101ST GENERAL ASSEMBLY
State of Illinois
2019 and 2020
HB3414

 

Introduced , by Rep. Justin Slaughter

 

SYNOPSIS AS INTRODUCED:
 
See Index

    Creates the Prescription Drug Repository Pilot Program Act. Requires the Department of Public Health to establish a prescription drug repository program. Provides that collection efforts shall be performed by the Metropolitan Water Reclamation District. 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 to participate in the prescription drug repository pilot program. Provides for civil and criminal immunity regarding the donation, acceptance, or dispensing of prescription drugs or supplies under the program. Imposes conditions on any rulemaking authority. Provides that the Department, in collaboration with the Metropolitan Water Reclamation District, shall submit 2 reports to the General Assembly before December 31, 2024. Provides that after submission of the second report, the pilot program shall terminate. Repeals the Act on January 1, 2026. 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 Pilot Program Act are exempt from provisions of those other Acts that might prohibit or otherwise regulate such activity. Effective immediately.


LRB101 10547 CPF 55653 b

FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB3414LRB101 10547 CPF 55653 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 Pilot 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    "District" means the Metropolitan Water Reclamation
13District.
14    "Pharmacist" means an individual licensed to engage in the
15practice of pharmacy under the Pharmacy Practice Act.
16    "Pharmacy" means a pharmacy registered in this State under
17the Pharmacy Practice Act.
18    "Practitioner" means a person licensed in this State to
19prescribe and administer drugs or licensed in another state and
20recognized by this State as a person authorized to prescribe
21and administer drugs.
22    "Prescription drug" means any prescribed drug that may be
23legally dispensed by a pharmacy. "Prescription drug" does not

 

 

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

 

 

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1prescription drugs and supplies. A prescription drug or
2supplies needed to administer a prescription drug may be
3accepted and dispensed under the pilot program only if all of
4the following requirements are met:
5        (1) The prescription drug or supplies needed to
6    administer a prescription drug are in their original,
7    unopened, sealed, and tamper-evident unit-dose packaging
8    or, if packaged in single-unit doses, the single-unit-dose
9    packaging is unopened.
10        (2) The prescription drug bears an expiration date that
11    is later than 6 months after the date that the drug was
12    donated.
13        (3) The prescription drug or supplies needed to
14    administer a prescription drug are not adulterated or
15    misbranded, as determined by a pharmacist employed by, or
16    under contract with, the pharmacy where the drug or
17    supplies are accepted or dispensed. The pharmacist must
18    inspect the drug or supplies before the drug or supplies
19    are dispensed.
20        (4) The prescription drug or supplies needed to
21    administer a prescription drug are prescribed by a
22    practitioner for use by an eligible individual.
23        (5) The prescription drug is not a controlled
24    substance.
 
25    Section 20. Resale of donated drugs or supplies prohibited.

 

 

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1No prescription drug or supplies needed to administer a
2prescription drug that are donated for use under this Act may
3be resold.
 
4    Section 25. Participation in program not required. Nothing
5in this Act requires that a pharmacy or pharmacist participate
6in the prescription drug repository pilot program.
 
7    Section 30. 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, including
15a pharmacist or other health professional, is immune from civil
16liability for injury to or the death of the individual to whom
17the prescription drug or supply is dispensed and may not be
18found guilty of unprofessional conduct for his or her acts or
19omissions related to donating, accepting, distributing, or
20dispensing a prescription drug or supply under this Act. The
21immunity granted under this subsection does not apply to acts
22or omissions outside the scope of the pilot program.
 
23    Section 35. Reports; termination. Not later than December

 

 

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131, 2022 the Department, in collaboration with the District,
2shall submit a report on the pilot program's effectiveness,
3viability, and benefit to public health to the General
4Assembly. Not later than December 31, 2024, the Department, in
5collaboration with the MWRD, shall submit a final report to the
6General Assembly and the pilot program shall terminate.
 
7    Section 40. Repeal. This Act is repealed on January 1,
82026.
 
9    Section 90. The Pharmacy Practice Act is amended by
10changing Section 4 as follows:
 
11    (225 ILCS 85/4)  (from Ch. 111, par. 4124)
12    (Section scheduled to be repealed on January 1, 2020)
13    Sec. 4. Exemptions. Nothing contained in any Section of
14this Act shall apply to, or in any manner interfere with:
15        (a) the lawful practice of any physician licensed to
16    practice medicine in all of its branches, dentist,
17    podiatric physician, veterinarian, or therapeutically or
18    diagnostically certified optometrist within the limits of
19    his or her license, or prevent him or her from supplying to
20    his or her bona fide patients such drugs, medicines, or
21    poisons as may seem to him appropriate;
22        (b) the sale of compressed gases;
23        (c) the sale of patent or proprietary medicines and

 

 

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1    household remedies when sold in original and unbroken
2    packages only, if such patent or proprietary medicines and
3    household remedies be properly and adequately labeled as to
4    content and usage and generally considered and accepted as
5    harmless and nonpoisonous when used according to the
6    directions on the label, and also do not contain opium or
7    coca leaves, or any compound, salt or derivative thereof,
8    or any drug which, according to the latest editions of the
9    following authoritative pharmaceutical treatises and
10    standards, namely, The United States
11    Pharmacopoeia/National Formulary (USP/NF), the United
12    States Dispensatory, and the Accepted Dental Remedies of
13    the Council of Dental Therapeutics of the American Dental
14    Association or any or either of them, in use on the
15    effective date of this Act, or according to the existing
16    provisions of the Federal Food, Drug, and Cosmetic Act and
17    Regulations of the Department of Health and Human Services,
18    Food and Drug Administration, promulgated thereunder now
19    in effect, is designated, described or considered as a
20    narcotic, hypnotic, habit forming, dangerous, or poisonous
21    drug;
22        (d) the sale of poultry and livestock remedies in
23    original and unbroken packages only, labeled for poultry
24    and livestock medication;
25        (e) the sale of poisonous substances or mixture of
26    poisonous substances, in unbroken packages, for

 

 

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1    nonmedicinal use in the arts or industries or for
2    insecticide purposes; provided, they are properly and
3    adequately labeled as to content and such nonmedicinal
4    usage, in conformity with the provisions of all applicable
5    federal, state and local laws and regulations promulgated
6    thereunder now in effect relating thereto and governing the
7    same, and those which are required under such applicable
8    laws and regulations to be labeled with the word "Poison",
9    are also labeled with the word "Poison" printed thereon in
10    prominent type and the name of a readily obtainable
11    antidote with directions for its administration;
12        (f) the delegation of limited prescriptive authority
13    by a physician licensed to practice medicine in all its
14    branches to a physician assistant under Section 7.5 of the
15    Physician Assistant Practice Act of 1987. This delegated
16    authority under Section 7.5 of the Physician Assistant
17    Practice Act of 1987 may, but is not required to, include
18    prescription of controlled substances, as defined in
19    Article II of the Illinois Controlled Substances Act, in
20    accordance with a written supervision agreement;
21        (g) the delegation of prescriptive authority by a
22    physician licensed to practice medicine in all its branches
23    or a licensed podiatric physician to an advanced practice
24    registered nurse in accordance with a written
25    collaborative agreement under Sections 65-35 and 65-40 of
26    the Nurse Practice Act; and

 

 

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1        (g-5) the donation or acceptance, or the packaging,
2    repackaging, or labeling, of prescription drugs to the
3    extent permitted or required under the Prescription Drug
4    Repository Pilot Program Act; and
5        (h) the sale or distribution of dialysate or devices
6    necessary to perform home peritoneal renal dialysis for
7    patients with end-stage renal disease, provided that all of
8    the following conditions are met:
9            (1) the dialysate, comprised of dextrose or
10        icodextrin, or devices are approved or cleared by the
11        federal Food and Drug Administration, as required by
12        federal law;
13            (2) the dialysate or devices are lawfully held by a
14        manufacturer or the manufacturer's agent, which is
15        properly registered with the Board as a manufacturer or
16        wholesaler;
17            (3) the dialysate or devices are held and delivered
18        to the manufacturer or the manufacturer's agent in the
19        original, sealed packaging from the manufacturing
20        facility;
21            (4) the dialysate or devices are delivered only
22        upon receipt of a physician's prescription by a
23        licensed pharmacy in which the prescription is
24        processed in accordance with provisions set forth in
25        this Act, and the transmittal of an order from the
26        licensed pharmacy to the manufacturer or the

 

 

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1        manufacturer's agent; and
2            (5) the manufacturer or the manufacturer's agent
3        delivers the dialysate or devices directly to: (i) a
4        patient with end-stage renal disease, or his or her
5        designee, for the patient's self-administration of the
6        dialysis therapy or (ii) a health care provider or
7        institution for administration or delivery of the
8        dialysis therapy to a patient with end-stage renal
9        disease.
10        This paragraph (h) does not include any other drugs for
11    peritoneal dialysis, except dialysate, as described in
12    item (1) of this paragraph (h). All records of sales and
13    distribution of dialysate to patients made pursuant to this
14    paragraph (h) must be retained in accordance with Section
15    18 of this Act.
16(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
17100-863, eff. 8-14-18.)
 
18    Section 95. The Wholesale Drug Distribution Licensing Act
19is amended by changing Section 15 as follows:
 
20    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
21    (Section scheduled to be repealed on January 1, 2023)
22    Sec. 15. Definitions. As used in this Act:
23    "Authentication" means the affirmative verification,
24before any wholesale distribution of a prescription drug

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1wholesale distribution; and chain pharmacy warehouses that
2conduct wholesale distribution. In order to be considered part
3of the normal distribution channel, a wholesale distributor
4must also be an authorized distributor of record.
5(Source: P.A. 97-804, eff. 1-1-13.)
 
6    Section 100. The Senior Pharmaceutical Assistance Act is
7amended by changing Section 10 as follows:
 
8    (320 ILCS 50/10)
9    Sec. 10. Definitions. In this Act:
10    "Manufacturer" includes:
11        (1) An entity that is engaged in (a) the production,
12    preparation, propagation, compounding, conversion, or
13    processing of prescription drug products (i) directly or
14    indirectly by extraction from substances of natural
15    origin, (ii) independently by means of chemical synthesis,
16    or (iii) by combination of extraction and chemical
17    synthesis; or (b) the packaging, repackaging, labeling or
18    re-labeling, or distribution of prescription drug
19    products.
20        (2) The entity holding legal title to or possession of
21    the national drug code number for the covered prescription
22    drug.
23    The term does not include a wholesale distributor of drugs,
24drugstore chain organization, or retail pharmacy licensed by

 

 

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1the State. The term also does not include anyone who is engaged
2in the packaging, repackaging, or labeling of prescription
3drugs only to the extent required under the Prescription Drug
4Repository Pilot Program Act.
5    "Prescription drug" means a drug that may be dispensed only
6upon prescription by an authorized prescriber and that is
7approved for safety and effectiveness as a prescription drug
8under Section 505 or 507 of the Federal Food, Drug and Cosmetic
9Act.
10    "Senior citizen" or "senior" means a person 65 years of age
11or older.
12(Source: P.A. 92-594, eff. 6-27-02.)
 
13    Section 105. The Illinois Food, Drug and Cosmetic Act is
14amended by changing Section 16 as follows:
 
15    (410 ILCS 620/16)  (from Ch. 56 1/2, par. 516)
16    Sec. 16. (a) The Director is hereby authorized to
17promulgate regulations exempting from any labeling or
18packaging requirement of this Act drugs and devices which are
19(i) , in accordance with the practice of the trade, to be
20processed, labeled or repacked in substantial quantities at
21establishments other than those where originally processed or
22packaged on condition that such drugs and devices are not
23adulterated or misbranded under the provisions of this Act upon
24removal from such processing, labeling or repacking

 

 

HB3414- 20 -LRB101 10547 CPF 55653 b

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

 

 

HB3414- 21 -LRB101 10547 CPF 55653 b

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

 

 

HB3414- 22 -LRB101 10547 CPF 55653 b

1prior to dispensing its label bears the caution statement
2quoted in the preceding sentence.
3    (g) Nothing in this Section shall be construed to relieve
4any person from any requirement prescribed by or under
5authority of law with respect to controlled substances now
6included or which may hereafter be included within the
7classifications of controlled substances cannabis as defined
8in applicable Federal laws relating to controlled substances or
9cannabis or the Cannabis Control Act.
10(Source: P.A. 84-1308.)
 
11    Section 110. The Illinois Controlled Substances Act is
12amended by changing Section 102 as follows:
 
13    (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
14    Sec. 102. Definitions. As used in this Act, unless the
15context otherwise requires:
16    (a) "Addict" means any person who habitually uses any drug,
17chemical, substance or dangerous drug other than alcohol so as
18to endanger the public morals, health, safety or welfare or who
19is so far addicted to the use of a dangerous drug or controlled
20substance other than alcohol as to have lost the power of self
21control with reference to his or her addiction.
22    (b) "Administer" means the direct application of a
23controlled substance, whether by injection, inhalation,
24ingestion, or any other means, to the body of a patient,

 

 

HB3414- 23 -LRB101 10547 CPF 55653 b

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

 

 

HB3414- 24 -LRB101 10547 CPF 55653 b

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

 

 

HB3414- 25 -LRB101 10547 CPF 55653 b

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

 

 

HB3414- 26 -LRB101 10547 CPF 55653 b

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

 

 

HB3414- 27 -LRB101 10547 CPF 55653 b

1        dihydroxyestr-4-ene), 
2    (xlv) 19-nor-5-androstenediol (3[beta], 17[beta]- 
3        dihydroxyestr-5-ene), 
4    (xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]- 
5        dihydroxyestr-5-ene), 
6    (xlvii) 19-nor-4,9(10)-androstadienedione  
7        (estra-4,9(10)-diene-3,17-dione), 
8    (xlviii) 19-nor-4-androstenedione (estr-4- 
9        en-3,17-dione), 
10    (xlix) 19-nor-5-androstenedione (estr-5- 
11        en-3,17-dione), 
12    (l) norbolethone (13[beta], 17a-diethyl-17[beta]- 
13        hydroxygon-4-en-3-one), 
14    (li) norclostebol (4-chloro-17[beta]- 
15        hydroxyestr-4-en-3-one), 
16    (lii) norethandrolone (17[alpha]-ethyl-17[beta]- 
17        hydroxyestr-4-en-3-one), 
18    (liii) normethandrolone (17[alpha]-methyl-17[beta]- 
19        hydroxyestr-4-en-3-one), 
20    (liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy- 
21        2-oxa-5[alpha]-androstan-3-one), 
22    (lv) oxymesterone (17[alpha]-methyl-4,17[beta]- 
23        dihydroxyandrost-4-en-3-one), 
24    (lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene- 
25        17[beta]-hydroxy-(5[alpha]-androstan-3-one), 
26    (lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy- 

 

 

HB3414- 28 -LRB101 10547 CPF 55653 b

1        (5[alpha]-androst-2-eno[3,2-c]-pyrazole), 
2    (lviii) stenbolone (17[beta]-hydroxy-2-methyl- 
3        (5[alpha]-androst-1-en-3-one), 
4    (lix) testolactone (13-hydroxy-3-oxo-13,17- 
5        secoandrosta-1,4-dien-17-oic 
6        acid lactone), 
7    (lx) testosterone (17[beta]-hydroxyandrost- 
8        4-en-3-one), 
9    (lxi) tetrahydrogestrinone (13[beta], 17[alpha]- 
10        diethyl-17[beta]-hydroxygon- 
11        4,9,11-trien-3-one), 
12    (lxii) trenbolone (17[beta]-hydroxyestr-4,9, 
13        11-trien-3-one). 
14    Any person who is otherwise lawfully in possession of an
15anabolic steroid, or who otherwise lawfully manufactures,
16distributes, dispenses, delivers, or possesses with intent to
17deliver an anabolic steroid, which anabolic steroid is
18expressly intended for and lawfully allowed to be administered
19through implants to livestock or other nonhuman species, and
20which is approved by the Secretary of Health and Human Services
21for such administration, and which the person intends to
22administer or have administered through such implants, shall
23not be considered to be in unauthorized possession or to
24unlawfully manufacture, distribute, dispense, deliver, or
25possess with intent to deliver such anabolic steroid for
26purposes of this Act.

 

 

HB3414- 29 -LRB101 10547 CPF 55653 b

1    (d) "Administration" means the Drug Enforcement
2Administration, United States Department of Justice, or its
3successor agency.
4    (d-5) "Clinical Director, Prescription Monitoring Program"
5means a Department of Human Services administrative employee
6licensed to either prescribe or dispense controlled substances
7who shall run the clinical aspects of the Department of Human
8Services Prescription Monitoring Program and its Prescription
9Information Library.
10    (d-10) "Compounding" means the preparation and mixing of
11components, excluding flavorings, (1) as the result of a
12prescriber's prescription drug order or initiative based on the
13prescriber-patient-pharmacist relationship in the course of
14professional practice or (2) for the purpose of, or incident
15to, research, teaching, or chemical analysis and not for sale
16or dispensing. "Compounding" includes the preparation of drugs
17or devices in anticipation of receiving prescription drug
18orders based on routine, regularly observed dispensing
19patterns. Commercially available products may be compounded
20for dispensing to individual patients only if both of the
21following conditions are met: (i) the commercial product is not
22reasonably available from normal distribution channels in a
23timely manner to meet the patient's needs and (ii) the
24prescribing practitioner has requested that the drug be
25compounded.
26    (e) "Control" means to add a drug or other substance, or

 

 

HB3414- 30 -LRB101 10547 CPF 55653 b

1immediate precursor, to a Schedule whether by transfer from
2another Schedule or otherwise.
3    (f) "Controlled Substance" means (i) a drug, substance,
4immediate precursor, or synthetic drug in the Schedules of
5Article II of this Act or (ii) a drug or other substance, or
6immediate precursor, designated as a controlled substance by
7the Department through administrative rule. The term does not
8include distilled spirits, wine, malt beverages, or tobacco, as
9those terms are defined or used in the Liquor Control Act of
101934 and the Tobacco Products Tax Act of 1995.
11    (f-5) "Controlled substance analog" means a substance:
12        (1) the chemical structure of which is substantially
13    similar to the chemical structure of a controlled substance
14    in Schedule I or II;
15        (2) which has a stimulant, depressant, or
16    hallucinogenic effect on the central nervous system that is
17    substantially similar to or greater than the stimulant,
18    depressant, or hallucinogenic effect on the central
19    nervous system of a controlled substance in Schedule I or
20    II; or
21        (3) with respect to a particular person, which such
22    person represents or intends to have a stimulant,
23    depressant, or hallucinogenic effect on the central
24    nervous system that is substantially similar to or greater
25    than the stimulant, depressant, or hallucinogenic effect
26    on the central nervous system of a controlled substance in

 

 

HB3414- 31 -LRB101 10547 CPF 55653 b

1    Schedule I or II.
2    (g) "Counterfeit substance" means a controlled substance,
3which, or the container or labeling of which, without
4authorization bears the trademark, trade name, or other
5identifying mark, imprint, number or device, or any likeness
6thereof, of a manufacturer, distributor, or dispenser other
7than the person who in fact manufactured, distributed, or
8dispensed the substance.
9    (h) "Deliver" or "delivery" means the actual, constructive
10or attempted transfer of possession of a controlled substance,
11with or without consideration, whether or not there is an
12agency relationship. "Deliver" or "delivery" does not include
13the donation of prescription drugs to the extent permitted
14under the Prescription Drug Repository Pilot Program Act.
15    (i) "Department" means the Illinois Department of Human
16Services (as successor to the Department of Alcoholism and
17Substance Abuse) or its successor agency.
18    (j) (Blank).
19    (k) "Department of Corrections" means the Department of
20Corrections of the State of Illinois or its successor agency.
21    (l) "Department of Financial and Professional Regulation"
22means the Department of Financial and Professional Regulation
23of the State of Illinois or its successor agency.
24    (m) "Depressant" means any drug that (i) causes an overall
25depression of central nervous system functions, (ii) causes
26impaired consciousness and awareness, and (iii) can be

 

 

HB3414- 32 -LRB101 10547 CPF 55653 b

1habit-forming or lead to a substance abuse problem, including
2but not limited to alcohol, cannabis and its active principles
3and their analogs, benzodiazepines and their analogs,
4barbiturates and their analogs, opioids (natural and
5synthetic) and their analogs, and chloral hydrate and similar
6sedative hypnotics.
7    (n) (Blank).
8    (o) "Director" means the Director of the Illinois State
9Police or his or her designated agents.
10    (p) "Dispense" means to deliver a controlled substance to
11an ultimate user or research subject by or pursuant to the
12lawful order of a prescriber, including the prescribing,
13administering, packaging, labeling, or compounding necessary
14to prepare the substance for that delivery.
15    (q) "Dispenser" means a practitioner who dispenses.
16    (r) "Distribute" means to deliver, other than by
17administering or dispensing, a controlled substance.
18    (s) "Distributor" means a person who distributes.
19    (t) "Drug" means (1) substances recognized as drugs in the
20official United States Pharmacopoeia, Official Homeopathic
21Pharmacopoeia of the United States, or official National
22Formulary, or any supplement to any of them; (2) substances
23intended for use in diagnosis, cure, mitigation, treatment, or
24prevention of disease in man or animals; (3) substances (other
25than food) intended to affect the structure of any function of
26the body of man or animals and (4) substances intended for use

 

 

HB3414- 33 -LRB101 10547 CPF 55653 b

1as a component of any article specified in clause (1), (2), or
2(3) of this subsection. It does not include devices or their
3components, parts, or accessories.
4    (t-3) "Electronic health record" or "EHR" means an
5electronic record of health-related information on an
6individual that is created, gathered, managed, and consulted by
7authorized health care clinicians and staff.
8    (t-4) "Emergency medical services personnel" has the
9meaning ascribed to it in the Emergency Medical Services (EMS)
10Systems Act.
11    (t-5) "Euthanasia agency" means an entity certified by the
12Department of Financial and Professional Regulation for the
13purpose of animal euthanasia that holds an animal control
14facility license or animal shelter license under the Animal
15Welfare Act. A euthanasia agency is authorized to purchase,
16store, possess, and utilize Schedule II nonnarcotic and
17Schedule III nonnarcotic drugs for the sole purpose of animal
18euthanasia.
19    (t-10) "Euthanasia drugs" means Schedule II or Schedule III
20substances (nonnarcotic controlled substances) that are used
21by a euthanasia agency for the purpose of animal euthanasia.
22    (u) "Good faith" means the prescribing or dispensing of a
23controlled substance by a practitioner in the regular course of
24professional treatment to or for any person who is under his or
25her treatment for a pathology or condition other than that
26individual's physical or psychological dependence upon or

 

 

HB3414- 34 -LRB101 10547 CPF 55653 b

1addiction to a controlled substance, except as provided herein:
2and application of the term to a pharmacist shall mean the
3dispensing of a controlled substance pursuant to the
4prescriber's order which in the professional judgment of the
5pharmacist is lawful. The pharmacist shall be guided by
6accepted professional standards including, but not limited to
7the following, in making the judgment:
8        (1) lack of consistency of prescriber-patient
9    relationship,
10        (2) frequency of prescriptions for same drug by one
11    prescriber for large numbers of patients,
12        (3) quantities beyond those normally prescribed,
13        (4) unusual dosages (recognizing that there may be
14    clinical circumstances where more or less than the usual
15    dose may be used legitimately),
16        (5) unusual geographic distances between patient,
17    pharmacist and prescriber,
18        (6) consistent prescribing of habit-forming drugs.
19    (u-0.5) "Hallucinogen" means a drug that causes markedly
20altered sensory perception leading to hallucinations of any
21type.
22    (u-1) "Home infusion services" means services provided by a
23pharmacy in compounding solutions for direct administration to
24a patient in a private residence, long-term care facility, or
25hospice setting by means of parenteral, intravenous,
26intramuscular, subcutaneous, or intraspinal infusion.

 

 

HB3414- 35 -LRB101 10547 CPF 55653 b

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

 

 

HB3414- 36 -LRB101 10547 CPF 55653 b

1substance or is distributed under circumstances which would
2lead a reasonable person to believe that the substance is a
3controlled substance. For the purpose of determining whether
4the representations made or the circumstances of the
5distribution would lead a reasonable person to believe the
6substance to be a controlled substance under this clause (2) of
7subsection (y), the court or other authority may consider the
8following factors in addition to any other factor that may be
9relevant:
10        (a) statements made by the owner or person in control
11    of the substance concerning its nature, use or effect;
12        (b) statements made to the buyer or recipient that the
13    substance may be resold for profit;
14        (c) whether the substance is packaged in a manner
15    normally used for the illegal distribution of controlled
16    substances;
17        (d) whether the distribution or attempted distribution
18    included an exchange of or demand for money or other
19    property as consideration, and whether the amount of the
20    consideration was substantially greater than the
21    reasonable retail market value of the substance.
22    Clause (1) of this subsection (y) shall not apply to a
23noncontrolled substance in its finished dosage form that was
24initially introduced into commerce prior to the initial
25introduction into commerce of a controlled substance in its
26finished dosage form which it may substantially resemble.

 

 

HB3414- 37 -LRB101 10547 CPF 55653 b

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

 

 

HB3414- 38 -LRB101 10547 CPF 55653 b

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

 

 

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1practice registered nurse certified as a nurse practitioner,
2nurse midwife, or clinical nurse specialist who has been
3granted authority to prescribe by a hospital affiliate in
4accordance with Section 65-45 of the Nurse Practice Act, (iv)
5an animal euthanasia agency, or (v) a prescribing psychologist.
6    (aa) "Narcotic drug" means any of the following, whether
7produced directly or indirectly by extraction from substances
8of vegetable origin, or independently by means of chemical
9synthesis, or by a combination of extraction and chemical
10synthesis:
11        (1) opium, opiates, derivatives of opium and opiates,
12    including their isomers, esters, ethers, salts, and salts
13    of isomers, esters, and ethers, whenever the existence of
14    such isomers, esters, ethers, and salts is possible within
15    the specific chemical designation; however the term
16    "narcotic drug" does not include the isoquinoline
17    alkaloids of opium;
18        (2) (blank);
19        (3) opium poppy and poppy straw;
20        (4) coca leaves, except coca leaves and extracts of
21    coca leaves from which substantially all of the cocaine and
22    ecgonine, and their isomers, derivatives and salts, have
23    been removed;
24        (5) cocaine, its salts, optical and geometric isomers,
25    and salts of isomers;
26        (6) ecgonine, its derivatives, their salts, isomers,

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1has full practice authority pursuant to Section 65-43 of the
2Nurse Practice Act.
3    (nn-5) "Prescription Information Library" (PIL) means an
4electronic library that contains reported controlled substance
5data.
6    (nn-10) "Prescription Monitoring Program" (PMP) means the
7entity that collects, tracks, and stores reported data on
8controlled substances and select drugs pursuant to Section 316.
9    (oo) "Production" or "produce" means manufacture,
10planting, cultivating, growing, or harvesting of a controlled
11substance other than methamphetamine.
12    (pp) "Registrant" means every person who is required to
13register under Section 302 of this Act.
14    (qq) "Registry number" means the number assigned to each
15person authorized to handle controlled substances under the
16laws of the United States and of this State.
17    (qq-5) "Secretary" means, as the context requires, either
18the Secretary of the Department or the Secretary of the
19Department of Financial and Professional Regulation, and the
20Secretary's designated agents.
21    (rr) "State" includes the State of Illinois and any state,
22district, commonwealth, territory, insular possession thereof,
23and any area subject to the legal authority of the United
24States of America.
25    (rr-5) "Stimulant" means any drug that (i) causes an
26overall excitation of central nervous system functions, (ii)

 

 

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1causes impaired consciousness and awareness, and (iii) can be
2habit-forming or lead to a substance abuse problem, including
3but not limited to amphetamines and their analogs,
4methylphenidate and its analogs, cocaine, and phencyclidine
5and its analogs.
6    (rr-10) "Synthetic drug" includes, but is not limited to,
7any synthetic cannabinoids or piperazines or any synthetic
8cathinones as provided for in Schedule I.
9    (ss) "Ultimate user" means a person who lawfully possesses
10a controlled substance for his or her own use or for the use of
11a member of his or her household or for administering to an
12animal owned by him or her or by a member of his or her
13household.
14(Source: P.A. 99-78, eff. 7-20-15; 99-173, eff. 7-29-15;
1599-371, eff. 1-1-16; 99-480, eff. 9-9-15; 99-642, eff. 7-28-16;
16100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513, eff.
171-1-18; 100-789, eff. 1-1-19; 100-863, eff. 8-14-18.)
 
18    Section 115. The Cannabis and Controlled Substances Tort
19Claims Act is amended by changing Section 3 as follows:
 
20    (740 ILCS 20/3)  (from Ch. 70, par. 903)
21    Sec. 3. Definitions. As used in this Act, unless the
22context otherwise requires:
23    "Cannabis" includes marihuana, hashish, and other
24substances that are identified as including any parts of the

 

 

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

 

 

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1    "Deliver" or "delivery" means the actual, constructive, or
2attempted transfer of possession of a controlled substance or
3cannabis, with or without consideration, whether or not there
4is an agency relationship. "Deliver" or "delivery" does not
5include the donation of prescription drugs to the extent
6permitted under the Prescription Drug Repository Pilot Program
7Act.
8    "Manufacture" means the production, preparation,
9propagation, compounding, conversion, or processing of a
10controlled substance, either directly or indirectly, by
11extraction from substances of natural origin, independently by
12means of chemical synthesis, or by a combination of extraction
13and chemical synthesis, and includes any packaging or
14repackaging of the substance or labeling of its container,
15except that the term does not include:
16        (1) by an ultimate user, the preparation or compounding
17    of a controlled substance for his own use;
18        (2) by a practitioner or his authorized agent under his
19    supervision, the preparation, compounding, packaging, or
20    labeling of a controlled substance:
21            (A) as an incident to his administering or
22        dispensing of a controlled substance in the course of
23        his professional practice; or
24            (B) as an incident to lawful research, teaching or
25        chemical analysis and not for sale; or
26        (3) the preparation, compounding, packaging, or

 

 

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1    labeling of cannabis as an incident to lawful research,
2    teaching, or chemical analysis and not for sale; or .
3        (4) the packaging, repackaging, or labeling of
4    prescription drugs only to the extent required under the
5    Prescription Drug Repository Pilot Program Act.
6    "Owner" means a person who has possession of or any
7interest whatsoever in the property involved.
8    "Person" means an individual, a corporation, a government,
9a governmental subdivision or agency, a business trust, an
10estate, a trust, a partnership or association, or any other
11entity.
12    "Production" means planting, cultivating, tending, or
13harvesting.
14    "Property" means real property, including things growing
15on, affixed to, and found in land, and tangible or intangible
16personal property, including rights, services, privileges,
17interests, claims, and securities.
18(Source: P.A. 96-328, eff. 8-11-09.)
 
19    Section 999. Effective date. This Act takes effect upon
20becoming law.

 

 

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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