Bill Text: IL SB0600 | 2021-2022 | 102nd General Assembly | Introduced


Bill Title: Creates the Prescription Drug Repository Program Act. Requires the Department of Public Health to, by rule, establish a prescription drug repository program, under which a donor 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 uninsured and underinsured individuals shall be given priority over other eligible persons for drugs and supplies donated under the Act. 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 individuals in relation to the donation, acceptance, or dispensing of prescription drugs or supplies under the prescription drug repository program. Imposes conditions on any rulemaking authority. Contains other provisions. Amends the Pharmacy Practice Act, the Wholesale Drug Distribution Licensing Act, the Senior Pharmaceutical Assistance Act, the Illinois Food, Drug and Cosmetic 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 2-0)

Status: (Introduced) 2021-04-16 - Rule 3-9(a) / Re-referred to Assignments [SB0600 Detail]

Download: Illinois-2021-SB0600-Introduced.html


102ND GENERAL ASSEMBLY
State of Illinois
2021 and 2022
SB0600

Introduced 2/24/2021, by Sen. Sue Rezin

SYNOPSIS AS INTRODUCED:
See Index

Creates the Prescription Drug Repository Program Act. Requires the Department of Public Health to, by rule, establish a prescription drug repository program, under which a donor 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 uninsured and underinsured individuals shall be given priority over other eligible persons for drugs and supplies donated under the Act. 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 individuals in relation to the donation, acceptance, or dispensing of prescription drugs or supplies under the prescription drug repository program. Imposes conditions on any rulemaking authority. Contains other provisions. Amends the Pharmacy Practice Act, the Wholesale Drug Distribution Licensing Act, the Senior Pharmaceutical Assistance Act, the Illinois Food, Drug and Cosmetic 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.
LRB102 16677 CPF 22078 b
FISCAL NOTE ACT MAY APPLY

A BILL FOR

SB0600LRB102 16677 CPF 22078 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 "Controlled substance" means a drug, substance, or
8immediate precursor in Schedules I through V of 21 CFR 1308.
9 "Department" means the Department of Public Health.
10 "Dispense" has the meaning given to that term in the
11Pharmacy Practice Act.
12 "Donor" means any person, including an individual member
13of the public, or any entity legally authorized to possess
14medicine with a license or permit in the state in which it is
15located, including, but not limited to, the following:
16wholesalers, distributors, third-party logistic providers,
17pharmacies, dispensers, clinics, surgical or health centers,
18detention and rehabilitation centers, laboratories, medical or
19pharmacy schools, prescribers or other health care
20professionals, or health care facilities. "Donor" includes
21government agencies and entities that are federally authorized
22to possess medicine, including, but not limited to, drug
23manufacturers, repackagers, relabelers, outsourcing

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1facilities, Veterans Affairs hospitals, and prisons.
2 "Pharmacist" means an individual licensed to engage in the
3practice of pharmacy under the Pharmacy Practice Act.
4 "Practitioner" means a person licensed in this State to
5prescribe and administer drugs or licensed in another state
6and recognized by this State as a person authorized to
7prescribe and administer drugs.
8 "Prescription drug" means any prescribed drug that may be
9legally dispensed by a pharmacy.
10 "Program" means the prescription drug repository program
11established under this Act.
12 "Recipient pharmacy" means a pharmacy licensed under the
13Pharmacy Practice Act that receives a donated prescription
14drug or supplies needed to administer a prescription drug
15under this Act.
16 Section 10. Prescription drug repository program. The
17Department shall, by rule, establish and maintain a
18prescription drug repository program, under which a donor may
19donate a prescription drug or supplies needed to administer a
20prescription drug for use by an individual who meets
21appropriate eligibility criteria. The Department shall adopt
22the rules within one year after the effective date of this Act.
23A recipient pharmacy may charge an individual who receives a
24prescription drug or supplies needed to administer a
25prescription drug under this Act a handling fee that may not

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1exceed an appropriate amount. A recipient pharmacy may
2distribute the prescription drug or supplies to another
3eligible recipient pharmacy for use under the program or to
4another state's drug repository program.
5 Section 15. Priority. Uninsured and underinsured
6individuals shall be given priority over other eligible
7persons for drugs and supplies donated under this Act.
8 Section 20. Requirements for accepting and dispensing
9prescription drugs and supplies. A prescription drug or
10supplies needed to administer a prescription drug may be
11accepted and dispensed under the program only if all of the
12following requirements are met:
13 (1) The prescription drug or supplies needed to
14 administer a prescription drug are in their original,
15 unopened, sealed, and tamper-evident packaging or, if
16 packaged in single-unit doses, the single-unit-dose
17 packaging is unopened. A prescription drug or supplies
18 needed to administer a prescription drug originally packed
19 by a pharmacy, whether or not it is a recipient pharmacy,
20 is acceptable for donation.
21 (2) The prescription drug is not expired.
22 (3) The prescription drug or supplies needed to
23 administer a prescription drug are not adulterated or
24 misbranded, as determined by a pharmacist employed by, or

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1 under contract with, the pharmacy, whether or not it is a
2 recipient pharmacy, where the drug or supplies needed to
3 administer a prescription drug are accepted or dispensed.
4 The pharmacist must inspect the drug or supplies needed to
5 administer a prescription drug before the drug or supplies
6 needed to administer a prescription drug are dispensed.
7 (4) The prescription drug or supplies needed to
8 administer a prescription drug are prescribed by a
9 practitioner for use by an eligible individual.
10 (5) The prescription drug is not a controlled
11 substance.
12 (6) If the prescription drug can be dispensed only to
13 a patient registered with the drug's manufacturer in
14 accordance with federal Food and Drug Administration
15 requirements, the prescription drug may not be dispensed
16 through the program unless the patient receiving the drug
17 is registered with the manufacturer at the time the drug
18 is dispensed and the amount dispensed does not exceed the
19 duration of the registration period.
20 (7) The recipient pharmacy maintains a written or
21 electronic record of a donation made under this Act
22 consisting of the name, strength, and quantity of each
23 accepted drug and the name, address, and telephone number
24 of the donor. No other record of a donation is required.
25 Section 25. Resale of donated drugs or supplies

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1prohibited. No prescription drug or supplies needed to
2administer a prescription drug that are donated for use under
3this Act may be resold.
4 Section 30. Participation in program not required. Nothing
5in this Act requires that a pharmacy or pharmacist participate
6in the prescription drug repository program.
7 Section 35. Immunity.
8 (a) A manufacturer of a drug or supply acting reasonably
9and in good faith is not subject to criminal or civil liability
10for injury, death, or loss to a person or property for matters
11related to the donation, acceptance, or dispensing of a
12prescription drug or supply manufactured by the manufacturer
13that is donated by any person under this Act.
14 (b) A person acting reasonably and in good faith,
15including a pharmacist or other health professional, is immune
16from civil liability for injury to or the death of the
17individual to whom the prescription drug or supply is
18dispensed and may not be found guilty of unprofessional
19conduct for his or her acts or omissions related to donating,
20accepting, distributing, or dispensing a prescription drug or
21supply under this Act. The immunity granted under this
22subsection does not apply to acts or omissions outside the
23scope of the program.

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1 Section 90. The Pharmacy Practice Act is amended by
2changing Section 4 as follows:
3 (225 ILCS 85/4) (from Ch. 111, par. 4124)
4 (Section scheduled to be repealed on January 1, 2023)
5 Sec. 4. Exemptions. Nothing contained in any Section of
6this Act shall apply to, or in any manner interfere with:
7 (a) the lawful practice of any physician licensed to
8 practice medicine in all of its branches, dentist,
9 podiatric physician, veterinarian, or therapeutically or
10 diagnostically certified optometrist within the limits of
11 his or her license, or prevent him or her from supplying to
12 his or her bona fide patients such drugs, medicines, or
13 poisons as may seem to him appropriate;
14 (b) the sale of compressed gases;
15 (c) the sale of patent or proprietary medicines and
16 household remedies when sold in original and unbroken
17 packages only, if such patent or proprietary medicines and
18 household remedies be properly and adequately labeled as
19 to content and usage and generally considered and accepted
20 as harmless and nonpoisonous when used according to the
21 directions on the label, and also do not contain opium or
22 coca leaves, or any compound, salt or derivative thereof,
23 or any drug which, according to the latest editions of the
24 following authoritative pharmaceutical treatises and
25 standards, namely, The United States

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1 Pharmacopoeia/National Formulary (USP/NF), the United
2 States Dispensatory, and the Accepted Dental Remedies of
3 the Council of Dental Therapeutics of the American Dental
4 Association or any or either of them, in use on the
5 effective date of this Act, or according to the existing
6 provisions of the Federal Food, Drug, and Cosmetic Act and
7 Regulations of the Department of Health and Human
8 Services, Food and Drug Administration, promulgated
9 thereunder now in effect, is designated, described or
10 considered as a narcotic, hypnotic, habit forming,
11 dangerous, or poisonous drug;
12 (d) the sale of poultry and livestock remedies in
13 original and unbroken packages only, labeled for poultry
14 and livestock medication;
15 (e) the sale of poisonous substances or mixture of
16 poisonous substances, in unbroken packages, for
17 nonmedicinal use in the arts or industries or for
18 insecticide purposes; provided, they are properly and
19 adequately labeled as to content and such nonmedicinal
20 usage, in conformity with the provisions of all applicable
21 federal, state and local laws and regulations promulgated
22 thereunder now in effect relating thereto and governing
23 the same, and those which are required under such
24 applicable laws and regulations to be labeled with the
25 word "Poison", are also labeled with the word "Poison"
26 printed thereon in prominent type and the name of a

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1 readily obtainable antidote with directions for its
2 administration;
3 (f) the delegation of limited prescriptive authority
4 by a physician licensed to practice medicine in all its
5 branches to a physician assistant under Section 7.5 of the
6 Physician Assistant Practice Act of 1987. This delegated
7 authority under Section 7.5 of the Physician Assistant
8 Practice Act of 1987 may, but is not required to, include
9 prescription of controlled substances, as defined in
10 Article II of the Illinois Controlled Substances Act, in
11 accordance with a written supervision agreement;
12 (g) the delegation of prescriptive authority by a
13 physician licensed to practice medicine in all its
14 branches or a licensed podiatric physician to an advanced
15 practice registered nurse in accordance with a written
16 collaborative agreement under Sections 65-35 and 65-40 of
17 the Nurse Practice Act; and
18 (g-5) the donation or acceptance, or the packaging,
19 repackaging, or labeling, of prescription drugs to the
20 extent permitted or required under the Prescription Drug
21 Repository Program Act; and
22 (h) the sale or distribution of dialysate or devices
23 necessary to perform home peritoneal renal dialysis for
24 patients with end-stage renal disease, provided that all
25 of the following conditions are met:
26 (1) the dialysate, comprised of dextrose or

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1 icodextrin, or devices are approved or cleared by the
2 federal Food and Drug Administration, as required by
3 federal law;
4 (2) the dialysate or devices are lawfully held by
5 a manufacturer or the manufacturer's agent, which is
6 properly registered with the Board as a manufacturer,
7 third-party logistics provider, or wholesaler;
8 (3) the dialysate or devices are held and
9 delivered to the manufacturer or the manufacturer's
10 agent in the original, sealed packaging from the
11 manufacturing facility;
12 (4) the dialysate or devices are delivered only
13 upon receipt of a physician's prescription by a
14 licensed pharmacy in which the prescription is
15 processed in accordance with provisions set forth in
16 this Act, and the transmittal of an order from the
17 licensed pharmacy to the manufacturer or the
18 manufacturer's agent; and
19 (5) the manufacturer or the manufacturer's agent
20 delivers the dialysate or devices directly to: (i) a
21 patient with end-stage renal disease, or his or her
22 designee, for the patient's self-administration of the
23 dialysis therapy or (ii) a health care provider or
24 institution for administration or delivery of the
25 dialysis therapy to a patient with end-stage renal
26 disease.

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1 This paragraph (h) does not include any other drugs
2 for peritoneal dialysis, except dialysate, as described in
3 item (1) of this paragraph (h). All records of sales and
4 distribution of dialysate to patients made pursuant to
5 this paragraph (h) must be retained in accordance with
6 Section 18 of this Act.
7(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
8100-863, eff. 8-14-18; 101-420, eff. 8-16-19.)
9 Section 95. The Wholesale Drug Distribution Licensing Act
10is amended by changing Section 15 as follows:
11 (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
12 (Section scheduled to be repealed on January 1, 2023)
13 Sec. 15. Definitions. As used in this Act:
14 "Authentication" means the affirmative verification,
15before any wholesale distribution of a prescription drug
16occurs, that each transaction listed on the pedigree has
17occurred.
18 "Authorized distributor of record" means a wholesale
19distributor with whom a manufacturer has established an
20ongoing relationship to distribute the manufacturer's
21prescription drug. An ongoing relationship is deemed to exist
22between a wholesale distributor and a manufacturer when the
23wholesale distributor, including any affiliated group of the
24wholesale distributor, as defined in Section 1504 of the

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1Internal Revenue Code, complies with the following:
2 (1) The wholesale distributor has a written agreement
3 currently in effect with the manufacturer evidencing the
4 ongoing relationship; and
5 (2) The wholesale distributor is listed on the
6 manufacturer's current list of authorized distributors of
7 record, which is updated by the manufacturer on no less
8 than a monthly basis.
9 "Blood" means whole blood collected from a single donor
10and processed either for transfusion or further manufacturing.
11 "Blood component" means that part of blood separated by
12physical or mechanical means.
13 "Board" means the State Board of Pharmacy of the
14Department of Professional Regulation.
15 "Chain pharmacy warehouse" means a physical location for
16prescription drugs that acts as a central warehouse and
17performs intracompany sales or transfers of the drugs to a
18group of chain or mail order pharmacies that have the same
19common ownership and control. Notwithstanding any other
20provision of this Act, a chain pharmacy warehouse shall be
21considered part of the normal distribution channel.
22 "Co-licensed partner or product" means an instance where
23one or more parties have the right to engage in the
24manufacturing or marketing of a prescription drug, consistent
25with the FDA's implementation of the Prescription Drug
26Marketing Act.

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1 "Department" means the Department of Financial and
2Professional Regulation.
3 "Drop shipment" means the sale of a prescription drug to a
4wholesale distributor by the manufacturer of the prescription
5drug or that manufacturer's co-licensed product partner, that
6manufacturer's third party logistics provider, or that
7manufacturer's exclusive distributor or by an authorized
8distributor of record that purchased the product directly from
9the manufacturer or one of these entities whereby the
10wholesale distributor or chain pharmacy warehouse takes title
11but not physical possession of such prescription drug and the
12wholesale distributor invoices the pharmacy, chain pharmacy
13warehouse, or other person authorized by law to dispense or
14administer such drug to a patient and the pharmacy, chain
15pharmacy warehouse, or other authorized person receives
16delivery of the prescription drug directly from the
17manufacturer, that manufacturer's third party logistics
18provider, or that manufacturer's exclusive distributor or from
19an authorized distributor of record that purchased the product
20directly from the manufacturer or one of these entities.
21 "Drug sample" means a unit of a prescription drug that is
22not intended to be sold and is intended to promote the sale of
23the drug.
24 "Facility" means a facility of a wholesale distributor
25where prescription drugs are stored, handled, repackaged, or
26offered for sale, or a facility of a third-party logistics

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1provider where prescription drugs are stored or handled.
2 "FDA" means the United States Food and Drug
3Administration.
4 "Manufacturer" means a person licensed or approved by the
5FDA to engage in the manufacture of drugs or devices,
6consistent with the definition of "manufacturer" set forth in
7the FDA's regulations and guidances implementing the
8Prescription Drug Marketing Act. "Manufacturer" does not
9include anyone who is engaged in the packaging, repackaging,
10or labeling of prescription drugs only to the extent required
11under the Prescription Drug Repository Program Act.
12 "Manufacturer's exclusive distributor" means anyone who
13contracts with a manufacturer to provide or coordinate
14warehousing, distribution, or other services on behalf of a
15manufacturer and who takes title to that manufacturer's
16prescription drug, but who does not have general
17responsibility to direct the sale or disposition of the
18manufacturer's prescription drug. A manufacturer's exclusive
19distributor must be licensed as a wholesale distributor under
20this Act and, in order to be considered part of the normal
21distribution channel, must also be an authorized distributor
22of record.
23 "Normal distribution channel" means a chain of custody for
24a prescription drug that goes, directly or by drop shipment,
25from (i) a manufacturer of the prescription drug, (ii) that
26manufacturer to that manufacturer's co-licensed partner, (iii)

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1that manufacturer to that manufacturer's third party logistics
2provider, or (iv) that manufacturer to that manufacturer's
3exclusive distributor to:
4 (1) a pharmacy or to other designated persons
5 authorized by law to dispense or administer the drug to a
6 patient;
7 (2) a wholesale distributor to a pharmacy or other
8 designated persons authorized by law to dispense or
9 administer the drug to a patient;
10 (3) a wholesale distributor to a chain pharmacy
11 warehouse to that chain pharmacy warehouse's intracompany
12 pharmacy to a patient or other designated persons
13 authorized by law to dispense or administer the drug to a
14 patient;
15 (4) a chain pharmacy warehouse to the chain pharmacy
16 warehouse's intracompany pharmacy or other designated
17 persons authorized by law to dispense or administer the
18 drug to the patient;
19 (5) an authorized distributor of record to one other
20 authorized distributor of record to an office-based health
21 care practitioner authorized by law to dispense or
22 administer the drug to the patient; or
23 (6) an authorized distributor to a pharmacy or other
24 persons licensed to dispense or administer the drug.
25 "Pedigree" means a document or electronic file containing
26information that records each wholesale distribution of any

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

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1 "Secretary" means the Secretary of Financial and
2Professional Regulation.
3 "Third-party logistics provider" means anyone who
4contracts with a prescription drug manufacturer to provide or
5coordinate warehousing, distribution, or other services on
6behalf of a manufacturer, but does not take title to the
7prescription drug or have general responsibility to direct the
8prescription drug's sale or disposition.
9 "Wholesale distribution" means the distribution of
10prescription drugs to persons other than a consumer or
11patient, but does not include any of the following:
12 (1) Intracompany sales of prescription drugs, meaning
13 (i) any transaction or transfer between any division,
14 subsidiary, parent, or affiliated or related company under
15 the common ownership and control of a corporate entity or
16 (ii) any transaction or transfer between co-licensees of a
17 co-licensed product.
18 (2) The sale, purchase, distribution, trade, or
19 transfer of a prescription drug or offer to sell,
20 purchase, distribute, trade, or transfer a prescription
21 drug for emergency medical reasons.
22 (3) The distribution of prescription drug samples by
23 manufacturers' representatives.
24 (4) Drug returns, when conducted by a hospital, health
25 care entity, or charitable institution in accordance with
26 federal regulation.

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1 (5) The sale of minimal quantities of prescription
2 drugs by licensed pharmacies to licensed practitioners for
3 office use or other licensed pharmacies.
4 (6) The sale, purchase, or trade of a drug, an offer to
5 sell, purchase, or trade a drug, or the dispensing of a
6 drug pursuant to a prescription.
7 (7) The sale, transfer, merger, or consolidation of
8 all or part of the business of a pharmacy or pharmacies
9 from or with another pharmacy or pharmacies, whether
10 accomplished as a purchase and sale of stock or business
11 assets.
12 (8) The sale, purchase, distribution, trade, or
13 transfer of a prescription drug from one authorized
14 distributor of record to one additional authorized
15 distributor of record when the manufacturer has stated in
16 writing to the receiving authorized distributor of record
17 that the manufacturer is unable to supply the prescription
18 drug and the supplying authorized distributor of record
19 states in writing that the prescription drug being
20 supplied had until that time been exclusively in the
21 normal distribution channel.
22 (9) The delivery of or the offer to deliver a
23 prescription drug by a common carrier solely in the common
24 carrier's usual course of business of transporting
25 prescription drugs when the common carrier does not store,
26 warehouse, or take legal ownership of the prescription

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1 drug.
2 (10) The sale or transfer from a retail pharmacy, mail
3 order pharmacy, or chain pharmacy warehouse of expired,
4 damaged, returned, or recalled prescription drugs to the
5 original manufacturer, the originating wholesale
6 distributor, or a third party returns processor.
7 (11) The donation of prescription drugs to the extent
8 permitted under the Prescription Drug Repository Program
9 Act.
10 "Wholesale drug distributor" means anyone engaged in the
11wholesale distribution of prescription drugs into, out of, or
12within the State, including without limitation manufacturers;
13repackers; own label distributors; jobbers; private label
14distributors; brokers; warehouses, including manufacturers'
15and distributors' warehouses; manufacturer's exclusive
16distributors; and authorized distributors of record; drug
17wholesalers or distributors; independent wholesale drug
18traders; specialty wholesale distributors; and retail
19pharmacies that conduct wholesale distribution; and chain
20pharmacy warehouses that conduct wholesale distribution. In
21order to be considered part of the normal distribution
22channel, a wholesale distributor must also be an authorized
23distributor of record.
24(Source: P.A. 101-420, eff. 8-16-19.)
25 Section 100. The Senior Pharmaceutical Assistance Act is

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1amended by changing Section 10 as follows:
2 (320 ILCS 50/10)
3 Sec. 10. Definitions. In this Act:
4 "Manufacturer" includes:
5 (1) An entity that is engaged in (a) the production,
6 preparation, propagation, compounding, conversion, or
7 processing of prescription drug products (i) directly or
8 indirectly by extraction from substances of natural
9 origin, (ii) independently by means of chemical synthesis,
10 or (iii) by combination of extraction and chemical
11 synthesis; or (b) the packaging, repackaging, labeling or
12 re-labeling, or distribution of prescription drug
13 products.
14 (2) The entity holding legal title to or possession of
15 the national drug code number for the covered prescription
16 drug.
17 The term does not include a wholesale distributor of
18drugs, drugstore chain organization, or retail pharmacy
19licensed by the State. The term also does not include anyone
20who is engaged in the packaging, repackaging, or labeling of
21prescription drugs only to the extent required under the
22Prescription Drug Repository Program Act.
23 "Prescription drug" means a drug that may be dispensed
24only upon prescription by an authorized prescriber and that is
25approved for safety and effectiveness as a prescription drug

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1under Section 505 or 507 of the Federal Food, Drug and Cosmetic
2Act.
3 "Senior citizen" or "senior" means a person 65 years of
4age or older.
5(Source: P.A. 92-594, eff. 6-27-02.)
6 Section 105. The Illinois Food, Drug and Cosmetic Act is
7amended by changing Section 16 as follows:
8 (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
9 Sec. 16. (a) The Director is hereby authorized to
10promulgate regulations exempting from any labeling or
11packaging requirement of this Act drugs and devices which are
12(i) , in accordance with the practice of the trade, to be
13processed, labeled or repacked in substantial quantities at
14establishments other than those where originally processed or
15packaged on condition that such drugs and devices are not
16adulterated or misbranded under the provisions of this Act
17upon removal from such processing, labeling or repacking
18establishment or (ii) packaged, repackaged, or labeled to the
19extent required under the Prescription Drug Repository Program
20Act.
21 (b) Drugs and device labeling or packaging exemptions
22adopted under the Federal Act and supplements thereto or
23revisions thereof shall apply to drugs and devices in Illinois
24except insofar as modified or rejected by regulations

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1promulgated by the Director.
2 (c) A drug intended for use by man which (A) is a
3habit-forming drug to which Section 15 (d) applies; or (B)
4because of its toxicity or other potentiality for harmful
5effect or the method of its use or the collateral measures
6necessary to its use is not safe for use except under the
7supervision of a practitioner licensed by law to administer
8such drug; or (C) is limited by an approved application under
9Section 505 of the Federal Act or Section 17 of this Act to use
10under the professional supervision of a practitioner licensed
11by law to administer such drug, shall be dispensed only in
12accordance with the provisions of the "Illinois Controlled
13Substances Act". The act of dispensing a drug contrary to the
14provisions of this paragraph shall be deemed to be an act which
15results in a drug being misbranded while held for sale.
16 (d) Any drug dispensed by filling or refilling a written
17or oral prescription of a practitioner licensed by law to
18administer such drug shall be exempt from the requirements of
19Section 15, except subsections (a), (k) and (l) and clauses
20(2) and (3) of subsection (i), and the packaging requirements
21of subsections (g), (h) and (q), if the drug bears a label
22containing the proprietary name or names, or if there is none,
23the established name or names of the drugs, the dosage and
24quantity, unless the prescribing practitioner, in the interest
25of the health of the patient, directs otherwise in writing,
26the name and address of the dispenser, the serial number and

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1date of the prescription or of its filling, the name of the
2prescriber and, if stated in the prescription, the name of the
3patient, and the directions for use and the cautionary
4statements, if any, contained in such prescription. This
5exemption shall not apply to any drug dispensed in the course
6of the conduct of business of dispensing drugs pursuant to
7diagnosis by mail, or to a drug dispensed in violation of
8subsection (a) of this Section.
9 (e) The Director may by regulation remove drugs subject to
10Section 15 (d) and Section 17 from the requirements of
11subsection (c) of this Section when such requirements are not
12necessary for the protection of the public health.
13 (f) A drug which is subject to subsection (c) of this
14Section shall be deemed to be misbranded if at any time before
15dispensing its label fails to bear the statement "Caution:
16Federal Law Prohibits Dispensing Without Prescription" or
17"Caution: State Law Prohibits Dispensing Without
18Prescription". A drug to which subsection (c) of this Section
19does not apply shall be deemed to be misbranded if at any time
20prior to dispensing its label bears the caution statement
21quoted in the preceding sentence.
22 (g) Nothing in this Section shall be construed to relieve
23any person from any requirement prescribed by or under
24authority of law with respect to controlled substances now
25included or which may hereafter be included within the
26classifications of controlled substances cannabis as defined

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1in applicable Federal laws relating to controlled substances
2or cannabis or the Cannabis Control Act.
3(Source: P.A. 84-1308.)
4 Section 110. The Cannabis and Controlled Substances Tort
5Claims Act is amended by changing Section 3 as follows:
6 (740 ILCS 20/3) (from Ch. 70, par. 903)
7 Sec. 3. Definitions. As used in this Act, unless the
8context otherwise requires:
9 "Cannabis" includes marihuana, hashish, and other
10substances that are identified as including any parts of the
11plant Cannabis Sativa, whether growing or not, the seeds of
12that plant, the resin extracted from any part of that plant,
13and any compound, manufacture, salt, derivative, mixture, or
14preparation of that plant, its seeds, or resin, including
15tetrahydrocannabinol (THC) and all other cannabinol
16derivatives, including its naturally occurring or
17synthetically produced ingredients, whether produced directly
18or indirectly by extraction, independently by means of
19chemical synthesis, or by a combination of extraction and
20chemical synthesis. "Cannabis" does not include the mature
21stalks of that plant, fiber produced from those stalks, oil or
22cake made from the seeds of that plant, any other compound,
23manufacture, salt, derivative, mixture, or preparation of
24mature stalks (except the extracted resin), fiber, oil or

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

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

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1personal property, including rights, services, privileges,
2interests, claims, and securities.
3(Source: P.A. 96-328, eff. 8-11-09.)

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1 INDEX
2 Statutes amended in order of appearance