens and minority senior citizens or purposes related
16 thereto.
17     (6) To provide consultation and assistance to communities,
18 area agencies on aging, and groups developing local services
19 for senior citizens and minority senior citizens.
20     (7) To promote community education regarding the problems
21 of senior citizens and minority senior citizens through
22 institutes, publications, radio, television and the local
23 press.
24     (8) To cooperate with agencies of the federal government in
25 studies and conferences designed to examine the needs of senior
26 citizens and minority senior citizens and to prepare programs

 

 

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1 and facilities to meet those needs.
2     (9) To establish and maintain information and referral
3 sources throughout the State when not provided by other
4 agencies.
5     (10) To provide the staff support as may reasonably be
6 required by the Council and the Coordinating Committee of State
7 Agencies Serving Older Persons.
8     (11) To make and enforce rules and regulations necessary
9 and proper to the performance of its duties.
10     (12) To establish and fund programs or projects or
11 experimental facilities that are specially designed as
12 alternatives to institutional care.
13     (13) To develop a training program to train the counselors
14 presently employed by the Department's aging network to provide
15 Medicare beneficiaries with counseling and advocacy in
16 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
19 before December 1, 1986.
20     (14) To make a grant to an institution of higher learning
21 to study the feasibility of establishing and implementing an
22 affirmative action employment plan for the recruitment,
23 hiring, training and retraining of persons 60 or more years old
24 for jobs for which their employment would not be precluded by
25 law.
26     (15) To present one award annually in each of the

 

 

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1 categories of community service, education, the performance
2 and graphic arts, and the labor force to outstanding Illinois
3 senior citizens and minority senior citizens in recognition of
4 their individual contributions to either community service,
5 education, the performance and graphic arts, or the labor
6 force. The awards shall be presented to four senior citizens
7 and minority senior citizens selected from a list of 44
8 nominees compiled annually by the Department. Nominations
9 shall be solicited from senior citizens' service providers,
10 area agencies on aging, senior citizens' centers, and senior
11 citizens' organizations. The Department shall consult with the
12 Coordinating Committee of State Agencies Serving Older Persons
13 to determine which of the nominees shall be the recipient in
14 each category of community service. The Department shall
15 establish a central location within the State to be designated
16 as the Senior Illinoisans Hall of Fame for the public display
17 of all the annual awards, or replicas thereof.
18     (16) To establish multipurpose senior centers through area
19 agencies on aging and to fund those new and existing
20 multipurpose senior centers through area agencies on aging, the
21 establishment and funding to begin in such areas of the State
22 as the Department shall designate by rule and as specifically
23 appropriated funds become available.
24     (17) To develop the content and format of the
25 acknowledgment regarding non-recourse reverse mortgage loans
26 under Section 6.1 of the Illinois Banking Act; to provide

 

 

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1 independent consumer information on reverse mortgages and
2 alternatives; and to refer consumers to independent counseling
3 services with expertise in reverse mortgages.
4     (18) To develop a pamphlet in English and Spanish which may
5 be used by physicians licensed to practice medicine in all of
6 its branches pursuant to the Medical Practice Act of 1987,
7 pharmacists licensed pursuant to the Pharmacy Practice Act of
8 1987, and Illinois residents 65 years of age or older for the
9 purpose of assisting physicians, pharmacists, and patients in
10 monitoring prescriptions provided by various physicians and to
11 aid persons 65 years of age or older in complying with
12 directions for proper use of pharmaceutical prescriptions. The
13 pamphlet may provide space for recording information including
14 but not limited to the following:
15         (a) name and telephone number of the patient;
16         (b) name and telephone number of the prescribing
17     physician;
18         (c) date of prescription;
19         (d) name of drug prescribed;
20         (e) directions for patient compliance; and
21         (f) name and telephone number of dispensing pharmacy.
22     In developing the pamphlet, the Department shall consult
23 with the Illinois State Medical Society, the Center for
24 Minority Health Services, the Illinois Pharmacists Association
25 and senior citizens organizations. The Department shall
26 distribute the pamphlets to physicians, pharmacists and

 

 

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1 persons 65 years of age or older or various senior citizen
2 organizations throughout the State.
3     (19) To conduct a study by April 1, 1994 of the feasibility
4 of implementing the Senior Companion Program throughout the
5 State for the fiscal year beginning July 1, 1994.
6     (20) With respect to contracts in effect on July 1, 1994,
7 the Department shall increase the grant amounts so that the
8 reimbursement rates paid through the community care program for
9 chore housekeeping services and homemakers are at the same
10 rate, which shall be the higher of the 2 rates currently paid.
11 With respect to all contracts entered into, renewed, or
12 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.
15     (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
21 years of age and older.
22     (22) To distribute, through its area agencies on aging,
23 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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1 instructions for safety and all emergency telephone numbers of
2 organizations that will provide additional information and
3 assistance.
4     (23) To develop guidelines for the organization and
5 implementation of Volunteer Services Credit Programs to be
6 administered by Area Agencies on Aging or community based
7 senior service organizations. The Department shall hold public
8 hearings on the proposed guidelines for public comment,
9 suggestion, and determination of public interest. The
10 guidelines shall be based on the findings of other states and
11 of community organizations in Illinois that are currently
12 operating volunteer services credit programs or demonstration
13 volunteer services credit programs. The Department shall offer
14 guidelines for all aspects of the programs including, but not
15 limited to, the following:
16         (a) types of services to be offered by volunteers;
17         (b) types of services to be received upon the
18     redemption of service credits;
19         (c) issues of liability for the volunteers and the
20     administering organizations;
21         (d) methods of tracking service credits earned and
22     service credits redeemed;
23         (e) issues of time limits for redemption of service
24     credits;
25         (f) methods of recruitment of volunteers;
26         (g) utilization of community volunteers, community

 

 

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1     service groups, and other resources for delivering
2     services to be received by service credit program clients;
3         (h) accountability and assurance that services will be
4     available to individuals who have earned service credits;
5     and
6         (i) volunteer screening and qualifications.
7 The Department shall submit a written copy of the guidelines to
8 the General Assembly by July 1, 1998.
9 (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:
 
13     (20 ILCS 1705/56)  (from Ch. 91 1/2, par. 100-56)
14     Sec. 56. The Secretary, upon making a determination based
15 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
23 license. All relevant evidence, or copies thereof, in the
24 Department's possession may also be submitted in conjunction

 

 

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1 with the written communication. A copy of such written
2 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.)
 
19     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:
 
22     (20 ILCS 2105/2105-400)
23     Sec. 2105-400. Emergency Powers.
24     (a) Upon proclamation of a disaster by the Governor, as

 

 

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1 provided for in the Illinois Emergency Management Agency Act,
2 the Secretary of Financial and Professional Regulation shall
3 have the following powers, which shall be exercised only in
4 coordination with the Illinois Emergency Management Agency and
5 the Department of Public Health:
6         (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.
11         (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.
17         (3) The power to expand the exemption in Section 4(a)
18     of the Pharmacy Practice Act of 1987 to those licensed
19     professionals whose scope of practice has been modified,
20     under paragraph (2) of subsection (a) of this Section, to
21     include any element of the practice of pharmacy as defined
22     in the Pharmacy Practice Act of 1987 for any person working
23     under the direction of the Illinois Emergency Management
24     Agency and the Illinois Department of Public Health
25     pursuant to the declared disaster.
26     (b) Persons exempt from licensure under paragraph (1) of

 

 

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1 subsection (a) of this Section and persons operating under
2 modified scope of practice provisions under paragraph (2) of
3 subsection (a) of this Section shall be exempt from licensure
4 or be subject to modified scope of practice only until the
5 declared disaster has ended as provided by law. For purposes of
6 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.
14 (Source: P.A. 93-829, eff. 7-28-04; 94-733, eff. 4-27-06.)
 
15     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:
 
18     (20 ILCS 2310/2310-140)  (was 20 ILCS 2310/55.37a)
19     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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1 Regulation indicating that determination and additionally (i)
2 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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1     (65 ILCS 5/11-22-1)  (from Ch. 24, par. 11-22-1)
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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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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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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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:
 

 

 

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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.)
 

 

 

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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"

 

 

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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

 

 

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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.

 

 

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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

 

 

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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.

 

 

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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

 

 

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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

 

 

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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)

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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.

 

 

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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.

 

 

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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

 

 

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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.

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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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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

 

 

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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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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

 

 

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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.

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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.

 

 

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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

 

 

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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

 

 

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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

 

 

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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.

 

 

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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.

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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".

 

 

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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

 

 

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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

 

 

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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

 

 

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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.

 

 

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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.

 

 

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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

 

 

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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.

 

 

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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

 

 

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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

 

 

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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.

 

 

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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

 

 

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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

 

 

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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.

 

 

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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

 

 

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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

 

 

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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,

 

 

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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

 

 

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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

 

 

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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

 

 

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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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1 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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1 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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1 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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1 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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1     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.)
 

 

 

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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

 

 

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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.

 

 

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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

 

 

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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

 

 

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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.

 

 

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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

 

 

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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

 

 

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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,

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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:

 

 

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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

 

 

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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

 

 

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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;

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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

 

 

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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,

 

 

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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.

 

 

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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,

 

 

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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

 

 

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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.
 

 

 

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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

 

 

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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

 

 

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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)

 

 

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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

 

 

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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

 

 

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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;

 

 

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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

 

 

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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

 

 

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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:

 

 

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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

 

 

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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.

 

 

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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

 

 

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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.

 

 

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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:
 

 

 

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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 - 160 - 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.

 

 

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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

 

 

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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.)
 

 

 

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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;

 

 

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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

 

 

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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:
 

 

 

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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

 

 

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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,

 

 

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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,

 

 

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1             (iii) chostebol,
2             (iv) dehydrochlormethyltestosterone,
3             (v) dihydrotestosterone,
4             (vi) drostanolone,
5             (vii) ethylestrenol,
6             (viii) fluoxymesterone,
7             (ix) formebulone,
8             (x) mesterolone,
9             (xi) methandienone,
10             (xii) methandranone,
11             (xiii) methandriol,
12             (xiv) methandrostenolone,
13             (xv) methenolone,
14             (xvi) methyltestosterone,
15             (xvii) mibolerone,
16             (xviii) nandrolone,
17             (xix) norethandrolone,
18             (xx) oxandrolone,
19             (xxi) oxymesterone,
20             (xxii) oxymetholone,
21             (xxiii) stanolone,
22             (xxiv) stanozolol,
23             (xxv) testolactone,
24             (xxvi) testosterone,
25             (xxvii) trenbolone, and
26             (xxviii) any salt, ester, or isomer of a drug or

 

 

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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

 

 

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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

 

 

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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:

 

 

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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

 

 

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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

 

 

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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,

 

 

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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.

 

 

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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,

 

 

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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

 

 

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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,

 

 

SB0509 Enrolled - 182 - LRB095 10560 RAS 30780 b

1 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

 

 

SB0509 Enrolled - 183 - LRB095 10560 RAS 30780 b

1 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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1 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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1 (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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1 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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1 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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1     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

 

 

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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.