Full Text of HB0647 94th General Assembly
HB0647 94TH GENERAL ASSEMBLY
|
|
|
94TH GENERAL ASSEMBLY
State of Illinois
2005 and 2006 HB0647
Introduced 1/28/2005, by Rep. Jack D. Franks SYNOPSIS AS INTRODUCED: |
|
225 ILCS 85/3 |
from Ch. 111, par. 4123 |
225 ILCS 85/16a |
from Ch. 111, par. 4136a |
225 ILCS 85/16b new |
|
225 ILCS 85/35.1 |
from Ch. 111, par. 4155.1 |
|
Amends the Pharmacy Practice Act of 1987. Provides for the registration of
foreign mail-order pharmacies as nonresident pharmacies if specified
disclosures and
certifications are provided and the pharmacies are located in a foreign
country, state or
province whose pharmacy laws and regulations have been determined by the
Department
of Financial and Professional Regulation to be substantially similar to those of the State of
Illinois and
whose regulatory scheme for approval and quality contro of prescription drugs
has been
found by the Department to be substantially equivalent tol that of the State of
Illinois and
the federal government. Effective immediately.
|
| |
|
|
| FISCAL NOTE ACT MAY APPLY | |
|
|
A BILL FOR
|
|
|
|
|
HB0647 |
|
LRB094 04105 RAS 34125 b |
|
| 1 |
| AN ACT concerning pharmacies.
| 2 |
| Be it enacted by the People of the State of Illinois, | 3 |
| represented in the General Assembly:
| 4 |
| Section 5. The Pharmacy Practice Act of 1987 is amended by | 5 |
| changing
Sections 3, 16a, and 35.1 and adding Section 16b as | 6 |
| follows:
| 7 |
| (225 ILCS 85/3) (from Ch. 111, par. 4123)
| 8 |
| (Section scheduled to be repealed on January 1, 2008)
| 9 |
| Sec. 3. Definitions. For the purpose of this Act, except | 10 |
| where otherwise
limited therein:
| 11 |
| (a) "Pharmacy" or "drugstore" means and includes every | 12 |
| store, shop,
pharmacy department, or other place where | 13 |
| pharmaceutical care is
provided
by a pharmacist (1) where | 14 |
| drugs, medicines, or poisons are
dispensed, sold or
offered for | 15 |
| sale at retail, or displayed for sale at retail; or
(2)
where
| 16 |
| prescriptions of physicians, dentists, veterinarians, | 17 |
| podiatrists, or
therapeutically certified optometrists, within | 18 |
| the limits of their
licenses, are
compounded, filled, or | 19 |
| dispensed; or (3) which has upon it or
displayed within
it, or | 20 |
| affixed to or used in connection with it, a sign bearing the | 21 |
| word or
words "Pharmacist", "Druggist", "Pharmacy", | 22 |
| "Pharmaceutical
Care", "Apothecary", "Drugstore",
"Medicine | 23 |
| Store", "Prescriptions", "Drugs", "Medicines", or any word
or | 24 |
| words of similar or like import, either in the English language
| 25 |
| or any other language; or (4) where the characteristic | 26 |
| prescription
sign (Rx) or similar design is exhibited; or (5) | 27 |
| any store, or
shop,
or other place with respect to which any of | 28 |
| the above words, objects,
signs or designs are used in any | 29 |
| advertisement.
| 30 |
| (b) "Drugs" means and includes (l) articles recognized
in | 31 |
| the official United States Pharmacopoeia/National Formulary | 32 |
| (USP/NF),
or any supplement thereto and being intended for and |
|
|
|
HB0647 |
- 2 - |
LRB094 04105 RAS 34125 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 the provision of | 20 |
| pharmaceutical care to
patients as determined by the | 21 |
| 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 | 27 |
| medications and medical devices, and outcome of drug therapy, | 28 |
| (4)
participation in drug selection, drug monitoring, drug | 29 |
| utilization review,
evaluation, administration, | 30 |
| interpretation, application of
pharmacokinetic and
laboratory | 31 |
| data to design safe and effective drug
regimens, (5) drug | 32 |
| research
(clinical and scientific), and (6) compounding and | 33 |
| dispensing of drugs and medical
devices.
| 34 |
| (e) "Prescription" means and includes any written, oral, | 35 |
| facsimile, or
electronically transmitted order for drugs
or | 36 |
| medical devices, issued by a physician licensed to practice |
|
|
|
HB0647 |
- 3 - |
LRB094 04105 RAS 34125 b |
|
| 1 |
| medicine in
all its branches, dentist, veterinarian, or | 2 |
| podiatrist, or therapeutically
certified
optometrist, within | 3 |
| the
limits of their licenses, by a physician assistant in | 4 |
| accordance with
subsection (f) of Section 4, or by an advanced | 5 |
| practice nurse in
accordance with subsection (g) of Section 4, | 6 |
| containing the
following: (l) name
of the patient; (2) date | 7 |
| when prescription was issued; (3) name
and strength of drug or | 8 |
| description of the medical device prescribed;
and (4) quantity, | 9 |
| (5) directions for use, (6) prescriber's name,
address
and | 10 |
| signature, and (7) DEA number where required, for controlled
| 11 |
| substances.
DEA numbers shall not be required on inpatient drug | 12 |
| orders.
| 13 |
| (f) "Person" means and includes a natural person, | 14 |
| copartnership,
association, corporation, government entity, or | 15 |
| any other legal
entity.
| 16 |
| (g) "Department" means the Department of Professional | 17 |
| Regulation.
| 18 |
| (h) "Board of Pharmacy" or "Board" means the State Board
of | 19 |
| Pharmacy of the Department of Professional Regulation.
| 20 |
| (i) "Director" means the Director of Professional | 21 |
| Regulation.
| 22 |
| (j) "Drug product selection" means the interchange for a
| 23 |
| prescribed pharmaceutical product in accordance with Section | 24 |
| 25 of
this Act and Section 3.14 of the Illinois Food, Drug and | 25 |
| Cosmetic Act.
| 26 |
| (k) "Inpatient drug order" means an order issued by an | 27 |
| authorized
prescriber for a resident or patient of a facility | 28 |
| licensed under the
Nursing Home Care Act or the Hospital | 29 |
| Licensing Act, or "An Act in relation to
the founding and | 30 |
| operation of the University of Illinois Hospital and the
| 31 |
| conduct of University of Illinois health care programs", | 32 |
| approved July 3, 1931,
as amended, or a facility which is | 33 |
| operated by the Department of Human
Services (as successor to | 34 |
| the Department of Mental Health
and Developmental | 35 |
| Disabilities) or the Department of Corrections.
| 36 |
| (k-5) "Pharmacist" means an individual health care |
|
|
|
HB0647 |
- 4 - |
LRB094 04105 RAS 34125 b |
|
| 1 |
| professional and
provider currently licensed by this State to | 2 |
| engage in the practice of
pharmacy.
| 3 |
| (l) "Pharmacist in charge" means the licensed pharmacist | 4 |
| whose name appears
on a pharmacy license and who is responsible | 5 |
| for all aspects of the
operation related to the practice of | 6 |
| pharmacy.
| 7 |
| (m) "Dispense" means the delivery of drugs and medical | 8 |
| devices, in
accordance with applicable State and federal laws | 9 |
| and regulations, to the
patient or the patient's representative | 10 |
| authorized to receive these products,
including the | 11 |
| compounding, packaging, and labeling necessary for delivery, | 12 |
| and
any recommending or advising concerning the contents and | 13 |
| therapeutic values and
uses thereof. "Dispense" does not mean | 14 |
| the physical delivery to a patient or a
patient's | 15 |
| representative in a home or institution by a designee of a | 16 |
| pharmacist
or by common carrier. "Dispense" also does not mean | 17 |
| the physical delivery
of a drug or medical device to a patient | 18 |
| or patient's representative by a
pharmacist's designee within a | 19 |
| pharmacy or drugstore while the pharmacist is
on duty and the | 20 |
| pharmacy is open.
| 21 |
| (n) " Domestic mail-order pharmacy" means a pharmacy that is | 22 |
| located in a
state
of the United States, other than Illinois, | 23 |
| that delivers, dispenses or
distributes, through the United | 24 |
| States Postal Service or other common
carrier, to Illinois | 25 |
| residents, any substance which requires a prescription.
| 26 |
| (n-5) "Foreign mail-order pharmacy" means a pharmacy that | 27 |
| is located in a
country other than the United States that | 28 |
| delivers, dispenses, or distributes,
through the
United States | 29 |
| Postal Service or other common carrier, to Illinois residents | 30 |
| any
substance
that requires a prescription.
| 31 |
| (o) "Compounding" means the preparation, mixing, | 32 |
| assembling,
packaging, or labeling of a drug or medical device: | 33 |
| (1) as the result of a
practitioner's prescription drug order | 34 |
| or initiative that is dispensed pursuant
to a prescription in | 35 |
| the course of professional practice; or (2) for the
purpose of, | 36 |
| or incident to, research, teaching, or chemical analysis; or |
|
|
|
HB0647 |
- 5 - |
LRB094 04105 RAS 34125 b |
|
| 1 |
| (3) in
anticipation of prescription drug orders
based on | 2 |
| routine, regularly observed prescribing patterns.
| 3 |
| (p) "Confidential information" means information,
| 4 |
| maintained by the
pharmacist in the patient's records, released | 5 |
| only (i) to the patient or,
as the patient directs, to other | 6 |
| practitioners and other pharmacists or (ii)
to any other person | 7 |
| authorized by law to receive the
information.
| 8 |
| (q) "Prospective drug review" or "drug utilization | 9 |
| evaluation" means a
screening for potential drug therapy | 10 |
| problems due to
therapeutic duplication, drug-disease | 11 |
| contraindications, drug-drug
interactions (including serious | 12 |
| interactions with nonprescription or
over-the-counter drugs), | 13 |
| drug-food interactions, incorrect drug dosage
or duration of | 14 |
| drug
treatment, drug-allergy interactions, and clinical abuse | 15 |
| or misuse.
| 16 |
| (r) "Patient counseling" means the communication between a | 17 |
| pharmacist or
a student pharmacist under the direct supervision | 18 |
| of a pharmacist and a
patient or the patient's representative | 19 |
| about the patient's medication or
device for the purpose of | 20 |
| optimizing proper use of prescription medications
or devices. | 21 |
| The offer to counsel by the pharmacist or the pharmacist's
| 22 |
| designee, and subsequent patient counseling by the pharmacist | 23 |
| or student
pharmacist, shall be made in a face-to-face | 24 |
| communication with the patient
or patient's representative | 25 |
| unless, in the professional judgment of the
pharmacist, a | 26 |
| face-to-face communication is deemed inappropriate or
| 27 |
| unnecessary. In that instance, the offer to counsel or patient | 28 |
| counseling may
be made in a written communication, by | 29 |
| telephone, or in a manner determined by
the pharmacist to be | 30 |
| appropriate.
| 31 |
| (s) "Patient profiles" or "patient drug therapy record" | 32 |
| means the
obtaining, recording, and maintenance of patient | 33 |
| prescription
information, including prescriptions for | 34 |
| controlled substances, and
personal information.
| 35 |
| (t) "Pharmaceutical care" includes, but is not limited to, | 36 |
| the act of
monitoring drug use and other patient care services |
|
|
|
HB0647 |
- 6 - |
LRB094 04105 RAS 34125 b |
|
| 1 |
| intended to achieve
outcomes that improve the patient's quality | 2 |
| of life but shall not include
the sale of over-the-counter | 3 |
| drugs by a seller of goods and services who
does not dispense | 4 |
| prescription drugs.
| 5 |
| (u) "Medical device" means an instrument, apparatus, | 6 |
| implement, machine,
contrivance, implant, in vitro reagent, or | 7 |
| other similar or related article,
including any component part | 8 |
| or accessory, required under federal law to
bear the label | 9 |
| "Caution: Federal law requires dispensing by or on the order
of | 10 |
| a physician". A seller of goods and services who, only for the | 11 |
| purpose of
retail sales, compounds, sells, rents, or leases | 12 |
| medical devices shall not,
by reasons thereof, be required to | 13 |
| be a licensed pharmacy.
| 14 |
| (v) "Unique identifier" means an electronic signature, | 15 |
| handwritten
signature or initials, thumb print, or other | 16 |
| acceptable individual biometric
or electronic identification | 17 |
| process as approved by the Department.
| 18 |
| (Source: P.A. 92-880, eff. 1-1-04; 93-571, eff. 8-20-03.)
| 19 |
| (225 ILCS 85/16a) (from Ch. 111, par. 4136a)
| 20 |
| (Section scheduled to be repealed on January 1, 2008)
| 21 |
| Sec. 16a. (a) The Department shall establish rules and | 22 |
| regulations,
consistent with the provisions of this Act, | 23 |
| governing domestic mail-order
pharmacies,
including pharmacies | 24 |
| providing services via the Internet,
which sell, or offer for | 25 |
| sale, drugs, medicines, or other pharmaceutical
services in | 26 |
| this State.
| 27 |
| (b) The Board shall require and provide for an annual | 28 |
| nonresident
special pharmacy registration for all pharmacies | 29 |
| located outside of this
State that dispense medications for | 30 |
| Illinois residents and mail, ship, or
deliver prescription | 31 |
| medications into this State. Nonresident special
pharmacy | 32 |
| registration shall be granted by the Board upon the disclosure | 33 |
| and
certification by a pharmacy:
| 34 |
| (1) that it is licensed in the state in which the | 35 |
| dispensing facility
is located and from which the drugs are |
|
|
|
HB0647 |
- 7 - |
LRB094 04105 RAS 34125 b |
|
| 1 |
| dispensed;
| 2 |
| (2) of the location, names, and titles of all principal | 3 |
| corporate
officers and all pharmacists who are dispensing | 4 |
| drugs to residents of this
State;
| 5 |
| (3) that it complies with all lawful directions and | 6 |
| requests for
information from the board of pharmacy of each | 7 |
| state in which it is
licensed or registered, except that it | 8 |
| shall respond directly to all
communications from the Board | 9 |
| concerning emergency circumstances arising
from the | 10 |
| dispensing of drugs to residents of this State;
| 11 |
| (4) that it maintains its records of drugs dispensed to | 12 |
| residents of
this State so that the records are readily | 13 |
| retrievable from the records of
other drugs dispensed;
| 14 |
| (5) that it cooperates with the Board in providing | 15 |
| information to the
board of pharmacy of the state in which | 16 |
| it is licensed concerning matters
related to the dispensing | 17 |
| of drugs to residents of this State; and
| 18 |
| (6) that during its regular hours of operation, but not | 19 |
| less than 6
days per week, for a minimum of 40 hours per | 20 |
| week, a toll-free telephone
service is provided to | 21 |
| facilitate communication between patients in this
State | 22 |
| and a pharmacist at the pharmacy who has access to the | 23 |
| patients'
records. The toll-free number must be disclosed | 24 |
| on the label affixed to
each container of drugs dispensed | 25 |
| to residents of this State.
| 26 |
| (c) The provisions of this Section do not apply to | 27 |
| pharmacies for which
registration is provided under Section | 28 |
| 16b.
| 29 |
| (Source: P.A. 91-438, eff. 1-1-00.)
| 30 |
| (225 ILCS 85/16b new)
| 31 |
| Sec. 16b. Foreign mail-order pharmacy.
| 32 |
| (a) Notwithstanding any other Section of this Act, the | 33 |
| Department shall
provide
for the registration of foreign | 34 |
| mail-order pharmacies as nonresident
pharmacies, upon the
| 35 |
| disclosure and certification by a foreign mail-order pharmacy |
|
|
|
HB0647 |
- 8 - |
LRB094 04105 RAS 34125 b |
|
| 1 |
| of the following:
| 2 |
| (1) That it is licensed in the country, state, or | 3 |
| province in which the
dispensing facility is located and | 4 |
| from which the drugs are dispensed.
| 5 |
| (2) The location, names, and titles of all principal | 6 |
| corporate officers
and
all pharmacists who are dispensing | 7 |
| drugs to residents of this State.
| 8 |
| (3) That it complies with all lawful directions and | 9 |
| requests for information
from the board of pharmacy of each | 10 |
| country, state, or province in which it is
licensed or | 11 |
| registered, except that it shall respond directly to all | 12 |
| communications
from the Board concerning emergency | 13 |
| circumstances arising from the dispensing
of drugs to | 14 |
| residents of this State.
| 15 |
| (4) That it maintains its records of drugs dispensed to | 16 |
| residents of this
State so that the records are readily | 17 |
| retrievable from the records of other drugs
dispensed.
| 18 |
| (5) That it cooperates with the Board of Pharmacy in | 19 |
| providing
information to the board of pharmacy of the | 20 |
| country, state, or province in which it
is licensed | 21 |
| concerning matters related to the dispensing of drugs to | 22 |
| residents of
this State.
| 23 |
| (6) That during its regular hours of operation, but not | 24 |
| less than 6 days per
week, for a minimum of 40 hours per | 25 |
| week, a toll-free telephone service is
provided to | 26 |
| facilitate communication between patients in this State | 27 |
| and a
pharmacist at the pharmacy who has access to the | 28 |
| patients' records. The toll-free
number must be disclosed | 29 |
| on the label affixed to each container of drugs
dispensed | 30 |
| to residents of this State.
| 31 |
| (7) That it consents to the jurisdiction of the | 32 |
| Department over pharmacy
practices affecting the State of | 33 |
| Illinois.
| 34 |
| (b) Only a pharmacy located within a foreign country, | 35 |
| state, or province
whose pharmacy laws and regulations have | 36 |
| been determined by the Department to
be
substantially similar |
|
|
|
HB0647 |
- 9 - |
LRB094 04105 RAS 34125 b |
|
| 1 |
| to those of the State of Illinois and whose regulatory
scheme | 2 |
| for
approval and quality control of prescription drugs has been | 3 |
| found by the
Department to
be substantially equivalent to that | 4 |
| of the State of Illinois and the federal
government may
be | 5 |
| registered as a nonresident pharmacy.
| 6 |
| (c) The Department's criteria for determining substantial | 7 |
| equivalence shall
be
set
by rule.
| 8 |
| (d) The Department shall maintain a list of all foreign | 9 |
| countries, states, and
provinces that have been evaluated on | 10 |
| its website with a designation of
"approved" or
"denied". Any | 11 |
| pharmacy located within a foreign country, state, or province
| 12 |
| that has not
been evaluated by the Department may request that | 13 |
| the Department conduct an
evaluation.
| 14 |
| (225 ILCS 85/35.1) (from Ch. 111, par. 4155.1)
| 15 |
| (Section scheduled to be repealed on January 1, 2008)
| 16 |
| Sec. 35.1. (a) If any person violates the provision of this | 17 |
| Act,
the
Director may, in the name of the People of the State | 18 |
| of Illinois, through the
Attorney General of the State of | 19 |
| Illinois, or the State's Attorney
of any county in which the | 20 |
| action is brought, petition, for an order
enjoining such | 21 |
| violation or for an order enforcing compliance with
this Act. | 22 |
| Upon the filing of a verified petition in such court, the
court | 23 |
| may issue a temporary restraining order, without notice or | 24 |
| bond,
and may preliminarily and permanently enjoin such | 25 |
| violation, and if
it is established that such person has | 26 |
| violated or is violating the
injunction, the Court may punish | 27 |
| the offender for contempt of court.
Proceedings under this | 28 |
| Section shall be in addition to, and not in
lieu of, all other | 29 |
| remedies and penalties provided by this Act.
| 30 |
| (b) If any person shall practice as a pharmacist or hold | 31 |
| himself
out
as a pharmacist or operate a pharmacy or drugstore, | 32 |
| including a domestic
mail-order
pharmacy under Section 16a or a | 33 |
| foreign mail-order pharmacy under Section
16b , without being | 34 |
| licensed under the provisions of
this
Act, then any licensed | 35 |
| pharmacist, any interested party or any person
injured thereby |
|
|
|
HB0647 |
- 10 - |
LRB094 04105 RAS 34125 b |
|
| 1 |
| may, in addition to the Director, petition for relief
as | 2 |
| provided in subsection (a) of this Section.
| 3 |
| Whoever knowingly practices or offers to practice in this | 4 |
| State without
being appropriately licensed or registered under | 5 |
| this Act shall be guilty
of a Class A misdemeanor and for each | 6 |
| subsequent conviction, shall
be guilty of a Class 4 felony.
| 7 |
| (c) Whenever in the opinion of the Department any person | 8 |
| not
licensed
in good standing under this Act violates any | 9 |
| provision of this Act,
the Department may issue a rule to show | 10 |
| cause why an order to cease
and desist should not be entered | 11 |
| against him. The rule shall clearly
set forth the grounds | 12 |
| relied upon by the Department and shall provide
a period of 7 | 13 |
| days from the date of the rule to file an answer to the
| 14 |
| satisfaction of the Department. Failure to answer to the | 15 |
| satisfaction
of the Department shall cause an order to cease | 16 |
| and desist to be issued
forthwith.
| 17 |
| (Source: P.A. 92-678, eff. 7-16-02.)
| 18 |
| Section 99. Effective date. This Act takes effect upon | 19 |
| becoming law.
|
|