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

HB0119sam001 102ND GENERAL ASSEMBLY

Sen. Karina Villa

Filed: 5/6/2021

 

 


 

 


 
10200HB0119sam001LRB102 04093 CPF 26058 a

1
AMENDMENT TO HOUSE BILL 119

2    AMENDMENT NO. ______. Amend House Bill 119 by replacing
3everything after the enacting clause with the following:
 
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

 

 

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1pharmacy school, prescriber or other health care professional,
2long-term care facility, or healthcare facility. "Donor"
3includes government agencies and entities that are federally
4authorized to possess medicine, including, but not limited to,
5drug manufacturers, repackagers, relabelers, outsourcing
6facilities, health care facilities operated by the U.S.
7Department of Veterans Affairs, and prisons.
8    "Drug" means a prescription drug, over-the-counter drug,
9or supplies needed to administer a prescription or
10over-the-counter drug.
11    "Eligible patient" means an individual:
12        (1) with a prescription for the drug, if a
13    prescription is required to dispense the drug, or who
14    reports symptoms treated by the drug if the drug is
15    over-the-counter; and
16        (2) who is registered with the drug's manufacturer in
17    accordance with federal Food and Drug Administration
18    requirements, if the registration is required to dispense
19    the drug.
20    "Manufacturer" has the same meaning as defined in Section
2115 of the Wholesale Drug Distribution Licensing Act.
22    "Pharmacist" means an individual licensed to engage in the
23practice of pharmacy under the Pharmacy Practice Act or
24licensed to engage in the practice of pharmacy in another
25state.
26    "Practitioner" means a person licensed in this State to

 

 

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1dispense or administer drugs or who is licensed in another
2state as a person authorized to dispense or administer drugs.
3    "Prescription drug" means any prescribed drug that may be
4legally dispensed by a pharmacy. "Prescription drug" does not
5include a drug for the treatment of cancer that can only be
6dispensed to a patient registered with the drug manufacturer
7in accordance with the federal Food and Drug Administration's
8requirements.
9    "Priority patient" means an eligible patient who is an
10Illinois resident and who is indigent, uninsured,
11underinsured, or enrolled in a public health benefits program.
12    "Recipient" means any person or entity legally authorized
13to possess medicine with a license or permit in the state in
14which the person or entity is located, including, but not
15limited to, a wholesaler or distributor, reverse distributor,
16repackager, hospital, pharmacy, or clinic.
17    "Returns processor" has the same meaning as defined in
18paragraph (18) of 21 U.S.C. 360eee. "Returns processor"
19includes, but is not limited to, a reverse distributor.
20    "Unopened tamper-evident packaging" has the same meaning
21as defined in the United States Pharmacopeia (USP) General
22Chapter 659, Packaging and Storage Requirements, including,
23but not limited to, unopened unit-dose, multiple-dose,
24immediate, secondary, and tertiary packaging.
 
25    Section 10. Donating and receiving drugs. Notwithstanding

 

 

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1any other law or rule, donors may donate drugs to recipients
2and recipients may receive donated drugs from donors.
3Recipients shall only dispense or administer drugs to eligible
4patients as described in Section 20, further donate drugs to
5another recipient as described in Section 30, or dispose of
6drugs as described in Section 35.
 
7    Section 15. Cost-free provision of drugs. Drugs donated
8for use under this Act are considered nonsaleable. When
9dispensing a drug to an eligible patient, the recipient must
10do so at no cost to the eligible patient, except that a uniform
11reasonable handling fee may be charged. The handling fee may
12not exceed the direct or indirect cost to the recipient of
13providing the drug. Charging the fee does not constitute
14reselling.
 
15    Section 20. Requirements for dispensing drugs; priority.
16    (a) A recipient may only dispense or administer a
17prescription drug or provide an over-the-counter drug:
18        (1) if the recipient is otherwise permitted by law to
19    dispense or administer the drug;
20        (2) that meets the requirements in Section 25;
21        (3) that is repackaged into a new container or is in
22    its original container with all previous patient
23    information redacted or removed;
24        (4) that is properly labeled in accordance with the

 

 

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1    rules and regulations of the Board of Pharmacy;
2        (5) that has an expiration or beyond-use date brought
3    forward from the donated prescription drug or
4    over-the-counter drug that will not expire before the use
5    by the eligible patient based on the prescribing
6    practitioner's directions for use or, for over-the-counter
7    medicine, on the package's label; and
8        (6) that is not adulterated or misbranded, as
9    determined by a pharmacist or practitioner.
10    (b) Recipients shall, to the greatest extent practicable,
11dispense drugs received under this Act to priority patients.
 
12    Section 25. Requirements for accepting drugs. A drug
13received but not yet accepted into inventory shall be kept in a
14separate designated area. A drug may be accepted under this
15Act only if all of the following requirements are met:
16        (1) The drug is in unopened tamper-evident packaging
17    or has been repackaged according to Section 30.
18        (2) The drug is not expired.
19        (3) The drug is not a controlled substance.
20        (4) The recipient maintains a written or electronic
21    record of a donation made under this Act consisting of the
22    name, strength, and quantity of each accepted drug and the
23    name, address, and telephone number of the donor, unless a
24    recipient is further donating to a recipient under common
25    ownership or common control. Notwithstanding any other law

 

 

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1    or rule, no other record of a donation is required.
2        (5) The donor has removed or redacted any patient name
3    and prescription number and any other patient identifying
4    information on the drug or otherwise maintains patient
5    confidentiality by executing a confidentiality agreement
6    with the recipient according to all State and federal
7    medical patient privacy laws, rules, or regulations.
8        (6) The drug has a method recognized by the United
9    States Pharmacopeia to detect improper temperature
10    variations if the drug requires temperature control other
11    than room temperature storage.
 
12    Section 30. Donating and repackaging. Notwithstanding any
13other law or rule, a recipient may:
14        (1) further donate drugs to another recipient;
15        (2) repackage donated drugs as necessary for storage,
16    dispensing, administration, or transfers in accordance
17    with the following:
18            (A) repackaged medicine shall be labeled with the
19        drug's name, strength, and expiration date, and shall
20        be kept in a separate designated area until inspected
21        and initialed by a pharmacist, practitioner, or a
22        pharmacy technician; and
23            (B) if multiple packaged donated medicines with
24        varied expiration dates are repackaged together, the
25        shortest expiration date shall be used; and

 

 

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1        (3) replenish a drug of the same drug name and
2    strength previously dispensed or administered to an
3    eligible patient in accordance with Section 340B of the
4    federal Public Health Service Act.
 
5    Section 35. Disposition of drugs. A donated drug that does
6not meet the requirements of Section 25 must be disposed of by
7returning it to the donor, destroying it by an incinerator,
8medical waste hauler, or other lawful method, or transferring
9it to a returns processor. A record of disposal shall consist
10of the disposal method, the date of disposal, and the name and
11quantity of the drug disposed of. Notwithstanding any other
12law or rule, no other record of disposal shall be required.
 
13    Section 40. Participation not required. Nothing in this
14Act requires that a pharmacy or pharmacist be a recipient of
15drugs under this Act.
 
16    Section 45. Recordkeeping requirements. When performing
17any action associated with a program under this Act or
18otherwise processing a donated drug for tax, manufacturer, or
19other credit, a recipient shall be considered to be acting as a
20returns processor and shall comply with all recordkeeping
21requirements for nonsaleable returns under federal law.
 
22    Section 50. Change of ownership. A donation or other

 

 

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1transfer of possession or control of a drug under this Act
2shall not be construed as a change of ownership unless it is
3specified as such by the recipient. If a record of the
4donation's transaction information or history is required, the
5history shall begin with the donor of the drug, include all
6prior donations, and, if the drug was previously dispensed,
7only include drug information required to be on the patient
8label in accordance with the Board of Pharmacy's rules and
9regulations.
 
10    Section 55. Retention of records. All records required
11under this Act shall be retained in physical or electronic
12format and on or off the recipient's premises for a period of 6
13years. Donors or recipients may contract with one another or a
14third party to create or maintain records on each other's
15behalf. An identifier, such as a serial number or bar code, may
16be used in place of any or all information required by a record
17or label pursuant to this Act if it allows for such information
18to be readily retrievable. Upon request by a State or federal
19regulatory agency, the identifier used for requested records
20shall be replaced with the original information. An identifier
21shall not be used on patient labels when dispensing or
22administering a drug.
 
23    Section 60. Authority. This Act supersedes any
24inconsistent law or rule for activities conducted under this

 

 

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1Act.
 
2    Section 65. Immunity.
3    (a) Except as provided in subsection (b), no manufacturer,
4donor, or recipient shall be liable in any criminal or civil
5action, or be subject to professional discipline, for
6activities solely and directly attributable to donating,
7receiving, or dispensing drugs under this Act.
8    (b) The immunity provided in subsection (a) shall not
9apply:
10        (1) if it is shown that the act or omission was an
11    unreasonable, willful, wanton, or reckless act;
12        (2) if it is shown that the person or entity knew or
13    should have known that the donated drug was adulterated or
14    misbranded; or
15        (3) to acts or omissions outside the scope of a
16    program under this Act.
 
17    Section 90. The Pharmacy Practice Act is amended by
18changing Section 4 as follows:
 
19    (225 ILCS 85/4)  (from Ch. 111, par. 4124)
20    (Section scheduled to be repealed on January 1, 2023)
21    Sec. 4. Exemptions. Nothing contained in any Section of
22this Act shall apply to, or in any manner interfere with:
23        (a) the lawful practice of any physician licensed to

 

 

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1    practice medicine in all of its branches, dentist,
2    podiatric physician, veterinarian, or therapeutically or
3    diagnostically certified optometrist within the limits of
4    his or her license, or prevent him or her from supplying to
5    his or her bona fide patients such drugs, medicines, or
6    poisons as may seem to him appropriate;
7        (b) the sale of compressed gases;
8        (c) the sale of patent or proprietary medicines and
9    household remedies when sold in original and unbroken
10    packages only, if such patent or proprietary medicines and
11    household remedies be properly and adequately labeled as
12    to content and usage and generally considered and accepted
13    as harmless and nonpoisonous when used according to the
14    directions on the label, and also do not contain opium or
15    coca leaves, or any compound, salt or derivative thereof,
16    or any drug which, according to the latest editions of the
17    following authoritative pharmaceutical treatises and
18    standards, namely, The United States
19    Pharmacopoeia/National Formulary (USP/NF), the United
20    States Dispensatory, and the Accepted Dental Remedies of
21    the Council of Dental Therapeutics of the American Dental
22    Association or any or either of them, in use on the
23    effective date of this Act, or according to the existing
24    provisions of the Federal Food, Drug, and Cosmetic Act and
25    Regulations of the Department of Health and Human
26    Services, Food and Drug Administration, promulgated

 

 

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1    thereunder now in effect, is designated, described or
2    considered as a narcotic, hypnotic, habit forming,
3    dangerous, or poisonous drug;
4        (d) the sale of poultry and livestock remedies in
5    original and unbroken packages only, labeled for poultry
6    and livestock medication;
7        (e) the sale of poisonous substances or mixture of
8    poisonous substances, in unbroken packages, for
9    nonmedicinal use in the arts or industries or for
10    insecticide purposes; provided, they are properly and
11    adequately labeled as to content and such nonmedicinal
12    usage, in conformity with the provisions of all applicable
13    federal, state and local laws and regulations promulgated
14    thereunder now in effect relating thereto and governing
15    the same, and those which are required under such
16    applicable laws and regulations to be labeled with the
17    word "Poison", are also labeled with the word "Poison"
18    printed thereon in prominent type and the name of a
19    readily obtainable antidote with directions for its
20    administration;
21        (f) the delegation of limited prescriptive authority
22    by a physician licensed to practice medicine in all its
23    branches to a physician assistant under Section 7.5 of the
24    Physician Assistant Practice Act of 1987. This delegated
25    authority under Section 7.5 of the Physician Assistant
26    Practice Act of 1987 may, but is not required to, include

 

 

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1    prescription of controlled substances, as defined in
2    Article II of the Illinois Controlled Substances Act, in
3    accordance with a written supervision agreement;
4        (g) the delegation of prescriptive authority by a
5    physician licensed to practice medicine in all its
6    branches or a licensed podiatric physician to an advanced
7    practice registered nurse in accordance with a written
8    collaborative agreement under Sections 65-35 and 65-40 of
9    the Nurse Practice Act; and
10        (g-5) the donation or acceptance, or the packaging,
11    repackaging, or labeling, of drugs to the extent permitted
12    under the Illinois Drug Reuse Opportunity Program Act; and
13        (h) the sale or distribution of dialysate or devices
14    necessary to perform home peritoneal renal dialysis for
15    patients with end-stage renal disease, provided that all
16    of the following conditions are met:
17            (1) the dialysate, comprised of dextrose or
18        icodextrin, or devices are approved or cleared by the
19        federal Food and Drug Administration, as required by
20        federal law;
21            (2) the dialysate or devices are lawfully held by
22        a manufacturer or the manufacturer's agent, which is
23        properly registered with the Board as a manufacturer,
24        third-party logistics provider, or wholesaler;
25            (3) the dialysate or devices are held and
26        delivered to the manufacturer or the manufacturer's

 

 

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1        agent in the original, sealed packaging from the
2        manufacturing facility;
3            (4) the dialysate or devices are delivered only
4        upon receipt of a physician's prescription by a
5        licensed pharmacy in which the prescription is
6        processed in accordance with provisions set forth in
7        this Act, and the transmittal of an order from the
8        licensed pharmacy to the manufacturer or the
9        manufacturer's agent; and
10            (5) the manufacturer or the manufacturer's agent
11        delivers the dialysate or devices directly to: (i) a
12        patient with end-stage renal disease, or his or her
13        designee, for the patient's self-administration of the
14        dialysis therapy or (ii) a health care provider or
15        institution for administration or delivery of the
16        dialysis therapy to a patient with end-stage renal
17        disease.
18        This paragraph (h) does not include any other drugs
19    for peritoneal dialysis, except dialysate, as described in
20    item (1) of this paragraph (h). All records of sales and
21    distribution of dialysate to patients made pursuant to
22    this paragraph (h) must be retained in accordance with
23    Section 18 of this Act.
24(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
25100-863, eff. 8-14-18; 101-420, eff. 8-16-19.)
 

 

 

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1    Section 95. The Wholesale Drug Distribution Licensing Act
2is amended by changing Section 15 as follows:
 
3    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
4    (Section scheduled to be repealed on January 1, 2023)
5    Sec. 15. Definitions. As used in this Act:
6    "Authentication" means the affirmative verification,
7before any wholesale distribution of a prescription drug
8occurs, that each transaction listed on the pedigree has
9occurred.
10    "Authorized distributor of record" means a wholesale
11distributor with whom a manufacturer has established an
12ongoing relationship to distribute the manufacturer's
13prescription drug. An ongoing relationship is deemed to exist
14between a wholesale distributor and a manufacturer when the
15wholesale distributor, including any affiliated group of the
16wholesale distributor, as defined in Section 1504 of the
17Internal Revenue Code, complies with the following:
18        (1) The wholesale distributor has a written agreement
19    currently in effect with the manufacturer evidencing the
20    ongoing relationship; and
21        (2) The wholesale distributor is listed on the
22    manufacturer's current list of authorized distributors of
23    record, which is updated by the manufacturer on no less
24    than a monthly basis.
25    "Blood" means whole blood collected from a single donor

 

 

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1and processed either for transfusion or further manufacturing.
2    "Blood component" means that part of blood separated by
3physical or mechanical means.
4    "Board" means the State Board of Pharmacy of the
5Department of Professional Regulation.
6    "Chain pharmacy warehouse" means a physical location for
7prescription drugs that acts as a central warehouse and
8performs intracompany sales or transfers of the drugs to a
9group of chain or mail order pharmacies that have the same
10common ownership and control. Notwithstanding any other
11provision of this Act, a chain pharmacy warehouse shall be
12considered part of the normal distribution channel.
13    "Co-licensed partner or product" means an instance where
14one or more parties have the right to engage in the
15manufacturing or marketing of a prescription drug, consistent
16with the FDA's implementation of the Prescription Drug
17Marketing Act.
18    "Department" means the Department of Financial and
19Professional Regulation.
20    "Drop shipment" means the sale of a prescription drug to a
21wholesale distributor by the manufacturer of the prescription
22drug or that manufacturer's co-licensed product partner, that
23manufacturer's third party logistics provider, or that
24manufacturer's exclusive distributor or by an authorized
25distributor of record that purchased the product directly from
26the manufacturer or one of these entities whereby the

 

 

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

 

 

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

 

 

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1        (3) a wholesale distributor to a chain pharmacy
2    warehouse to that chain pharmacy warehouse's intracompany
3    pharmacy to a patient or other designated persons
4    authorized by law to dispense or administer the drug to a
5    patient;
6        (4) a chain pharmacy warehouse to the chain pharmacy
7    warehouse's intracompany pharmacy or other designated
8    persons authorized by law to dispense or administer the
9    drug to the patient;
10        (5) an authorized distributor of record to one other
11    authorized distributor of record to an office-based health
12    care practitioner authorized by law to dispense or
13    administer the drug to the patient; or
14        (6) an authorized distributor to a pharmacy or other
15    persons licensed to dispense or administer the drug.
16    "Pedigree" means a document or electronic file containing
17information that records each wholesale distribution of any
18given prescription drug from the point of origin to the final
19wholesale distribution point of any given prescription drug.
20    "Person" means and includes a natural person, partnership,
21association, corporation, or any other legal business entity.
22    "Pharmacy distributor" means any pharmacy licensed in this
23State or hospital pharmacy that is engaged in the delivery or
24distribution of prescription drugs either to any other
25pharmacy licensed in this State or to any other person or
26entity including, but not limited to, a wholesale drug

 

 

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

 

 

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

 

 

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1    accomplished as a purchase and sale of stock or business
2    assets.
3        (8) The sale, purchase, distribution, trade, or
4    transfer of a prescription drug from one authorized
5    distributor of record to one additional authorized
6    distributor of record when the manufacturer has stated in
7    writing to the receiving authorized distributor of record
8    that the manufacturer is unable to supply the prescription
9    drug and the supplying authorized distributor of record
10    states in writing that the prescription drug being
11    supplied had until that time been exclusively in the
12    normal distribution channel.
13        (9) The delivery of or the offer to deliver a
14    prescription drug by a common carrier solely in the common
15    carrier's usual course of business of transporting
16    prescription drugs when the common carrier does not store,
17    warehouse, or take legal ownership of the prescription
18    drug.
19        (10) The sale or transfer from a retail pharmacy, mail
20    order pharmacy, or chain pharmacy warehouse of expired,
21    damaged, returned, or recalled prescription drugs to the
22    original manufacturer, the originating wholesale
23    distributor, or a third party returns processor.
24        (11) The donation of drugs to the extent permitted
25    under the Illinois Drug Reuse Opportunity Program Act.
26    "Wholesale drug distributor" means anyone engaged in the

 

 

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1wholesale distribution of prescription drugs into, out of, or
2within the State, including without limitation manufacturers;
3repackers; own label distributors; jobbers; private label
4distributors; brokers; warehouses, including manufacturers'
5and distributors' warehouses; manufacturer's exclusive
6distributors; and authorized distributors of record; drug
7wholesalers or distributors; independent wholesale drug
8traders; specialty wholesale distributors; and retail
9pharmacies that conduct wholesale distribution; and chain
10pharmacy warehouses that conduct wholesale distribution. In
11order to be considered part of the normal distribution
12channel, a wholesale distributor must also be an authorized
13distributor of record.
14(Source: P.A. 101-420, eff. 8-16-19.)
 
15    Section 100. The Senior Pharmaceutical Assistance Act is
16amended by changing Section 10 as follows:
 
17    (320 ILCS 50/10)
18    Sec. 10. Definitions. In this Act:
19    "Manufacturer" includes:
20        (1) An entity that is engaged in (a) the production,
21    preparation, propagation, compounding, conversion, or
22    processing of prescription drug products (i) directly or
23    indirectly by extraction from substances of natural
24    origin, (ii) independently by means of chemical synthesis,

 

 

10200HB0119sam001- 23 -LRB102 04093 CPF 26058 a

1    or (iii) by combination of extraction and chemical
2    synthesis; or (b) the packaging, repackaging, labeling or
3    re-labeling, or distribution of prescription drug
4    products.
5        (2) The entity holding legal title to or possession of
6    the national drug code number for the covered prescription
7    drug.
8    The term does not include a wholesale distributor of
9drugs, drugstore chain organization, or retail pharmacy
10licensed by the State. The term also does not include anyone
11who is engaged in the packaging, repackaging, or labeling of
12drugs only to the extent permitted under the Illinois Drug
13Reuse Opportunity Program Act.
14    "Prescription drug" means a drug that may be dispensed
15only upon prescription by an authorized prescriber and that is
16approved for safety and effectiveness as a prescription drug
17under Section 505 or 507 of the Federal Food, Drug and Cosmetic
18Act.
19    "Senior citizen" or "senior" means a person 65 years of
20age or older.
21(Source: P.A. 92-594, eff. 6-27-02.)
 
22    Section 105. The Illinois Food, Drug and Cosmetic Act is
23amended by changing Section 16 as follows:
 
24    (410 ILCS 620/16)  (from Ch. 56 1/2, par. 516)

 

 

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1    Sec. 16. (a) The Director is hereby authorized to
2promulgate regulations exempting from any labeling or
3packaging requirement of this Act drugs and devices which are
4(i) , in accordance with the practice of the trade, to be
5processed, labeled or repacked in substantial quantities at
6establishments other than those where originally processed or
7packaged on condition that such drugs and devices are not
8adulterated or misbranded under the provisions of this Act
9upon removal from such processing, labeling or repacking
10establishment or (ii) packaged, repackaged, or labeled to the
11extent permitted under the Illinois Drug Reuse Opportunity
12Program Act.
13    (b) Drugs and device labeling or packaging exemptions
14adopted under the Federal Act and supplements thereto or
15revisions thereof shall apply to drugs and devices in Illinois
16except insofar as modified or rejected by regulations
17promulgated by the Director.
18    (c) A drug intended for use by man which (A) is a
19habit-forming drug to which Section 15 (d) applies; or (B)
20because of its toxicity or other potentiality for harmful
21effect or the method of its use or the collateral measures
22necessary to its use is not safe for use except under the
23supervision of a practitioner licensed by law to administer
24such drug; or (C) is limited by an approved application under
25Section 505 of the Federal Act or Section 17 of this Act to use
26under the professional supervision of a practitioner licensed

 

 

10200HB0119sam001- 25 -LRB102 04093 CPF 26058 a

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

 

 

10200HB0119sam001- 26 -LRB102 04093 CPF 26058 a

1subsection (c) of this Section when such requirements are not
2necessary for the protection of the public health.
3    (f) A drug which is subject to subsection (c) of this
4Section shall be deemed to be misbranded if at any time before
5dispensing its label fails to bear the statement "Caution:
6Federal Law Prohibits Dispensing Without Prescription" or
7"Caution: State Law Prohibits Dispensing Without
8Prescription". A drug to which subsection (c) of this Section
9does not apply shall be deemed to be misbranded if at any time
10prior to dispensing its label bears the caution statement
11quoted in the preceding sentence.
12    (g) Nothing in this Section shall be construed to relieve
13any person from any requirement prescribed by or under
14authority of law with respect to controlled substances now
15included or which may hereafter be included within the
16classifications of controlled substances cannabis as defined
17in applicable Federal laws relating to controlled substances
18or cannabis or the Cannabis Control Act.
19(Source: P.A. 84-1308.)
 
20    Section 110. The Illinois Controlled Substances Act is
21amended by changing Section 102 as follows:
 
22    (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
23    Sec. 102. Definitions. As used in this Act, unless the
24context otherwise requires:

 

 

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1    (a) "Addict" means any person who habitually uses any
2drug, chemical, substance or dangerous drug other than alcohol
3so as to endanger the public morals, health, safety or welfare
4or who is so far addicted to the use of a dangerous drug or
5controlled substance other than alcohol as to have lost the
6power of self control with reference to his or her addiction.
7    (b) "Administer" means the direct application of a
8controlled substance, whether by injection, inhalation,
9ingestion, or any other means, to the body of a patient,
10research subject, or animal (as defined by the Humane
11Euthanasia in Animal Shelters Act) by:
12        (1) a practitioner (or, in his or her presence, by his
13    or her authorized agent),
14        (2) the patient or research subject pursuant to an
15    order, or
16        (3) a euthanasia technician as defined by the Humane
17    Euthanasia in Animal Shelters Act.
18    (c) "Agent" means an authorized person who acts on behalf
19of or at the direction of a manufacturer, distributor,
20dispenser, prescriber, or practitioner. It does not include a
21common or contract carrier, public warehouseman or employee of
22the carrier or warehouseman.
23    (c-1) "Anabolic Steroids" means any drug or hormonal
24substance, chemically and pharmacologically related to
25testosterone (other than estrogens, progestins,
26corticosteroids, and dehydroepiandrosterone), and includes:

 

 

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1    (i) 3[beta],17-dihydroxy-5a-androstane, 
2    (ii) 3[alpha],17[beta]-dihydroxy-5a-androstane, 
3    (iii) 5[alpha]-androstan-3,17-dione, 
4    (iv) 1-androstenediol (3[beta], 
5        17[beta]-dihydroxy-5[alpha]-androst-1-ene), 
6    (v) 1-androstenediol (3[alpha], 
7        17[beta]-dihydroxy-5[alpha]-androst-1-ene), 
8    (vi) 4-androstenediol  
9        (3[beta],17[beta]-dihydroxy-androst-4-ene), 
10    (vii) 5-androstenediol  
11        (3[beta],17[beta]-dihydroxy-androst-5-ene), 
12    (viii) 1-androstenedione  
13        ([5alpha]-androst-1-en-3,17-dione), 
14    (ix) 4-androstenedione  
15        (androst-4-en-3,17-dione), 
16    (x) 5-androstenedione  
17        (androst-5-en-3,17-dione), 
18    (xi) bolasterone (7[alpha],17a-dimethyl-17[beta]- 
19        hydroxyandrost-4-en-3-one), 
20    (xii) boldenone (17[beta]-hydroxyandrost- 
21        1,4,-diene-3-one), 
22    (xiii) boldione (androsta-1,4- 
23        diene-3,17-dione), 
24    (xiv) calusterone (7[beta],17[alpha]-dimethyl-17 
25        [beta]-hydroxyandrost-4-en-3-one), 
26    (xv) clostebol (4-chloro-17[beta]- 

 

 

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1        hydroxyandrost-4-en-3-one), 
2    (xvi) dehydrochloromethyltestosterone (4-chloro- 
3        17[beta]-hydroxy-17[alpha]-methyl- 
4        androst-1,4-dien-3-one), 
5    (xvii) desoxymethyltestosterone 
6    (17[alpha]-methyl-5[alpha] 
7        -androst-2-en-17[beta]-ol)(a.k.a., madol), 
8    (xviii) [delta]1-dihydrotestosterone (a.k.a.  
9        '1-testosterone') (17[beta]-hydroxy- 
10        5[alpha]-androst-1-en-3-one), 
11    (xix) 4-dihydrotestosterone (17[beta]-hydroxy- 
12        androstan-3-one), 
13    (xx) drostanolone (17[beta]-hydroxy-2[alpha]-methyl- 
14        5[alpha]-androstan-3-one), 
15    (xxi) ethylestrenol (17[alpha]-ethyl-17[beta]- 
16        hydroxyestr-4-ene), 
17    (xxii) fluoxymesterone (9-fluoro-17[alpha]-methyl- 
18        1[beta],17[beta]-dihydroxyandrost-4-en-3-one), 
19    (xxiii) formebolone (2-formyl-17[alpha]-methyl-11[alpha], 
20        17[beta]-dihydroxyandrost-1,4-dien-3-one), 
21    (xxiv) furazabol (17[alpha]-methyl-17[beta]- 
22        hydroxyandrostano[2,3-c]-furazan), 
23    (xxv) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one, 
24    (xxvi) 4-hydroxytestosterone (4,17[beta]-dihydroxy- 
25        androst-4-en-3-one), 
26    (xxvii) 4-hydroxy-19-nortestosterone (4,17[beta]- 

 

 

10200HB0119sam001- 30 -LRB102 04093 CPF 26058 a

1        dihydroxy-estr-4-en-3-one), 
2    (xxviii) mestanolone (17[alpha]-methyl-17[beta]- 
3        hydroxy-5-androstan-3-one), 
4    (xxix) mesterolone (1amethyl-17[beta]-hydroxy- 
5        [5a]-androstan-3-one), 
6    (xxx) methandienone (17[alpha]-methyl-17[beta]- 
7        hydroxyandrost-1,4-dien-3-one), 
8    (xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]- 
9        dihydroxyandrost-5-ene), 
10    (xxxii) methenolone (1-methyl-17[beta]-hydroxy- 
11        5[alpha]-androst-1-en-3-one), 
12    (xxxiii) 17[alpha]-methyl-3[beta], 17[beta]- 
13        dihydroxy-5a-androstane, 
14    (xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy 
15        -5a-androstane, 
16    (xxxv) 17[alpha]-methyl-3[beta],17[beta]- 
17        dihydroxyandrost-4-ene), 
18    (xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]- 
19        methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one), 
20    (xxxvii) methyldienolone (17[alpha]-methyl-17[beta]- 
21        hydroxyestra-4,9(10)-dien-3-one), 
22    (xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]- 
23        hydroxyestra-4,9-11-trien-3-one), 
24    (xxxix) methyltestosterone (17[alpha]-methyl-17[beta]- 
25        hydroxyandrost-4-en-3-one), 
26    (xl) mibolerone (7[alpha],17a-dimethyl-17[beta]- 

 

 

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1        hydroxyestr-4-en-3-one), 
2    (xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone  
3        (17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]- 
4        androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl- 
5        1-testosterone'), 
6    (xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one), 
7    (xliii) 19-nor-4-androstenediol (3[beta], 17[beta]- 
8        dihydroxyestr-4-ene), 
9    (xliv) 19-nor-4-androstenediol (3[alpha], 17[beta]- 
10        dihydroxyestr-4-ene), 
11    (xlv) 19-nor-5-androstenediol (3[beta], 17[beta]- 
12        dihydroxyestr-5-ene), 
13    (xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]- 
14        dihydroxyestr-5-ene), 
15    (xlvii) 19-nor-4,9(10)-androstadienedione  
16        (estra-4,9(10)-diene-3,17-dione), 
17    (xlviii) 19-nor-4-androstenedione (estr-4- 
18        en-3,17-dione), 
19    (xlix) 19-nor-5-androstenedione (estr-5- 
20        en-3,17-dione), 
21    (l) norbolethone (13[beta], 17a-diethyl-17[beta]- 
22        hydroxygon-4-en-3-one), 
23    (li) norclostebol (4-chloro-17[beta]- 
24        hydroxyestr-4-en-3-one), 
25    (lii) norethandrolone (17[alpha]-ethyl-17[beta]- 
26        hydroxyestr-4-en-3-one), 

 

 

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1    (liii) normethandrolone (17[alpha]-methyl-17[beta]- 
2        hydroxyestr-4-en-3-one), 
3    (liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy- 
4        2-oxa-5[alpha]-androstan-3-one), 
5    (lv) oxymesterone (17[alpha]-methyl-4,17[beta]- 
6        dihydroxyandrost-4-en-3-one), 
7    (lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene- 
8        17[beta]-hydroxy-(5[alpha]-androstan-3-one), 
9    (lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy- 
10        (5[alpha]-androst-2-eno[3,2-c]-pyrazole), 
11    (lviii) stenbolone (17[beta]-hydroxy-2-methyl- 
12        (5[alpha]-androst-1-en-3-one), 
13    (lix) testolactone (13-hydroxy-3-oxo-13,17- 
14        secoandrosta-1,4-dien-17-oic 
15        acid lactone), 
16    (lx) testosterone (17[beta]-hydroxyandrost- 
17        4-en-3-one), 
18    (lxi) tetrahydrogestrinone (13[beta], 17[alpha]- 
19        diethyl-17[beta]-hydroxygon- 
20        4,9,11-trien-3-one), 
21    (lxii) trenbolone (17[beta]-hydroxyestr-4,9, 
22        11-trien-3-one). 
23    Any person who is otherwise lawfully in possession of an
24anabolic steroid, or who otherwise lawfully manufactures,
25distributes, dispenses, delivers, or possesses with intent to
26deliver an anabolic steroid, which anabolic steroid is

 

 

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1expressly intended for and lawfully allowed to be administered
2through implants to livestock or other nonhuman species, and
3which is approved by the Secretary of Health and Human
4Services for such administration, and which the person intends
5to administer or have administered through such implants,
6shall not be considered to be in unauthorized possession or to
7unlawfully manufacture, distribute, dispense, deliver, or
8possess with intent to deliver such anabolic steroid for
9purposes of this Act.
10    (d) "Administration" means the Drug Enforcement
11Administration, United States Department of Justice, or its
12successor agency.
13    (d-5) "Clinical Director, Prescription Monitoring Program"
14means a Department of Human Services administrative employee
15licensed to either prescribe or dispense controlled substances
16who shall run the clinical aspects of the Department of Human
17Services Prescription Monitoring Program and its Prescription
18Information Library.
19    (d-10) "Compounding" means the preparation and mixing of
20components, excluding flavorings, (1) as the result of a
21prescriber's prescription drug order or initiative based on
22the prescriber-patient-pharmacist relationship in the course
23of professional practice or (2) for the purpose of, or
24incident to, research, teaching, or chemical analysis and not
25for sale or dispensing. "Compounding" includes the preparation
26of drugs or devices in anticipation of receiving prescription

 

 

10200HB0119sam001- 34 -LRB102 04093 CPF 26058 a

1drug orders based on routine, regularly observed dispensing
2patterns. Commercially available products may be compounded
3for dispensing to individual patients only if both of the
4following conditions are met: (i) the commercial product is
5not reasonably available from normal distribution channels in
6a timely manner to meet the patient's needs and (ii) the
7prescribing practitioner has requested that the drug be
8compounded.
9    (e) "Control" means to add a drug or other substance, or
10immediate precursor, to a Schedule whether by transfer from
11another Schedule or otherwise.
12    (f) "Controlled Substance" means (i) a drug, substance,
13immediate precursor, or synthetic drug in the Schedules of
14Article II of this Act or (ii) a drug or other substance, or
15immediate precursor, designated as a controlled substance by
16the Department through administrative rule. The term does not
17include distilled spirits, wine, malt beverages, or tobacco,
18as those terms are defined or used in the Liquor Control Act of
191934 and the Tobacco Products Tax Act of 1995.
20    (f-5) "Controlled substance analog" means a substance:
21        (1) the chemical structure of which is substantially
22    similar to the chemical structure of a controlled
23    substance in Schedule I or II;
24        (2) which has a stimulant, depressant, or
25    hallucinogenic effect on the central nervous system that
26    is substantially similar to or greater than the stimulant,

 

 

10200HB0119sam001- 35 -LRB102 04093 CPF 26058 a

1    depressant, or hallucinogenic effect on the central
2    nervous system of a controlled substance in Schedule I or
3    II; or
4        (3) with respect to a particular person, which such
5    person represents or intends to have a stimulant,
6    depressant, or hallucinogenic effect on the central
7    nervous system that is substantially similar to or greater
8    than the stimulant, depressant, or hallucinogenic effect
9    on the central nervous system of a controlled substance in
10    Schedule I or II.
11    (g) "Counterfeit substance" means a controlled substance,
12which, or the container or labeling of which, without
13authorization bears the trademark, trade name, or other
14identifying mark, imprint, number or device, or any likeness
15thereof, of a manufacturer, distributor, or dispenser other
16than the person who in fact manufactured, distributed, or
17dispensed the substance.
18    (h) "Deliver" or "delivery" means the actual, constructive
19or attempted transfer of possession of a controlled substance,
20with or without consideration, whether or not there is an
21agency relationship. "Deliver" or "delivery" does not include
22the donation of drugs to the extent permitted under the
23Illinois Drug Reuse Opportunity Program Act.
24    (i) "Department" means the Illinois Department of Human
25Services (as successor to the Department of Alcoholism and
26Substance Abuse) or its successor agency.

 

 

10200HB0119sam001- 36 -LRB102 04093 CPF 26058 a

1    (j) (Blank).
2    (k) "Department of Corrections" means the Department of
3Corrections of the State of Illinois or its successor agency.
4    (l) "Department of Financial and Professional Regulation"
5means the Department of Financial and Professional Regulation
6of the State of Illinois or its successor agency.
7    (m) "Depressant" means any drug that (i) causes an overall
8depression of central nervous system functions, (ii) causes
9impaired consciousness and awareness, and (iii) can be
10habit-forming or lead to a substance abuse problem, including
11but not limited to alcohol, cannabis and its active principles
12and their analogs, benzodiazepines and their analogs,
13barbiturates and their analogs, opioids (natural and
14synthetic) and their analogs, and chloral hydrate and similar
15sedative hypnotics.
16    (n) (Blank).
17    (o) "Director" means the Director of the Illinois State
18Police or his or her designated agents.
19    (p) "Dispense" means to deliver a controlled substance to
20an ultimate user or research subject by or pursuant to the
21lawful order of a prescriber, including the prescribing,
22administering, packaging, labeling, or compounding necessary
23to prepare the substance for that delivery.
24    (q) "Dispenser" means a practitioner who dispenses.
25    (r) "Distribute" means to deliver, other than by
26administering or dispensing, a controlled substance.

 

 

10200HB0119sam001- 37 -LRB102 04093 CPF 26058 a

1    (s) "Distributor" means a person who distributes.
2    (t) "Drug" means (1) substances recognized as drugs in the
3official United States Pharmacopoeia, Official Homeopathic
4Pharmacopoeia of the United States, or official National
5Formulary, or any supplement to any of them; (2) substances
6intended for use in diagnosis, cure, mitigation, treatment, or
7prevention of disease in man or animals; (3) substances (other
8than food) intended to affect the structure of any function of
9the body of man or animals and (4) substances intended for use
10as a component of any article specified in clause (1), (2), or
11(3) of this subsection. It does not include devices or their
12components, parts, or accessories.
13    (t-3) "Electronic health record" or "EHR" means an
14electronic record of health-related information on an
15individual that is created, gathered, managed, and consulted
16by authorized health care clinicians and staff.
17    (t-4) "Emergency medical services personnel" has the
18meaning ascribed to it in the Emergency Medical Services (EMS)
19Systems Act.
20    (t-5) "Euthanasia agency" means an entity certified by the
21Department of Financial and Professional Regulation for the
22purpose of animal euthanasia that holds an animal control
23facility license or animal shelter license under the Animal
24Welfare Act. A euthanasia agency is authorized to purchase,
25store, possess, and utilize Schedule II nonnarcotic and
26Schedule III nonnarcotic drugs for the sole purpose of animal

 

 

10200HB0119sam001- 38 -LRB102 04093 CPF 26058 a

1euthanasia.
2    (t-10) "Euthanasia drugs" means Schedule II or Schedule
3III substances (nonnarcotic controlled substances) that are
4used by a euthanasia agency for the purpose of animal
5euthanasia.
6    (u) "Good faith" means the prescribing or dispensing of a
7controlled substance by a practitioner in the regular course
8of professional treatment to or for any person who is under his
9or her treatment for a pathology or condition other than that
10individual's physical or psychological dependence upon or
11addiction to a controlled substance, except as provided
12herein: and application of the term to a pharmacist shall mean
13the dispensing of a controlled substance pursuant to the
14prescriber's order which in the professional judgment of the
15pharmacist is lawful. The pharmacist shall be guided by
16accepted professional standards including, but not limited to
17the following, in making the judgment:
18        (1) lack of consistency of prescriber-patient
19    relationship,
20        (2) frequency of prescriptions for same drug by one
21    prescriber for large numbers of patients,
22        (3) quantities beyond those normally prescribed,
23        (4) unusual dosages (recognizing that there may be
24    clinical circumstances where more or less than the usual
25    dose may be used legitimately),
26        (5) unusual geographic distances between patient,

 

 

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1    pharmacist and prescriber,
2        (6) consistent prescribing of habit-forming drugs.
3    (u-0.5) "Hallucinogen" means a drug that causes markedly
4altered sensory perception leading to hallucinations of any
5type.
6    (u-1) "Home infusion services" means services provided by
7a pharmacy in compounding solutions for direct administration
8to a patient in a private residence, long-term care facility,
9or hospice setting by means of parenteral, intravenous,
10intramuscular, subcutaneous, or intraspinal infusion.
11    (u-5) "Illinois State Police" means the State Police of
12the State of Illinois, or its successor agency.
13    (v) "Immediate precursor" means a substance:
14        (1) which the Department has found to be and by rule
15    designated as being a principal compound used, or produced
16    primarily for use, in the manufacture of a controlled
17    substance;
18        (2) which is an immediate chemical intermediary used
19    or likely to be used in the manufacture of such controlled
20    substance; and
21        (3) the control of which is necessary to prevent,
22    curtail or limit the manufacture of such controlled
23    substance.
24    (w) "Instructional activities" means the acts of teaching,
25educating or instructing by practitioners using controlled
26substances within educational facilities approved by the State

 

 

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1Board of Education or its successor agency.
2    (x) "Local authorities" means a duly organized State,
3County or Municipal peace unit or police force.
4    (y) "Look-alike substance" means a substance, other than a
5controlled substance which (1) by overall dosage unit
6appearance, including shape, color, size, markings or lack
7thereof, taste, consistency, or any other identifying physical
8characteristic of the substance, would lead a reasonable
9person to believe that the substance is a controlled
10substance, or (2) is expressly or impliedly represented to be
11a controlled substance or is distributed under circumstances
12which would lead a reasonable person to believe that the
13substance is a controlled substance. For the purpose of
14determining whether the representations made or the
15circumstances of the distribution would lead a reasonable
16person to believe the substance to be a controlled substance
17under this clause (2) of subsection (y), the court or other
18authority may consider the following factors in addition to
19any other factor that may be relevant:
20        (a) statements made by the owner or person in control
21    of the substance concerning its nature, use or effect;
22        (b) statements made to the buyer or recipient that the
23    substance may be resold for profit;
24        (c) whether the substance is packaged in a manner
25    normally used for the illegal distribution of controlled
26    substances;

 

 

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1        (d) whether the distribution or attempted distribution
2    included an exchange of or demand for money or other
3    property as consideration, and whether the amount of the
4    consideration was substantially greater than the
5    reasonable retail market value of the substance.
6    Clause (1) of this subsection (y) shall not apply to a
7noncontrolled substance in its finished dosage form that was
8initially introduced into commerce prior to the initial
9introduction into commerce of a controlled substance in its
10finished dosage form which it may substantially resemble.
11    Nothing in this subsection (y) prohibits the dispensing or
12distributing of noncontrolled substances by persons authorized
13to dispense and distribute controlled substances under this
14Act, provided that such action would be deemed to be carried
15out in good faith under subsection (u) if the substances
16involved were controlled substances.
17    Nothing in this subsection (y) or in this Act prohibits
18the manufacture, preparation, propagation, compounding,
19processing, packaging, advertising or distribution of a drug
20or drugs by any person registered pursuant to Section 510 of
21the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
22    (y-1) "Mail-order pharmacy" means a pharmacy that is
23located in a state of the United States that delivers,
24dispenses or distributes, through the United States Postal
25Service or other common carrier, to Illinois residents, any
26substance which requires a prescription.

 

 

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1    (z) "Manufacture" means the production, preparation,
2propagation, compounding, conversion or processing of a
3controlled substance other than methamphetamine, either
4directly or indirectly, by extraction from substances of
5natural origin, or independently by means of chemical
6synthesis, or by a combination of extraction and chemical
7synthesis, and includes any packaging or repackaging of the
8substance or labeling of its container, except that this term
9does not include:
10        (1) by an ultimate user, the preparation or
11    compounding of a controlled substance for his or her own
12    use; or
13        (2) by a practitioner, or his or her authorized agent
14    under his or her supervision, the preparation,
15    compounding, packaging, or labeling of a controlled
16    substance:
17            (a) as an incident to his or her administering or
18        dispensing of a controlled substance in the course of
19        his or her professional practice; or
20            (b) as an incident to lawful research, teaching or
21        chemical analysis and not for sale; or .
22        (3) the packaging, repackaging, or labeling of drugs
23    only to the extent permitted under the Illinois Drug Reuse
24    Opportunity Program Act.
25    (z-1) (Blank).
26    (z-5) "Medication shopping" means the conduct prohibited

 

 

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1under subsection (a) of Section 314.5 of this Act.
2    (z-10) "Mid-level practitioner" means (i) a physician
3assistant who has been delegated authority to prescribe
4through a written delegation of authority by a physician
5licensed to practice medicine in all of its branches, in
6accordance with Section 7.5 of the Physician Assistant
7Practice Act of 1987, (ii) an advanced practice registered
8nurse who has been delegated authority to prescribe through a
9written delegation of authority by a physician licensed to
10practice medicine in all of its branches or by a podiatric
11physician, in accordance with Section 65-40 of the Nurse
12Practice Act, (iii) an advanced practice registered nurse
13certified as a nurse practitioner, nurse midwife, or clinical
14nurse specialist who has been granted authority to prescribe
15by a hospital affiliate in accordance with Section 65-45 of
16the Nurse Practice Act, (iv) an animal euthanasia agency, or
17(v) a prescribing psychologist.
18    (aa) "Narcotic drug" means any of the following, whether
19produced directly or indirectly by extraction from substances
20of vegetable origin, or independently by means of chemical
21synthesis, or by a combination of extraction and chemical
22synthesis:
23        (1) opium, opiates, derivatives of opium and opiates,
24    including their isomers, esters, ethers, salts, and salts
25    of isomers, esters, and ethers, whenever the existence of
26    such isomers, esters, ethers, and salts is possible within

 

 

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1    the specific chemical designation; however the term
2    "narcotic drug" does not include the isoquinoline
3    alkaloids of opium;
4        (2) (blank);
5        (3) opium poppy and poppy straw;
6        (4) coca leaves, except coca leaves and extracts of
7    coca leaves from which substantially all of the cocaine
8    and ecgonine, and their isomers, derivatives and salts,
9    have been removed;
10        (5) cocaine, its salts, optical and geometric isomers,
11    and salts of isomers;
12        (6) ecgonine, its derivatives, their salts, isomers,
13    and salts of isomers;
14        (7) any compound, mixture, or preparation which
15    contains any quantity of any of the substances referred to
16    in subparagraphs (1) through (6).
17    (bb) "Nurse" means a registered nurse licensed under the
18Nurse Practice Act.
19    (cc) (Blank).
20    (dd) "Opiate" means any substance having an addiction
21forming or addiction sustaining liability similar to morphine
22or being capable of conversion into a drug having addiction
23forming or addiction sustaining liability.
24    (ee) "Opium poppy" means the plant of the species Papaver
25somniferum L., except its seeds.
26    (ee-5) "Oral dosage" means a tablet, capsule, elixir, or

 

 

10200HB0119sam001- 45 -LRB102 04093 CPF 26058 a

1solution or other liquid form of medication intended for
2administration by mouth, but the term does not include a form
3of medication intended for buccal, sublingual, or transmucosal
4administration.
5    (ff) "Parole and Pardon Board" means the Parole and Pardon
6Board of the State of Illinois or its successor agency.
7    (gg) "Person" means any individual, corporation,
8mail-order pharmacy, government or governmental subdivision or
9agency, business trust, estate, trust, partnership or
10association, or any other entity.
11    (hh) "Pharmacist" means any person who holds a license or
12certificate of registration as a registered pharmacist, a
13local registered pharmacist or a registered assistant
14pharmacist under the Pharmacy Practice Act.
15    (ii) "Pharmacy" means any store, ship or other place in
16which pharmacy is authorized to be practiced under the
17Pharmacy Practice Act.
18    (ii-5) "Pharmacy shopping" means the conduct prohibited
19under subsection (b) of Section 314.5 of this Act.
20    (ii-10) "Physician" (except when the context otherwise
21requires) means a person licensed to practice medicine in all
22of its branches.
23    (jj) "Poppy straw" means all parts, except the seeds, of
24the opium poppy, after mowing.
25    (kk) "Practitioner" means a physician licensed to practice
26medicine in all its branches, dentist, optometrist, podiatric

 

 

10200HB0119sam001- 46 -LRB102 04093 CPF 26058 a

1physician, veterinarian, scientific investigator, pharmacist,
2physician assistant, advanced practice registered nurse,
3licensed practical nurse, registered nurse, emergency medical
4services personnel, hospital, laboratory, or pharmacy, or
5other person licensed, registered, or otherwise lawfully
6permitted by the United States or this State to distribute,
7dispense, conduct research with respect to, administer or use
8in teaching or chemical analysis, a controlled substance in
9the course of professional practice or research.
10    (ll) "Pre-printed prescription" means a written
11prescription upon which the designated drug has been indicated
12prior to the time of issuance; the term does not mean a written
13prescription that is individually generated by machine or
14computer in the prescriber's office.
15    (mm) "Prescriber" means a physician licensed to practice
16medicine in all its branches, dentist, optometrist,
17prescribing psychologist licensed under Section 4.2 of the
18Clinical Psychologist Licensing Act with prescriptive
19authority delegated under Section 4.3 of the Clinical
20Psychologist Licensing Act, podiatric physician, or
21veterinarian who issues a prescription, a physician assistant
22who issues a prescription for a controlled substance in
23accordance with Section 303.05, a written delegation, and a
24written collaborative agreement required under Section 7.5 of
25the Physician Assistant Practice Act of 1987, an advanced
26practice registered nurse with prescriptive authority

 

 

10200HB0119sam001- 47 -LRB102 04093 CPF 26058 a

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

 

 

10200HB0119sam001- 48 -LRB102 04093 CPF 26058 a

1prescriptive authority delegated under Section 65-40 of the
2Nurse Practice Act who issues a prescription for a controlled
3substance in accordance with Section 303.05, a written
4delegation, and a written collaborative agreement under
5Section 65-35 of the Nurse Practice Act, of an advanced
6practice registered nurse certified as a nurse practitioner,
7nurse midwife, or clinical nurse specialist who has been
8granted authority to prescribe by a hospital affiliate in
9accordance with Section 65-45 of the Nurse Practice Act and in
10accordance with Section 303.05 when required by law, or of an
11advanced practice registered nurse certified as a nurse
12practitioner, nurse midwife, or clinical nurse specialist who
13has full practice authority pursuant to Section 65-43 of the
14Nurse Practice Act.
15    (nn-5) "Prescription Information Library" (PIL) means an
16electronic library that contains reported controlled substance
17data.
18    (nn-10) "Prescription Monitoring Program" (PMP) means the
19entity that collects, tracks, and stores reported data on
20controlled substances and select drugs pursuant to Section
21316.
22    (oo) "Production" or "produce" means manufacture,
23planting, cultivating, growing, or harvesting of a controlled
24substance other than methamphetamine.
25    (pp) "Registrant" means every person who is required to
26register under Section 302 of this Act.

 

 

10200HB0119sam001- 49 -LRB102 04093 CPF 26058 a

1    (qq) "Registry number" means the number assigned to each
2person authorized to handle controlled substances under the
3laws of the United States and of this State.
4    (qq-5) "Secretary" means, as the context requires, either
5the Secretary of the Department or the Secretary of the
6Department of Financial and Professional Regulation, and the
7Secretary's designated agents.
8    (rr) "State" includes the State of Illinois and any state,
9district, commonwealth, territory, insular possession thereof,
10and any area subject to the legal authority of the United
11States of America.
12    (rr-5) "Stimulant" means any drug that (i) causes an
13overall excitation of central nervous system functions, (ii)
14causes impaired consciousness and awareness, and (iii) can be
15habit-forming or lead to a substance abuse problem, including
16but not limited to amphetamines and their analogs,
17methylphenidate and its analogs, cocaine, and phencyclidine
18and its analogs.
19    (rr-10) "Synthetic drug" includes, but is not limited to,
20any synthetic cannabinoids or piperazines or any synthetic
21cathinones as provided for in Schedule I.
22    (ss) "Ultimate user" means a person who lawfully possesses
23a controlled substance for his or her own use or for the use of
24a member of his or her household or for administering to an
25animal owned by him or her or by a member of his or her
26household.

 

 

10200HB0119sam001- 50 -LRB102 04093 CPF 26058 a

1(Source: P.A. 99-78, eff. 7-20-15; 99-173, eff. 7-29-15;
299-371, eff. 1-1-16; 99-480, eff. 9-9-15; 99-642, eff.
37-28-16; 100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513,
4eff. 1-1-18; 100-789, eff. 1-1-19; 100-863, eff. 8-14-18.)
 
5    Section 115. The Cannabis and Controlled Substances Tort
6Claims Act is amended by changing Section 3 as follows:
 
7    (740 ILCS 20/3)  (from Ch. 70, par. 903)
8    Sec. 3. Definitions. As used in this Act, unless the
9context otherwise requires:
10    "Cannabis" includes marihuana, hashish, and other
11substances that are identified as including any parts of the
12plant Cannabis Sativa, whether growing or not, the seeds of
13that plant, the resin extracted from any part of that plant,
14and any compound, manufacture, salt, derivative, mixture, or
15preparation of that plant, its seeds, or resin, including
16tetrahydrocannabinol (THC) and all other cannabinol
17derivatives, including its naturally occurring or
18synthetically produced ingredients, whether produced directly
19or indirectly by extraction, independently by means of
20chemical synthesis, or by a combination of extraction and
21chemical synthesis. "Cannabis" does not include the mature
22stalks of that plant, fiber produced from those stalks, oil or
23cake made from the seeds of that plant, any other compound,
24manufacture, salt, derivative, mixture, or preparation of

 

 

10200HB0119sam001- 51 -LRB102 04093 CPF 26058 a

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

 

 

10200HB0119sam001- 52 -LRB102 04093 CPF 26058 a

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

 

 

10200HB0119sam001- 53 -LRB102 04093 CPF 26058 a

1on, affixed to, and found in land, and tangible or intangible
2personal property, including rights, services, privileges,
3interests, claims, and securities.
4(Source: P.A. 96-328, eff. 8-11-09.)".