Illinois General Assembly - Full Text of SB0516
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Full Text of SB0516  102nd General Assembly

SB0516 102ND GENERAL ASSEMBLY


 


 
102ND GENERAL ASSEMBLY
State of Illinois
2021 and 2022
SB0516

 

Introduced 2/23/2021, by Sen. Karina Villa

 

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 any person may donate a prescription drug or supplies needed to administer a prescription drug for use by an individual who meets eligibility criteria specified by the Department. Sets forth requirements that prescription drugs or supplies must meet in order to be accepted and dispensed under the program. Provides that no drugs or supplies donated under the prescription drug repository program may be resold. Provides that nothing in the Act requires that a pharmacy or pharmacist participate in the prescription drug repository program. Provides for civil and criminal immunity for drug and supply manufacturers and 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. 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 16149 CPF 21525 b

FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

SB0516LRB102 16149 CPF 21525 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    "Pharmacist" means an individual licensed to engage in the
13practice of pharmacy under the Pharmacy Practice Act.
14    "Pharmacy" means a pharmacy registered in this State under
15the Pharmacy Practice Act.
16    "Practitioner" means a person licensed in this State to
17prescribe and administer drugs or licensed in another state
18and recognized by this State as a person authorized to
19prescribe and administer drugs.
20    "Prescription drug" means any prescribed drug that may be
21legally dispensed by a pharmacy. "Prescription drug" does not
22include drugs for the treatment of cancer that can only be
23dispensed to a patient registered with the drug manufacturer

 

 

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

 

 

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1        (1) The prescription drug or supplies needed to
2    administer a prescription drug are in their original,
3    unopened, sealed, and tamper-evident unit-dose packaging
4    or, if packaged in single-unit doses, the single-unit-dose
5    packaging is unopened.
6        (2) The prescription drug bears an expiration date
7    that is later than 6 months after the date that the drug
8    was donated.
9        (3) The prescription drug or supplies needed to
10    administer a prescription drug are not adulterated or
11    misbranded, as determined by a pharmacist employed by, or
12    under contract with, the pharmacy where the drug or
13    supplies are accepted or dispensed. The pharmacist must
14    inspect the drug or supplies before the drug or supplies
15    are dispensed.
16        (4) The prescription drug or supplies needed to
17    administer a prescription drug are prescribed by a
18    practitioner for use by an eligible individual.
19        (5) The prescription drug is not a controlled
20    substance.
 
21    Section 20. Resale of donated drugs or supplies
22prohibited. No prescription drug or supplies needed to
23administer a prescription drug that are donated for use under
24this Act may be resold.
 

 

 

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1    Section 25. Participation in program not required. Nothing
2in this Act requires that a pharmacy or pharmacist participate
3in the prescription drug repository program.
 
4    Section 30. Immunity.
5    (a) A manufacturer of a drug or supply acting reasonably
6and in good faith is not subject to criminal or civil liability
7for injury, death, or loss to a person or property for matters
8related to the donation, acceptance, or dispensing of a
9prescription drug or supply manufactured by the manufacturer
10that is donated by any person under this Act.
11    (b) A person acting reasonably and in good faith,
12including a pharmacist or other health professional, is immune
13from civil liability for injury to or the death of the
14individual to whom the prescription drug or supply is
15dispensed and may not be found guilty of unprofessional
16conduct for his or her acts or omissions related to donating,
17accepting, distributing, or dispensing a prescription drug or
18supply under this Act. The immunity granted under this
19subsection does not apply to acts or omissions outside the
20scope of the program.
 
21    Section 90. The Pharmacy Practice Act is amended by
22changing Section 4 as follows:
 
23    (225 ILCS 85/4)  (from Ch. 111, par. 4124)

 

 

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

 

 

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

 

 

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

 

 

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1        a manufacturer or the manufacturer's agent, which is
2        properly registered with the Board as a manufacturer,
3        third-party logistics provider, or wholesaler;
4            (3) the dialysate or devices are held and
5        delivered to the manufacturer or the manufacturer's
6        agent in the original, sealed packaging from the
7        manufacturing facility;
8            (4) the dialysate or devices are delivered only
9        upon receipt of a physician's prescription by a
10        licensed pharmacy in which the prescription is
11        processed in accordance with provisions set forth in
12        this Act, and the transmittal of an order from the
13        licensed pharmacy to the manufacturer or the
14        manufacturer's agent; and
15            (5) the manufacturer or the manufacturer's agent
16        delivers the dialysate or devices directly to: (i) a
17        patient with end-stage renal disease, or his or her
18        designee, for the patient's self-administration of the
19        dialysis therapy or (ii) a health care provider or
20        institution for administration or delivery of the
21        dialysis therapy to a patient with end-stage renal
22        disease.
23        This paragraph (h) does not include any other drugs
24    for peritoneal dialysis, except dialysate, as described in
25    item (1) of this paragraph (h). All records of sales and
26    distribution of dialysate to patients made pursuant to

 

 

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1    this paragraph (h) must be retained in accordance with
2    Section 18 of this Act.
3(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
4100-863, eff. 8-14-18; 101-420, eff. 8-16-19.)
 
5    Section 95. The Wholesale Drug Distribution Licensing Act
6is amended by changing Section 15 as follows:
 
7    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
8    (Section scheduled to be repealed on January 1, 2023)
9    Sec. 15. Definitions. As used in this Act:
10    "Authentication" means the affirmative verification,
11before any wholesale distribution of a prescription drug
12occurs, that each transaction listed on the pedigree has
13occurred.
14    "Authorized distributor of record" means a wholesale
15distributor with whom a manufacturer has established an
16ongoing relationship to distribute the manufacturer's
17prescription drug. An ongoing relationship is deemed to exist
18between a wholesale distributor and a manufacturer when the
19wholesale distributor, including any affiliated group of the
20wholesale distributor, as defined in Section 1504 of the
21Internal Revenue Code, complies with the following:
22        (1) The wholesale distributor has a written agreement
23    currently in effect with the manufacturer evidencing the
24    ongoing relationship; and

 

 

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

 

 

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

 

 

SB0516- 12 -LRB102 16149 CPF 21525 b

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

 

 

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1    authorized by law to dispense or administer the drug to a
2    patient;
3        (2) a wholesale distributor to a pharmacy or other
4    designated persons authorized by law to dispense or
5    administer the drug to a patient;
6        (3) a wholesale distributor to a chain pharmacy
7    warehouse to that chain pharmacy warehouse's intracompany
8    pharmacy to a patient or other designated persons
9    authorized by law to dispense or administer the drug to a
10    patient;
11        (4) a chain pharmacy warehouse to the chain pharmacy
12    warehouse's intracompany pharmacy or other designated
13    persons authorized by law to dispense or administer the
14    drug to the patient;
15        (5) an authorized distributor of record to one other
16    authorized distributor of record to an office-based health
17    care practitioner authorized by law to dispense or
18    administer the drug to the patient; or
19        (6) an authorized distributor to a pharmacy or other
20    persons licensed to dispense or administer the drug.
21    "Pedigree" means a document or electronic file containing
22information that records each wholesale distribution of any
23given prescription drug from the point of origin to the final
24wholesale distribution point of any given prescription drug.
25    "Person" means and includes a natural person, partnership,
26association, corporation, or any other legal business entity.

 

 

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

 

 

SB0516- 15 -LRB102 16149 CPF 21525 b

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

 

 

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

 

 

SB0516- 17 -LRB102 16149 CPF 21525 b

1    original manufacturer, the originating wholesale
2    distributor, or a third party returns processor.
3        (11) The donation of prescription drugs to the extent
4    permitted under the Prescription Drug Repository Program
5    Act.
6    "Wholesale drug distributor" means anyone engaged in the
7wholesale distribution of prescription drugs into, out of, or
8within the State, including without limitation manufacturers;
9repackers; own label distributors; jobbers; private label
10distributors; brokers; warehouses, including manufacturers'
11and distributors' warehouses; manufacturer's exclusive
12distributors; and authorized distributors of record; drug
13wholesalers or distributors; independent wholesale drug
14traders; specialty wholesale distributors; and retail
15pharmacies that conduct wholesale distribution; and chain
16pharmacy warehouses that conduct wholesale distribution. In
17order to be considered part of the normal distribution
18channel, a wholesale distributor must also be an authorized
19distributor of record.
20(Source: P.A. 101-420, eff. 8-16-19.)
 
21    Section 100. The Senior Pharmaceutical Assistance Act is
22amended by changing Section 10 as follows:
 
23    (320 ILCS 50/10)
24    Sec. 10. Definitions. In this Act:

 

 

SB0516- 18 -LRB102 16149 CPF 21525 b

1    "Manufacturer" includes:
2        (1) An entity that is engaged in (a) the production,
3    preparation, propagation, compounding, conversion, or
4    processing of prescription drug products (i) directly or
5    indirectly by extraction from substances of natural
6    origin, (ii) independently by means of chemical synthesis,
7    or (iii) by combination of extraction and chemical
8    synthesis; or (b) the packaging, repackaging, labeling or
9    re-labeling, or distribution of prescription drug
10    products.
11        (2) The entity holding legal title to or possession of
12    the national drug code number for the covered prescription
13    drug.
14    The term does not include a wholesale distributor of
15drugs, drugstore chain organization, or retail pharmacy
16licensed by the State. The term also does not include anyone
17who is engaged in the packaging, repackaging, or labeling of
18prescription drugs only to the extent required under the
19Prescription Drug Repository Program Act.
20    "Prescription drug" means a drug that may be dispensed
21only upon prescription by an authorized prescriber and that is
22approved for safety and effectiveness as a prescription drug
23under Section 505 or 507 of the Federal Food, Drug and Cosmetic
24Act.
25    "Senior citizen" or "senior" means a person 65 years of
26age or older.

 

 

SB0516- 19 -LRB102 16149 CPF 21525 b

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

 

 

SB0516- 20 -LRB102 16149 CPF 21525 b

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

 

 

SB0516- 21 -LRB102 16149 CPF 21525 b

1exemption shall not apply to any drug dispensed in the course
2of the conduct of business of dispensing drugs pursuant to
3diagnosis by mail, or to a drug dispensed in violation of
4subsection (a) of this Section.
5    (e) The Director may by regulation remove drugs subject to
6Section 15 (d) and Section 17 from the requirements of
7subsection (c) of this Section when such requirements are not
8necessary for the protection of the public health.
9    (f) A drug which is subject to subsection (c) of this
10Section shall be deemed to be misbranded if at any time before
11dispensing its label fails to bear the statement "Caution:
12Federal Law Prohibits Dispensing Without Prescription" or
13"Caution: State Law Prohibits Dispensing Without
14Prescription". A drug to which subsection (c) of this Section
15does not apply shall be deemed to be misbranded if at any time
16prior to dispensing its label bears the caution statement
17quoted in the preceding sentence.
18    (g) Nothing in this Section shall be construed to relieve
19any person from any requirement prescribed by or under
20authority of law with respect to controlled substances now
21included or which may hereafter be included within the
22classifications of controlled substances cannabis as defined
23in applicable Federal laws relating to controlled substances
24or cannabis or the Cannabis Control Act.
25(Source: P.A. 84-1308.)
 

 

 

SB0516- 22 -LRB102 16149 CPF 21525 b

1    Section 110. The Illinois Controlled Substances Act is
2amended by changing Section 102 as follows:
 
3    (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
4    Sec. 102. Definitions. As used in this Act, unless the
5context otherwise requires:
6    (a) "Addict" means any person who habitually uses any
7drug, chemical, substance or dangerous drug other than alcohol
8so as to endanger the public morals, health, safety or welfare
9or who is so far addicted to the use of a dangerous drug or
10controlled substance other than alcohol as to have lost the
11power of self control with reference to his or her addiction.
12    (b) "Administer" means the direct application of a
13controlled substance, whether by injection, inhalation,
14ingestion, or any other means, to the body of a patient,
15research subject, or animal (as defined by the Humane
16Euthanasia in Animal Shelters Act) by:
17        (1) a practitioner (or, in his or her presence, by his
18    or her authorized agent),
19        (2) the patient or research subject pursuant to an
20    order, or
21        (3) a euthanasia technician as defined by the Humane
22    Euthanasia in Animal Shelters Act.
23    (c) "Agent" means an authorized person who acts on behalf
24of or at the direction of a manufacturer, distributor,
25dispenser, prescriber, or practitioner. It does not include a

 

 

SB0516- 23 -LRB102 16149 CPF 21525 b

1common or contract carrier, public warehouseman or employee of
2the carrier or warehouseman.
3    (c-1) "Anabolic Steroids" means any drug or hormonal
4substance, chemically and pharmacologically related to
5testosterone (other than estrogens, progestins,
6corticosteroids, and dehydroepiandrosterone), and includes:
7    (i) 3[beta],17-dihydroxy-5a-androstane, 
8    (ii) 3[alpha],17[beta]-dihydroxy-5a-androstane, 
9    (iii) 5[alpha]-androstan-3,17-dione, 
10    (iv) 1-androstenediol (3[beta], 
11        17[beta]-dihydroxy-5[alpha]-androst-1-ene), 
12    (v) 1-androstenediol (3[alpha], 
13        17[beta]-dihydroxy-5[alpha]-androst-1-ene), 
14    (vi) 4-androstenediol  
15        (3[beta],17[beta]-dihydroxy-androst-4-ene), 
16    (vii) 5-androstenediol  
17        (3[beta],17[beta]-dihydroxy-androst-5-ene), 
18    (viii) 1-androstenedione  
19        ([5alpha]-androst-1-en-3,17-dione), 
20    (ix) 4-androstenedione  
21        (androst-4-en-3,17-dione), 
22    (x) 5-androstenedione  
23        (androst-5-en-3,17-dione), 
24    (xi) bolasterone (7[alpha],17a-dimethyl-17[beta]- 
25        hydroxyandrost-4-en-3-one), 
26    (xii) boldenone (17[beta]-hydroxyandrost- 

 

 

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

 

 

SB0516- 25 -LRB102 16149 CPF 21525 b

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

 

 

SB0516- 26 -LRB102 16149 CPF 21525 b

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

 

 

SB0516- 27 -LRB102 16149 CPF 21525 b

1    (l) norbolethone (13[beta], 17a-diethyl-17[beta]- 
2        hydroxygon-4-en-3-one), 
3    (li) norclostebol (4-chloro-17[beta]- 
4        hydroxyestr-4-en-3-one), 
5    (lii) norethandrolone (17[alpha]-ethyl-17[beta]- 
6        hydroxyestr-4-en-3-one), 
7    (liii) normethandrolone (17[alpha]-methyl-17[beta]- 
8        hydroxyestr-4-en-3-one), 
9    (liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy- 
10        2-oxa-5[alpha]-androstan-3-one), 
11    (lv) oxymesterone (17[alpha]-methyl-4,17[beta]- 
12        dihydroxyandrost-4-en-3-one), 
13    (lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene- 
14        17[beta]-hydroxy-(5[alpha]-androstan-3-one), 
15    (lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy- 
16        (5[alpha]-androst-2-eno[3,2-c]-pyrazole), 
17    (lviii) stenbolone (17[beta]-hydroxy-2-methyl- 
18        (5[alpha]-androst-1-en-3-one), 
19    (lix) testolactone (13-hydroxy-3-oxo-13,17- 
20        secoandrosta-1,4-dien-17-oic 
21        acid lactone), 
22    (lx) testosterone (17[beta]-hydroxyandrost- 
23        4-en-3-one), 
24    (lxi) tetrahydrogestrinone (13[beta], 17[alpha]- 
25        diethyl-17[beta]-hydroxygon- 
26        4,9,11-trien-3-one), 

 

 

SB0516- 28 -LRB102 16149 CPF 21525 b

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

 

 

SB0516- 29 -LRB102 16149 CPF 21525 b

1prescriber's prescription drug order or initiative based on
2the prescriber-patient-pharmacist relationship in the course
3of professional practice or (2) for the purpose of, or
4incident to, research, teaching, or chemical analysis and not
5for sale or dispensing. "Compounding" includes the preparation
6of drugs or devices in anticipation of receiving prescription
7drug orders based on routine, regularly observed dispensing
8patterns. Commercially available products may be compounded
9for dispensing to individual patients only if both of the
10following conditions are met: (i) the commercial product is
11not reasonably available from normal distribution channels in
12a timely manner to meet the patient's needs and (ii) the
13prescribing practitioner has requested that the drug be
14compounded.
15    (e) "Control" means to add a drug or other substance, or
16immediate precursor, to a Schedule whether by transfer from
17another Schedule or otherwise.
18    (f) "Controlled Substance" means (i) a drug, substance,
19immediate precursor, or synthetic drug in the Schedules of
20Article II of this Act or (ii) a drug or other substance, or
21immediate precursor, designated as a controlled substance by
22the Department through administrative rule. The term does not
23include distilled spirits, wine, malt beverages, or tobacco,
24as those terms are defined or used in the Liquor Control Act of
251934 and the Tobacco Products Tax Act of 1995.
26    (f-5) "Controlled substance analog" means a substance:

 

 

SB0516- 30 -LRB102 16149 CPF 21525 b

1        (1) the chemical structure of which is substantially
2    similar to the chemical structure of a controlled
3    substance in Schedule I or II;
4        (2) which has a stimulant, depressant, or
5    hallucinogenic effect on the central nervous system that
6    is substantially similar to or greater than the stimulant,
7    depressant, or hallucinogenic effect on the central
8    nervous system of a controlled substance in Schedule I or
9    II; or
10        (3) with respect to a particular person, which such
11    person represents or intends to have a stimulant,
12    depressant, or hallucinogenic effect on the central
13    nervous system that is substantially similar to or greater
14    than the stimulant, depressant, or hallucinogenic effect
15    on the central nervous system of a controlled substance in
16    Schedule I or II.
17    (g) "Counterfeit substance" means a controlled substance,
18which, or the container or labeling of which, without
19authorization bears the trademark, trade name, or other
20identifying mark, imprint, number or device, or any likeness
21thereof, of a manufacturer, distributor, or dispenser other
22than the person who in fact manufactured, distributed, or
23dispensed the substance.
24    (h) "Deliver" or "delivery" means the actual, constructive
25or attempted transfer of possession of a controlled substance,
26with or without consideration, whether or not there is an

 

 

SB0516- 31 -LRB102 16149 CPF 21525 b

1agency relationship. "Deliver" or "delivery" does not include
2the donation of prescription drugs to the extent permitted
3under the Prescription Drug Repository Program Act.
4    (i) "Department" means the Illinois Department of Human
5Services (as successor to the Department of Alcoholism and
6Substance Abuse) or its successor agency.
7    (j) (Blank).
8    (k) "Department of Corrections" means the Department of
9Corrections of the State of Illinois or its successor agency.
10    (l) "Department of Financial and Professional Regulation"
11means the Department of Financial and Professional Regulation
12of the State of Illinois or its successor agency.
13    (m) "Depressant" means any drug that (i) causes an overall
14depression of central nervous system functions, (ii) causes
15impaired consciousness and awareness, and (iii) can be
16habit-forming or lead to a substance abuse problem, including
17but not limited to alcohol, cannabis and its active principles
18and their analogs, benzodiazepines and their analogs,
19barbiturates and their analogs, opioids (natural and
20synthetic) and their analogs, and chloral hydrate and similar
21sedative hypnotics.
22    (n) (Blank).
23    (o) "Director" means the Director of the Illinois State
24Police or his or her designated agents.
25    (p) "Dispense" means to deliver a controlled substance to
26an ultimate user or research subject by or pursuant to the

 

 

SB0516- 32 -LRB102 16149 CPF 21525 b

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

 

 

SB0516- 33 -LRB102 16149 CPF 21525 b

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

 

 

SB0516- 34 -LRB102 16149 CPF 21525 b

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

 

 

SB0516- 35 -LRB102 16149 CPF 21525 b

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

 

 

SB0516- 36 -LRB102 16149 CPF 21525 b

1    of the substance concerning its nature, use or effect;
2        (b) statements made to the buyer or recipient that the
3    substance may be resold for profit;
4        (c) whether the substance is packaged in a manner
5    normally used for the illegal distribution of controlled
6    substances;
7        (d) whether the distribution or attempted distribution
8    included an exchange of or demand for money or other
9    property as consideration, and whether the amount of the
10    consideration was substantially greater than the
11    reasonable retail market value of the substance.
12    Clause (1) of this subsection (y) shall not apply to a
13noncontrolled substance in its finished dosage form that was
14initially introduced into commerce prior to the initial
15introduction into commerce of a controlled substance in its
16finished dosage form which it may substantially resemble.
17    Nothing in this subsection (y) prohibits the dispensing or
18distributing of noncontrolled substances by persons authorized
19to dispense and distribute controlled substances under this
20Act, provided that such action would be deemed to be carried
21out in good faith under subsection (u) if the substances
22involved were controlled substances.
23    Nothing in this subsection (y) or in this Act prohibits
24the manufacture, preparation, propagation, compounding,
25processing, packaging, advertising or distribution of a drug
26or drugs by any person registered pursuant to Section 510 of

 

 

SB0516- 37 -LRB102 16149 CPF 21525 b

1the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
2    (y-1) "Mail-order pharmacy" means a pharmacy that is
3located in a state of the United States that delivers,
4dispenses or distributes, through the United States Postal
5Service or other common carrier, to Illinois residents, any
6substance which requires a prescription.
7    (z) "Manufacture" means the production, preparation,
8propagation, compounding, conversion or processing of a
9controlled substance other than methamphetamine, either
10directly or indirectly, by extraction from substances of
11natural origin, or independently by means of chemical
12synthesis, or by a combination of extraction and chemical
13synthesis, and includes any packaging or repackaging of the
14substance or labeling of its container, except that this term
15does not include:
16        (1) by an ultimate user, the preparation or
17    compounding of a controlled substance for his or her own
18    use; or
19        (2) by a practitioner, or his or her authorized agent
20    under his or her supervision, the preparation,
21    compounding, packaging, or labeling of a controlled
22    substance:
23            (a) as an incident to his or her administering or
24        dispensing of a controlled substance in the course of
25        his or her professional practice; or
26            (b) as an incident to lawful research, teaching or

 

 

SB0516- 38 -LRB102 16149 CPF 21525 b

1        chemical analysis and not for sale; or .
2        (3) the packaging, repackaging, or labeling of
3    prescription drugs only to the extent required under the
4    Prescription Drug Repository Program Act.
5    (z-1) (Blank).
6    (z-5) "Medication shopping" means the conduct prohibited
7under subsection (a) of Section 314.5 of this Act.
8    (z-10) "Mid-level practitioner" means (i) a physician
9assistant who has been delegated authority to prescribe
10through a written delegation of authority by a physician
11licensed to practice medicine in all of its branches, in
12accordance with Section 7.5 of the Physician Assistant
13Practice Act of 1987, (ii) an advanced practice registered
14nurse who has been delegated authority to prescribe through a
15written delegation of authority by a physician licensed to
16practice medicine in all of its branches or by a podiatric
17physician, in accordance with Section 65-40 of the Nurse
18Practice Act, (iii) an advanced practice registered nurse
19certified as a nurse practitioner, nurse midwife, or clinical
20nurse specialist who has been granted authority to prescribe
21by a hospital affiliate in accordance with Section 65-45 of
22the Nurse Practice Act, (iv) an animal euthanasia agency, or
23(v) a prescribing psychologist.
24    (aa) "Narcotic drug" means any of the following, whether
25produced directly or indirectly by extraction from substances
26of vegetable origin, or independently by means of chemical

 

 

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1synthesis, or by a combination of extraction and chemical
2synthesis:
3        (1) opium, opiates, derivatives of opium and opiates,
4    including their isomers, esters, ethers, salts, and salts
5    of isomers, esters, and ethers, whenever the existence of
6    such isomers, esters, ethers, and salts is possible within
7    the specific chemical designation; however the term
8    "narcotic drug" does not include the isoquinoline
9    alkaloids of opium;
10        (2) (blank);
11        (3) opium poppy and poppy straw;
12        (4) coca leaves, except coca leaves and extracts of
13    coca leaves from which substantially all of the cocaine
14    and ecgonine, and their isomers, derivatives and salts,
15    have been removed;
16        (5) cocaine, its salts, optical and geometric isomers,
17    and salts of isomers;
18        (6) ecgonine, its derivatives, their salts, isomers,
19    and salts of isomers;
20        (7) any compound, mixture, or preparation which
21    contains any quantity of any of the substances referred to
22    in subparagraphs (1) through (6).
23    (bb) "Nurse" means a registered nurse licensed under the
24Nurse Practice Act.
25    (cc) (Blank).
26    (dd) "Opiate" means any substance having an addiction

 

 

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1forming or addiction sustaining liability similar to morphine
2or being capable of conversion into a drug having addiction
3forming or addiction sustaining liability.
4    (ee) "Opium poppy" means the plant of the species Papaver
5somniferum L., except its seeds.
6    (ee-5) "Oral dosage" means a tablet, capsule, elixir, or
7solution or other liquid form of medication intended for
8administration by mouth, but the term does not include a form
9of medication intended for buccal, sublingual, or transmucosal
10administration.
11    (ff) "Parole and Pardon Board" means the Parole and Pardon
12Board of the State of Illinois or its successor agency.
13    (gg) "Person" means any individual, corporation,
14mail-order pharmacy, government or governmental subdivision or
15agency, business trust, estate, trust, partnership or
16association, or any other entity.
17    (hh) "Pharmacist" means any person who holds a license or
18certificate of registration as a registered pharmacist, a
19local registered pharmacist or a registered assistant
20pharmacist under the Pharmacy Practice Act.
21    (ii) "Pharmacy" means any store, ship or other place in
22which pharmacy is authorized to be practiced under the
23Pharmacy Practice Act.
24    (ii-5) "Pharmacy shopping" means the conduct prohibited
25under subsection (b) of Section 314.5 of this Act.
26    (ii-10) "Physician" (except when the context otherwise

 

 

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1requires) means a person licensed to practice medicine in all
2of its branches.
3    (jj) "Poppy straw" means all parts, except the seeds, of
4the opium poppy, after mowing.
5    (kk) "Practitioner" means a physician licensed to practice
6medicine in all its branches, dentist, optometrist, podiatric
7physician, veterinarian, scientific investigator, pharmacist,
8physician assistant, advanced practice registered nurse,
9licensed practical nurse, registered nurse, emergency medical
10services personnel, hospital, laboratory, or pharmacy, or
11other person licensed, registered, or otherwise lawfully
12permitted by the United States or this State to distribute,
13dispense, conduct research with respect to, administer or use
14in teaching or chemical analysis, a controlled substance in
15the course of professional practice or research.
16    (ll) "Pre-printed prescription" means a written
17prescription upon which the designated drug has been indicated
18prior to the time of issuance; the term does not mean a written
19prescription that is individually generated by machine or
20computer in the prescriber's office.
21    (mm) "Prescriber" means a physician licensed to practice
22medicine in all its branches, dentist, optometrist,
23prescribing psychologist licensed under Section 4.2 of the
24Clinical Psychologist Licensing Act with prescriptive
25authority delegated under Section 4.3 of the Clinical
26Psychologist Licensing Act, podiatric physician, or

 

 

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

 

 

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

 

 

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1316.
2    (oo) "Production" or "produce" means manufacture,
3planting, cultivating, growing, or harvesting of a controlled
4substance other than methamphetamine.
5    (pp) "Registrant" means every person who is required to
6register under Section 302 of this Act.
7    (qq) "Registry number" means the number assigned to each
8person authorized to handle controlled substances under the
9laws of the United States and of this State.
10    (qq-5) "Secretary" means, as the context requires, either
11the Secretary of the Department or the Secretary of the
12Department of Financial and Professional Regulation, and the
13Secretary's designated agents.
14    (rr) "State" includes the State of Illinois and any state,
15district, commonwealth, territory, insular possession thereof,
16and any area subject to the legal authority of the United
17States of America.
18    (rr-5) "Stimulant" means any drug that (i) causes an
19overall excitation of central nervous system functions, (ii)
20causes impaired consciousness and awareness, and (iii) can be
21habit-forming or lead to a substance abuse problem, including
22but not limited to amphetamines and their analogs,
23methylphenidate and its analogs, cocaine, and phencyclidine
24and its analogs.
25    (rr-10) "Synthetic drug" includes, but is not limited to,
26any synthetic cannabinoids or piperazines or any synthetic

 

 

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1cathinones as provided for in Schedule I.
2    (ss) "Ultimate user" means a person who lawfully possesses
3a controlled substance for his or her own use or for the use of
4a member of his or her household or for administering to an
5animal owned by him or her or by a member of his or her
6household.
7(Source: P.A. 99-78, eff. 7-20-15; 99-173, eff. 7-29-15;
899-371, eff. 1-1-16; 99-480, eff. 9-9-15; 99-642, eff.
97-28-16; 100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513,
10eff. 1-1-18; 100-789, eff. 1-1-19; 100-863, eff. 8-14-18.)
 
11    Section 115. The Cannabis and Controlled Substances Tort
12Claims Act is amended by changing Section 3 as follows:
 
13    (740 ILCS 20/3)  (from Ch. 70, par. 903)
14    Sec. 3. Definitions. As used in this Act, unless the
15context otherwise requires:
16    "Cannabis" includes marihuana, hashish, and other
17substances that are identified as including any parts of the
18plant Cannabis Sativa, whether growing or not, the seeds of
19that plant, the resin extracted from any part of that plant,
20and any compound, manufacture, salt, derivative, mixture, or
21preparation of that plant, its seeds, or resin, including
22tetrahydrocannabinol (THC) and all other cannabinol
23derivatives, including its naturally occurring or
24synthetically produced ingredients, whether produced directly

 

 

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

 

 

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

 

 

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1a governmental subdivision or agency, a business trust, an
2estate, a trust, a partnership or association, or any other
3entity.
4    "Production" means planting, cultivating, tending, or
5harvesting.
6    "Property" means real property, including things growing
7on, affixed to, and found in land, and tangible or intangible
8personal property, including rights, services, privileges,
9interests, claims, and securities.
10(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