97TH GENERAL ASSEMBLY
State of Illinois
2011 and 2012
HB1660

 

Introduced 2/15/2011, 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

 

HB1660LRB097 08294 KTG 48421 b

1    AN ACT concerning health.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 1. Short title. This Act may be cited as the
5Prescription Drug Repository Program Act.
 
6    Section 5. Definitions. In this Act:
7    "Department" means the Department of Public Health.
8    "Dispense" has the meaning given to that term in the
9Pharmacy Practice Act.
10    "Healthcare facility" means an assisted living facility,
11hospice, rehabilitation facility, or long-term care facility.
12    "Pharmacist" means an individual licensed to engage in the
13practice of pharmacy under the Pharmacy Practice Act.
14    "Pharmacy" means a pharmacy registered in this State under
15the Pharmacy Practice Act.
16    "Practitioner" means a person licensed in this State to
17prescribe and administer drugs or licensed in another state and
18recognized by this State as a person authorized to prescribe
19and administer drugs.
20    "Prescription drug" means any prescribed drug that may be
21legally dispensed by a pharmacy. "Prescription drug" does not
22include drugs for the treatment of cancer that can only be
23dispensed to a patient registered with the drug manufacturer in

 

 

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1accordance with federal Food and Drug Administration
2requirements.
3    "Program" means the prescription drug repository program
4established under this Act.
 
5    Section 10. Prescription drug repository program. The
6Department shall establish and maintain a prescription drug
7repository program, under which a healthcare facility may
8donate a prescription drug or supplies needed to administer a
9prescription drug for use by an individual who meets
10appropriate eligibility criteria. Donations may be made on the
11premises of a pharmacy that elects to participate in the
12program and meets appropriate requirements. The pharmacy may
13charge an individual who receives a prescription drug or
14supplies needed to administer a prescription drug under this
15Act a handling fee that may not exceed an appropriate amount. A
16pharmacy that receives a donated prescription drug or supplies
17needed to administer a prescription drug under this Act may
18distribute the prescription drug or supplies to another
19eligible pharmacy for use under the program.
 
20    Section 15. Requirements for accepting and dispensing
21prescription drugs and supplies. A prescription drug or
22supplies needed to administer a prescription drug may be
23accepted and dispensed under the program only if all of the
24following requirements are met:

 

 

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1        (1) The prescription drug or supplies needed to
2    administer a prescription drug are in their original,
3    unopened, sealed, and tamper-evident unit-dose packaging
4    or, if packaged in single-unit doses, the single-unit-dose
5    packaging is unopened.
6        (2) The prescription drug bears an expiration date that
7    is later than 6 months after the date that the drug was
8    donated.
9        (3) The prescription drug or supplies needed to
10    administer a prescription drug are not adulterated or
11    misbranded, as determined by a pharmacist employed by, or
12    under contract with, the pharmacy where the drug or
13    supplies are accepted or dispensed. The pharmacist must
14    inspect the drug or supplies before the drug or supplies
15    are dispensed.
16        (4) The prescription drug or supplies needed to
17    administer a prescription drug are prescribed by a
18    practitioner for use by an eligible individual.
 
19    Section 20. Resale of donated drugs or supplies prohibited.
20No prescription drug or supplies needed to administer a
21prescription drug that are donated for use under this Act may
22be resold.
 
23    Section 25. Participation in program not required. Nothing
24in this Act requires that a pharmacy or pharmacist participate

 

 

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1in the prescription drug repository program.
 
2    Section 30. Immunity.
3    (a) Except in cases of willful and wanton misconduct, a
4manufacturer of a drug or supply is not subject to criminal or
5civil liability for injury, death, or loss to a person or
6property for matters related to the donation, acceptance, or
7dispensing of a prescription drug or supply manufactured by the
8manufacturer that is donated under this Act, including
9liability for failure to transfer or communicate product or
10consumer information or the expiration date of the donated
11prescription drug. The provisions of this subsection shall
12apply only to the donation, acceptance, or dispensing of drugs
13or supplies provided without fee or compensation. Immunity
14granted under this subsection is solely applicable to the
15donation, acceptance, or dispensing of a drug or supply under
16this Act and is not a general waiver of liability that would
17have existed under the original prescription.
18    (b) A pharmacist or other health care professional working
19in a pharmacy participating in the program dispensing,
20furnishing, or otherwise providing in good faith without fee or
21compensation donated prescription drugs to eligible
22individuals under this Act shall not be subject to professional
23or civil liability, except for willful or wanton misconduct.
 
24    Section 90. The Pharmacy Practice Act is amended by

 

 

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1changing Section 4 as follows:
 
2    (225 ILCS 85/4)  (from Ch. 111, par. 4124)
3    (Section scheduled to be repealed on January 1, 2018)
4    Sec. 4. Exemptions. Nothing contained in any Section of
5this Act shall apply to, or in any manner interfere with:
6    (a) the lawful practice of any physician licensed to
7practice medicine in all of its branches, dentist, podiatrist,
8veterinarian, or therapeutically or diagnostically certified
9optometrist within the limits of his or her license, or prevent
10him or her from supplying to his or her bona fide patients such
11drugs, medicines, or poisons as may seem to him appropriate;
12    (b) the sale of compressed gases;
13    (c) the sale of patent or proprietary medicines and
14household remedies when sold in original and unbroken packages
15only, if such patent or proprietary medicines and household
16remedies be properly and adequately labeled as to content and
17usage and generally considered and accepted as harmless and
18nonpoisonous when used according to the directions on the
19label, and also do not contain opium or coca leaves, or any
20compound, salt or derivative thereof, or any drug which,
21according to the latest editions of the following authoritative
22pharmaceutical treatises and standards, namely, The United
23States Pharmacopoeia/National Formulary (USP/NF), the United
24States Dispensatory, and the Accepted Dental Remedies of the
25Council of Dental Therapeutics of the American Dental

 

 

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1Association or any or either of them, in use on the effective
2date of this Act, or according to the existing provisions of
3the Federal Food, Drug, and Cosmetic Act and Regulations of the
4Department of Health and Human Services, Food and Drug
5Administration, promulgated thereunder now in effect, is
6designated, described or considered as a narcotic, hypnotic,
7habit forming, dangerous, or poisonous drug;
8    (d) the sale of poultry and livestock remedies in original
9and unbroken packages only, labeled for poultry and livestock
10medication;
11    (e) the sale of poisonous substances or mixture of
12poisonous substances, in unbroken packages, for nonmedicinal
13use in the arts or industries or for insecticide purposes;
14provided, they are properly and adequately labeled as to
15content and such nonmedicinal usage, in conformity with the
16provisions of all applicable federal, state and local laws and
17regulations promulgated thereunder now in effect relating
18thereto and governing the same, and those which are required
19under such applicable laws and regulations to be labeled with
20the word "Poison", are also labeled with the word "Poison"
21printed thereon in prominent type and the name of a readily
22obtainable antidote with directions for its administration;
23    (f) the delegation of limited prescriptive authority by a
24physician licensed to practice medicine in all its branches to
25a physician assistant under Section 7.5 of the Physician
26Assistant Practice Act of 1987. This delegated authority under

 

 

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1Section 7.5 of the Physician Assistant Practice Act of 1987
2may, but is not required to, include prescription of controlled
3substances, as defined in Article II of the Illinois Controlled
4Substances Act, in accordance with a written supervision
5agreement; and
6    (g) the delegation of prescriptive authority by a physician
7licensed to practice medicine in all its branches or a licensed
8podiatrist to an advanced practice nurse in accordance with a
9written collaborative agreement under Sections 65-35 and 65-40
10of the Nurse Practice Act; and .
11    (h) the donation or acceptance, or the packaging,
12repackaging, or labeling, of prescription drugs to the extent
13permitted or required under the Prescription Drug Repository
14Program Act.
15(Source: P.A. 95-639, eff. 10-5-07; 96-189, eff. 8-10-09;
1696-268, eff. 8-11-09.)
 
17    Section 91. The Wholesale Drug Distribution Licensing Act
18is amended by changing Section 15 as follows:
 
19    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
20    (Section scheduled to be repealed on January 1, 2013)
21    Sec. 15. Definitions. As used in this Act:
22    "Authentication" means the affirmative verification,
23before any wholesale distribution of a prescription drug
24occurs, that each transaction listed on the pedigree has

 

 

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1occurred.
2    "Authorized distributor of record" means a wholesale
3distributor with whom a manufacturer has established an ongoing
4relationship to distribute the manufacturer's prescription
5drug. An ongoing relationship is deemed to exist between a
6wholesale distributor and a manufacturer when the wholesale
7distributor, including any affiliated group of the wholesale
8distributor, as defined in Section 1504 of the Internal Revenue
9Code, complies with the following:
10        (1) The wholesale distributor has a written agreement
11    currently in effect with the manufacturer evidencing the
12    ongoing relationship; and
13        (2) The wholesale distributor is listed on the
14    manufacturer's current list of authorized distributors of
15    record, which is updated by the manufacturer on no less
16    than a monthly basis.
17    "Blood" means whole blood collected from a single donor and
18processed either for transfusion or further manufacturing.
19    "Blood component" means that part of blood separated by
20physical or mechanical means.
21    "Board" means the State Board of Pharmacy of the Department
22of Professional Regulation.
23    "Chain pharmacy warehouse" means a physical location for
24prescription drugs that acts as a central warehouse and
25performs intracompany sales or transfers of the drugs to a
26group of chain or mail order pharmacies that have the same

 

 

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1common ownership and control. Notwithstanding any other
2provision of this Act, a chain pharmacy warehouse shall be
3considered part of the normal distribution channel.
4    "Co-licensed partner or product" means an instance where
5one or more parties have the right to engage in the
6manufacturing or marketing of a prescription drug, consistent
7with the FDA's implementation of the Prescription Drug
8Marketing Act.
9    "Department" means the Department of Financial and
10Professional Regulation.
11    "Drop shipment" means the sale of a prescription drug to a
12wholesale distributor by the manufacturer of the prescription
13drug or that manufacturer's co-licensed product partner, that
14manufacturer's third party logistics provider, or that
15manufacturer's exclusive distributor or by an authorized
16distributor of record that purchased the product directly from
17the manufacturer or one of these entities whereby the wholesale
18distributor or chain pharmacy warehouse takes title but not
19physical possession of such prescription drug and the wholesale
20distributor invoices the pharmacy, chain pharmacy warehouse,
21or other person authorized by law to dispense or administer
22such drug to a patient and the pharmacy, chain pharmacy
23warehouse, or other authorized person receives delivery of the
24prescription drug directly from the manufacturer, that
25manufacturer's third party logistics provider, or that
26manufacturer's exclusive distributor or from an authorized

 

 

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1distributor of record that purchased the product directly from
2the manufacturer or one of these entities.
3    "Drug sample" means a unit of a prescription drug that is
4not intended to be sold and is intended to promote the sale of
5the drug.
6    "Facility" means a facility of a wholesale distributor
7where prescription drugs are stored, handled, repackaged, or
8offered for sale.
9    "FDA" means the United States Food and Drug Administration.
10    "Manufacturer" means a person licensed or approved by the
11FDA to engage in the manufacture of drugs or devices,
12consistent with the definition of "manufacturer" set forth in
13the FDA's regulations and guidances implementing the
14Prescription Drug Marketing Act. "Manufacturer" does not
15include anyone who is engaged in the packaging, repackaging, or
16labeling of prescription drugs only to the extent required
17under the Prescription Drug Repository Program Act.
18    "Manufacturer's exclusive distributor" means anyone who
19contracts with a manufacturer to provide or coordinate
20warehousing, distribution, or other services on behalf of a
21manufacturer and who takes title to that manufacturer's
22prescription drug, but who does not have general responsibility
23to direct the sale or disposition of the manufacturer's
24prescription drug. A manufacturer's exclusive distributor must
25be licensed as a wholesale distributor under this Act and, in
26order to be considered part of the normal distribution channel,

 

 

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1must also be an authorized distributor of record.
2    "Normal distribution channel" means a chain of custody for
3a prescription drug that goes, directly or by drop shipment,
4from (i) a manufacturer of the prescription drug, (ii) that
5manufacturer to that manufacturer's co-licensed partner, (iii)
6that manufacturer to that manufacturer's third party logistics
7provider, or (iv) that manufacturer to that manufacturer's
8exclusive distributor to:
9        (1) a pharmacy or to other designated persons
10    authorized by law to dispense or administer the drug to a
11    patient;
12        (2) a wholesale distributor to a pharmacy or other
13    designated persons authorized by law to dispense or
14    administer the drug to a patient;
15        (3) a wholesale distributor to a chain pharmacy
16    warehouse to that chain pharmacy warehouse's intracompany
17    pharmacy to a patient or other designated persons
18    authorized by law to dispense or administer the drug to a
19    patient;
20        (4) a chain pharmacy warehouse to the chain pharmacy
21    warehouse's intracompany pharmacy or other designated
22    persons authorized by law to dispense or administer the
23    drug to the patient;
24        (5) an authorized distributor of record to one other
25    authorized distributor of record to an office-based health
26    care practitioner authorized by law to dispense or

 

 

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1    administer the drug to the patient; or
2        (6) an authorized distributor to a pharmacy or other
3    persons licensed to dispense or administer the drug.
4    "Pedigree" means a document or electronic file containing
5information that records each wholesale distribution of any
6given prescription drug from the point of origin to the final
7wholesale distribution point of any given prescription drug.
8    "Person" means and includes a natural person, partnership,
9association or corporation.
10    "Pharmacy distributor" means any pharmacy licensed in this
11State or hospital pharmacy that is engaged in the delivery or
12distribution of prescription drugs either to any other pharmacy
13licensed in this State or to any other person or entity
14including, but not limited to, a wholesale drug distributor
15engaged in the delivery or distribution of prescription drugs
16who is involved in the actual, constructive, or attempted
17transfer of a drug in this State to other than the ultimate
18consumer except as otherwise provided for by law.
19    "Prescription drug" means any human drug, including any
20biological product (except for blood and blood components
21intended for transfusion or biological products that are also
22medical devices), required by federal law or regulation to be
23dispensed only by a prescription, including finished dosage
24forms and bulk drug substances subject to Section 503 of the
25Federal Food, Drug and Cosmetic Act.
26    "Repackage" means repackaging or otherwise changing the

 

 

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1container, wrapper, or labeling to further the distribution of
2a prescription drug, excluding that completed by the pharmacist
3responsible for dispensing the product to a patient.
4    "Secretary" means the Secretary of Financial and
5Professional Regulation.
6    "Third party logistics provider" means anyone who
7contracts with a prescription drug manufacturer to provide or
8coordinate warehousing, distribution, or other services on
9behalf of a manufacturer, but does not take title to the
10prescription drug or have general responsibility to direct the
11prescription drug's sale or disposition. A third party
12logistics provider must be licensed as a wholesale distributor
13under this Act and, in order to be considered part of the
14normal distribution channel, must also be an authorized
15distributor of record.
16    "Wholesale distribution" means the distribution of
17prescription drugs to persons other than a consumer or patient,
18but does not include any of the following:
19        (1) Intracompany sales of prescription drugs, meaning
20    (i) any transaction or transfer between any division,
21    subsidiary, parent, or affiliated or related company under
22    the common ownership and control of a corporate entity or
23    (ii) any transaction or transfer between co-licensees of a
24    co-licensed product.
25        (2) The sale, purchase, distribution, trade, or
26    transfer of a prescription drug or offer to sell, purchase,

 

 

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

 

 

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1    distribution channel.
2        (9) The delivery of or the offer to deliver a
3    prescription drug by a common carrier solely in the common
4    carrier's usual course of business of transporting
5    prescription drugs when the common carrier does not store,
6    warehouse, or take legal ownership of the prescription
7    drug.
8        (10) The sale or transfer from a retail pharmacy, mail
9    order pharmacy, or chain pharmacy warehouse of expired,
10    damaged, returned, or recalled prescription drugs to the
11    original manufacturer, the originating wholesale
12    distributor, or a third party returns processor.
13        (11) The donation of prescription drugs to the extent
14    permitted under the Prescription Drug Repository Program
15    Act.
16    "Wholesale drug distributor" means anyone engaged in the
17wholesale distribution of prescription drugs, including
18without limitation manufacturers; repackers; own label
19distributors; jobbers; private label distributors; brokers;
20warehouses, including manufacturers' and distributors'
21warehouses; manufacturer's exclusive distributors; and
22authorized distributors of record; drug wholesalers or
23distributors; independent wholesale drug traders; specialty
24wholesale distributors; third party logistics providers; and
25retail pharmacies that conduct wholesale distribution; and
26chain pharmacy warehouses that conduct wholesale distribution.

 

 

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1In order to be considered part of the normal distribution
2channel, a wholesale distributor must also be an authorized
3distributor of record.
4(Source: P.A. 95-689, eff. 10-29-07.)
 
5    Section 92. The Senior Pharmaceutical Assistance Act is
6amended by changing Section 10 as follows:
 
7    (320 ILCS 50/10)
8    Sec. 10. Definitions. In this Act:
9    "Manufacturer" includes:
10        (1) An entity that is engaged in (a) the production,
11    preparation, propagation, compounding, conversion, or
12    processing of prescription drug products (i) directly or
13    indirectly by extraction from substances of natural
14    origin, (ii) independently by means of chemical synthesis,
15    or (iii) by combination of extraction and chemical
16    synthesis; or (b) the packaging, repackaging, labeling or
17    re-labeling, or distribution of prescription drug
18    products.
19        (2) The entity holding legal title to or possession of
20    the national drug code number for the covered prescription
21    drug.
22    The term does not include a wholesale distributor of drugs,
23drugstore chain organization, or retail pharmacy licensed by
24the State. The term also does not include anyone who is engaged

 

 

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1in the packaging, repackaging, or labeling of prescription
2drugs only to the extent required under the Prescription Drug
3Repository Program Act.
4    "Prescription drug" means a drug that may be dispensed only
5upon prescription by an authorized prescriber and that is
6approved for safety and effectiveness as a prescription drug
7under Section 505 or 507 of the Federal Food, Drug and Cosmetic
8Act.
9    "Senior citizen" or "senior" means a person 65 years of age
10or older.
11(Source: P.A. 92-594, eff. 6-27-02.)
 
12    Section 93. The Illinois Food, Drug and Cosmetic Act is
13amended by changing Section 16 as follows:
 
14    (410 ILCS 620/16)  (from Ch. 56 1/2, par. 516)
15    Sec. 16. (a) The Director is hereby authorized to
16promulgate regulations exempting from any labeling or
17packaging requirement of this Act drugs and devices which are
18(i) , in accordance with the practice of the trade, to be
19processed, labeled or repacked in substantial quantities at
20establishments other than those where originally processed or
21packaged on condition that such drugs and devices are not
22adulterated or misbranded under the provisions of this Act upon
23removal from such processing, labeling or repacking
24establishment or (ii) packaged, repackaged, or labeled to the

 

 

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1extent required under the Prescription Drug Repository Program
2Act.
3    (b) Drugs and device labeling or packaging exemptions
4adopted under the Federal Act and supplements thereto or
5revisions thereof shall apply to drugs and devices in Illinois
6except insofar as modified or rejected by regulations
7promulgated by the Director.
8    (c) A drug intended for use by man which (A) is a
9habit-forming drug to which Section 15 (d) applies; or (B)
10because of its toxicity or other potentiality for harmful
11effect or the method of its use or the collateral measures
12necessary to its use is not safe for use except under the
13supervision of a practitioner licensed by law to administer
14such drug; or (C) is limited by an approved application under
15Section 505 of the Federal Act or Section 17 of this Act to use
16under the professional supervision of a practitioner licensed
17by law to administer such drug, shall be dispensed only in
18accordance with the provisions of the "Illinois Controlled
19Substances Act". The act of dispensing a drug contrary to the
20provisions of this paragraph shall be deemed to be an act which
21results in a drug being misbranded while held for sale.
22    (d) Any drug dispensed by filling or refilling a written or
23oral prescription of a practitioner licensed by law to
24administer such drug shall be exempt from the requirements of
25Section 15, except subsections (a), (k) and (l) and clauses (2)
26and (3) of subsection (i), and the packaging requirements of

 

 

HB1660- 19 -LRB097 08294 KTG 48421 b

1subsections (g), (h) and (q), if the drug bears a label
2containing the proprietary name or names, or if there is none,
3the established name or names of the drugs, the dosage and
4quantity, unless the prescribing practitioner, in the interest
5of the health of the patient, directs otherwise in writing, the
6name and address of the dispenser, the serial number and date
7of the prescription or of its filling, the name of the
8prescriber and, if stated in the prescription, the name of the
9patient, and the directions for use and the cautionary
10statements, if any, contained in such prescription. This
11exemption shall not apply to any drug dispensed in the course
12of the conduct of business of dispensing drugs pursuant to
13diagnosis by mail, or to a drug dispensed in violation of
14subsection (a) of this Section.
15    (e) The Director may by regulation remove drugs subject to
16Section 15 (d) and Section 17 from the requirements of
17subsection (c) of this Section when such requirements are not
18necessary for the protection of the public health.
19    (f) A drug which is subject to subsection (c) of this
20Section shall be deemed to be misbranded if at any time before
21dispensing its label fails to bear the statement "Caution:
22Federal Law Prohibits Dispensing Without Prescription" or
23"Caution: State Law Prohibits Dispensing Without
24Prescription". A drug to which subsection (c) of this Section
25does not apply shall be deemed to be misbranded if at any time
26prior to dispensing its label bears the caution statement

 

 

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1quoted in the preceding sentence.
2    (g) Nothing in this Section shall be construed to relieve
3any person from any requirement prescribed by or under
4authority of law with respect to controlled substances now
5included or which may hereafter be included within the
6classifications of controlled substances cannabis as defined
7in applicable Federal laws relating to controlled substances or
8cannabis or the Cannabis Control Act.
9(Source: P.A. 84-1308.)
 
10    Section 94. The Illinois Controlled Substances Act is
11amended by changing Section 102 as follows:
 
12    (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
13    Sec. 102. Definitions. As used in this Act, unless the
14context otherwise requires:
15    (a) "Addict" means any person who habitually uses any drug,
16chemical, substance or dangerous drug other than alcohol so as
17to endanger the public morals, health, safety or welfare or who
18is so far addicted to the use of a dangerous drug or controlled
19substance other than alcohol as to have lost the power of self
20control with reference to his addiction.
21    (b) "Administer" means the direct application of a
22controlled substance, whether by injection, inhalation,
23ingestion, or any other means, to the body of a patient,
24research subject, or animal (as defined by the Humane

 

 

HB1660- 21 -LRB097 08294 KTG 48421 b

1Euthanasia in Animal Shelters Act) by:
2        (1) a practitioner (or, in his presence, by his
3    authorized agent),
4        (2) the patient or research subject at the lawful
5    direction of the practitioner, or
6        (3) a euthanasia technician as defined by the Humane
7    Euthanasia in Animal Shelters Act.
8    (c) "Agent" means an authorized person who acts on behalf
9of or at the direction of a manufacturer, distributor, or
10dispenser. It does not include a common or contract carrier,
11public warehouseman or employee of the carrier or warehouseman.
12    (c-1) "Anabolic Steroids" means any drug or hormonal
13substance, chemically and pharmacologically related to
14testosterone (other than estrogens, progestins, and
15corticosteroids) that promotes muscle growth, and includes:
16            (i) boldenone,
17            (ii) chlorotestosterone,
18            (iii) chostebol,
19            (iv) dehydrochlormethyltestosterone,
20            (v) dihydrotestosterone,
21            (vi) drostanolone,
22            (vii) ethylestrenol,
23            (viii) fluoxymesterone,
24            (ix) formebulone,
25            (x) mesterolone,
26            (xi) methandienone,

 

 

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1            (xii) methandranone,
2            (xiii) methandriol,
3            (xiv) methandrostenolone,
4            (xv) methenolone,
5            (xvi) methyltestosterone,
6            (xvii) mibolerone,
7            (xviii) nandrolone,
8            (xix) norethandrolone,
9            (xx) oxandrolone,
10            (xxi) oxymesterone,
11            (xxii) oxymetholone,
12            (xxiii) stanolone,
13            (xxiv) stanozolol,
14            (xxv) testolactone,
15            (xxvi) testosterone,
16            (xxvii) trenbolone, and
17            (xxviii) any salt, ester, or isomer of a drug or
18        substance described or listed in this paragraph, if
19        that salt, ester, or isomer promotes muscle growth.
20    Any person who is otherwise lawfully in possession of an
21anabolic steroid, or who otherwise lawfully manufactures,
22distributes, dispenses, delivers, or possesses with intent to
23deliver an anabolic steroid, which anabolic steroid is
24expressly intended for and lawfully allowed to be administered
25through implants to livestock or other nonhuman species, and
26which is approved by the Secretary of Health and Human Services

 

 

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1for such administration, and which the person intends to
2administer or have administered through such implants, shall
3not be considered to be in unauthorized possession or to
4unlawfully manufacture, distribute, dispense, deliver, or
5possess with intent to deliver such anabolic steroid for
6purposes of this Act.
7    (d) "Administration" means the Drug Enforcement
8Administration, United States Department of Justice, or its
9successor agency.
10    (e) "Control" means to add a drug or other substance, or
11immediate precursor, to a Schedule under Article II of this Act
12whether by transfer from another Schedule or otherwise.
13    (f) "Controlled Substance" means a drug, substance, or
14immediate precursor in the Schedules of Article II of this Act.
15    (g) "Counterfeit substance" means a controlled substance,
16which, or the container or labeling of which, without
17authorization bears the trademark, trade name, or other
18identifying mark, imprint, number or device, or any likeness
19thereof, of a manufacturer, distributor, or dispenser other
20than the person who in fact manufactured, distributed, or
21dispensed the substance.
22    (h) "Deliver" or "delivery" means the actual, constructive
23or attempted transfer of possession of a controlled substance,
24with or without consideration, whether or not there is an
25agency relationship. The term does not include the donation of
26prescription drugs to the extent permitted under the

 

 

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1Prescription Drug Repository Program Act.
2    (i) "Department" means the Illinois Department of Human
3Services (as successor to the Department of Alcoholism and
4Substance Abuse) or its successor agency.
5    (j) "Department of State Police" means the Department of
6State Police of the State of Illinois or its successor agency.
7    (k) "Department of Corrections" means the Department of
8Corrections of the State of Illinois or its successor agency.
9    (l) "Department of Professional Regulation" means the
10Department of Professional Regulation of the State of Illinois
11or its successor agency.
12    (m) "Depressant" or "stimulant substance" means:
13        (1) a drug which contains any quantity of (i)
14    barbituric acid or any of the salts of barbituric acid
15    which has been designated as habit forming under section
16    502 (d) of the Federal Food, Drug, and Cosmetic Act (21
17    U.S.C. 352 (d)); or
18        (2) a drug which contains any quantity of (i)
19    amphetamine or methamphetamine and any of their optical
20    isomers; (ii) any salt of amphetamine or methamphetamine or
21    any salt of an optical isomer of amphetamine; or (iii) any
22    substance which the Department, after investigation, has
23    found to be, and by rule designated as, habit forming
24    because of its depressant or stimulant effect on the
25    central nervous system; or
26        (3) lysergic acid diethylamide; or

 

 

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1        (4) any drug which contains any quantity of a substance
2    which the Department, after investigation, has found to
3    have, and by rule designated as having, a potential for
4    abuse because of its depressant or stimulant effect on the
5    central nervous system or its hallucinogenic effect.
6    (n) (Blank).
7    (o) "Director" means the Director of the Department of
8State Police or the Department of Professional Regulation or
9his designated agents.
10    (p) "Dispense" means to deliver a controlled substance to
11an ultimate user or research subject by or pursuant to the
12lawful order of a prescriber, including the prescribing,
13administering, packaging, labeling, or compounding necessary
14to prepare the substance for that delivery.
15    (q) "Dispenser" means a practitioner who dispenses.
16    (r) "Distribute" means to deliver, other than by
17administering or dispensing, a controlled substance.
18    (s) "Distributor" means a person who distributes.
19    (t) "Drug" means (1) substances recognized as drugs in the
20official United States Pharmacopoeia, Official Homeopathic
21Pharmacopoeia of the United States, or official National
22Formulary, or any supplement to any of them; (2) substances
23intended for use in diagnosis, cure, mitigation, treatment, or
24prevention of disease in man or animals; (3) substances (other
25than food) intended to affect the structure of any function of
26the body of man or animals and (4) substances intended for use

 

 

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1as a component of any article specified in clause (1), (2), or
2(3) of this subsection. It does not include devices or their
3components, parts, or accessories.
4    (t-5) "Euthanasia agency" means an entity certified by the
5Department of Professional Regulation for the purpose of animal
6euthanasia that holds an animal control facility license or
7animal shelter license under the Animal Welfare Act. A
8euthanasia agency is authorized to purchase, store, possess,
9and utilize Schedule II nonnarcotic and Schedule III
10nonnarcotic drugs for the sole purpose of animal euthanasia.
11    (t-10) "Euthanasia drugs" means Schedule II or Schedule III
12substances (nonnarcotic controlled substances) that are used
13by a euthanasia agency for the purpose of animal euthanasia.
14    (u) "Good faith" means the prescribing or dispensing of a
15controlled substance by a practitioner in the regular course of
16professional treatment to or for any person who is under his
17treatment for a pathology or condition other than that
18individual's physical or psychological dependence upon or
19addiction to a controlled substance, except as provided herein:
20and application of the term to a pharmacist shall mean the
21dispensing of a controlled substance pursuant to the
22prescriber's order which in the professional judgment of the
23pharmacist is lawful. The pharmacist shall be guided by
24accepted professional standards including, but not limited to
25the following, in making the judgment:
26        (1) lack of consistency of doctor-patient

 

 

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1    relationship,
2        (2) frequency of prescriptions for same drug by one
3    prescriber for large numbers of patients,
4        (3) quantities beyond those normally prescribed,
5        (4) unusual dosages,
6        (5) unusual geographic distances between patient,
7    pharmacist and prescriber,
8        (6) consistent prescribing of habit-forming drugs.
9    (u-1) "Home infusion services" means services provided by a
10pharmacy in compounding solutions for direct administration to
11a patient in a private residence, long-term care facility, or
12hospice setting by means of parenteral, intravenous,
13intramuscular, subcutaneous, or intraspinal infusion.
14    (v) "Immediate precursor" means a substance:
15        (1) which the Department has found to be and by rule
16    designated as being a principal compound used, or produced
17    primarily for use, in the manufacture of a controlled
18    substance;
19        (2) which is an immediate chemical intermediary used or
20    likely to be used in the manufacture of such controlled
21    substance; and
22        (3) the control of which is necessary to prevent,
23    curtail or limit the manufacture of such controlled
24    substance.
25    (w) "Instructional activities" means the acts of teaching,
26educating or instructing by practitioners using controlled

 

 

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1substances within educational facilities approved by the State
2Board of Education or its successor agency.
3    (x) "Local authorities" means a duly organized State,
4County or Municipal peace unit or police force.
5    (y) "Look-alike substance" means a substance, other than a
6controlled substance which (1) by overall dosage unit
7appearance, including shape, color, size, markings or lack
8thereof, taste, consistency, or any other identifying physical
9characteristic of the substance, would lead a reasonable person
10to believe that the substance is a controlled substance, or (2)
11is expressly or impliedly represented to be a controlled
12substance or is distributed under circumstances which would
13lead a reasonable person to believe that the substance is a
14controlled substance. For the purpose of determining whether
15the representations made or the circumstances of the
16distribution would lead a reasonable person to believe the
17substance to be a controlled substance under this clause (2) of
18subsection (y), the court or other authority may consider the
19following factors in addition to any other factor that may be
20relevant:
21        (a) statements made by the owner or person in control
22    of the substance concerning its nature, use or effect;
23        (b) statements made to the buyer or recipient that the
24    substance may be resold for profit;
25        (c) whether the substance is packaged in a manner
26    normally used for the illegal distribution of controlled

 

 

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1    substances;
2        (d) whether the distribution or attempted distribution
3    included an exchange of or demand for money or other
4    property as consideration, and whether the amount of the
5    consideration was substantially greater than the
6    reasonable retail market value of the substance.
7    Clause (1) of this subsection (y) shall not apply to a
8noncontrolled substance in its finished dosage form that was
9initially introduced into commerce prior to the initial
10introduction into commerce of a controlled substance in its
11finished dosage form which it may substantially resemble.
12    Nothing in this subsection (y) prohibits the dispensing or
13distributing of noncontrolled substances by persons authorized
14to dispense and distribute controlled substances under this
15Act, provided that such action would be deemed to be carried
16out in good faith under subsection (u) if the substances
17involved were controlled substances.
18    Nothing in this subsection (y) or in this Act prohibits the
19manufacture, preparation, propagation, compounding,
20processing, packaging, advertising or distribution of a drug or
21drugs by any person registered pursuant to Section 510 of the
22Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
23    (y-1) "Mail-order pharmacy" means a pharmacy that is
24located in a state of the United States, other than Illinois,
25that delivers, dispenses or distributes, through the United
26States Postal Service or other common carrier, to Illinois

 

 

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1residents, any substance which requires a prescription.
2    (z) "Manufacture" means the production, preparation,
3propagation, compounding, conversion or processing of a
4controlled substance other than methamphetamine, either
5directly or indirectly, by extraction from substances of
6natural origin, or independently by means of chemical
7synthesis, or by a combination of extraction and chemical
8synthesis, and includes any packaging or repackaging of the
9substance or labeling of its container, except that this term
10does not include:
11        (1) by an ultimate user, the preparation or compounding
12    of a controlled substance for his own use; or
13        (2) by a practitioner, or his authorized agent under
14    his supervision, the preparation, compounding, packaging,
15    or labeling of a controlled substance:
16            (a) as an incident to his administering or
17        dispensing of a controlled substance in the course of
18        his professional practice; or
19            (b) as an incident to lawful research, teaching or
20        chemical analysis and not for sale; or .
21        (3) the packaging, repackaging, or labeling of
22    prescription drugs only to the extent required under the
23    Prescription Drug Repository Program Act.
24    (z-1) (Blank).
25    (aa) "Narcotic drug" means any of the following, whether
26produced directly or indirectly by extraction from substances

 

 

HB1660- 31 -LRB097 08294 KTG 48421 b

1of natural origin, or independently by means of chemical
2synthesis, or by a combination of extraction and chemical
3synthesis:
4        (1) opium and opiate, and any salt, compound,
5    derivative, or preparation of opium or opiate;
6        (2) any salt, compound, isomer, derivative, or
7    preparation thereof which is chemically equivalent or
8    identical with any of the substances referred to in clause
9    (1), but not including the isoquinoline alkaloids of opium;
10        (3) opium poppy and poppy straw;
11        (4) coca leaves and any salts, compound, isomer, salt
12    of an isomer, derivative, or preparation of coca leaves
13    including cocaine or ecgonine, and any salt, compound,
14    isomer, derivative, or preparation thereof which is
15    chemically equivalent or identical with any of these
16    substances, but not including decocainized coca leaves or
17    extractions of coca leaves which do not contain cocaine or
18    ecgonine (for the purpose of this paragraph, the term
19    "isomer" includes optical, positional and geometric
20    isomers).
21    (bb) "Nurse" means a registered nurse licensed under the
22Nurse Practice Act.
23    (cc) (Blank).
24    (dd) "Opiate" means any substance having an addiction
25forming or addiction sustaining liability similar to morphine
26or being capable of conversion into a drug having addiction

 

 

HB1660- 32 -LRB097 08294 KTG 48421 b

1forming or addiction sustaining liability.
2    (ee) "Opium poppy" means the plant of the species Papaver
3somniferum L., except its seeds.
4    (ff) "Parole and Pardon Board" means the Parole and Pardon
5Board of the State of Illinois or its successor agency.
6    (gg) "Person" means any individual, corporation,
7mail-order pharmacy, government or governmental subdivision or
8agency, business trust, estate, trust, partnership or
9association, or any other entity.
10    (hh) "Pharmacist" means any person who holds a license or
11certificate of registration as a registered pharmacist, a local
12registered pharmacist or a registered assistant pharmacist
13under the Pharmacy Practice Act.
14    (ii) "Pharmacy" means any store, ship or other place in
15which pharmacy is authorized to be practiced under the Pharmacy
16Practice Act.
17    (jj) "Poppy straw" means all parts, except the seeds, of
18the opium poppy, after mowing.
19    (kk) "Practitioner" means a physician licensed to practice
20medicine in all its branches, dentist, optometrist,
21podiatrist, veterinarian, scientific investigator, pharmacist,
22physician assistant, advanced practice nurse, licensed
23practical nurse, registered nurse, hospital, laboratory, or
24pharmacy, or other person licensed, registered, or otherwise
25lawfully permitted by the United States or this State to
26distribute, dispense, conduct research with respect to,

 

 

HB1660- 33 -LRB097 08294 KTG 48421 b

1administer or use in teaching or chemical analysis, a
2controlled substance in the course of professional practice or
3research.
4    (ll) "Pre-printed prescription" means a written
5prescription upon which the designated drug has been indicated
6prior to the time of issuance.
7    (mm) "Prescriber" means a physician licensed to practice
8medicine in all its branches, dentist, optometrist, podiatrist
9or veterinarian who issues a prescription, a physician
10assistant who issues a prescription for a controlled substance
11in accordance with Section 303.05, a written delegation, and a
12written supervision agreement required under Section 7.5 of the
13Physician Assistant Practice Act of 1987, or an advanced
14practice nurse with prescriptive authority delegated under
15Section 65-40 of the Nurse Practice Act and in accordance with
16Section 303.05, a written delegation, and a written
17collaborative agreement under Section 65-35 of the Nurse
18Practice Act.
19    (nn) "Prescription" means a lawful written, facsimile, or
20verbal order of a physician licensed to practice medicine in
21all its branches, dentist, podiatrist or veterinarian for any
22controlled substance, of an optometrist for a Schedule III, IV,
23or V controlled substance in accordance with Section 15.1 of
24the Illinois Optometric Practice Act of 1987, of a physician
25assistant for a controlled substance in accordance with Section
26303.05, a written delegation, and a written supervision

 

 

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1agreement required under Section 7.5 of the Physician Assistant
2Practice Act of 1987, or of an advanced practice nurse with
3prescriptive authority delegated under Section 65-40 of the
4Nurse Practice Act who issues a prescription for a controlled
5substance in accordance with Section 303.05, a written
6delegation, and a written collaborative agreement under
7Section 65-35 of the Nurse Practice Act.
8    (oo) "Production" or "produce" means manufacture,
9planting, cultivating, growing, or harvesting of a controlled
10substance other than methamphetamine.
11    (pp) "Registrant" means every person who is required to
12register under Section 302 of this Act.
13    (qq) "Registry number" means the number assigned to each
14person authorized to handle controlled substances under the
15laws of the United States and of this State.
16    (rr) "State" includes the State of Illinois and any state,
17district, commonwealth, territory, insular possession thereof,
18and any area subject to the legal authority of the United
19States of America.
20    (ss) "Ultimate user" means a person who lawfully possesses
21a controlled substance for his own use or for the use of a
22member of his household or for administering to an animal owned
23by him or by a member of his household.
24(Source: P.A. 95-242, eff. 1-1-08; 95-639, eff. 10-5-07;
2595-689, eff. 10-29-07; 95-876, eff. 8-21-08; 96-189, eff.
268-10-09; 96-268, eff. 8-11-09.)
 

 

 

HB1660- 35 -LRB097 08294 KTG 48421 b

1    Section 95. The Cannabis and Controlled Substances Tort
2Claims Act is amended by changing Section 3 as follows:
 
3    (740 ILCS 20/3)  (from Ch. 70, par. 903)
4    Sec. 3. Definitions. As used in this Act, unless the
5context otherwise requires:
6    "Cannabis" includes marihuana, hashish, and other
7substances that are identified as including any parts of the
8plant Cannabis Sativa, whether growing or not, the seeds of
9that plant, the resin extracted from any part of that plant,
10and any compound, manufacture, salt, derivative, mixture, or
11preparation of that plant, its seeds, or resin, including
12tetrahydrocannabinol (THC) and all other cannabinol
13derivatives, including its naturally occurring or
14synthetically produced ingredients, whether produced directly
15or indirectly by extraction, independently by means of chemical
16synthesis, or by a combination of extraction and chemical
17synthesis. "Cannabis" does not include the mature stalks of
18that plant, fiber produced from those stalks, oil or cake made
19from the seeds of that plant, any other compound, manufacture,
20salt, derivative, mixture, or preparation of mature stalks
21(except the extracted resin), fiber, oil or cake, or the
22sterilized seeds of that plant that are incapable of
23germination.
24    "Controlled substance" means a drug, substance, or

 

 

HB1660- 36 -LRB097 08294 KTG 48421 b

1immediate precursor in the Schedules of Article II of the
2Illinois Controlled Substances Act.
3    "Counterfeit substance" means a controlled substance or
4the container or labeling of a controlled substance that,
5without authorization, bears the trademark, trade name, or
6other identifying mark, imprint, number, device, or any
7likeness thereof of a manufacturer, distributor, or dispenser
8other than the person who in fact manufactured, distributed, or
9dispensed the substance.
10    "Deliver" or "delivery" means the actual, constructive, or
11attempted transfer of possession of a controlled substance or
12cannabis, with or without consideration, whether or not there
13is an agency relationship. The term does not include the
14donation of prescription drugs to the extent permitted under
15the Prescription Drug Repository Program Act.
16    "Manufacture" means the production, preparation,
17propagation, compounding, conversion, or processing of a
18controlled substance, either directly or indirectly, by
19extraction from substances of natural origin, independently by
20means of chemical synthesis, or by a combination of extraction
21and chemical synthesis, and includes any packaging or
22repackaging of the substance or labeling of its container,
23except that the term does not include:
24        (1) by an ultimate user, the preparation or compounding
25    of a controlled substance for his own use;
26        (2) by a practitioner or his authorized agent under his

 

 

HB1660- 37 -LRB097 08294 KTG 48421 b

1    supervision, the preparation, compounding, packaging, or
2    labeling of a controlled substance:
3            (A) as an incident to his administering or
4        dispensing of a controlled substance in the course of
5        his professional practice; or
6            (B) as an incident to lawful research, teaching or
7        chemical analysis and not for sale; or
8        (3) the preparation, compounding, packaging, or
9    labeling of cannabis as an incident to lawful research,
10    teaching, or chemical analysis and not for sale; or .
11        (4) the packaging, repackaging, or labeling of
12    prescription drugs only to the extent required under the
13    Prescription Drug Repository Program Act.
14    "Owner" means a person who has possession of or any
15interest whatsoever in the property involved.
16    "Person" means an individual, a corporation, a government,
17a governmental subdivision or agency, a business trust, an
18estate, a trust, a partnership or association, or any other
19entity.
20    "Production" means planting, cultivating, tending, or
21harvesting.
22    "Property" means real property, including things growing
23on, affixed to, and found in land, and tangible or intangible
24personal property, including rights, services, privileges,
25interests, claims, and securities.
26(Source: P.A. 96-328, eff. 8-11-09.)

 

 

HB1660- 38 -LRB097 08294 KTG 48421 b

1 INDEX
2 Statutes amended in order of appearance
3    New Act
4    225 ILCS 85/4from Ch. 111, par. 4124
5    225 ILCS 120/15from Ch. 111, par. 8301-15
6    320 ILCS 50/10
7    410 ILCS 620/16from Ch. 56 1/2, par. 516
8    720 ILCS 570/102from Ch. 56 1/2, par. 1102
9    740 ILCS 20/3from Ch. 70, par. 903