Bill Text: IL HB5115 | 2009-2010 | 96th General Assembly | Introduced

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Bill Title: Creates the Prescription Drug Repository Program Act. Requires the Department of Public Health to establish a prescription drug repository program, under which a healthcare facility may donate a prescription drug or supplies needed to administer a prescription drug for use by an individual who meets eligibility criteria specified by the Department. Sets forth requirements that prescription drugs or supplies must meet in order to be accepted and dispensed under the program. Provides that no drugs or supplies donated under the prescription drug repository program may be resold. Provides that nothing in the Act requires that a pharmacy or pharmacist participate in the prescription drug repository program. Provides for civil and criminal immunity for drug and supply manufacturers and pharmacists in relation to the donation, acceptance, or dispensing of prescription drugs or supplies under the prescription drug repository program. Amends the Pharmacy Practice Act, the Wholesale Drug Distribution Licensing Act, the Senior Pharmaceutical Assistance Act, the Illinois Food, Drug and Cosmetic Act, the Illinois Controlled Substances Act, and the Cannabis and Controlled Substances Tort Claims Act to provide that persons engaged in donating or accepting, or packaging, repackaging, or labeling, prescription drugs to the extent permitted or required under the Prescription Drug Repository Program Act are exempt from provisions of those other Acts that might prohibit or otherwise regulate such activity.

Spectrum: Partisan Bill (Republican 3-0)

Status: (Introduced - Dead) 2010-03-15 - Rule 19(a) / Re-referred to Rules Committee [HB5115 Detail]

Download: Illinois-2009-HB5115-Introduced.html

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96TH GENERAL ASSEMBLY State of Illinois 2009 and 2010 HB5115 Introduced 1/29/2010, by Rep. Patricia R. Bellock SYNOPSIS AS INTRODUCED:
See Index
Creates the Prescription Drug Repository Program Act. Requires the Department of Public Health to establish a prescription drug repository program, under which a healthcare facility may donate a prescription drug or supplies needed to administer a prescription drug for use by an individual who meets eligibility criteria specified by the Department. Sets forth requirements that prescription drugs or supplies must meet in order to be accepted and dispensed under the program. Provides that no drugs or supplies donated under the prescription drug repository program may be resold. Provides that nothing in the Act requires that a pharmacy or pharmacist participate in the prescription drug repository program. Provides for civil and criminal immunity for drug and supply manufacturers and pharmacists in relation to the donation, acceptance, or dispensing of prescription drugs or supplies under the prescription drug repository program. Amends the Pharmacy Practice Act, the Wholesale Drug Distribution Licensing Act, the Senior Pharmaceutical Assistance Act, the Illinois Food, Drug and Cosmetic Act, the Illinois Controlled Substances Act, and the Cannabis and Controlled Substances Tort Claims Act to provide that persons engaged in donating or accepting, or packaging, repackaging, or labeling, prescription drugs to the extent permitted or required under the Prescription Drug Repository Program Act are exempt from provisions of those other Acts that might prohibit or otherwise regulate such activity.
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FISCAL NOTE ACT MAY APPLY
A BILL FOR
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AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 1. Short title. This Act may be cited as the
Prescription Drug Repository Program Act.
Section 5. Definitions. In this Act:
"Department" means the Department of Public Health.
"Dispense" has the meaning given to that term in the
Pharmacy Practice Act.
"Healthcare facility" means an assisted living facility,
hospice, rehabilitation facility, or long-term care facility.
"Pharmacist" means an individual licensed to engage in the
practice of pharmacy under the Pharmacy Practice Act.
"Pharmacy" means a pharmacy registered in this State under
the Pharmacy Practice Act.
"Practitioner" means a person licensed in this State to
prescribe and administer drugs or licensed in another state and
recognized by this State as a person authorized to prescribe
and administer drugs.
"Prescription drug" means any prescribed drug that may be
legally dispensed by a pharmacy. "Prescription drug" does not
include drugs for the treatment of cancer that can only be
dispensed to a patient registered with the drug manufacturer in

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accordance with federal Food and Drug Administration
requirements.
"Program" means the prescription drug repository program
established under this Act.
Section 10. Prescription drug repository program. The
Department shall establish and maintain a prescription drug
repository program, under which a healthcare facility may
donate a prescription drug or supplies needed to administer a
prescription drug for use by an individual who meets
appropriate eligibility criteria. Donations may be made on the
premises of a pharmacy that elects to participate in the
program and meets appropriate requirements. The pharmacy may
charge an individual who receives a prescription drug or
supplies needed to administer a prescription drug under this
Act a handling fee that may not exceed an appropriate amount. A
pharmacy that receives a donated prescription drug or supplies
needed to administer a prescription drug under this Act may
distribute the prescription drug or supplies to another
eligible pharmacy for use under the program.
Section 15. Requirements for accepting and dispensing
prescription drugs and supplies. A prescription drug or
supplies needed to administer a prescription drug may be
accepted and dispensed under the program only if all of the
following requirements are met:

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(1) The prescription drug or supplies needed to
administer a prescription drug are in their original,
unopened, sealed, and tamper-evident unit-dose packaging
or, if packaged in single-unit doses, the single-unit-dose
packaging is unopened.
(2) The prescription drug bears an expiration date that
is later than 6 months after the date that the drug was
donated.
(3) The prescription drug or supplies needed to
administer a prescription drug are not adulterated or
misbranded, as determined by a pharmacist employed by, or
under contract with, the pharmacy where the drug or
supplies are accepted or dispensed. The pharmacist must
inspect the drug or supplies before the drug or supplies
are dispensed.
(4) The prescription drug or supplies needed to
administer a prescription drug are prescribed by a
practitioner for use by an eligible individual.
Section 20. Resale of donated drugs or supplies prohibited.
No prescription drug or supplies needed to administer a
prescription drug that are donated for use under this Act may
be resold.
Section 25. Participation in program not required. Nothing
in this Act requires that a pharmacy or pharmacist participate

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in the prescription drug repository program.
Section 30. Immunity.
(a) Except in cases of willful and wanton misconduct, a
manufacturer of a drug or supply is not subject to criminal or
civil liability for injury, death, or loss to a person or
property for matters related to the donation, acceptance, or
dispensing of a prescription drug or supply manufactured by the
manufacturer that is donated under this Act, including
liability for failure to transfer or communicate product or
consumer information or the expiration date of the donated
prescription drug. The provisions of this subsection shall
apply only to the donation, acceptance, or dispensing of drugs
or supplies provided without fee or compensation. Immunity
granted under this subsection is solely applicable to the
donation, acceptance, or dispensing of a drug or supply under
this Act and is not a general waiver of liability that would
have existed under the original prescription.
(b) A pharmacist or other health care professional working
in a pharmacy participating in the program dispensing,
furnishing, or otherwise providing in good faith without fee or
compensation donated prescription drugs to eligible
individuals under this Act shall not be subject to professional
or civil liability, except for willful or wanton misconduct.
Section 90. The Pharmacy Practice Act is amended by

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changing Section 4 as follows:
(225 ILCS 85/4) (from Ch. 111, par. 4124)
(Section scheduled to be repealed on January 1, 2018)
Sec. 4. Exemptions. Nothing contained in any Section of
this Act shall apply to, or in any manner interfere with:
(a) the lawful practice of any physician licensed to
practice medicine in all of its branches, dentist, podiatrist,
veterinarian, or therapeutically or diagnostically certified
optometrist within the limits of his or her license, or prevent
him or her from supplying to his or her bona fide patients such
drugs, medicines, or poisons as may seem to him appropriate;
(b) the sale of compressed gases;
(c) the sale of patent or proprietary medicines and
household remedies when sold in original and unbroken packages
only, if such patent or proprietary medicines and household
remedies be properly and adequately labeled as to content and
usage and generally considered and accepted as harmless and
nonpoisonous when used according to the directions on the
label, and also do not contain opium or coca leaves, or any
compound, salt or derivative thereof, or any drug which,
according to the latest editions of the following authoritative
pharmaceutical treatises and standards, namely, The United
States Pharmacopoeia/National Formulary (USP/NF), the United
States Dispensatory, and the Accepted Dental Remedies of the
Council of Dental Therapeutics of the American Dental

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Association or any or either of them, in use on the effective
date of this Act, or according to the existing provisions of
the Federal Food, Drug, and Cosmetic Act and Regulations of the
Department of Health and Human Services, Food and Drug
Administration, promulgated thereunder now in effect, is
designated, described or considered as a narcotic, hypnotic,
habit forming, dangerous, or poisonous drug;
(d) the sale of poultry and livestock remedies in original
and unbroken packages only, labeled for poultry and livestock
medication;
(e) the sale of poisonous substances or mixture of
poisonous substances, in unbroken packages, for nonmedicinal
use in the arts or industries or for insecticide purposes;
provided, they are properly and adequately labeled as to
content and such nonmedicinal usage, in conformity with the
provisions of all applicable federal, state and local laws and
regulations promulgated thereunder now in effect relating
thereto and governing the same, and those which are required
under such applicable laws and regulations to be labeled with
the word "Poison", are also labeled with the word "Poison"
printed thereon in prominent type and the name of a readily
obtainable antidote with directions for its administration;
(f) the delegation of limited prescriptive authority by a
physician licensed to practice medicine in all its branches to
a physician assistant under Section 7.5 of the Physician
Assistant Practice Act of 1987. This delegated authority under

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Section 7.5 of the Physician Assistant Practice Act of 1987
may, but is not required to, include prescription of controlled
substances, as defined in Article II of the Illinois Controlled
Substances Act, in accordance with a written supervision
agreement; and
(g) the delegation of prescriptive authority by a physician
licensed to practice medicine in all its branches or a licensed
podiatrist to an advanced practice nurse in accordance with a
written collaborative agreement under Sections 65-35 and 65-40
of the Nurse Practice Act; and .
(h) the donation or acceptance, or the packaging,
repackaging, or labeling, of prescription drugs to the extent
permitted or required under the Prescription Drug Repository
Program Act.
(Source: P.A. 95-639, eff. 10-5-07; 96-189, eff. 8-10-09;
96-268, eff. 8-11-09.)
Section 91. The Wholesale Drug Distribution Licensing Act
is amended by changing Section 15 as follows:
(225 ILCS 120/15) (from Ch. 111, par. 8301-15)
(Section scheduled to be repealed on January 1, 2013)
Sec. 15. Definitions. As used in this Act:
"Authentication" means the affirmative verification,
before any wholesale distribution of a prescription drug
occurs, that each transaction listed on the pedigree has

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occurred.
"Authorized distributor of record" means a wholesale
distributor with whom a manufacturer has established an ongoing
relationship to distribute the manufacturer's prescription
drug. An ongoing relationship is deemed to exist between a
wholesale distributor and a manufacturer when the wholesale
distributor, including any affiliated group of the wholesale
distributor, as defined in Section 1504 of the Internal Revenue
Code, complies with the following:
(1) The wholesale distributor has a written agreement
currently in effect with the manufacturer evidencing the
ongoing relationship; and
(2) The wholesale distributor is listed on the
manufacturer's current list of authorized distributors of
record, which is updated by the manufacturer on no less
than a monthly basis.
"Blood" means whole blood collected from a single donor and
processed either for transfusion or further manufacturing.
"Blood component" means that part of blood separated by
physical or mechanical means.
"Board" means the State Board of Pharmacy of the Department
of Professional Regulation.
"Chain pharmacy warehouse" means a physical location for
prescription drugs that acts as a central warehouse and
performs intracompany sales or transfers of the drugs to a
group of chain or mail order pharmacies that have the same

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common ownership and control. Notwithstanding any other
provision of this Act, a chain pharmacy warehouse shall be
considered part of the normal distribution channel.
"Co-licensed partner or product" means an instance where
one or more parties have the right to engage in the
manufacturing or marketing of a prescription drug, consistent
with the FDA's implementation of the Prescription Drug
Marketing Act.
"Department" means the Department of Financial and
Professional Regulation.
"Drop shipment" means the sale of a prescription drug to a
wholesale distributor by the manufacturer of the prescription
drug or that manufacturer's co-licensed product partner, that
manufacturer's third party logistics provider, or that
manufacturer's exclusive distributor or by an authorized
distributor of record that purchased the product directly from
the manufacturer or one of these entities whereby the wholesale
distributor or chain pharmacy warehouse takes title but not
physical possession of such prescription drug and the wholesale
distributor invoices the pharmacy, chain pharmacy warehouse,
or other person authorized by law to dispense or administer
such drug to a patient and the pharmacy, chain pharmacy
warehouse, or other authorized person receives delivery of the
prescription drug directly from the manufacturer, that
manufacturer's third party logistics provider, or that
manufacturer's exclusive distributor or from an authorized

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distributor of record that purchased the product directly from
the manufacturer or one of these entities.
"Drug sample" means a unit of a prescription drug that is
not intended to be sold and is intended to promote the sale of
the drug.
"Facility" means a facility of a wholesale distributor
where prescription drugs are stored, handled, repackaged, or
offered for sale.
"FDA" means the United States Food and Drug Administration.
"Manufacturer" means a person licensed or approved by the
FDA to engage in the manufacture of drugs or devices,
consistent with the definition of "manufacturer" set forth in
the FDA's regulations and guidances implementing the
Prescription Drug Marketing Act. "Manufacturer" does not
include anyone who is engaged in the packaging, repackaging, or
labeling of prescription drugs only to the extent required
under the Prescription Drug Repository Program Act.
"Manufacturer's exclusive distributor" means anyone who
contracts with a manufacturer to provide or coordinate
warehousing, distribution, or other services on behalf of a
manufacturer and who takes title to that manufacturer's
prescription drug, but who does not have general responsibility
to direct the sale or disposition of the manufacturer's
prescription drug. A manufacturer's exclusive distributor must
be licensed as a wholesale distributor under this Act and, in
order to be considered part of the normal distribution channel,

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must also be an authorized distributor of record.
"Normal distribution channel" means a chain of custody for
a prescription drug that goes, directly or by drop shipment,
from (i) a manufacturer of the prescription drug, (ii) that
manufacturer to that manufacturer's co-licensed partner, (iii)
that manufacturer to that manufacturer's third party logistics
provider, or (iv) that manufacturer to that manufacturer's
exclusive distributor to:
(1) a pharmacy or to other designated persons
authorized by law to dispense or administer the drug to a
patient;
(2) a wholesale distributor to a pharmacy or other
designated persons authorized by law to dispense or
administer the drug to a patient;
(3) a wholesale distributor to a chain pharmacy
warehouse to that chain pharmacy warehouse's intracompany
pharmacy to a patient or other designated persons
authorized by law to dispense or administer the drug to a
patient;
(4) a chain pharmacy warehouse to the chain pharmacy
warehouse's intracompany pharmacy or other designated
persons authorized by law to dispense or administer the
drug to the patient;
(5) an authorized distributor of record to one other
authorized distributor of record to an office-based health
care practitioner authorized by law to dispense or

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administer the drug to the patient; or
(6) an authorized distributor to a pharmacy or other
persons licensed to dispense or administer the drug.
"Pedigree" means a document or electronic file containing
information that records each wholesale distribution of any
given prescription drug from the point of origin to the final
wholesale distribution point of any given prescription drug.
"Person" means and includes a natural person, partnership,
association or corporation.
"Pharmacy distributor" means any pharmacy licensed in this
State or hospital pharmacy that is engaged in the delivery or
distribution of prescription drugs either to any other pharmacy
licensed in this State or to any other person or entity
including, but not limited to, a wholesale drug distributor
engaged in the delivery or distribution of prescription drugs
who is involved in the actual, constructive, or attempted
transfer of a drug in this State to other than the ultimate
consumer except as otherwise provided for by law.
"Prescription drug" means any human drug, including any
biological product (except for blood and blood components
intended for transfusion or biological products that are also
medical devices), required by federal law or regulation to be
dispensed only by a prescription, including finished dosage
forms and bulk drug substances subject to Section 503 of the
Federal Food, Drug and Cosmetic Act.
"Repackage" means repackaging or otherwise changing the

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container, wrapper, or labeling to further the distribution of
a prescription drug, excluding that completed by the pharmacist
responsible for dispensing the product to a patient.
"Secretary" means the Secretary of Financial and
Professional Regulation.
"Third party logistics provider" means anyone who
contracts with a prescription drug manufacturer to provide or
coordinate warehousing, distribution, or other services on
behalf of a manufacturer, but does not take title to the
prescription drug or have general responsibility to direct the
prescription drug's sale or disposition. A third party
logistics provider must be licensed as a wholesale distributor
under this Act and, in order to be considered part of the
normal distribution channel, must also be an authorized
distributor of record.
"Wholesale distribution" means the distribution of
prescription drugs to persons other than a consumer or patient,
but does not include any of the following:
(1) Intracompany sales of prescription drugs, meaning
(i) any transaction or transfer between any division,
subsidiary, parent, or affiliated or related company under
the common ownership and control of a corporate entity or
(ii) any transaction or transfer between co-licensees of a
co-licensed product.
(2) The sale, purchase, distribution, trade, or
transfer of a prescription drug or offer to sell, purchase,

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distribute, trade, or transfer a prescription drug for
emergency medical reasons.
(3) The distribution of prescription drug samples by
manufacturers' representatives.
(4) Drug returns, when conducted by a hospital, health
care entity, or charitable institution in accordance with
federal regulation.
(5) The sale of minimal quantities of prescription
drugs by retail pharmacies to licensed practitioners for
office use.
(6) The sale, purchase, or trade of a drug, an offer to
sell, purchase, or trade a drug, or the dispensing of a
drug pursuant to a prescription.
(7) The sale, transfer, merger, or consolidation of all
or part of the business of a pharmacy or pharmacies from or
with another pharmacy or pharmacies, whether accomplished
as a purchase and sale of stock or business assets.
(8) The sale, purchase, distribution, trade, or
transfer of a prescription drug from one authorized
distributor of record to one additional authorized
distributor of record when the manufacturer has stated in
writing to the receiving authorized distributor of record
that the manufacturer is unable to supply the prescription
drug and the supplying authorized distributor of record
states in writing that the prescription drug being supplied
had until that time been exclusively in the normal

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distribution channel.
(9) The delivery of or the offer to deliver a
prescription drug by a common carrier solely in the common
carrier's usual course of business of transporting
prescription drugs when the common carrier does not store,
warehouse, or take legal ownership of the prescription
drug.
(10) The sale or transfer from a retail pharmacy, mail
order pharmacy, or chain pharmacy warehouse of expired,
damaged, returned, or recalled prescription drugs to the
original manufacturer, the originating wholesale
distributor, or a third party returns processor.
(11) The donation of prescription drugs to the extent
permitted under the Prescription Drug Repository Program
Act.
"Wholesale drug distributor" means anyone engaged in the
wholesale distribution of prescription drugs, including
without limitation manufacturers; repackers; own label
distributors; jobbers; private label distributors; brokers;
warehouses, including manufacturers' and distributors'
warehouses; manufacturer's exclusive distributors; and
authorized distributors of record; drug wholesalers or
distributors; independent wholesale drug traders; specialty
wholesale distributors; third party logistics providers; and
retail pharmacies that conduct wholesale distribution; and
chain pharmacy warehouses that conduct wholesale distribution.

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In order to be considered part of the normal distribution
channel, a wholesale distributor must also be an authorized
distributor of record.
(Source: P.A. 95-689, eff. 10-29-07.)
Section 92. The Senior Pharmaceutical Assistance Act is
amended by changing Section 10 as follows:
(320 ILCS 50/10)
Sec. 10. Definitions. In this Act:
"Manufacturer" includes:
(1) An entity that is engaged in (a) the production,
preparation, propagation, compounding, conversion, or
processing of prescription drug products (i) directly or
indirectly by extraction from substances of natural
origin, (ii) independently by means of chemical synthesis,
or (iii) by combination of extraction and chemical
synthesis; or (b) the packaging, repackaging, labeling or
re-labeling, or distribution of prescription drug
products.
(2) The entity holding legal title to or possession of
the national drug code number for the covered prescription
drug.
The term does not include a wholesale distributor of drugs,
drugstore chain organization, or retail pharmacy licensed by
the State. The term also does not include anyone who is engaged

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in the packaging, repackaging, or labeling of prescription
drugs only to the extent required under the Prescription Drug
Repository Program Act.
"Prescription drug" means a drug that may be dispensed only
upon prescription by an authorized prescriber and that is
approved for safety and effectiveness as a prescription drug
under Section 505 or 507 of the Federal Food, Drug and Cosmetic
Act.
"Senior citizen" or "senior" means a person 65 years of age
or older.
(Source: P.A. 92-594, eff. 6-27-02.)
Section 93. The Illinois Food, Drug and Cosmetic Act is
amended by changing Section 16 as follows:
(410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
Sec. 16. (a) The Director is hereby authorized to
promulgate regulations exempting from any labeling or
packaging requirement of this Act drugs and devices which are
(i) , in accordance with the practice of the trade, to be
processed, labeled or repacked in substantial quantities at
establishments other than those where originally processed or
packaged on condition that such drugs and devices are not
adulterated or misbranded under the provisions of this Act upon
removal from such processing, labeling or repacking
establishment or (ii) packaged, repackaged, or labeled to the

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extent required under the Prescription Drug Repository Program
Act.
(b) Drugs and device labeling or packaging exemptions
adopted under the Federal Act and supplements thereto or
revisions thereof shall apply to drugs and devices in Illinois
except insofar as modified or rejected by regulations
promulgated by the Director.
(c) A drug intended for use by man which (A) is a
habit-forming drug to which Section 15 (d) applies; or (B)
because of its toxicity or other potentiality for harmful
effect or the method of its use or the collateral measures
necessary to its use is not safe for use except under the
supervision of a practitioner licensed by law to administer
such drug; or (C) is limited by an approved application under
Section 505 of the Federal Act or Section 17 of this Act to use
under the professional supervision of a practitioner licensed
by law to administer such drug, shall be dispensed only in
accordance with the provisions of the "Illinois Controlled
Substances Act". The act of dispensing a drug contrary to the
provisions of this paragraph shall be deemed to be an act which
results in a drug being misbranded while held for sale.
(d) Any drug dispensed by filling or refilling a written or
oral prescription of a practitioner licensed by law to
administer such drug shall be exempt from the requirements of
Section 15, except subsections (a), (k) and (l) and clauses (2)
and (3) of subsection (i), and the packaging requirements of

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subsections (g), (h) and (q), if the drug bears a label
containing the proprietary name or names, or if there is none,
the established name or names of the drugs, the dosage and
quantity, unless the prescribing practitioner, in the interest
of the health of the patient, directs otherwise in writing, the
name and address of the dispenser, the serial number and date
of the prescription or of its filling, the name of the
prescriber and, if stated in the prescription, the name of the
patient, and the directions for use and the cautionary
statements, if any, contained in such prescription. This
exemption shall not apply to any drug dispensed in the course
of the conduct of business of dispensing drugs pursuant to
diagnosis by mail, or to a drug dispensed in violation of
subsection (a) of this Section.
(e) The Director may by regulation remove drugs subject to
Section 15 (d) and Section 17 from the requirements of
subsection (c) of this Section when such requirements are not
necessary for the protection of the public health.
(f) A drug which is subject to subsection (c) of this
Section shall be deemed to be misbranded if at any time before
dispensing its label fails to bear the statement "Caution:
Federal Law Prohibits Dispensing Without Prescription" or
"Caution: State Law Prohibits Dispensing Without
Prescription". A drug to which subsection (c) of this Section
does not apply shall be deemed to be misbranded if at any time
prior to dispensing its label bears the caution statement

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quoted in the preceding sentence.
(g) Nothing in this Section shall be construed to relieve
any person from any requirement prescribed by or under
authority of law with respect to controlled substances now
included or which may hereafter be included within the
classifications of controlled substances cannabis as defined
in applicable Federal laws relating to controlled substances or
cannabis or the Cannabis Control Act.
(Source: P.A. 84-1308.)
Section 94. The Illinois Controlled Substances Act is
amended by changing Section 102 as follows:
(720 ILCS 570/102) (from Ch. 56 1/2, par. 1102)
Sec. 102. Definitions. As used in this Act, unless the
context otherwise requires:
(a) "Addict" means any person who habitually uses any drug,
chemical, substance or dangerous drug other than alcohol so as
to endanger the public morals, health, safety or welfare or who
is so far addicted to the use of a dangerous drug or controlled
substance other than alcohol as to have lost the power of self
control with reference to his addiction.
(b) "Administer" means the direct application of a
controlled substance, whether by injection, inhalation,
ingestion, or any other means, to the body of a patient,
research subject, or animal (as defined by the Humane

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Euthanasia in Animal Shelters Act) by:
(1) a practitioner (or, in his presence, by his
authorized agent),
(2) the patient or research subject at the lawful
direction of the practitioner, or
(3) a euthanasia technician as defined by the Humane
Euthanasia in Animal Shelters Act.
(c) "Agent" means an authorized person who acts on behalf
of or at the direction of a manufacturer, distributor, or
dispenser. It does not include a common or contract carrier,
public warehouseman or employee of the carrier or warehouseman.
(c-1) "Anabolic Steroids" means any drug or hormonal
substance, chemically and pharmacologically related to
testosterone (other than estrogens, progestins, and
corticosteroids) that promotes muscle growth, and includes:
(i) boldenone,
(ii) chlorotestosterone,
(iii) chostebol,
(iv) dehydrochlormethyltestosterone,
(v) dihydrotestosterone,
(vi) drostanolone,
(vii) ethylestrenol,
(viii) fluoxymesterone,
(ix) formebulone,
(x) mesterolone,
(xi) methandienone,

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(xii) methandranone,
(xiii) methandriol,
(xiv) methandrostenolone,
(xv) methenolone,
(xvi) methyltestosterone,
(xvii) mibolerone,
(xviii) nandrolone,
(xix) norethandrolone,
(xx) oxandrolone,
(xxi) oxymesterone,
(xxii) oxymetholone,
(xxiii) stanolone,
(xxiv) stanozolol,
(xxv) testolactone,
(xxvi) testosterone,
(xxvii) trenbolone, and
(xxviii) any salt, ester, or isomer of a drug or
substance described or listed in this paragraph, if
that salt, ester, or isomer promotes muscle growth.
Any person who is otherwise lawfully in possession of an
anabolic steroid, or who otherwise lawfully manufactures,
distributes, dispenses, delivers, or possesses with intent to
deliver an anabolic steroid, which anabolic steroid is
expressly intended for and lawfully allowed to be administered
through implants to livestock or other nonhuman species, and
which is approved by the Secretary of Health and Human Services

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for such administration, and which the person intends to
administer or have administered through such implants, shall
not be considered to be in unauthorized possession or to
unlawfully manufacture, distribute, dispense, deliver, or
possess with intent to deliver such anabolic steroid for
purposes of this Act.
(d) "Administration" means the Drug Enforcement
Administration, United States Department of Justice, or its
successor agency.
(e) "Control" means to add a drug or other substance, or
immediate precursor, to a Schedule under Article II of this Act
whether by transfer from another Schedule or otherwise.
(f) "Controlled Substance" means a drug, substance, or
immediate precursor in the Schedules of Article II of this Act.
(g) "Counterfeit substance" means a controlled substance,
which, or the container or labeling of which, without
authorization bears the trademark, trade name, or other
identifying mark, imprint, number or device, or any likeness
thereof, of a manufacturer, distributor, or dispenser other
than the person who in fact manufactured, distributed, or
dispensed the substance.
(h) "Deliver" or "delivery" means the actual, constructive
or attempted transfer of possession of a controlled substance,
with or without consideration, whether or not there is an
agency relationship. The term does not include the donation of
prescription drugs to the extent permitted under the

HB5115 - 24 - LRB096 19820 KTG 35268 b
Prescription Drug Repository Program Act.
(i) "Department" means the Illinois Department of Human
Services (as successor to the Department of Alcoholism and
Substance Abuse) or its successor agency.
(j) "Department of State Police" means the Department of
State Police of the State of Illinois or its successor agency.
(k) "Department of Corrections" means the Department of
Corrections of the State of Illinois or its successor agency.
(l) "Department of Professional Regulation" means the
Department of Professional Regulation of the State of Illinois
or its successor agency.
(m) "Depressant" or "stimulant substance" means:
(1) a drug which contains any quantity of (i)
barbituric acid or any of the salts of barbituric acid
which has been designated as habit forming under section
502 (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352 (d)); or
(2) a drug which contains any quantity of (i)
amphetamine or methamphetamine and any of their optical
isomers; (ii) any salt of amphetamine or methamphetamine or
any salt of an optical isomer of amphetamine; or (iii) any
substance which the Department, after investigation, has
found to be, and by rule designated as, habit forming
because of its depressant or stimulant effect on the
central nervous system; or
(3) lysergic acid diethylamide; or

HB5115 - 25 - LRB096 19820 KTG 35268 b
(4) any drug which contains any quantity of a substance
which the Department, after investigation, has found to
have, and by rule designated as having, a potential for
abuse because of its depressant or stimulant effect on the
central nervous system or its hallucinogenic effect.
(n) (Blank).
(o) "Director" means the Director of the Department of
State Police or the Department of Professional Regulation or
his designated agents.
(p) "Dispense" means to deliver a controlled substance to
an ultimate user or research subject by or pursuant to the
lawful order of a prescriber, including the prescribing,
administering, packaging, labeling, or compounding necessary
to prepare the substance for that delivery.
(q) "Dispenser" means a practitioner who dispenses.
(r) "Distribute" means to deliver, other than by
administering or dispensing, a controlled substance.
(s) "Distributor" means a person who distributes.
(t) "Drug" means (1) substances recognized as drugs in the
official United States Pharmacopoeia, Official Homeopathic
Pharmacopoeia of the United States, or official National
Formulary, or any supplement to any of them; (2) substances
intended for use in diagnosis, cure, mitigation, treatment, or
prevention of disease in man or animals; (3) substances (other
than food) intended to affect the structure of any function of
the body of man or animals and (4) substances intended for use

HB5115 - 26 - LRB096 19820 KTG 35268 b
as a component of any article specified in clause (1), (2), or
(3) of this subsection. It does not include devices or their
components, parts, or accessories.
(t-5) "Euthanasia agency" means an entity certified by the
Department of Professional Regulation for the purpose of animal
euthanasia that holds an animal control facility license or
animal shelter license under the Animal Welfare Act. A
euthanasia agency is authorized to purchase, store, possess,
and utilize Schedule II nonnarcotic and Schedule III
nonnarcotic drugs for the sole purpose of animal euthanasia.
(t-10) "Euthanasia drugs" means Schedule II or Schedule III
substances (nonnarcotic controlled substances) that are used
by a euthanasia agency for the purpose of animal euthanasia.
(u) "Good faith" means the prescribing or dispensing of a
controlled substance by a practitioner in the regular course of
professional treatment to or for any person who is under his
treatment for a pathology or condition other than that
individual's physical or psychological dependence upon or
addiction to a controlled substance, except as provided herein:
and application of the term to a pharmacist shall mean the
dispensing of a controlled substance pursuant to the
prescriber's order which in the professional judgment of the
pharmacist is lawful. The pharmacist shall be guided by
accepted professional standards including, but not limited to
the following, in making the judgment:
(1) lack of consistency of doctor-patient

HB5115 - 27 - LRB096 19820 KTG 35268 b
relationship,
(2) frequency of prescriptions for same drug by one
prescriber for large numbers of patients,
(3) quantities beyond those normally prescribed,
(4) unusual dosages,
(5) unusual geographic distances between patient,
pharmacist and prescriber,
(6) consistent prescribing of habit-forming drugs.
(u-1) "Home infusion services" means services provided by a
pharmacy in compounding solutions for direct administration to
a patient in a private residence, long-term care facility, or
hospice setting by means of parenteral, intravenous,
intramuscular, subcutaneous, or intraspinal infusion.
(v) "Immediate precursor" means a substance:
(1) which the Department has found to be and by rule
designated as being a principal compound used, or produced
primarily for use, in the manufacture of a controlled
substance;
(2) which is an immediate chemical intermediary used or
likely to be used in the manufacture of such controlled
substance; and
(3) the control of which is necessary to prevent,
curtail or limit the manufacture of such controlled
substance.
(w) "Instructional activities" means the acts of teaching,
educating or instructing by practitioners using controlled

HB5115 - 28 - LRB096 19820 KTG 35268 b
substances within educational facilities approved by the State
Board of Education or its successor agency.
(x) "Local authorities" means a duly organized State,
County or Municipal peace unit or police force.
(y) "Look-alike substance" means a substance, other than a
controlled substance which (1) by overall dosage unit
appearance, including shape, color, size, markings or lack
thereof, taste, consistency, or any other identifying physical
characteristic of the substance, would lead a reasonable person
to believe that the substance is a controlled substance, or (2)
is expressly or impliedly represented to be a controlled
substance or is distributed under circumstances which would
lead a reasonable person to believe that the substance is a
controlled substance. For the purpose of determining whether
the representations made or the circumstances of the
distribution would lead a reasonable person to believe the
substance to be a controlled substance under this clause (2) of
subsection (y), the court or other authority may consider the
following factors in addition to any other factor that may be
relevant:
(a) statements made by the owner or person in control
of the substance concerning its nature, use or effect;
(b) statements made to the buyer or recipient that the
substance may be resold for profit;
(c) whether the substance is packaged in a manner
normally used for the illegal distribution of controlled

HB5115 - 29 - LRB096 19820 KTG 35268 b
substances;
(d) whether the distribution or attempted distribution
included an exchange of or demand for money or other
property as consideration, and whether the amount of the
consideration was substantially greater than the
reasonable retail market value of the substance.
Clause (1) of this subsection (y) shall not apply to a
noncontrolled substance in its finished dosage form that was
initially introduced into commerce prior to the initial
introduction into commerce of a controlled substance in its
finished dosage form which it may substantially resemble.
Nothing in this subsection (y) prohibits the dispensing or
distributing of noncontrolled substances by persons authorized
to dispense and distribute controlled substances under this
Act, provided that such action would be deemed to be carried
out in good faith under subsection (u) if the substances
involved were controlled substances.
Nothing in this subsection (y) or in this Act prohibits the
manufacture, preparation, propagation, compounding,
processing, packaging, advertising or distribution of a drug or
drugs by any person registered pursuant to Section 510 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
(y-1) "Mail-order pharmacy" means a pharmacy that is
located in a state of the United States, other than Illinois,
that delivers, dispenses or distributes, through the United
States Postal Service or other common carrier, to Illinois

HB5115 - 30 - LRB096 19820 KTG 35268 b
residents, any substance which requires a prescription.
(z) "Manufacture" means the production, preparation,
propagation, compounding, conversion or processing of a
controlled substance other than methamphetamine, either
directly or indirectly, by extraction from substances of
natural origin, or independently by means of chemical
synthesis, or by a combination of extraction and chemical
synthesis, and includes any packaging or repackaging of the
substance or labeling of its container, except that this term
does not include:
(1) by an ultimate user, the preparation or compounding
of a controlled substance for his own use; or
(2) by a practitioner, or his authorized agent under
his supervision, the preparation, compounding, packaging,
or labeling of a controlled substance:
(a) as an incident to his administering or
dispensing of a controlled substance in the course of
his professional practice; or
(b) as an incident to lawful research, teaching or
chemical analysis and not for sale; or .
(3) the packaging, repackaging, or labeling of
prescription drugs only to the extent required under the
Prescription Drug Repository Program Act.
(z-1) (Blank).
(aa) "Narcotic drug" means any of the following, whether
produced directly or indirectly by extraction from substances

HB5115 - 31 - LRB096 19820 KTG 35268 b
of natural origin, or independently by means of chemical
synthesis, or by a combination of extraction and chemical
synthesis:
(1) opium and opiate, and any salt, compound,
derivative, or preparation of opium or opiate;
(2) any salt, compound, isomer, derivative, or
preparation thereof which is chemically equivalent or
identical with any of the substances referred to in clause
(1), but not including the isoquinoline alkaloids of opium;
(3) opium poppy and poppy straw;
(4) coca leaves and any salts, compound, isomer, salt
of an isomer, derivative, or preparation of coca leaves
including cocaine or ecgonine, and any salt, compound,
isomer, derivative, or preparation thereof which is
chemically equivalent or identical with any of these
substances, but not including decocainized coca leaves or
extractions of coca leaves which do not contain cocaine or
ecgonine (for the purpose of this paragraph, the term
"isomer" includes optical, positional and geometric
isomers).
(bb) "Nurse" means a registered nurse licensed under the
Nurse Practice Act.
(cc) (Blank).
(dd) "Opiate" means any substance having an addiction
forming or addiction sustaining liability similar to morphine
or being capable of conversion into a drug having addiction

HB5115 - 32 - LRB096 19820 KTG 35268 b
forming or addiction sustaining liability.
(ee) "Opium poppy" means the plant of the species Papaver
somniferum L., except its seeds.
(ff) "Parole and Pardon Board" means the Parole and Pardon
Board of the State of Illinois or its successor agency.
(gg) "Person" means any individual, corporation,
mail-order pharmacy, government or governmental subdivision or
agency, business trust, estate, trust, partnership or
association, or any other entity.
(hh) "Pharmacist" means any person who holds a license or
certificate of registration as a registered pharmacist, a local
registered pharmacist or a registered assistant pharmacist
under the Pharmacy Practice Act.
(ii) "Pharmacy" means any store, ship or other place in
which pharmacy is authorized to be practiced under the Pharmacy
Practice Act.
(jj) "Poppy straw" means all parts, except the seeds, of
the opium poppy, after mowing.
(kk) "Practitioner" means a physician licensed to practice
medicine in all its branches, dentist, optometrist,
podiatrist, veterinarian, scientific investigator, pharmacist,
physician assistant, advanced practice nurse, licensed
practical nurse, registered nurse, hospital, laboratory, or
pharmacy, or other person licensed, registered, or otherwise
lawfully permitted by the United States or this State to
distribute, dispense, conduct research with respect to,

HB5115 - 33 - LRB096 19820 KTG 35268 b
administer or use in teaching or chemical analysis, a
controlled substance in the course of professional practice or
research.
(ll) "Pre-printed prescription" means a written
prescription upon which the designated drug has been indicated
prior to the time of issuance.
(mm) "Prescriber" means a physician licensed to practice
medicine in all its branches, dentist, optometrist, podiatrist
or veterinarian who issues a prescription, a physician
assistant who issues a prescription for a controlled substance
in accordance with Section 303.05, a written delegation, and a
written supervision agreement required under Section 7.5 of the
Physician Assistant Practice Act of 1987, or an advanced
practice nurse with prescriptive authority delegated under
Section 65-40 of the Nurse Practice Act and in accordance with
Section 303.05, a written delegation, and a written
collaborative agreement under Section 65-35 of the Nurse
Practice Act.
(nn) "Prescription" means a lawful written, facsimile, or
verbal order of a physician licensed to practice medicine in
all its branches, dentist, podiatrist or veterinarian for any
controlled substance, of an optometrist for a Schedule III, IV,
or V controlled substance in accordance with Section 15.1 of
the Illinois Optometric Practice Act of 1987, of a physician
assistant for a controlled substance in accordance with Section
303.05, a written delegation, and a written supervision

HB5115 - 34 - LRB096 19820 KTG 35268 b
agreement required under Section 7.5 of the Physician Assistant
Practice Act of 1987, or of an advanced practice nurse with
prescriptive authority delegated under Section 65-40 of the
Nurse Practice Act who issues a prescription for a controlled
substance in accordance with Section 303.05, a written
delegation, and a written collaborative agreement under
Section 65-35 of the Nurse Practice Act.
(oo) "Production" or "produce" means manufacture,
planting, cultivating, growing, or harvesting of a controlled
substance other than methamphetamine.
(pp) "Registrant" means every person who is required to
register under Section 302 of this Act.
(qq) "Registry number" means the number assigned to each
person authorized to handle controlled substances under the
laws of the United States and of this State.
(rr) "State" includes the State of Illinois and any state,
district, commonwealth, territory, insular possession thereof,
and any area subject to the legal authority of the United
States of America.
(ss) "Ultimate user" means a person who lawfully possesses
a controlled substance for his own use or for the use of a
member of his household or for administering to an animal owned
by him or by a member of his household.
(Source: P.A. 95-242, eff. 1-1-08; 95-639, eff. 10-5-07;
95-689, eff. 10-29-07; 95-876, eff. 8-21-08; 96-189, eff.
8-10-09; 96-268, eff. 8-11-09.)

HB5115 - 35 - LRB096 19820 KTG 35268 b
Section 95. The Cannabis and Controlled Substances Tort
Claims Act is amended by changing Section 3 as follows:
(740 ILCS 20/3) (from Ch. 70, par. 903)
Sec. 3. Definitions. As used in this Act, unless the
context otherwise requires:
"Cannabis" includes marihuana, hashish, and other
substances that are identified as including any parts of the
plant Cannabis Sativa, whether growing or not, the seeds of
that plant, the resin extracted from any part of that plant,
and any compound, manufacture, salt, derivative, mixture, or
preparation of that plant, its seeds, or resin, including
tetrahydrocannabinol (THC) and all other cannabinol
derivatives, including its naturally occurring or
synthetically produced ingredients, whether produced directly
or indirectly by extraction, independently by means of chemical
synthesis, or by a combination of extraction and chemical
synthesis. "Cannabis" does not include the mature stalks of
that plant, fiber produced from those stalks, oil or cake made
from the seeds of that plant, any other compound, manufacture,
salt, derivative, mixture, or preparation of mature stalks
(except the extracted resin), fiber, oil or cake, or the
sterilized seeds of that plant that are incapable of
germination.
"Controlled substance" means a drug, substance, or

HB5115 - 36 - LRB096 19820 KTG 35268 b
immediate precursor in the Schedules of Article II of the
Illinois Controlled Substances Act.
"Counterfeit substance" means a controlled substance or
the container or labeling of a controlled substance that,
without authorization, bears the trademark, trade name, or
other identifying mark, imprint, number, device, or any
likeness thereof of a manufacturer, distributor, or dispenser
other than the person who in fact manufactured, distributed, or
dispensed the substance.
"Deliver" or "delivery" means the actual, constructive, or
attempted transfer of possession of a controlled substance or
cannabis, with or without consideration, whether or not there
is an agency relationship. The term does not include the
donation of prescription drugs to the extent permitted under
the Prescription Drug Repository Program Act.
"Manufacture" means the production, preparation,
propagation, compounding, conversion, or processing of a
controlled substance, either directly or indirectly, by
extraction from substances of natural origin, independently by
means of chemical synthesis, or by a combination of extraction
and chemical synthesis, and includes any packaging or
repackaging of the substance or labeling of its container,
except that the term does not include:
(1) by an ultimate user, the preparation or compounding
of a controlled substance for his own use;
(2) by a practitioner or his authorized agent under his

HB5115 - 37 - LRB096 19820 KTG 35268 b
supervision, the preparation, compounding, packaging, or
labeling of a controlled substance:
(A) as an incident to his administering or
dispensing of a controlled substance in the course of
his professional practice; or
(B) as an incident to lawful research, teaching or
chemical analysis and not for sale; or
(3) the preparation, compounding, packaging, or
labeling of cannabis as an incident to lawful research,
teaching, or chemical analysis and not for sale; or .
(4) the packaging, repackaging, or labeling of
prescription drugs only to the extent required under the
Prescription Drug Repository Program Act.
"Owner" means a person who has possession of or any
interest whatsoever in the property involved.
"Person" means an individual, a corporation, a government,
a governmental subdivision or agency, a business trust, an
estate, a trust, a partnership or association, or any other
entity.
"Production" means planting, cultivating, tending, or
harvesting.
"Property" means real property, including things growing
on, affixed to, and found in land, and tangible or intangible
personal property, including rights, services, privileges,
interests, claims, and securities.
(Source: P.A. 96-328, eff. 8-11-09.)
HB5115 - 38 - LRB096 19820 KTG 35268 b
INDEX
Statutes amended in order of appearance
New Act
225 ILCS 85/4 from Ch. 111, par. 4124
225 ILCS 120/15 from Ch. 111, par. 8301-15
320 ILCS 50/10
410 ILCS 620/16 from Ch. 56 1/2, par. 516
720 ILCS 570/102 from Ch. 56 1/2, par. 1102
740 ILCS 20/3