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


Rep. Will Guzzardi

Filed: 3/10/2021





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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
26    "Practitioner" means a person licensed in this State to



10200HB0119ham001- 3 -LRB102 04093 CPF 23038 a

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.
5    "Priority patient" means an eligible patient who is an
6Illinois resident and who is indigent, uninsured,
7underinsured, or enrolled in a public health benefits program.
8    "Recipient" means any person or entity legally authorized
9to possess medicine with a license or permit in the state in
10which the person or entity is located, including, but not
11limited to, a wholesaler or distributor, reverse distributor,
12repackager, hospital, pharmacy, clinic, or prescriber office.
13    "Returns processor" has the same meaning as defined in
14paragraph (18) of 21 U.S.C. 360eee. "Returns processor"
15includes, but is not limited to, a reverse distributor.
16    "Unopened tamper-evident packaging" has the same meaning
17as defined in the United States Pharmacopeia (USP) General
18Chapter 659, Packaging and Storage Requirements, including,
19but not limited to, unopened unit-dose, multiple-dose,
20immediate, secondary, and tertiary packaging.
21    Section 10. Donating and receiving drugs. Notwithstanding
22any other law or rule, donors may donate drugs to recipients
23and recipients may receive donated drugs from donors.
24Recipients shall only dispense or administer drugs to eligible
25patients as described in Section 20, further donate drugs to



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



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1    by the eligible patient based on the prescribing
2    practitioner's directions for use or, for over-the-counter
3    medicine, on the package's label; and
4        (6) that is not adulterated or misbranded, as
5    determined by a pharmacist or practitioner.
6    (b) Recipients shall, to the greatest extent practicable,
7dispense drugs received under this Act to priority patients.
8    Section 25. Requirements for accepting drugs. A drug
9received but not yet accepted into inventory shall be kept in a
10separate designated area. A drug may be accepted under this
11Act only if all of the following requirements are met:
12        (1) The drug is in unopened tamper-evident packaging
13    or has been repackaged according to Section 30.
14        (2) The drug is not expired.
15        (3) The drug is not a controlled substance.
16        (4) The recipient maintains a written or electronic
17    record of a donation made under this Act consisting of the
18    name, strength, and quantity of each accepted drug and the
19    name, address, and telephone number of the donor, unless a
20    recipient is further donating to a recipient under common
21    ownership or common control. Notwithstanding any other law
22    or rule, no other record of a donation is required.
23        (5) The donor has removed or redacted any patient name
24    and prescription number on the drug or otherwise maintains
25    patient confidentiality by executing a confidentiality



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1    agreement with the recipient.
2        (6) The drug has a method recognized by the United
3    States Pharmacopeia to detect improper temperature
4    variations if the drug requires temperature control other
5    than room temperature storage.
6    Section 30. Donating and repackaging. Notwithstanding any
7other law or rule, a recipient may:
8        (1) further donate drugs to another recipient;
9        (2) repackage donated drugs as necessary for storage,
10    dispensing, administration, or transfers in accordance
11    with the following:
12            (A) repackaged medicine shall be labeled with the
13        drug's name, strength, and expiration date, and shall
14        be kept in a separate designated area until inspected
15        and initialed by a pharmacist, practitioner, or a
16        pharmacy technician; and
17            (B) if multiple packaged donated medicines with
18        varied expiration dates are repackaged together, the
19        shortest expiration date shall be used; and
20        (3) replenish a drug of the same drug name and
21    strength previously dispensed or administered to an
22    eligible patient in accordance with Section 340B of the
23    federal Public Health Service Act.
24    Section 35. Disposition of drugs. A donated drug that does



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1not meet the requirements of Section 25 must be disposed of by
2returning it to the donor, destroying it by an incinerator,
3medical waste hauler, or other lawful method, or transferring
4it to a returns processor. A record of disposal shall consist
5of the disposal method, the date of disposal, and the name and
6quantity of the drug disposed of. Notwithstanding any other
7law or rule, no other record of disposal shall be required.
8    Section 40. Participation not required. Nothing in this
9Act requires that a pharmacy or pharmacist be a recipient of
10drugs under this Act.
11    Section 45. Recordkeeping requirements. When performing
12any action associated with a program under this Act or
13otherwise processing a donated drug for tax, manufacturer, or
14other credit, a recipient shall be considered to be acting as a
15returns processor and shall comply with all recordkeeping
16requirements for nonsaleable returns under federal law.
17    Section 50. Change of ownership. A donation or other
18transfer of possession or control of a drug under this Act
19shall not be construed as a change of ownership unless it is
20specified as such by the recipient. If a record of the
21donation's transaction information or history is required, the
22history shall begin with the donor of the drug, include all
23prior donations, and, if the drug was previously dispensed,



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1only include drug information required to be on the patient
2label in accordance with the Board of Pharmacy's rules and
4    Section 55. Retention of records. All records required
5under this Act shall be retained in physical or electronic
6format and on or off the recipient's premises for a period of 6
7years. Donors or recipients may contract with one another or a
8third party to create or maintain records on each other's
9behalf. An identifier, such as a serial number or bar code, may
10be used in place of any or all information required by a record
11or label pursuant to this Act if it allows for such information
12to be readily retrievable. Upon request by a State or federal
13regulatory agency, the identifier used for requested records
14shall be replaced with the original information. An identifier
15shall not be used on patient labels when dispensing or
16administering a drug.
17    Section 60. Authority. This Act supersedes any
18inconsistent law or rule for activities conducted under this
20    Section 65. Immunity.
21    (a) Except as provided in subsection (b), no manufacturer,
22donor, or recipient shall be liable in any criminal or civil
23action, or be subject to professional discipline, for



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1activities solely and directly attributable to donating,
2receiving, or dispensing drugs under this Act.
3    (b) The immunity provided in subsection (a) shall not
5        (1) if it is shown that the act or omission was an
6    unreasonable, willful, wanton, or reckless act;
7        (2) if it is shown that the person or entity knew or
8    should have known that the donated drug was adulterated or
9    misbranded; or
10        (3) to acts or omissions outside the scope of a
11    program under this Act.
12    Section 90. The Pharmacy Practice Act is amended by
13changing Section 4 as follows:
14    (225 ILCS 85/4)  (from Ch. 111, par. 4124)
15    (Section scheduled to be repealed on January 1, 2023)
16    Sec. 4. Exemptions. Nothing contained in any Section of
17this Act shall apply to, or in any manner interfere with:
18        (a) the lawful practice of any physician licensed to
19    practice medicine in all of its branches, dentist,
20    podiatric physician, veterinarian, or therapeutically or
21    diagnostically certified optometrist within the limits of
22    his or her license, or prevent him or her from supplying to
23    his or her bona fide patients such drugs, medicines, or
24    poisons as may seem to him appropriate;



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



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



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



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1        this Act, and the transmittal of an order from the
2        licensed pharmacy to the manufacturer or the
3        manufacturer's agent; and
4            (5) the manufacturer or the manufacturer's agent
5        delivers the dialysate or devices directly to: (i) a
6        patient with end-stage renal disease, or his or her
7        designee, for the patient's self-administration of the
8        dialysis therapy or (ii) a health care provider or
9        institution for administration or delivery of the
10        dialysis therapy to a patient with end-stage renal
11        disease.
12        This paragraph (h) does not include any other drugs
13    for peritoneal dialysis, except dialysate, as described in
14    item (1) of this paragraph (h). All records of sales and
15    distribution of dialysate to patients made pursuant to
16    this paragraph (h) must be retained in accordance with
17    Section 18 of this Act.
18(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
19100-863, eff. 8-14-18; 101-420, eff. 8-16-19.)
20    Section 95. The Wholesale Drug Distribution Licensing Act
21is amended by changing Section 15 as follows:
22    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
23    (Section scheduled to be repealed on January 1, 2023)
24    Sec. 15. Definitions. As used in this Act:



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



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



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



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



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



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1biological product (except for blood and blood components
2intended for transfusion or biological products that are also
3medical devices), required by federal law or regulation to be
4dispensed only by a prescription, including finished dosage
5forms and bulk drug substances subject to Section 503 of the
6Federal Food, Drug and Cosmetic Act.
7    "Repackage" means repackaging or otherwise changing the
8container, wrapper, or labeling to further the distribution of
9a prescription drug, excluding that completed by the
10pharmacist responsible for dispensing the product to a
12    "Secretary" means the Secretary of Financial and
13Professional Regulation.
14    "Third-party logistics provider" means anyone who
15contracts with a prescription drug manufacturer to provide or
16coordinate warehousing, distribution, or other services on
17behalf of a manufacturer, but does not take title to the
18prescription drug or have general responsibility to direct the
19prescription drug's sale or disposition.
20    "Wholesale distribution" means the distribution of
21prescription drugs to persons other than a consumer or
22patient, but does not include any of the following:
23        (1) Intracompany sales of prescription drugs, meaning
24    (i) any transaction or transfer between any division,
25    subsidiary, parent, or affiliated or related company under
26    the common ownership and control of a corporate entity or



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



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



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1wholesalers or distributors; independent wholesale drug
2traders; specialty wholesale distributors; and retail
3pharmacies that conduct wholesale distribution; and chain
4pharmacy warehouses that conduct wholesale distribution. In
5order to be considered part of the normal distribution
6channel, a wholesale distributor must also be an authorized
7distributor of record.
8(Source: P.A. 101-420, eff. 8-16-19.)
9    Section 100. The Senior Pharmaceutical Assistance Act is
10amended by changing Section 10 as follows:
11    (320 ILCS 50/10)
12    Sec. 10. Definitions. In this Act:
13    "Manufacturer" includes:
14        (1) An entity that is engaged in (a) the production,
15    preparation, propagation, compounding, conversion, or
16    processing of prescription drug products (i) directly or
17    indirectly by extraction from substances of natural
18    origin, (ii) independently by means of chemical synthesis,
19    or (iii) by combination of extraction and chemical
20    synthesis; or (b) the packaging, repackaging, labeling or
21    re-labeling, or distribution of prescription drug
22    products.
23        (2) The entity holding legal title to or possession of
24    the national drug code number for the covered prescription



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



10200HB0119ham001- 24 -LRB102 04093 CPF 23038 a

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



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



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1"Caution: State Law Prohibits Dispensing Without
2Prescription". A drug to which subsection (c) of this Section
3does not apply shall be deemed to be misbranded if at any time
4prior to dispensing its label bears the caution statement
5quoted in the preceding sentence.
6    (g) Nothing in this Section shall be construed to relieve
7any person from any requirement prescribed by or under
8authority of law with respect to controlled substances now
9included or which may hereafter be included within the
10classifications of controlled substances cannabis as defined
11in applicable Federal laws relating to controlled substances
12or cannabis or the Cannabis Control Act.
13(Source: P.A. 84-1308.)
14    Section 110. The Illinois Controlled Substances Act is
15amended by changing Section 102 as follows:
16    (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
17    Sec. 102. Definitions. As used in this Act, unless the
18context otherwise requires:
19    (a) "Addict" means any person who habitually uses any
20drug, chemical, substance or dangerous drug other than alcohol
21so as to endanger the public morals, health, safety or welfare
22or who is so far addicted to the use of a dangerous drug or
23controlled substance other than alcohol as to have lost the
24power of self control with reference to his or her addiction.



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



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



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



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1        hydroxyandrost-1,4-dien-3-one), 
2    (xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]- 
3        dihydroxyandrost-5-ene), 
4    (xxxii) methenolone (1-methyl-17[beta]-hydroxy- 
5        5[alpha]-androst-1-en-3-one), 
6    (xxxiii) 17[alpha]-methyl-3[beta], 17[beta]- 
7        dihydroxy-5a-androstane, 
8    (xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy 
9        -5a-androstane, 
10    (xxxv) 17[alpha]-methyl-3[beta],17[beta]- 
11        dihydroxyandrost-4-ene), 
12    (xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]- 
13        methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one), 
14    (xxxvii) methyldienolone (17[alpha]-methyl-17[beta]- 
15        hydroxyestra-4,9(10)-dien-3-one), 
16    (xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]- 
17        hydroxyestra-4,9-11-trien-3-one), 
18    (xxxix) methyltestosterone (17[alpha]-methyl-17[beta]- 
19        hydroxyandrost-4-en-3-one), 
20    (xl) mibolerone (7[alpha],17a-dimethyl-17[beta]- 
21        hydroxyestr-4-en-3-one), 
22    (xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone  
23        (17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]- 
24        androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl- 
25        1-testosterone'), 
26    (xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one), 



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



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



10200HB0119ham001- 33 -LRB102 04093 CPF 23038 a

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



10200HB0119ham001- 34 -LRB102 04093 CPF 23038 a

1prescribing practitioner has requested that the drug be
3    (e) "Control" means to add a drug or other substance, or
4immediate precursor, to a Schedule whether by transfer from
5another Schedule or otherwise.
6    (f) "Controlled Substance" means (i) a drug, substance,
7immediate precursor, or synthetic drug in the Schedules of
8Article II of this Act or (ii) a drug or other substance, or
9immediate precursor, designated as a controlled substance by
10the Department through administrative rule. The term does not
11include distilled spirits, wine, malt beverages, or tobacco,
12as those terms are defined or used in the Liquor Control Act of
131934 and the Tobacco Products Tax Act of 1995.
14    (f-5) "Controlled substance analog" means a substance:
15        (1) the chemical structure of which is substantially
16    similar to the chemical structure of a controlled
17    substance in Schedule I or II;
18        (2) which has a stimulant, depressant, or
19    hallucinogenic effect on the central nervous system that
20    is substantially similar to or greater than the stimulant,
21    depressant, or hallucinogenic effect on the central
22    nervous system of a controlled substance in Schedule I or
23    II; or
24        (3) with respect to a particular person, which such
25    person represents or intends to have a stimulant,
26    depressant, or hallucinogenic effect on the central



10200HB0119ham001- 35 -LRB102 04093 CPF 23038 a

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



10200HB0119ham001- 36 -LRB102 04093 CPF 23038 a

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



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



10200HB0119ham001- 38 -LRB102 04093 CPF 23038 a

1controlled substance by a practitioner in the regular course
2of professional treatment to or for any person who is under his
3or her treatment for a pathology or condition other than that
4individual's physical or psychological dependence upon or
5addiction to a controlled substance, except as provided
6herein: and application of the term to a pharmacist shall mean
7the dispensing of a controlled substance pursuant to the
8prescriber's order which in the professional judgment of the
9pharmacist is lawful. The pharmacist shall be guided by
10accepted professional standards including, but not limited to
11the following, in making the judgment:
12        (1) lack of consistency of prescriber-patient
13    relationship,
14        (2) frequency of prescriptions for same drug by one
15    prescriber for large numbers of patients,
16        (3) quantities beyond those normally prescribed,
17        (4) unusual dosages (recognizing that there may be
18    clinical circumstances where more or less than the usual
19    dose may be used legitimately),
20        (5) unusual geographic distances between patient,
21    pharmacist and prescriber,
22        (6) consistent prescribing of habit-forming drugs.
23    (u-0.5) "Hallucinogen" means a drug that causes markedly
24altered sensory perception leading to hallucinations of any
26    (u-1) "Home infusion services" means services provided by



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1a pharmacy in compounding solutions for direct administration
2to a patient in a private residence, long-term care facility,
3or hospice setting by means of parenteral, intravenous,
4intramuscular, subcutaneous, or intraspinal infusion.
5    (u-5) "Illinois State Police" means the State Police of
6the State of Illinois, or its successor agency.
7    (v) "Immediate precursor" means a substance:
8        (1) which the Department has found to be and by rule
9    designated as being a principal compound used, or produced
10    primarily for use, in the manufacture of a controlled
11    substance;
12        (2) which is an immediate chemical intermediary used
13    or likely to be used in the manufacture of such controlled
14    substance; and
15        (3) the control of which is necessary to prevent,
16    curtail or limit the manufacture of such controlled
17    substance.
18    (w) "Instructional activities" means the acts of teaching,
19educating or instructing by practitioners using controlled
20substances within educational facilities approved by the State
21Board of Education or its successor agency.
22    (x) "Local authorities" means a duly organized State,
23County or Municipal peace unit or police force.
24    (y) "Look-alike substance" means a substance, other than a
25controlled substance which (1) by overall dosage unit
26appearance, including shape, color, size, markings or lack



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



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1noncontrolled substance in its finished dosage form that was
2initially introduced into commerce prior to the initial
3introduction into commerce of a controlled substance in its
4finished dosage form which it may substantially resemble.
5    Nothing in this subsection (y) prohibits the dispensing or
6distributing of noncontrolled substances by persons authorized
7to dispense and distribute controlled substances under this
8Act, provided that such action would be deemed to be carried
9out in good faith under subsection (u) if the substances
10involved were controlled substances.
11    Nothing in this subsection (y) or in this Act prohibits
12the manufacture, preparation, propagation, compounding,
13processing, packaging, advertising or distribution of a drug
14or drugs by any person registered pursuant to Section 510 of
15the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
16    (y-1) "Mail-order pharmacy" means a pharmacy that is
17located in a state of the United States that delivers,
18dispenses or distributes, through the United States Postal
19Service or other common carrier, to Illinois residents, any
20substance which requires a prescription.
21    (z) "Manufacture" means the production, preparation,
22propagation, compounding, conversion or processing of a
23controlled substance other than methamphetamine, either
24directly or indirectly, by extraction from substances of
25natural origin, or independently by means of chemical
26synthesis, or by a combination of extraction and chemical



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



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1Practice Act of 1987, (ii) an advanced practice registered
2nurse who has been delegated authority to prescribe through a
3written delegation of authority by a physician licensed to
4practice medicine in all of its branches or by a podiatric
5physician, in accordance with Section 65-40 of the Nurse
6Practice Act, (iii) an advanced practice registered nurse
7certified as a nurse practitioner, nurse midwife, or clinical
8nurse specialist who has been granted authority to prescribe
9by a hospital affiliate in accordance with Section 65-45 of
10the Nurse Practice Act, (iv) an animal euthanasia agency, or
11(v) a prescribing psychologist.
12    (aa) "Narcotic drug" means any of the following, whether
13produced directly or indirectly by extraction from substances
14of vegetable origin, or independently by means of chemical
15synthesis, or by a combination of extraction and chemical
17        (1) opium, opiates, derivatives of opium and opiates,
18    including their isomers, esters, ethers, salts, and salts
19    of isomers, esters, and ethers, whenever the existence of
20    such isomers, esters, ethers, and salts is possible within
21    the specific chemical designation; however the term
22    "narcotic drug" does not include the isoquinoline
23    alkaloids of opium;
24        (2) (blank);
25        (3) opium poppy and poppy straw;
26        (4) coca leaves, except coca leaves and extracts of



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1    coca leaves from which substantially all of the cocaine
2    and ecgonine, and their isomers, derivatives and salts,
3    have been removed;
4        (5) cocaine, its salts, optical and geometric isomers,
5    and salts of isomers;
6        (6) ecgonine, its derivatives, their salts, isomers,
7    and salts of isomers;
8        (7) any compound, mixture, or preparation which
9    contains any quantity of any of the substances referred to
10    in subparagraphs (1) through (6).
11    (bb) "Nurse" means a registered nurse licensed under the
12Nurse Practice Act.
13    (cc) (Blank).
14    (dd) "Opiate" means any substance having an addiction
15forming or addiction sustaining liability similar to morphine
16or being capable of conversion into a drug having addiction
17forming or addiction sustaining liability.
18    (ee) "Opium poppy" means the plant of the species Papaver
19somniferum L., except its seeds.
20    (ee-5) "Oral dosage" means a tablet, capsule, elixir, or
21solution or other liquid form of medication intended for
22administration by mouth, but the term does not include a form
23of medication intended for buccal, sublingual, or transmucosal
25    (ff) "Parole and Pardon Board" means the Parole and Pardon
26Board of the State of Illinois or its successor agency.



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1    (gg) "Person" means any individual, corporation,
2mail-order pharmacy, government or governmental subdivision or
3agency, business trust, estate, trust, partnership or
4association, or any other entity.
5    (hh) "Pharmacist" means any person who holds a license or
6certificate of registration as a registered pharmacist, a
7local registered pharmacist or a registered assistant
8pharmacist under the Pharmacy Practice Act.
9    (ii) "Pharmacy" means any store, ship or other place in
10which pharmacy is authorized to be practiced under the
11Pharmacy Practice Act.
12    (ii-5) "Pharmacy shopping" means the conduct prohibited
13under subsection (b) of Section 314.5 of this Act.
14    (ii-10) "Physician" (except when the context otherwise
15requires) means a person licensed to practice medicine in all
16of its branches.
17    (jj) "Poppy straw" means all parts, except the seeds, of
18the opium poppy, after mowing.
19    (kk) "Practitioner" means a physician licensed to practice
20medicine in all its branches, dentist, optometrist, podiatric
21physician, veterinarian, scientific investigator, pharmacist,
22physician assistant, advanced practice registered nurse,
23licensed practical nurse, registered nurse, emergency medical
24services personnel, hospital, laboratory, or pharmacy, or
25other person licensed, registered, or otherwise lawfully
26permitted by the United States or this State to distribute,



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1dispense, conduct research with respect to, administer or use
2in teaching or chemical analysis, a controlled substance in
3the course of professional practice or research.
4    (ll) "Pre-printed prescription" means a written
5prescription upon which the designated drug has been indicated
6prior to the time of issuance; the term does not mean a written
7prescription that is individually generated by machine or
8computer in the prescriber's office.
9    (mm) "Prescriber" means a physician licensed to practice
10medicine in all its branches, dentist, optometrist,
11prescribing psychologist licensed under Section 4.2 of the
12Clinical Psychologist Licensing Act with prescriptive
13authority delegated under Section 4.3 of the Clinical
14Psychologist Licensing Act, podiatric physician, or
15veterinarian who issues a prescription, a physician assistant
16who issues a prescription for a controlled substance in
17accordance with Section 303.05, a written delegation, and a
18written collaborative agreement required under Section 7.5 of
19the Physician Assistant Practice Act of 1987, an advanced
20practice registered nurse with prescriptive authority
21delegated under Section 65-40 of the Nurse Practice Act and in
22accordance with Section 303.05, a written delegation, and a
23written collaborative agreement under Section 65-35 of the
24Nurse Practice Act, an advanced practice registered nurse
25certified as a nurse practitioner, nurse midwife, or clinical
26nurse specialist who has been granted authority to prescribe



10200HB0119ham001- 47 -LRB102 04093 CPF 23038 a

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



10200HB0119ham001- 48 -LRB102 04093 CPF 23038 a

1nurse midwife, or clinical nurse specialist who has been
2granted authority to prescribe by a hospital affiliate in
3accordance with Section 65-45 of the Nurse Practice Act and in
4accordance with Section 303.05 when required by law, or of an
5advanced practice registered nurse certified as a nurse
6practitioner, nurse midwife, or clinical nurse specialist who
7has full practice authority pursuant to Section 65-43 of the
8Nurse Practice Act.
9    (nn-5) "Prescription Information Library" (PIL) means an
10electronic library that contains reported controlled substance
12    (nn-10) "Prescription Monitoring Program" (PMP) means the
13entity that collects, tracks, and stores reported data on
14controlled substances and select drugs pursuant to Section
16    (oo) "Production" or "produce" means manufacture,
17planting, cultivating, growing, or harvesting of a controlled
18substance other than methamphetamine.
19    (pp) "Registrant" means every person who is required to
20register under Section 302 of this Act.
21    (qq) "Registry number" means the number assigned to each
22person authorized to handle controlled substances under the
23laws of the United States and of this State.
24    (qq-5) "Secretary" means, as the context requires, either
25the Secretary of the Department or the Secretary of the
26Department of Financial and Professional Regulation, and the



10200HB0119ham001- 49 -LRB102 04093 CPF 23038 a

1Secretary's designated agents.
2    (rr) "State" includes the State of Illinois and any state,
3district, commonwealth, territory, insular possession thereof,
4and any area subject to the legal authority of the United
5States of America.
6    (rr-5) "Stimulant" means any drug that (i) causes an
7overall excitation of central nervous system functions, (ii)
8causes impaired consciousness and awareness, and (iii) can be
9habit-forming or lead to a substance abuse problem, including
10but not limited to amphetamines and their analogs,
11methylphenidate and its analogs, cocaine, and phencyclidine
12and its analogs.
13    (rr-10) "Synthetic drug" includes, but is not limited to,
14any synthetic cannabinoids or piperazines or any synthetic
15cathinones as provided for in Schedule I.
16    (ss) "Ultimate user" means a person who lawfully possesses
17a controlled substance for his or her own use or for the use of
18a member of his or her household or for administering to an
19animal owned by him or her or by a member of his or her
21(Source: P.A. 99-78, eff. 7-20-15; 99-173, eff. 7-29-15;
2299-371, eff. 1-1-16; 99-480, eff. 9-9-15; 99-642, eff.
237-28-16; 100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513,
24eff. 1-1-18; 100-789, eff. 1-1-19; 100-863, eff. 8-14-18.)
25    Section 115. The Cannabis and Controlled Substances Tort



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1Claims Act is amended by changing Section 3 as follows:
2    (740 ILCS 20/3)  (from Ch. 70, par. 903)
3    Sec. 3. Definitions. As used in this Act, unless the
4context otherwise requires:
5    "Cannabis" includes marihuana, hashish, and other
6substances that are identified as including any parts of the
7plant Cannabis Sativa, whether growing or not, the seeds of
8that plant, the resin extracted from any part of that plant,
9and any compound, manufacture, salt, derivative, mixture, or
10preparation of that plant, its seeds, or resin, including
11tetrahydrocannabinol (THC) and all other cannabinol
12derivatives, including its naturally occurring or
13synthetically produced ingredients, whether produced directly
14or indirectly by extraction, independently by means of
15chemical synthesis, or by a combination of extraction and
16chemical synthesis. "Cannabis" does not include the mature
17stalks of that plant, fiber produced from those stalks, oil or
18cake made from the seeds of that plant, any other compound,
19manufacture, salt, derivative, mixture, or preparation of
20mature stalks (except the extracted resin), fiber, oil or
21cake, or the sterilized seeds of that plant that are incapable
22of germination.
23    "Controlled substance" means a drug, substance, or
24immediate precursor in the Schedules of Article II of the
25Illinois Controlled Substances Act.



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1    "Counterfeit substance" means a controlled substance or
2the container or labeling of a controlled substance that,
3without authorization, bears the trademark, trade name, or
4other identifying mark, imprint, number, device, or any
5likeness thereof of a manufacturer, distributor, or dispenser
6other than the person who in fact manufactured, distributed,
7or dispensed the substance.
8"Deliver" or "delivery" means the actual, constructive, or
9attempted transfer of possession of a controlled substance or
10cannabis, with or without consideration, whether or not there
11is an agency relationship. "Deliver" or "delivery" does not
12include the donation of drugs to the extent permitted under
13the Illinois Drug Reuse Opportunity Program Act.
14    "Manufacture" means the production, preparation,
15propagation, compounding, conversion, or processing of a
16controlled substance, either directly or indirectly, by
17extraction from substances of natural origin, independently by
18means of chemical synthesis, or by a combination of extraction
19and chemical synthesis, and includes any packaging or
20repackaging of the substance or labeling of its container,
21except that the term does not include:
22        (1) by an ultimate user, the preparation or
23    compounding of a controlled substance for his own use;
24        (2) by a practitioner or his authorized agent under
25    his supervision, the preparation, compounding, packaging,
26    or labeling of a controlled substance:



10200HB0119ham001- 52 -LRB102 04093 CPF 23038 a

1            (A) as an incident to his administering or
2        dispensing of a controlled substance in the course of
3        his professional practice; or
4            (B) as an incident to lawful research, teaching or
5        chemical analysis and not for sale; or
6        (3) the preparation, compounding, packaging, or
7    labeling of cannabis as an incident to lawful research,
8    teaching, or chemical analysis and not for sale; or .
9        (4) the packaging, repackaging, or labeling of drugs
10    only to the extent permitted under the Illinois Drug Reuse
11    Opportunity Program Act.
12    "Owner" means a person who has possession of or any
13interest whatsoever in the property involved.
14    "Person" means an individual, a corporation, a government,
15a governmental subdivision or agency, a business trust, an
16estate, a trust, a partnership or association, or any other
18    "Production" means planting, cultivating, tending, or
20    "Property" means real property, including things growing
21on, affixed to, and found in land, and tangible or intangible
22personal property, including rights, services, privileges,
23interests, claims, and securities.
24(Source: P.A. 96-328, eff. 8-11-09.)".