Illinois General Assembly - Full Text of HB0119
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Full Text of HB0119  102nd General Assembly

HB0119eng 102ND GENERAL ASSEMBLY



 


 
HB0119 EngrossedLRB102 04093 CPF 14109 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
5Illinois Drug Reuse Opportunity 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    "Dispense" has the same meaning as defined in Section 3 of
10the Pharmacy Practice Act.
11    "Donor" means any person, including an individual member
12of the public, or any entity legally authorized to possess
13medicine, including, but not limited to, a wholesaler or
14distributor, third party logistic provider, pharmacy,
15dispenser, clinic, surgical or health center, detention and
16rehabilitation center, jail, prison laboratory, medical or
17pharmacy school, prescriber or other health care professional,
18long-term care facility, or healthcare facility. "Donor"
19includes government agencies and entities that are federally
20authorized to possess medicine, including, but not limited to,
21drug manufacturers, repackagers, relabelers, outsourcing
22facilities, health care facilities operated by the U.S.
23Department of Veterans Affairs, and prisons.

 

 

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1    "Drug" means a prescription drug, over-the-counter drug,
2or supplies needed to administer a prescription or
3over-the-counter drug.
4    "Eligible patient" means an individual:
5        (1) with a prescription for the drug, if a
6    prescription is required to dispense the drug, or who
7    reports symptoms treated by the drug if the drug is
8    over-the-counter; and
9        (2) who is registered with the drug's manufacturer in
10    accordance with federal Food and Drug Administration
11    requirements, if the registration is required to dispense
12    the drug.
13    "Manufacturer" has the same meaning as defined in Section
1415 of the Wholesale Drug Distribution Licensing Act.
15    "Pharmacist" means an individual licensed to engage in the
16practice of pharmacy under the Pharmacy Practice Act or
17licensed to engage in the practice of pharmacy in another
18state.
19    "Practitioner" means a person licensed in this State to
20dispense or administer drugs or who is licensed in another
21state as a person authorized to dispense or administer drugs.
22    "Prescription drug" means any prescribed drug that may be
23legally dispensed by a pharmacy.
24    "Priority patient" means an eligible patient who is an
25Illinois resident and who is indigent, uninsured,
26underinsured, or enrolled in a public health benefits program.

 

 

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1    "Recipient" means any person or entity legally authorized
2to possess medicine with a license or permit in the state in
3which the person or entity is located, including, but not
4limited to, a wholesaler or distributor, reverse distributor,
5repackager, hospital, pharmacy, clinic, or prescriber office.
6    "Returns processor" has the same meaning as defined in
7paragraph (18) of 21 U.S.C. 360eee. "Returns processor"
8includes, but is not limited to, a reverse distributor.
9    "Unopened tamper-evident packaging" has the same meaning
10as defined in the United States Pharmacopeia (USP) General
11Chapter 659, Packaging and Storage Requirements, including,
12but not limited to, unopened unit-dose, multiple-dose,
13immediate, secondary, and tertiary packaging.
 
14    Section 10. Donating and receiving drugs. Notwithstanding
15any other law or rule, donors may donate drugs to recipients
16and recipients may receive donated drugs from donors.
17Recipients shall only dispense or administer drugs to eligible
18patients as described in Section 20, further donate drugs to
19another recipient as described in Section 30, or dispose of
20drugs as described in Section 35.
 
21    Section 15. Cost-free provision of drugs. Drugs donated
22for use under this Act are considered nonsaleable. When
23dispensing a drug to an eligible patient, the recipient must
24do so at no cost to the eligible patient, except that a

 

 

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1reasonable handling fee may be charged. The handling fee may
2not exceed the direct or indirect cost to the recipient of
3providing the drug. Charging the fee does not constitute
4reselling.
 
5    Section 20. Requirements for dispensing drugs; priority.
6    (a) A recipient may only dispense or administer a
7prescription drug or provide an over-the-counter drug:
8        (1) if the recipient is otherwise permitted by law to
9    dispense or administer the drug;
10        (2) that meets the requirements in Section 25;
11        (3) that is repackaged into a new container or is in
12    its original container with all previous patient
13    information redacted or removed;
14        (4) that is properly labeled in accordance with the
15    rules and regulations of the Board of Pharmacy;
16        (5) that has an expiration or beyond-use date brought
17    forward from the donated prescription drug or
18    over-the-counter drug that will not expire before the use
19    by the eligible patient based on the prescribing
20    practitioner's directions for use or, for over-the-counter
21    medicine, on the package's label; and
22        (6) that is not adulterated or misbranded, as
23    determined by a pharmacist or practitioner.
24    (b) Recipients shall, to the greatest extent practicable,
25dispense drugs received under this Act to priority patients.
 

 

 

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1    Section 25. Requirements for accepting drugs. A drug
2received but not yet accepted into inventory shall be kept in a
3separate designated area. A drug may be accepted under this
4Act only if all of the following requirements are met:
5        (1) The drug is in unopened tamper-evident packaging
6    or has been repackaged according to Section 30.
7        (2) The drug is not expired.
8        (3) The drug is not a controlled substance.
9        (4) The recipient maintains a written or electronic
10    record of a donation made under this Act consisting of the
11    name, strength, and quantity of each accepted drug and the
12    name, address, and telephone number of the donor, unless a
13    recipient is further donating to a recipient under common
14    ownership or common control. Notwithstanding any other law
15    or rule, no other record of a donation is required.
16        (5) The donor has removed or redacted any patient name
17    and prescription number on the drug or otherwise maintains
18    patient confidentiality by executing a confidentiality
19    agreement with the recipient.
20        (6) The drug has a method recognized by the United
21    States Pharmacopeia to detect improper temperature
22    variations if the drug requires temperature control other
23    than room temperature storage.
 
24    Section 30. Donating and repackaging. Notwithstanding any

 

 

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1other law or rule, a recipient may:
2        (1) further donate drugs to another recipient;
3        (2) repackage donated drugs as necessary for storage,
4    dispensing, administration, or transfers in accordance
5    with the following:
6            (A) repackaged medicine shall be labeled with the
7        drug's name, strength, and expiration date, and shall
8        be kept in a separate designated area until inspected
9        and initialed by a pharmacist, practitioner, or a
10        pharmacy technician; and
11            (B) if multiple packaged donated medicines with
12        varied expiration dates are repackaged together, the
13        shortest expiration date shall be used; and
14        (3) replenish a drug of the same drug name and
15    strength previously dispensed or administered to an
16    eligible patient in accordance with Section 340B of the
17    federal Public Health Service Act.
 
18    Section 35. Disposition of drugs. A donated drug that does
19not meet the requirements of Section 25 must be disposed of by
20returning it to the donor, destroying it by an incinerator,
21medical waste hauler, or other lawful method, or transferring
22it to a returns processor. A record of disposal shall consist
23of the disposal method, the date of disposal, and the name and
24quantity of the drug disposed of. Notwithstanding any other
25law or rule, no other record of disposal shall be required.
 

 

 

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1    Section 40. Participation not required. Nothing in this
2Act requires that a pharmacy or pharmacist be a recipient of
3drugs under this Act.
 
4    Section 45. Recordkeeping requirements. When performing
5any action associated with a program under this Act or
6otherwise processing a donated drug for tax, manufacturer, or
7other credit, a recipient shall be considered to be acting as a
8returns processor and shall comply with all recordkeeping
9requirements for nonsaleable returns under federal law.
 
10    Section 50. Change of ownership. A donation or other
11transfer of possession or control of a drug under this Act
12shall not be construed as a change of ownership unless it is
13specified as such by the recipient. If a record of the
14donation's transaction information or history is required, the
15history shall begin with the donor of the drug, include all
16prior donations, and, if the drug was previously dispensed,
17only include drug information required to be on the patient
18label in accordance with the Board of Pharmacy's rules and
19regulations.
 
20    Section 55. Retention of records. All records required
21under this Act shall be retained in physical or electronic
22format and on or off the recipient's premises for a period of 6

 

 

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1years. Donors or recipients may contract with one another or a
2third party to create or maintain records on each other's
3behalf. An identifier, such as a serial number or bar code, may
4be used in place of any or all information required by a record
5or label pursuant to this Act if it allows for such information
6to be readily retrievable. Upon request by a State or federal
7regulatory agency, the identifier used for requested records
8shall be replaced with the original information. An identifier
9shall not be used on patient labels when dispensing or
10administering a drug.
 
11    Section 60. Authority. This Act supersedes any
12inconsistent law or rule for activities conducted under this
13Act.
 
14    Section 65. Immunity.
15    (a) Except as provided in subsection (b), no manufacturer,
16donor, or recipient shall be liable in any criminal or civil
17action, or be subject to professional discipline, for
18activities solely and directly attributable to donating,
19receiving, or dispensing drugs under this Act.
20    (b) The immunity provided in subsection (a) shall not
21apply:
22        (1) if it is shown that the act or omission was an
23    unreasonable, willful, wanton, or reckless act;
24        (2) if it is shown that the person or entity knew or

 

 

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1    should have known that the donated drug was adulterated or
2    misbranded; or
3        (3) to acts or omissions outside the scope of a
4    program under this Act.
 
5    Section 90. The Pharmacy Practice Act is amended by
6changing Section 4 as follows:
 
7    (225 ILCS 85/4)  (from Ch. 111, par. 4124)
8    (Section scheduled to be repealed on January 1, 2023)
9    Sec. 4. Exemptions. Nothing contained in any Section of
10this Act shall apply to, or in any manner interfere with:
11        (a) the lawful practice of any physician licensed to
12    practice medicine in all of its branches, dentist,
13    podiatric physician, veterinarian, or therapeutically or
14    diagnostically certified optometrist within the limits of
15    his or her license, or prevent him or her from supplying to
16    his or her bona fide patients such drugs, medicines, or
17    poisons as may seem to him appropriate;
18        (b) the sale of compressed gases;
19        (c) the sale of patent or proprietary medicines and
20    household remedies when sold in original and unbroken
21    packages only, if such patent or proprietary medicines and
22    household remedies be properly and adequately labeled as
23    to content and usage and generally considered and accepted
24    as harmless and nonpoisonous when used according to the

 

 

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

 

 

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1    thereunder now in effect relating thereto and governing
2    the same, and those which are required under such
3    applicable laws and regulations to be labeled with the
4    word "Poison", are also labeled with the word "Poison"
5    printed thereon in prominent type and the name of a
6    readily obtainable antidote with directions for its
7    administration;
8        (f) the delegation of limited prescriptive authority
9    by a physician licensed to practice medicine in all its
10    branches to a physician assistant under Section 7.5 of the
11    Physician Assistant Practice Act of 1987. This delegated
12    authority under Section 7.5 of the Physician Assistant
13    Practice Act of 1987 may, but is not required to, include
14    prescription of controlled substances, as defined in
15    Article II of the Illinois Controlled Substances Act, in
16    accordance with a written supervision agreement;
17        (g) the delegation of prescriptive authority by a
18    physician licensed to practice medicine in all its
19    branches or a licensed podiatric physician to an advanced
20    practice registered nurse in accordance with a written
21    collaborative agreement under Sections 65-35 and 65-40 of
22    the Nurse Practice Act; and
23        (g-5) the donation or acceptance, or the packaging,
24    repackaging, or labeling, of drugs to the extent permitted
25    under the Illinois Drug Reuse Opportunity Program Act; and
26        (h) the sale or distribution of dialysate or devices

 

 

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

 

 

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1        dialysis therapy or (ii) a health care provider or
2        institution for administration or delivery of the
3        dialysis therapy to a patient with end-stage renal
4        disease.
5        This paragraph (h) does not include any other drugs
6    for peritoneal dialysis, except dialysate, as described in
7    item (1) of this paragraph (h). All records of sales and
8    distribution of dialysate to patients made pursuant to
9    this paragraph (h) must be retained in accordance with
10    Section 18 of this Act.
11(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
12100-863, eff. 8-14-18; 101-420, eff. 8-16-19.)
 
13    Section 95. The Wholesale Drug Distribution Licensing Act
14is amended by changing Section 15 as follows:
 
15    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
16    (Section scheduled to be repealed on January 1, 2023)
17    Sec. 15. Definitions. As used in this Act:
18    "Authentication" means the affirmative verification,
19before any wholesale distribution of a prescription drug
20occurs, that each transaction listed on the pedigree has
21occurred.
22    "Authorized distributor of record" means a wholesale
23distributor with whom a manufacturer has established an
24ongoing relationship to distribute the manufacturer's

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

HB0119 Engrossed- 19 -LRB102 04093 CPF 14109 b

1container, wrapper, or labeling to further the distribution of
2a prescription drug, excluding that completed by the
3pharmacist responsible for dispensing the product to a
4patient.
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.
13    "Wholesale distribution" means the distribution of
14prescription drugs to persons other than a consumer or
15patient, but does not include any of the following:
16        (1) Intracompany sales of prescription drugs, meaning
17    (i) any transaction or transfer between any division,
18    subsidiary, parent, or affiliated or related company under
19    the common ownership and control of a corporate entity or
20    (ii) any transaction or transfer between co-licensees of a
21    co-licensed product.
22        (2) The sale, purchase, distribution, trade, or
23    transfer of a prescription drug or offer to sell,
24    purchase, distribute, trade, or transfer a prescription
25    drug for emergency medical reasons.
26        (3) The distribution of prescription drug samples by

 

 

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

 

 

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

 

 

HB0119 Engrossed- 22 -LRB102 04093 CPF 14109 b

1(Source: P.A. 101-420, eff. 8-16-19.)
 
2    Section 100. The Senior Pharmaceutical Assistance Act is
3amended by changing Section 10 as follows:
 
4    (320 ILCS 50/10)
5    Sec. 10. Definitions. In this Act:
6    "Manufacturer" includes:
7        (1) An entity that is engaged in (a) the production,
8    preparation, propagation, compounding, conversion, or
9    processing of prescription drug products (i) directly or
10    indirectly by extraction from substances of natural
11    origin, (ii) independently by means of chemical synthesis,
12    or (iii) by combination of extraction and chemical
13    synthesis; or (b) the packaging, repackaging, labeling or
14    re-labeling, or distribution of prescription drug
15    products.
16        (2) The entity holding legal title to or possession of
17    the national drug code number for the covered prescription
18    drug.
19    The term does not include a wholesale distributor of
20drugs, drugstore chain organization, or retail pharmacy
21licensed by the State. The term also does not include anyone
22who is engaged in the packaging, repackaging, or labeling of
23drugs only to the extent permitted under the Illinois Drug
24Reuse Opportunity Program Act.

 

 

HB0119 Engrossed- 23 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 24 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 25 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 26 -LRB102 04093 CPF 14109 b

1authority of law with respect to controlled substances now
2included or which may hereafter be included within the
3classifications of controlled substances cannabis as defined
4in applicable Federal laws relating to controlled substances
5or cannabis or the Cannabis Control Act.
6(Source: P.A. 84-1308.)
 
7    Section 110. The Illinois Controlled Substances Act is
8amended by changing Section 102 as follows:
 
9    (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
10    Sec. 102. Definitions. As used in this Act, unless the
11context otherwise requires:
12    (a) "Addict" means any person who habitually uses any
13drug, chemical, substance or dangerous drug other than alcohol
14so as to endanger the public morals, health, safety or welfare
15or who is so far addicted to the use of a dangerous drug or
16controlled substance other than alcohol as to have lost the
17power of self control with reference to his or her addiction.
18    (b) "Administer" means the direct application of a
19controlled substance, whether by injection, inhalation,
20ingestion, or any other means, to the body of a patient,
21research subject, or animal (as defined by the Humane
22Euthanasia in Animal Shelters Act) by:
23        (1) a practitioner (or, in his or her presence, by his
24    or her authorized agent),

 

 

HB0119 Engrossed- 27 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 28 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 29 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 30 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 31 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 32 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 33 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 34 -LRB102 04093 CPF 14109 b

1Article II of this Act or (ii) a drug or other substance, or
2immediate precursor, designated as a controlled substance by
3the Department through administrative rule. The term does not
4include distilled spirits, wine, malt beverages, or tobacco,
5as those terms are defined or used in the Liquor Control Act of
61934 and the Tobacco Products Tax Act of 1995.
7    (f-5) "Controlled substance analog" means a substance:
8        (1) the chemical structure of which is substantially
9    similar to the chemical structure of a controlled
10    substance in Schedule I or II;
11        (2) which has a stimulant, depressant, or
12    hallucinogenic effect on the central nervous system that
13    is substantially similar to or greater than the stimulant,
14    depressant, or hallucinogenic effect on the central
15    nervous system of a controlled substance in Schedule I or
16    II; or
17        (3) with respect to a particular person, which such
18    person represents or intends to have a stimulant,
19    depressant, or hallucinogenic effect on the central
20    nervous system that is substantially similar to or greater
21    than the stimulant, depressant, or hallucinogenic effect
22    on the central nervous system of a controlled substance in
23    Schedule I or II.
24    (g) "Counterfeit substance" means a controlled substance,
25which, or the container or labeling of which, without
26authorization bears the trademark, trade name, or other

 

 

HB0119 Engrossed- 35 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 36 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 37 -LRB102 04093 CPF 14109 b

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

 

 

HB0119 Engrossed- 38 -LRB102 04093 CPF 14109 b

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1Nurse Practice Act.
2    (nn-5) "Prescription Information Library" (PIL) means an
3electronic library that contains reported controlled substance
4data.
5    (nn-10) "Prescription Monitoring Program" (PMP) means the
6entity that collects, tracks, and stores reported data on
7controlled substances and select drugs pursuant to Section
8316.
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.
167-28-16; 100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513,
17eff. 1-1-18; 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
9chemical synthesis, or by a combination of extraction and
10chemical synthesis. "Cannabis" does not include the mature
11stalks of that plant, fiber produced from those stalks, oil or
12cake made from the seeds of that plant, any other compound,
13manufacture, salt, derivative, mixture, or preparation of
14mature stalks (except the extracted resin), fiber, oil or
15cake, or the sterilized seeds of that plant that are incapable
16of germination.
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,
26or dispensed 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 drugs to the extent permitted under
6the Illinois Drug Reuse Opportunity Program Act.
7    "Manufacture" means the production, preparation,
8propagation, compounding, conversion, or processing of a
9controlled substance, either directly or indirectly, by
10extraction from substances of natural origin, independently by
11means of chemical synthesis, or by a combination of extraction
12and chemical synthesis, and includes any packaging or
13repackaging of the substance or labeling of its container,
14except that the term does not include:
15        (1) by an ultimate user, the preparation or
16    compounding of a controlled substance for his own use;
17        (2) by a practitioner or his authorized agent under
18    his supervision, the preparation, compounding, packaging,
19    or labeling of a controlled substance:
20            (A) as an incident to his administering or
21        dispensing of a controlled substance in the course of
22        his professional practice; or
23            (B) as an incident to lawful research, teaching or
24        chemical analysis and not for sale; or
25        (3) the preparation, compounding, packaging, or
26    labeling of cannabis as an incident to lawful research,

 

 

HB0119 Engrossed- 52 -LRB102 04093 CPF 14109 b

1    teaching, or chemical analysis and not for sale; or .
2        (4) the packaging, repackaging, or labeling of drugs
3    only to the extent permitted under the Illinois Drug Reuse
4    Opportunity Program Act.
5    "Owner" means a person who has possession of or any
6interest whatsoever in the property involved.
7    "Person" means an individual, a corporation, a government,
8a governmental subdivision or agency, a business trust, an
9estate, a trust, a partnership or association, or any other
10entity.
11    "Production" means planting, cultivating, tending, or
12harvesting.
13    "Property" means real property, including things growing
14on, affixed to, and found in land, and tangible or intangible
15personal property, including rights, services, privileges,
16interests, claims, and securities.
17(Source: P.A. 96-328, eff. 8-11-09.)