102ND GENERAL ASSEMBLY
State of Illinois
2021 and 2022
HB0099

 

Introduced 1/14/2021, by Rep. Jonathan Carroll

 

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, 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.


LRB102 04080 CPF 14096 b

FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB0099LRB102 04080 CPF 14096 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

 

 

HB0099- 21 -LRB102 04080 CPF 14096 b

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 Illinois Controlled Substances Act is
5amended by changing Section 102 as follows:
 
6    (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
7    Sec. 102. Definitions. As used in this Act, unless the
8context otherwise requires:
9    (a) "Addict" means any person who habitually uses any
10drug, chemical, substance or dangerous drug other than alcohol
11so as to endanger the public morals, health, safety or welfare
12or who is so far addicted to the use of a dangerous drug or
13controlled substance other than alcohol as to have lost the
14power of self control with reference to his or her addiction.
15    (b) "Administer" means the direct application of a
16controlled substance, whether by injection, inhalation,
17ingestion, or any other means, to the body of a patient,
18research subject, or animal (as defined by the Humane
19Euthanasia in Animal Shelters Act) by:
20        (1) a practitioner (or, in his or her presence, by his
21    or her authorized agent),
22        (2) the patient or research subject pursuant to an
23    order, or
24        (3) a euthanasia technician as defined by the Humane

 

 

HB0099- 24 -LRB102 04080 CPF 14096 b

1    Euthanasia in Animal Shelters Act.
2    (c) "Agent" means an authorized person who acts on behalf
3of or at the direction of a manufacturer, distributor,
4dispenser, prescriber, or practitioner. It does not include a
5common or contract carrier, public warehouseman or employee of
6the carrier or warehouseman.
7    (c-1) "Anabolic Steroids" means any drug or hormonal
8substance, chemically and pharmacologically related to
9testosterone (other than estrogens, progestins,
10corticosteroids, and dehydroepiandrosterone), and includes:
11    (i) 3[beta],17-dihydroxy-5a-androstane, 
12    (ii) 3[alpha],17[beta]-dihydroxy-5a-androstane, 
13    (iii) 5[alpha]-androstan-3,17-dione, 
14    (iv) 1-androstenediol (3[beta], 
15        17[beta]-dihydroxy-5[alpha]-androst-1-ene), 
16    (v) 1-androstenediol (3[alpha], 
17        17[beta]-dihydroxy-5[alpha]-androst-1-ene), 
18    (vi) 4-androstenediol  
19        (3[beta],17[beta]-dihydroxy-androst-4-ene), 
20    (vii) 5-androstenediol  
21        (3[beta],17[beta]-dihydroxy-androst-5-ene), 
22    (viii) 1-androstenedione  
23        ([5alpha]-androst-1-en-3,17-dione), 
24    (ix) 4-androstenedione  
25        (androst-4-en-3,17-dione), 
26    (x) 5-androstenedione  

 

 

HB0099- 25 -LRB102 04080 CPF 14096 b

1        (androst-5-en-3,17-dione), 
2    (xi) bolasterone (7[alpha],17a-dimethyl-17[beta]- 
3        hydroxyandrost-4-en-3-one), 
4    (xii) boldenone (17[beta]-hydroxyandrost- 
5        1,4,-diene-3-one), 
6    (xiii) boldione (androsta-1,4- 
7        diene-3,17-dione), 
8    (xiv) calusterone (7[beta],17[alpha]-dimethyl-17 
9        [beta]-hydroxyandrost-4-en-3-one), 
10    (xv) clostebol (4-chloro-17[beta]- 
11        hydroxyandrost-4-en-3-one), 
12    (xvi) dehydrochloromethyltestosterone (4-chloro- 
13        17[beta]-hydroxy-17[alpha]-methyl- 
14        androst-1,4-dien-3-one), 
15    (xvii) desoxymethyltestosterone 
16    (17[alpha]-methyl-5[alpha] 
17        -androst-2-en-17[beta]-ol)(a.k.a., madol), 
18    (xviii) [delta]1-dihydrotestosterone (a.k.a.  
19        '1-testosterone') (17[beta]-hydroxy- 
20        5[alpha]-androst-1-en-3-one), 
21    (xix) 4-dihydrotestosterone (17[beta]-hydroxy- 
22        androstan-3-one), 
23    (xx) drostanolone (17[beta]-hydroxy-2[alpha]-methyl- 
24        5[alpha]-androstan-3-one), 
25    (xxi) ethylestrenol (17[alpha]-ethyl-17[beta]- 
26        hydroxyestr-4-ene), 

 

 

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1    (xxii) fluoxymesterone (9-fluoro-17[alpha]-methyl- 
2        1[beta],17[beta]-dihydroxyandrost-4-en-3-one), 
3    (xxiii) formebolone (2-formyl-17[alpha]-methyl-11[alpha], 
4        17[beta]-dihydroxyandrost-1,4-dien-3-one), 
5    (xxiv) furazabol (17[alpha]-methyl-17[beta]- 
6        hydroxyandrostano[2,3-c]-furazan), 
7    (xxv) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one, 
8    (xxvi) 4-hydroxytestosterone (4,17[beta]-dihydroxy- 
9        androst-4-en-3-one), 
10    (xxvii) 4-hydroxy-19-nortestosterone (4,17[beta]- 
11        dihydroxy-estr-4-en-3-one), 
12    (xxviii) mestanolone (17[alpha]-methyl-17[beta]- 
13        hydroxy-5-androstan-3-one), 
14    (xxix) mesterolone (1amethyl-17[beta]-hydroxy- 
15        [5a]-androstan-3-one), 
16    (xxx) methandienone (17[alpha]-methyl-17[beta]- 
17        hydroxyandrost-1,4-dien-3-one), 
18    (xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]- 
19        dihydroxyandrost-5-ene), 
20    (xxxii) methenolone (1-methyl-17[beta]-hydroxy- 
21        5[alpha]-androst-1-en-3-one), 
22    (xxxiii) 17[alpha]-methyl-3[beta], 17[beta]- 
23        dihydroxy-5a-androstane, 
24    (xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy 
25        -5a-androstane, 
26    (xxxv) 17[alpha]-methyl-3[beta],17[beta]- 

 

 

HB0099- 27 -LRB102 04080 CPF 14096 b

1        dihydroxyandrost-4-ene), 
2    (xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]- 
3        methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one), 
4    (xxxvii) methyldienolone (17[alpha]-methyl-17[beta]- 
5        hydroxyestra-4,9(10)-dien-3-one), 
6    (xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]- 
7        hydroxyestra-4,9-11-trien-3-one), 
8    (xxxix) methyltestosterone (17[alpha]-methyl-17[beta]- 
9        hydroxyandrost-4-en-3-one), 
10    (xl) mibolerone (7[alpha],17a-dimethyl-17[beta]- 
11        hydroxyestr-4-en-3-one), 
12    (xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone  
13        (17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]- 
14        androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl- 
15        1-testosterone'), 
16    (xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one), 
17    (xliii) 19-nor-4-androstenediol (3[beta], 17[beta]- 
18        dihydroxyestr-4-ene), 
19    (xliv) 19-nor-4-androstenediol (3[alpha], 17[beta]- 
20        dihydroxyestr-4-ene), 
21    (xlv) 19-nor-5-androstenediol (3[beta], 17[beta]- 
22        dihydroxyestr-5-ene), 
23    (xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]- 
24        dihydroxyestr-5-ene), 
25    (xlvii) 19-nor-4,9(10)-androstadienedione  
26        (estra-4,9(10)-diene-3,17-dione), 

 

 

HB0099- 28 -LRB102 04080 CPF 14096 b

1    (xlviii) 19-nor-4-androstenedione (estr-4- 
2        en-3,17-dione), 
3    (xlix) 19-nor-5-androstenedione (estr-5- 
4        en-3,17-dione), 
5    (l) norbolethone (13[beta], 17a-diethyl-17[beta]- 
6        hydroxygon-4-en-3-one), 
7    (li) norclostebol (4-chloro-17[beta]- 
8        hydroxyestr-4-en-3-one), 
9    (lii) norethandrolone (17[alpha]-ethyl-17[beta]- 
10        hydroxyestr-4-en-3-one), 
11    (liii) normethandrolone (17[alpha]-methyl-17[beta]- 
12        hydroxyestr-4-en-3-one), 
13    (liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy- 
14        2-oxa-5[alpha]-androstan-3-one), 
15    (lv) oxymesterone (17[alpha]-methyl-4,17[beta]- 
16        dihydroxyandrost-4-en-3-one), 
17    (lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene- 
18        17[beta]-hydroxy-(5[alpha]-androstan-3-one), 
19    (lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy- 
20        (5[alpha]-androst-2-eno[3,2-c]-pyrazole), 
21    (lviii) stenbolone (17[beta]-hydroxy-2-methyl- 
22        (5[alpha]-androst-1-en-3-one), 
23    (lix) testolactone (13-hydroxy-3-oxo-13,17- 
24        secoandrosta-1,4-dien-17-oic 
25        acid lactone), 
26    (lx) testosterone (17[beta]-hydroxyandrost- 

 

 

HB0099- 29 -LRB102 04080 CPF 14096 b

1        4-en-3-one), 
2    (lxi) tetrahydrogestrinone (13[beta], 17[alpha]- 
3        diethyl-17[beta]-hydroxygon- 
4        4,9,11-trien-3-one), 
5    (lxii) trenbolone (17[beta]-hydroxyestr-4,9, 
6        11-trien-3-one). 
7    Any person who is otherwise lawfully in possession of an
8anabolic steroid, or who otherwise lawfully manufactures,
9distributes, dispenses, delivers, or possesses with intent to
10deliver an anabolic steroid, which anabolic steroid is
11expressly intended for and lawfully allowed to be administered
12through implants to livestock or other nonhuman species, and
13which is approved by the Secretary of Health and Human
14Services for such administration, and which the person intends
15to administer or have administered through such implants,
16shall not be considered to be in unauthorized possession or to
17unlawfully manufacture, distribute, dispense, deliver, or
18possess with intent to deliver such anabolic steroid for
19purposes of this Act.
20    (d) "Administration" means the Drug Enforcement
21Administration, United States Department of Justice, or its
22successor agency.
23    (d-5) "Clinical Director, Prescription Monitoring Program"
24means a Department of Human Services administrative employee
25licensed to either prescribe or dispense controlled substances
26who shall run the clinical aspects of the Department of Human

 

 

HB0099- 30 -LRB102 04080 CPF 14096 b

1Services Prescription Monitoring Program and its Prescription
2Information Library.
3    (d-10) "Compounding" means the preparation and mixing of
4components, excluding flavorings, (1) as the result of a
5prescriber's prescription drug order or initiative based on
6the prescriber-patient-pharmacist relationship in the course
7of professional practice or (2) for the purpose of, or
8incident to, research, teaching, or chemical analysis and not
9for sale or dispensing. "Compounding" includes the preparation
10of drugs or devices in anticipation of receiving prescription
11drug orders based on routine, regularly observed dispensing
12patterns. Commercially available products may be compounded
13for dispensing to individual patients only if both of the
14following conditions are met: (i) the commercial product is
15not reasonably available from normal distribution channels in
16a timely manner to meet the patient's needs and (ii) the
17prescribing practitioner has requested that the drug be
18compounded.
19    (e) "Control" means to add a drug or other substance, or
20immediate precursor, to a Schedule whether by transfer from
21another Schedule or otherwise.
22    (f) "Controlled Substance" means (i) a drug, substance,
23immediate precursor, or synthetic drug in the Schedules of
24Article II of this Act or (ii) a drug or other substance, or
25immediate precursor, designated as a controlled substance by
26the Department through administrative rule. The term does not

 

 

HB0099- 31 -LRB102 04080 CPF 14096 b

1include distilled spirits, wine, malt beverages, or tobacco,
2as those terms are defined or used in the Liquor Control Act of
31934 and the Tobacco Products Tax Act of 1995.
4    (f-5) "Controlled substance analog" means a substance:
5        (1) the chemical structure of which is substantially
6    similar to the chemical structure of a controlled
7    substance in Schedule I or II;
8        (2) which has a stimulant, depressant, or
9    hallucinogenic effect on the central nervous system that
10    is substantially similar to or greater than the stimulant,
11    depressant, or hallucinogenic effect on the central
12    nervous system of a controlled substance in Schedule I or
13    II; or
14        (3) with respect to a particular person, which such
15    person represents or intends to have a stimulant,
16    depressant, or hallucinogenic effect on the central
17    nervous system that is substantially similar to or greater
18    than the stimulant, depressant, or hallucinogenic effect
19    on the central nervous system of a controlled substance in
20    Schedule I or II.
21    (g) "Counterfeit substance" means a controlled substance,
22which, or the container or labeling of which, without
23authorization bears the trademark, trade name, or other
24identifying mark, imprint, number or device, or any likeness
25thereof, of a manufacturer, distributor, or dispenser other
26than the person who in fact manufactured, distributed, or

 

 

HB0099- 32 -LRB102 04080 CPF 14096 b

1dispensed the substance.
2    (h) "Deliver" or "delivery" means the actual, constructive
3or attempted transfer of possession of a controlled substance,
4with or without consideration, whether or not there is an
5agency relationship. "Deliver" or "delivery" does not include
6the donation of prescription drugs to the extent permitted
7under the Prescription Drug Repository Program Act.
8    (i) "Department" means the Illinois Department of Human
9Services (as successor to the Department of Alcoholism and
10Substance Abuse) or its successor agency.
11    (j) (Blank).
12    (k) "Department of Corrections" means the Department of
13Corrections of the State of Illinois or its successor agency.
14    (l) "Department of Financial and Professional Regulation"
15means the Department of Financial and Professional Regulation
16of the State of Illinois or its successor agency.
17    (m) "Depressant" means any drug that (i) causes an overall
18depression of central nervous system functions, (ii) causes
19impaired consciousness and awareness, and (iii) can be
20habit-forming or lead to a substance abuse problem, including
21but not limited to alcohol, cannabis and its active principles
22and their analogs, benzodiazepines and their analogs,
23barbiturates and their analogs, opioids (natural and
24synthetic) and their analogs, and chloral hydrate and similar
25sedative hypnotics.
26    (n) (Blank).

 

 

HB0099- 33 -LRB102 04080 CPF 14096 b

1    (o) "Director" means the Director of the Illinois State
2Police or his or her designated agents.
3    (p) "Dispense" means to deliver a controlled substance to
4an ultimate user or research subject by or pursuant to the
5lawful order of a prescriber, including the prescribing,
6administering, packaging, labeling, or compounding necessary
7to prepare the substance for that delivery.
8    (q) "Dispenser" means a practitioner who dispenses.
9    (r) "Distribute" means to deliver, other than by
10administering or dispensing, a controlled substance.
11    (s) "Distributor" means a person who distributes.
12    (t) "Drug" means (1) substances recognized as drugs in the
13official United States Pharmacopoeia, Official Homeopathic
14Pharmacopoeia of the United States, or official National
15Formulary, or any supplement to any of them; (2) substances
16intended for use in diagnosis, cure, mitigation, treatment, or
17prevention of disease in man or animals; (3) substances (other
18than food) intended to affect the structure of any function of
19the body of man or animals and (4) substances intended for use
20as a component of any article specified in clause (1), (2), or
21(3) of this subsection. It does not include devices or their
22components, parts, or accessories.
23    (t-3) "Electronic health record" or "EHR" means an
24electronic record of health-related information on an
25individual that is created, gathered, managed, and consulted
26by authorized health care clinicians and staff.

 

 

HB0099- 34 -LRB102 04080 CPF 14096 b

1    (t-4) "Emergency medical services personnel" has the
2meaning ascribed to it in the Emergency Medical Services (EMS)
3Systems Act.
4    (t-5) "Euthanasia agency" means an entity certified by the
5Department of Financial and Professional Regulation for the
6purpose of animal euthanasia that holds an animal control
7facility license or animal shelter license under the Animal
8Welfare Act. A euthanasia agency is authorized to purchase,
9store, possess, and utilize Schedule II nonnarcotic and
10Schedule III nonnarcotic drugs for the sole purpose of animal
11euthanasia.
12    (t-10) "Euthanasia drugs" means Schedule II or Schedule
13III substances (nonnarcotic controlled substances) that are
14used by a euthanasia agency for the purpose of animal
15euthanasia.
16    (u) "Good faith" means the prescribing or dispensing of a
17controlled substance by a practitioner in the regular course
18of professional treatment to or for any person who is under his
19or her treatment for a pathology or condition other than that
20individual's physical or psychological dependence upon or
21addiction to a controlled substance, except as provided
22herein: and application of the term to a pharmacist shall mean
23the dispensing of a controlled substance pursuant to the
24prescriber's order which in the professional judgment of the
25pharmacist is lawful. The pharmacist shall be guided by
26accepted professional standards including, but not limited to

 

 

HB0099- 35 -LRB102 04080 CPF 14096 b

1the following, in making the judgment:
2        (1) lack of consistency of prescriber-patient
3    relationship,
4        (2) frequency of prescriptions for same drug by one
5    prescriber for large numbers of patients,
6        (3) quantities beyond those normally prescribed,
7        (4) unusual dosages (recognizing that there may be
8    clinical circumstances where more or less than the usual
9    dose may be used legitimately),
10        (5) unusual geographic distances between patient,
11    pharmacist and prescriber,
12        (6) consistent prescribing of habit-forming drugs.
13    (u-0.5) "Hallucinogen" means a drug that causes markedly
14altered sensory perception leading to hallucinations of any
15type.
16    (u-1) "Home infusion services" means services provided by
17a pharmacy in compounding solutions for direct administration
18to a patient in a private residence, long-term care facility,
19or hospice setting by means of parenteral, intravenous,
20intramuscular, subcutaneous, or intraspinal infusion.
21    (u-5) "Illinois State Police" means the State Police of
22the State of Illinois, or its successor agency.
23    (v) "Immediate precursor" means a substance:
24        (1) which the Department has found to be and by rule
25    designated as being a principal compound used, or produced
26    primarily for use, in the manufacture of a controlled

 

 

HB0099- 36 -LRB102 04080 CPF 14096 b

1    substance;
2        (2) which is an immediate chemical intermediary used
3    or likely to be used in the manufacture of such controlled
4    substance; and
5        (3) the control of which is necessary to prevent,
6    curtail or limit the manufacture of such controlled
7    substance.
8    (w) "Instructional activities" means the acts of teaching,
9educating or instructing by practitioners using controlled
10substances within educational facilities approved by the State
11Board of Education or its successor agency.
12    (x) "Local authorities" means a duly organized State,
13County or Municipal peace unit or police force.
14    (y) "Look-alike substance" means a substance, other than a
15controlled substance which (1) by overall dosage unit
16appearance, including shape, color, size, markings or lack
17thereof, taste, consistency, or any other identifying physical
18characteristic of the substance, would lead a reasonable
19person to believe that the substance is a controlled
20substance, or (2) is expressly or impliedly represented to be
21a controlled substance or is distributed under circumstances
22which would lead a reasonable person to believe that the
23substance is a controlled substance. For the purpose of
24determining whether the representations made or the
25circumstances of the distribution would lead a reasonable
26person to believe the substance to be a controlled substance

 

 

HB0099- 37 -LRB102 04080 CPF 14096 b

1under this clause (2) of subsection (y), the court or other
2authority may consider the following factors in addition to
3any other factor that may be relevant:
4        (a) statements made by the owner or person in control
5    of the substance concerning its nature, use or effect;
6        (b) statements made to the buyer or recipient that the
7    substance may be resold for profit;
8        (c) whether the substance is packaged in a manner
9    normally used for the illegal distribution of controlled
10    substances;
11        (d) whether the distribution or attempted distribution
12    included an exchange of or demand for money or other
13    property as consideration, and whether the amount of the
14    consideration was substantially greater than the
15    reasonable retail market value of the substance.
16    Clause (1) of this subsection (y) shall not apply to a
17noncontrolled substance in its finished dosage form that was
18initially introduced into commerce prior to the initial
19introduction into commerce of a controlled substance in its
20finished dosage form which it may substantially resemble.
21    Nothing in this subsection (y) prohibits the dispensing or
22distributing of noncontrolled substances by persons authorized
23to dispense and distribute controlled substances under this
24Act, provided that such action would be deemed to be carried
25out in good faith under subsection (u) if the substances
26involved were controlled substances.

 

 

HB0099- 38 -LRB102 04080 CPF 14096 b

1    Nothing in this subsection (y) or in this Act prohibits
2the manufacture, preparation, propagation, compounding,
3processing, packaging, advertising or distribution of a drug
4or drugs by any person registered pursuant to Section 510 of
5the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
6    (y-1) "Mail-order pharmacy" means a pharmacy that is
7located in a state of the United States that delivers,
8dispenses or distributes, through the United States Postal
9Service or other common carrier, to Illinois residents, any
10substance which requires a prescription.
11    (z) "Manufacture" means the production, preparation,
12propagation, compounding, conversion or processing of a
13controlled substance other than methamphetamine, either
14directly or indirectly, by extraction from substances of
15natural origin, or independently by means of chemical
16synthesis, or by a combination of extraction and chemical
17synthesis, and includes any packaging or repackaging of the
18substance or labeling of its container, except that this term
19does not include:
20        (1) by an ultimate user, the preparation or
21    compounding of a controlled substance for his or her own
22    use; or
23        (2) by a practitioner, or his or her authorized agent
24    under his or her supervision, the preparation,
25    compounding, packaging, or labeling of a controlled
26    substance:

 

 

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1            (a) as an incident to his or her administering or
2        dispensing of a controlled substance in the course of
3        his or her professional practice; or
4            (b) as an incident to lawful research, teaching or
5        chemical analysis and not for sale; or .
6        (3) the packaging, repackaging, or labeling of
7    prescription drugs only to the extent required under the
8    Prescription Drug Repository Program Act.
9    (z-1) (Blank).
10    (z-5) "Medication shopping" means the conduct prohibited
11under subsection (a) of Section 314.5 of this Act.
12    (z-10) "Mid-level practitioner" means (i) a physician
13assistant who has been delegated authority to prescribe
14through a written delegation of authority by a physician
15licensed to practice medicine in all of its branches, in
16accordance with Section 7.5 of the Physician Assistant
17Practice Act of 1987, (ii) an advanced practice registered
18nurse who has been delegated authority to prescribe through a
19written delegation of authority by a physician licensed to
20practice medicine in all of its branches or by a podiatric
21physician, in accordance with Section 65-40 of the Nurse
22Practice Act, (iii) an advanced practice registered nurse
23certified as a nurse practitioner, nurse midwife, or clinical
24nurse specialist who has been granted authority to prescribe
25by a hospital affiliate in accordance with Section 65-45 of
26the Nurse Practice Act, (iv) an animal euthanasia agency, or

 

 

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1(v) a prescribing psychologist.
2    (aa) "Narcotic drug" means any of the following, whether
3produced directly or indirectly by extraction from substances
4of vegetable origin, or independently by means of chemical
5synthesis, or by a combination of extraction and chemical
6synthesis:
7        (1) opium, opiates, derivatives of opium and opiates,
8    including their isomers, esters, ethers, salts, and salts
9    of isomers, esters, and ethers, whenever the existence of
10    such isomers, esters, ethers, and salts is possible within
11    the specific chemical designation; however the term
12    "narcotic drug" does not include the isoquinoline
13    alkaloids of opium;
14        (2) (blank);
15        (3) opium poppy and poppy straw;
16        (4) coca leaves, except coca leaves and extracts of
17    coca leaves from which substantially all of the cocaine
18    and ecgonine, and their isomers, derivatives and salts,
19    have been removed;
20        (5) cocaine, its salts, optical and geometric isomers,
21    and salts of isomers;
22        (6) ecgonine, its derivatives, their salts, isomers,
23    and salts of isomers;
24        (7) any compound, mixture, or preparation which
25    contains any quantity of any of the substances referred to
26    in subparagraphs (1) through (6).

 

 

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1    (bb) "Nurse" means a registered nurse licensed under the
2Nurse Practice Act.
3    (cc) (Blank).
4    (dd) "Opiate" means any substance having an addiction
5forming or addiction sustaining liability similar to morphine
6or being capable of conversion into a drug having addiction
7forming or addiction sustaining liability.
8    (ee) "Opium poppy" means the plant of the species Papaver
9somniferum L., except its seeds.
10    (ee-5) "Oral dosage" means a tablet, capsule, elixir, or
11solution or other liquid form of medication intended for
12administration by mouth, but the term does not include a form
13of medication intended for buccal, sublingual, or transmucosal
14administration.
15    (ff) "Parole and Pardon Board" means the Parole and Pardon
16Board of the State of Illinois or its successor agency.
17    (gg) "Person" means any individual, corporation,
18mail-order pharmacy, government or governmental subdivision or
19agency, business trust, estate, trust, partnership or
20association, or any other entity.
21    (hh) "Pharmacist" means any person who holds a license or
22certificate of registration as a registered pharmacist, a
23local registered pharmacist or a registered assistant
24pharmacist under the Pharmacy Practice Act.
25    (ii) "Pharmacy" means any store, ship or other place in
26which pharmacy is authorized to be practiced under the

 

 

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1Pharmacy Practice Act.
2    (ii-5) "Pharmacy shopping" means the conduct prohibited
3under subsection (b) of Section 314.5 of this Act.
4    (ii-10) "Physician" (except when the context otherwise
5requires) means a person licensed to practice medicine in all
6of its branches.
7    (jj) "Poppy straw" means all parts, except the seeds, of
8the opium poppy, after mowing.
9    (kk) "Practitioner" means a physician licensed to practice
10medicine in all its branches, dentist, optometrist, podiatric
11physician, veterinarian, scientific investigator, pharmacist,
12physician assistant, advanced practice registered nurse,
13licensed practical nurse, registered nurse, emergency medical
14services personnel, hospital, laboratory, or pharmacy, or
15other person licensed, registered, or otherwise lawfully
16permitted by the United States or this State to distribute,
17dispense, conduct research with respect to, administer or use
18in teaching or chemical analysis, a controlled substance in
19the course of professional practice or research.
20    (ll) "Pre-printed prescription" means a written
21prescription upon which the designated drug has been indicated
22prior to the time of issuance; the term does not mean a written
23prescription that is individually generated by machine or
24computer in the prescriber's office.
25    (mm) "Prescriber" means a physician licensed to practice
26medicine in all its branches, dentist, optometrist,

 

 

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1prescribing psychologist licensed under Section 4.2 of the
2Clinical Psychologist Licensing Act with prescriptive
3authority delegated under Section 4.3 of the Clinical
4Psychologist Licensing Act, podiatric physician, or
5veterinarian who issues a prescription, a physician assistant
6who issues a prescription for a controlled substance in
7accordance with Section 303.05, a written delegation, and a
8written collaborative agreement required under Section 7.5 of
9the Physician Assistant Practice Act of 1987, an advanced
10practice registered nurse with prescriptive authority
11delegated under Section 65-40 of the Nurse Practice Act and in
12accordance with Section 303.05, a written delegation, and a
13written collaborative agreement under Section 65-35 of the
14Nurse Practice Act, an advanced practice registered nurse
15certified as a nurse practitioner, nurse midwife, or clinical
16nurse specialist who has been granted authority to prescribe
17by a hospital affiliate in accordance with Section 65-45 of
18the Nurse Practice Act and in accordance with Section 303.05,
19or an advanced practice registered nurse certified as a nurse
20practitioner, nurse midwife, or clinical nurse specialist who
21has full practice authority pursuant to Section 65-43 of the
22Nurse Practice Act.
23    (nn) "Prescription" means a written, facsimile, or oral
24order, or an electronic order that complies with applicable
25federal requirements, of a physician licensed to practice
26medicine in all its branches, dentist, podiatric physician or

 

 

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1veterinarian for any controlled substance, of an optometrist
2in accordance with Section 15.1 of the Illinois Optometric
3Practice Act of 1987, of a prescribing psychologist licensed
4under Section 4.2 of the Clinical Psychologist Licensing Act
5with prescriptive authority delegated under Section 4.3 of the
6Clinical Psychologist Licensing Act, of a physician assistant
7for a controlled substance in accordance with Section 303.05,
8a written delegation, and a written collaborative agreement
9required under Section 7.5 of the Physician Assistant Practice
10Act of 1987, of an advanced practice registered nurse with
11prescriptive authority delegated under Section 65-40 of the
12Nurse Practice Act who issues a prescription for a controlled
13substance in accordance with Section 303.05, a written
14delegation, and a written collaborative agreement under
15Section 65-35 of the Nurse Practice Act, of an advanced
16practice registered nurse certified as a nurse practitioner,
17nurse midwife, or clinical nurse specialist who has been
18granted authority to prescribe by a hospital affiliate in
19accordance with Section 65-45 of the Nurse Practice Act and in
20accordance with Section 303.05 when required by law, or of an
21advanced practice registered nurse certified as a nurse
22practitioner, nurse midwife, or clinical nurse specialist who
23has full practice authority pursuant to Section 65-43 of the
24Nurse Practice Act.
25    (nn-5) "Prescription Information Library" (PIL) means an
26electronic library that contains reported controlled substance

 

 

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1data.
2    (nn-10) "Prescription Monitoring Program" (PMP) means the
3entity that collects, tracks, and stores reported data on
4controlled substances and select drugs pursuant to Section
5316.
6    (oo) "Production" or "produce" means manufacture,
7planting, cultivating, growing, or harvesting of a controlled
8substance other than methamphetamine.
9    (pp) "Registrant" means every person who is required to
10register under Section 302 of this Act.
11    (qq) "Registry number" means the number assigned to each
12person authorized to handle controlled substances under the
13laws of the United States and of this State.
14    (qq-5) "Secretary" means, as the context requires, either
15the Secretary of the Department or the Secretary of the
16Department of Financial and Professional Regulation, and the
17Secretary's designated agents.
18    (rr) "State" includes the State of Illinois and any state,
19district, commonwealth, territory, insular possession thereof,
20and any area subject to the legal authority of the United
21States of America.
22    (rr-5) "Stimulant" means any drug that (i) causes an
23overall excitation of central nervous system functions, (ii)
24causes impaired consciousness and awareness, and (iii) can be
25habit-forming or lead to a substance abuse problem, including
26but not limited to amphetamines and their analogs,

 

 

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1methylphenidate and its analogs, cocaine, and phencyclidine
2and its analogs.
3    (rr-10) "Synthetic drug" includes, but is not limited to,
4any synthetic cannabinoids or piperazines or any synthetic
5cathinones as provided for in Schedule I.
6    (ss) "Ultimate user" means a person who lawfully possesses
7a controlled substance for his or her own use or for the use of
8a member of his or her household or for administering to an
9animal owned by him or her or by a member of his or her
10household.
11(Source: P.A. 99-78, eff. 7-20-15; 99-173, eff. 7-29-15;
1299-371, eff. 1-1-16; 99-480, eff. 9-9-15; 99-642, eff.
137-28-16; 100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513,
14eff. 1-1-18; 100-789, eff. 1-1-19; 100-863, eff. 8-14-18.)
 
15    Section 115. The Cannabis and Controlled Substances Tort
16Claims Act is amended by changing Section 3 as follows:
 
17    (740 ILCS 20/3)  (from Ch. 70, par. 903)
18    Sec. 3. Definitions. As used in this Act, unless the
19context otherwise requires:
20    "Cannabis" includes marihuana, hashish, and other
21substances that are identified as including any parts of the
22plant Cannabis Sativa, whether growing or not, the seeds of
23that plant, the resin extracted from any part of that plant,
24and any compound, manufacture, salt, derivative, mixture, or

 

 

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1preparation of that plant, its seeds, or resin, including
2tetrahydrocannabinol (THC) and all other cannabinol
3derivatives, including its naturally occurring or
4synthetically produced ingredients, whether produced directly
5or indirectly by extraction, independently by means of
6chemical synthesis, or by a combination of extraction and
7chemical synthesis. "Cannabis" does not include the mature
8stalks of that plant, fiber produced from those stalks, oil or
9cake made from the seeds of that plant, any other compound,
10manufacture, salt, derivative, mixture, or preparation of
11mature stalks (except the extracted resin), fiber, oil or
12cake, or the sterilized seeds of that plant that are incapable
13of germination.
14    "Controlled substance" means a drug, substance, or
15immediate precursor in the Schedules of Article II of the
16Illinois Controlled Substances Act.
17    "Counterfeit substance" means a controlled substance or
18the container or labeling of a controlled substance that,
19without authorization, bears the trademark, trade name, or
20other identifying mark, imprint, number, device, or any
21likeness thereof of a manufacturer, distributor, or dispenser
22other than the person who in fact manufactured, distributed,
23or dispensed the substance.
24    "Deliver" or "delivery" means the actual, constructive, or
25attempted transfer of possession of a controlled substance or
26cannabis, with or without consideration, whether or not there

 

 

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

 

 

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1    Prescription Drug Repository Program Act.
2    "Owner" means a person who has possession of or any
3interest whatsoever in the property involved.
4    "Person" means an individual, a corporation, a government,
5a governmental subdivision or agency, a business trust, an
6estate, a trust, a partnership or association, or any other
7entity.
8    "Production" means planting, cultivating, tending, or
9harvesting.
10    "Property" means real property, including things growing
11on, affixed to, and found in land, and tangible or intangible
12personal property, including rights, services, privileges,
13interests, claims, and securities.
14(Source: P.A. 96-328, eff. 8-11-09.)

 

 

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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