Full Text of HB3232 101st General Assembly
HB3232ham001 101ST GENERAL ASSEMBLY | Rep. Marcus C. Evans, Jr. Filed: 3/14/2019
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| 1 | | AMENDMENT TO HOUSE BILL 3232
| 2 | | AMENDMENT NO. ______. Amend House Bill 3232 by replacing | 3 | | everything after the enacting clause with the following:
| 4 | | "Section 1. Short title. This Act may be cited as the | 5 | | Prescription Drug Repository Program Act. | 6 | | Section 5. Definitions. In this Act: | 7 | | "Controlled substance" means a drug, substance, or | 8 | | immediate precursor in Schedules I through V of 21 CFR 1308. | 9 | | "Department" means the Department of Public Health. | 10 | | "Dispense" has the meaning given to that term in the | 11 | | Pharmacy Practice Act. | 12 | | "Donor" means any person, including an individual member of | 13 | | the public, or any entity legally authorized to possess | 14 | | medicine with a license or permit in the state in which it is | 15 | | located, including, but not limited to, the following: | 16 | | wholesalers, distributors, third-party logistic providers, |
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| 1 | | pharmacies, dispensers, clinics, surgical or health centers, | 2 | | detention and rehabilitation centers, laboratories, medical or | 3 | | pharmacy schools, prescribers or other health care | 4 | | professionals, or health care facilities. "Donor" includes | 5 | | government agencies and entities that are federally authorized | 6 | | to possess medicine, including, but not limited to, drug | 7 | | manufacturers, repackagers, relabelers, outsourcing | 8 | | facilities, Veterans Affairs hospitals, and prisons. | 9 | | "Pharmacist" means an individual licensed to engage in the | 10 | | practice of pharmacy under the Pharmacy Practice Act. | 11 | | "Practitioner" means a person licensed in this State to | 12 | | prescribe and administer drugs or licensed in another state and | 13 | | recognized by this State as a person authorized to prescribe | 14 | | and administer drugs. | 15 | | "Prescription drug" means any prescribed drug that may be | 16 | | legally dispensed by a pharmacy. | 17 | | "Program" means the prescription drug repository program | 18 | | established under this Act. | 19 | | "Recipient pharmacy" means a pharmacy licensed under the | 20 | | Pharmacy Practice Act that receives a donated prescription drug | 21 | | or supplies needed to administer a prescription drug under this | 22 | | Act. | 23 | | Section 10. Prescription drug repository program. The | 24 | | Department shall, by rule, establish and maintain a | 25 | | prescription drug repository program, under which a donor may |
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| 1 | | donate a prescription drug or supplies needed to administer a | 2 | | prescription drug for use by an individual who meets | 3 | | appropriate eligibility criteria. The Department shall adopt | 4 | | the rules within one year after the effective date of this Act. | 5 | | A recipient pharmacy may charge an individual who receives a | 6 | | prescription drug or supplies needed to administer a | 7 | | prescription drug under this Act a handling fee that may not | 8 | | exceed an appropriate amount. A recipient pharmacy may | 9 | | distribute the prescription drug or supplies to another | 10 | | eligible recipient pharmacy for use under the program or to | 11 | | another state's drug repository program.
| 12 | | Section 15. Priority. Uninsured and underinsured | 13 | | individuals shall be given priority over other eligible persons | 14 | | for drugs and supplies donated under this Act. | 15 | | Section 20. Requirements for accepting and dispensing | 16 | | prescription drugs and supplies. A prescription drug or | 17 | | supplies needed to administer a prescription drug may be | 18 | | accepted and dispensed under the program only if all of the | 19 | | following requirements are met:
| 20 | | (1) The prescription drug or supplies needed to | 21 | | administer a prescription drug are in their original, | 22 | | unopened, sealed, and tamper-evident packaging or, if | 23 | | packaged in single-unit doses, the single-unit-dose | 24 | | packaging is unopened.
A prescription drug or supplies |
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| 1 | | needed to administer a prescription drug originally packed | 2 | | by a pharmacy, whether or not it is a recipient pharmacy, | 3 | | is acceptable for donation. | 4 | | (2) The prescription drug is not expired.
| 5 | | (3) The prescription drug or supplies needed to | 6 | | administer a prescription drug are not adulterated or | 7 | | misbranded, as determined by a pharmacist employed by, or | 8 | | under contract with, the pharmacy, whether or not it is a | 9 | | recipient pharmacy, where the drug or supplies needed to | 10 | | administer a prescription drug are accepted or dispensed. | 11 | | The pharmacist must inspect the drug or supplies needed to | 12 | | administer a prescription drug before the drug or supplies | 13 | | needed to administer a prescription drug are dispensed.
| 14 | | (4) The prescription drug or supplies needed to | 15 | | administer a prescription drug are prescribed by a | 16 | | practitioner for use by an eligible individual.
| 17 | | (5) The prescription drug is not a controlled | 18 | | substance. | 19 | | (6) If the prescription drug can be dispensed only to a | 20 | | patient registered with the drug's manufacturer in | 21 | | accordance with federal Food and Drug Administration | 22 | | requirements, the prescription drug may not be dispensed | 23 | | through the program unless the patient receiving the drug | 24 | | is registered with the manufacturer at the time the drug is | 25 | | dispensed and the amount dispensed does not exceed the | 26 | | duration of the registration period. |
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| 1 | | (7) The recipient pharmacy maintains a written or | 2 | | electronic record of a donation made under this Act | 3 | | consisting of the name, strength, and quantity of each | 4 | | accepted drug and the name, address, and telephone number | 5 | | of the donor. No other record of a donation is required. | 6 | | Section 25. Resale of donated drugs or supplies prohibited. | 7 | | No prescription drug or supplies needed to administer a | 8 | | prescription drug that are donated for use under this Act may | 9 | | be resold.
| 10 | | Section 30. Participation in program not required. Nothing | 11 | | in this Act requires that a pharmacy or pharmacist participate | 12 | | in the prescription drug repository program.
| 13 | | Section 35. Immunity. | 14 | | (a) A manufacturer of a drug or supply acting reasonably | 15 | | and in good faith is not subject to criminal or civil liability | 16 | | for injury, death, or loss to a person or property for matters | 17 | | related to the donation, acceptance, or dispensing of a | 18 | | prescription drug or supply manufactured by the manufacturer | 19 | | that is donated by any person under this Act.
| 20 | | (b) A person acting reasonably and in good faith, including | 21 | | a pharmacist or other health professional, is immune from civil | 22 | | liability for injury to or the death of the individual to whom | 23 | | the prescription drug or supply is dispensed and may not be |
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| 1 | | found guilty of unprofessional conduct for his or her acts or | 2 | | omissions related to donating, accepting, distributing, or | 3 | | dispensing a prescription drug or supply under this Act. The | 4 | | immunity granted under this subsection does not apply to acts | 5 | | or omissions outside the scope of the program. | 6 | | Section 90. The Pharmacy Practice Act is amended by | 7 | | changing Section 4 as follows:
| 8 | | (225 ILCS 85/4) (from Ch. 111, par. 4124)
| 9 | | (Section scheduled to be repealed on January 1, 2020)
| 10 | | Sec. 4. Exemptions. Nothing contained in any Section of | 11 | | this Act shall
apply
to, or in any manner interfere with:
| 12 | | (a) the lawful practice of any physician licensed to | 13 | | practice medicine in
all of its branches, dentist, | 14 | | podiatric physician,
veterinarian, or therapeutically or | 15 | | diagnostically certified optometrist within
the limits of
| 16 | | his or her license, or prevent him or her from
supplying to | 17 | | his
or her
bona fide patients
such drugs, medicines, or | 18 | | poisons as may seem to him appropriate;
| 19 | | (b) the sale of compressed gases;
| 20 | | (c) the sale of patent or proprietary medicines and | 21 | | household remedies
when sold in original and unbroken | 22 | | packages only, if such patent or
proprietary medicines and | 23 | | household remedies be properly and adequately
labeled as to | 24 | | content and usage and generally considered and accepted
as |
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| 1 | | harmless and nonpoisonous when used according to the | 2 | | directions
on the label, and also do not contain opium or | 3 | | coca leaves, or any
compound, salt or derivative thereof, | 4 | | or any drug which, according
to the latest editions of the | 5 | | following authoritative pharmaceutical
treatises and | 6 | | standards, namely, The United States | 7 | | Pharmacopoeia/National
Formulary (USP/NF), the United | 8 | | States Dispensatory, and the Accepted
Dental Remedies of | 9 | | the Council of Dental Therapeutics of the American
Dental | 10 | | Association or any or either of them, in use on the | 11 | | effective
date of this Act, or according to the existing | 12 | | provisions of the Federal
Food, Drug, and Cosmetic Act and | 13 | | Regulations of the Department of Health
and Human Services, | 14 | | Food and Drug Administration, promulgated thereunder
now | 15 | | in effect, is designated, described or considered as a | 16 | | narcotic,
hypnotic, habit forming, dangerous, or poisonous | 17 | | drug;
| 18 | | (d) the sale of poultry and livestock remedies in | 19 | | original and unbroken
packages only, labeled for poultry | 20 | | and livestock medication;
| 21 | | (e) the sale of poisonous substances or mixture of | 22 | | poisonous substances,
in unbroken packages, for | 23 | | nonmedicinal use in the arts or industries
or for | 24 | | insecticide purposes; provided, they are properly and | 25 | | adequately
labeled as to content and such nonmedicinal | 26 | | usage, in conformity
with the provisions of all applicable |
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| 1 | | federal, state and local laws
and regulations promulgated | 2 | | thereunder now in effect relating thereto
and governing the | 3 | | same, and those which are required under such applicable
| 4 | | laws and regulations to be labeled with the word "Poison", | 5 | | are also labeled
with the word "Poison" printed
thereon in | 6 | | prominent type and the name of a readily obtainable | 7 | | antidote
with directions for its administration;
| 8 | | (f) the delegation of limited prescriptive authority | 9 | | by a physician
licensed to
practice medicine in all its | 10 | | branches to a physician assistant
under Section 7.5 of the | 11 | | Physician Assistant Practice Act of 1987. This
delegated | 12 | | authority under Section 7.5 of the Physician Assistant | 13 | | Practice Act of 1987 may, but is not required to, include | 14 | | prescription of
controlled substances, as defined in | 15 | | Article II of the
Illinois Controlled Substances Act, in | 16 | | accordance with a written supervision agreement;
| 17 | | (g) the delegation of prescriptive authority by a | 18 | | physician
licensed to practice medicine in all its branches | 19 | | or a licensed podiatric physician to an advanced practice
| 20 | | registered nurse in accordance with a written | 21 | | collaborative
agreement under Sections 65-35 and 65-40 of | 22 | | the Nurse Practice Act; and
| 23 | | (g-5) the donation or acceptance, or the packaging, | 24 | | repackaging, or labeling, of prescription drugs to the | 25 | | extent permitted or required under the Prescription Drug | 26 | | Repository Program Act; and |
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| 1 | | (h) the sale or distribution of dialysate or devices | 2 | | necessary to perform home peritoneal renal dialysis for | 3 | | patients with end-stage renal disease, provided that all of | 4 | | the following conditions are met: | 5 | | (1) the dialysate, comprised of dextrose or | 6 | | icodextrin, or devices are approved or cleared by the | 7 | | federal Food and Drug Administration, as required by | 8 | | federal law; | 9 | | (2) the dialysate or devices are lawfully held by a | 10 | | manufacturer or the manufacturer's agent, which is | 11 | | properly registered with the Board as a manufacturer or | 12 | | wholesaler; | 13 | | (3) the dialysate or devices are held and delivered | 14 | | to the manufacturer or the manufacturer's agent in the | 15 | | original, sealed packaging from the manufacturing | 16 | | facility; | 17 | | (4) the dialysate or devices are delivered only | 18 | | upon receipt of a physician's prescription by a | 19 | | licensed pharmacy in which the prescription is | 20 | | processed in accordance with provisions set forth in | 21 | | this Act, and the transmittal of an order from the | 22 | | licensed pharmacy to the manufacturer or the | 23 | | manufacturer's agent; and | 24 | | (5) the manufacturer or the manufacturer's agent | 25 | | delivers the dialysate or devices directly to: (i) a | 26 | | patient with end-stage renal disease, or his or her |
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| 1 | | designee, for the patient's self-administration of the | 2 | | dialysis therapy or (ii) a health care provider or | 3 | | institution for administration or delivery of the | 4 | | dialysis therapy to a patient with end-stage renal | 5 | | disease. | 6 | | This paragraph (h) does not include any other drugs for | 7 | | peritoneal dialysis, except dialysate, as described in | 8 | | item (1) of this paragraph (h). All records of sales and | 9 | | distribution of dialysate to patients made pursuant to this | 10 | | paragraph (h) must be retained in accordance with Section | 11 | | 18 of this Act. | 12 | | (Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18; | 13 | | 100-863, eff. 8-14-18.)
| 14 | | Section 95. The Wholesale Drug Distribution Licensing Act | 15 | | is amended by changing Section 15 as follows:
| 16 | | (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
| 17 | | (Section scheduled to be repealed on January 1, 2023)
| 18 | | Sec. 15. Definitions. As used in this Act:
| 19 | | "Authentication" means the affirmative verification, | 20 | | before any wholesale distribution of a prescription drug | 21 | | occurs, that each transaction listed on the pedigree has | 22 | | occurred. | 23 | | "Authorized distributor of record" means a wholesale | 24 | | distributor with whom a manufacturer has established an ongoing |
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| 1 | | relationship to distribute the manufacturer's prescription | 2 | | drug. An ongoing relationship is deemed to exist between a | 3 | | wholesale distributor and a manufacturer when the wholesale | 4 | | distributor, including any affiliated group of the wholesale | 5 | | distributor, as defined in Section 1504 of the Internal Revenue | 6 | | Code, complies with the following: | 7 | | (1) The wholesale distributor has a written agreement | 8 | | currently in effect with the manufacturer evidencing the | 9 | | ongoing relationship; and | 10 | | (2) The wholesale distributor is listed on the | 11 | | manufacturer's current list of authorized distributors of | 12 | | record, which is updated by the manufacturer on no less | 13 | | than a monthly basis.
| 14 | | "Blood" means whole blood collected from a single donor and | 15 | | processed
either for transfusion or further manufacturing.
| 16 | | "Blood component" means that part of blood separated by | 17 | | physical or
mechanical means.
| 18 | | "Board" means the State Board of Pharmacy of the Department | 19 | | of
Professional Regulation.
| 20 | | "Chain pharmacy warehouse" means a physical location for | 21 | | prescription drugs that acts as a central warehouse and | 22 | | performs intracompany sales or transfers of the drugs to a | 23 | | group of chain or mail order pharmacies that have the same | 24 | | common ownership and control. Notwithstanding any other | 25 | | provision of this Act, a chain pharmacy warehouse shall be | 26 | | considered part of the normal distribution channel. |
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| 1 | | "Co-licensed partner or product" means an instance where | 2 | | one or more parties have the right to engage in the | 3 | | manufacturing or marketing of a prescription drug, consistent | 4 | | with the FDA's implementation of the Prescription Drug | 5 | | Marketing Act.
| 6 | | "Department" means the Department of Financial and
| 7 | | Professional Regulation.
| 8 | | "Drop shipment" means the sale of a prescription drug to a | 9 | | wholesale distributor by the manufacturer of the prescription | 10 | | drug or that manufacturer's co-licensed product partner, that | 11 | | manufacturer's third party logistics provider, or that | 12 | | manufacturer's exclusive distributor or by an authorized | 13 | | distributor of record that purchased the product directly from | 14 | | the manufacturer or one of these entities whereby the wholesale | 15 | | distributor or chain pharmacy warehouse takes title but not | 16 | | physical possession of such prescription drug and the wholesale | 17 | | distributor invoices the pharmacy, chain pharmacy warehouse, | 18 | | or other person authorized by law to dispense or administer | 19 | | such drug to a patient and the pharmacy, chain pharmacy | 20 | | warehouse, or other authorized person receives delivery of the | 21 | | prescription drug directly from the manufacturer, that | 22 | | manufacturer's third party logistics provider, or that | 23 | | manufacturer's exclusive distributor or from an authorized | 24 | | distributor of record that purchased the product directly from | 25 | | the manufacturer or one of these entities.
| 26 | | "Drug sample" means a unit of a prescription drug that is |
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| 1 | | not intended to
be sold and is intended to promote the sale of | 2 | | the drug.
| 3 | | "Facility" means a facility of a wholesale distributor | 4 | | where prescription drugs are stored, handled, repackaged, or | 5 | | offered for sale. | 6 | | "FDA" means the United States Food and Drug Administration.
| 7 | | "Manufacturer" means a person licensed or approved by the | 8 | | FDA to engage in the manufacture of drugs or devices, | 9 | | consistent with the definition of "manufacturer" set forth in | 10 | | the FDA's regulations and guidances implementing the | 11 | | Prescription Drug Marketing Act. "Manufacturer" does not | 12 | | include anyone who is engaged in the packaging, repackaging, or | 13 | | labeling of prescription drugs only to the extent required | 14 | | under the Prescription Drug Repository Program Act. | 15 | | "Manufacturer's exclusive distributor" means anyone who | 16 | | contracts with a manufacturer to provide or coordinate | 17 | | warehousing, distribution, or other services on behalf of a | 18 | | manufacturer and who takes title to that manufacturer's | 19 | | prescription drug, but who does not have general responsibility | 20 | | to direct the sale or disposition of the manufacturer's | 21 | | prescription drug. A manufacturer's exclusive distributor must | 22 | | be licensed as a wholesale distributor under this Act and, in | 23 | | order to be considered part of the normal distribution channel, | 24 | | must also be an authorized distributor of record.
| 25 | | "Normal distribution channel" means a chain of custody for | 26 | | a prescription drug that goes, directly or by drop shipment, |
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| 1 | | from (i) a manufacturer of the prescription drug, (ii) that | 2 | | manufacturer to that manufacturer's co-licensed partner, (iii) | 3 | | that manufacturer to that manufacturer's third party logistics | 4 | | provider, or (iv) that manufacturer to that manufacturer's | 5 | | exclusive distributor to: | 6 | | (1) a pharmacy or to other designated persons | 7 | | authorized by law to dispense or administer the drug to a | 8 | | patient; | 9 | | (2) a wholesale distributor to a pharmacy or other | 10 | | designated persons authorized by law to dispense or | 11 | | administer the drug to a patient; | 12 | | (3) a wholesale distributor to a chain pharmacy | 13 | | warehouse to that chain pharmacy warehouse's intracompany | 14 | | pharmacy to a patient or other designated persons | 15 | | authorized by law to dispense or administer the drug to a | 16 | | patient; | 17 | | (4) a chain pharmacy warehouse to the chain pharmacy | 18 | | warehouse's intracompany pharmacy or other designated | 19 | | persons authorized by law to dispense or administer the | 20 | | drug to the patient; | 21 | | (5) an authorized distributor of record to one other | 22 | | authorized distributor of record to an office-based health | 23 | | care practitioner authorized by law to dispense or | 24 | | administer the drug to the patient; or | 25 | | (6) an authorized distributor to a pharmacy or other | 26 | | persons licensed to dispense or administer the drug. |
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| 1 | | "Pedigree" means a document or electronic file containing | 2 | | information that records each wholesale distribution of any | 3 | | given prescription drug from the point of origin to the final | 4 | | wholesale distribution point of any given prescription drug.
| 5 | | "Person" means and includes a natural person, partnership, | 6 | | association,
corporation, or any other legal business entity.
| 7 | | "Pharmacy distributor" means any pharmacy licensed in this | 8 | | State or
hospital pharmacy that is engaged in the delivery or | 9 | | distribution of
prescription drugs either to any other pharmacy | 10 | | licensed in this State or
to any other person or entity | 11 | | including, but not limited to, a wholesale
drug distributor | 12 | | engaged in the delivery or distribution of prescription
drugs | 13 | | who is involved in the actual, constructive, or attempted | 14 | | transfer of
a drug in this State to other than the ultimate | 15 | | consumer except as
otherwise provided for by law.
| 16 | | "Prescription drug" means any human drug, including any | 17 | | biological product (except for blood and blood components | 18 | | intended for transfusion or biological products that are also | 19 | | medical devices), required by federal law or
regulation to be | 20 | | dispensed only by a prescription, including finished
dosage | 21 | | forms and bulk drug substances
subject to Section
503 of the | 22 | | Federal Food, Drug and Cosmetic Act.
| 23 | | "Repackage" means repackaging or otherwise changing the | 24 | | container, wrapper, or labeling to further the distribution of | 25 | | a prescription drug, excluding that completed by the pharmacist | 26 | | responsible for dispensing the product to a patient. |
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| 1 | | "Secretary" means the Secretary of Financial and | 2 | | Professional Regulation. | 3 | | "Third party logistics provider" means anyone who | 4 | | contracts with a prescription drug manufacturer to provide or | 5 | | coordinate warehousing, distribution, or other services on | 6 | | behalf of a manufacturer, but does not take title to the | 7 | | prescription drug or have general responsibility to direct the | 8 | | prescription drug's sale or disposition. A third party | 9 | | logistics provider must be licensed as a wholesale distributor | 10 | | under this Act and, in order to be considered part of the | 11 | | normal distribution channel, must also be an authorized | 12 | | distributor of record. | 13 | | "Wholesale distribution"
means the distribution
of | 14 | | prescription drugs to persons other than a consumer or patient, | 15 | | but does
not include any of the following:
| 16 | | (1)
Intracompany sales of prescription drugs, meaning | 17 | | (i) any transaction or transfer
between any division, | 18 | | subsidiary, parent, or affiliated or related company
under | 19 | | the common ownership and control of a corporate entity or | 20 | | (ii) any transaction or transfer between co-licensees of a | 21 | | co-licensed product.
| 22 | | (2) The sale, purchase, distribution, trade, or | 23 | | transfer of a prescription drug or offer to sell, purchase, | 24 | | distribute, trade, or transfer a prescription drug for | 25 | | emergency medical reasons.
| 26 | | (3) The distribution of prescription drug samples by |
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| 1 | | manufacturers' representatives. | 2 | | (4) Drug returns, when conducted by a hospital, health | 3 | | care entity, or charitable institution in accordance with | 4 | | federal regulation. | 5 | | (5) The sale of minimal quantities of prescription | 6 | | drugs by licensed pharmacies to licensed practitioners for | 7 | | office use or other licensed pharmacies. | 8 | | (6) The sale, purchase, or trade of a drug, an offer to | 9 | | sell, purchase, or trade a drug, or the dispensing of a | 10 | | drug pursuant to a prescription. | 11 | | (7) The sale, transfer, merger, or consolidation of all | 12 | | or part of the business of a pharmacy or pharmacies from or | 13 | | with another pharmacy or pharmacies, whether accomplished | 14 | | as a purchase and sale of stock or business assets. | 15 | | (8) The sale, purchase, distribution, trade, or | 16 | | transfer of a prescription drug from one authorized | 17 | | distributor of record to one additional authorized | 18 | | distributor of record when the manufacturer has stated in | 19 | | writing to the receiving authorized distributor of record | 20 | | that the manufacturer is unable to supply the prescription | 21 | | drug and the supplying authorized distributor of record | 22 | | states in writing that the prescription drug being supplied | 23 | | had until that time been exclusively in the normal | 24 | | distribution channel. | 25 | | (9) The delivery of or the offer to deliver a | 26 | | prescription drug by a common carrier solely in the common |
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| 1 | | carrier's usual course of business of transporting | 2 | | prescription drugs when the common carrier does not store, | 3 | | warehouse, or take legal ownership of the prescription | 4 | | drug. | 5 | | (10) The sale or transfer from a retail pharmacy, mail | 6 | | order pharmacy, or chain pharmacy warehouse of expired, | 7 | | damaged, returned, or recalled prescription drugs to the | 8 | | original manufacturer, the originating wholesale | 9 | | distributor, or a third party returns processor.
| 10 | | (11) The donation of prescription drugs to the extent | 11 | | permitted under the Prescription Drug Repository Program | 12 | | Act.
| 13 | | "Wholesale drug distributor" means anyone
engaged in the
| 14 | | wholesale distribution of prescription drugs into, out of, or | 15 | | within the State, including without limitation
manufacturers; | 16 | | repackers; own label distributors; jobbers; private
label | 17 | | distributors; brokers; warehouses, including manufacturers' | 18 | | and
distributors' warehouses; manufacturer's exclusive | 19 | | distributors; and authorized distributors of record; drug | 20 | | wholesalers or distributors; independent wholesale drug | 21 | | traders; specialty wholesale distributors; third party | 22 | | logistics providers; and retail pharmacies that conduct | 23 | | wholesale distribution; and chain pharmacy warehouses that | 24 | | conduct wholesale distribution. In order to be considered part | 25 | | of the normal distribution channel, a wholesale distributor | 26 | | must also be an authorized distributor of record.
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| 1 | | (Source: P.A. 97-804, eff. 1-1-13.)
| 2 | | Section 100. The Senior Pharmaceutical Assistance Act is | 3 | | amended by changing Section 10 as follows:
| 4 | | (320 ILCS 50/10)
| 5 | | Sec. 10. Definitions. In this Act:
| 6 | | "Manufacturer" includes:
| 7 | | (1) An entity that is engaged in (a) the production, | 8 | | preparation,
propagation, compounding, conversion, or | 9 | | processing of prescription drug
products (i) directly or | 10 | | indirectly by extraction from substances of natural
| 11 | | origin,
(ii) independently by means of chemical synthesis, | 12 | | or (iii) by combination of
extraction
and chemical | 13 | | synthesis; or (b) the packaging, repackaging, labeling or
| 14 | | re-labeling, or distribution of prescription drug | 15 | | products.
| 16 | | (2) The entity holding legal title to or possession of | 17 | | the national
drug code number for the covered prescription | 18 | | drug.
| 19 | | The term does not include a wholesale distributor of drugs,
| 20 | | drugstore chain organization, or retail pharmacy licensed by | 21 | | the State. The term also does not include anyone who is engaged | 22 | | in the packaging, repackaging, or labeling of prescription | 23 | | drugs only to the extent required under the Prescription Drug | 24 | | Repository Program Act.
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| 1 | | "Prescription drug" means a drug that may be dispensed only | 2 | | upon
prescription by an authorized prescriber and that is | 3 | | approved for safety and
effectiveness as a prescription drug | 4 | | under Section 505 or 507 of the Federal
Food, Drug and Cosmetic | 5 | | Act.
| 6 | | "Senior citizen" or "senior" means a person 65 years of age | 7 | | or
older.
| 8 | | (Source: P.A. 92-594, eff. 6-27-02.)
| 9 | | Section 105. The Illinois Food, Drug and Cosmetic Act is | 10 | | amended by changing Section 16 as follows:
| 11 | | (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
| 12 | | Sec. 16. (a) The Director is hereby authorized to | 13 | | promulgate
regulations exempting from any labeling or | 14 | | packaging requirement of this
Act drugs and devices which are | 15 | | (i) , in accordance with the practice of the
trade, to be | 16 | | processed, labeled or repacked in substantial quantities at
| 17 | | establishments other than those where originally processed or | 18 | | packaged on
condition that such drugs and devices are not | 19 | | adulterated or misbranded
under the provisions of this Act upon | 20 | | removal from such processing,
labeling or repacking | 21 | | establishment or (ii) packaged, repackaged, or labeled to the | 22 | | extent required under the Prescription Drug Repository Program | 23 | | Act .
| 24 | | (b) Drugs and device labeling or packaging exemptions |
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| 1 | | adopted under the
Federal Act and supplements thereto or | 2 | | revisions thereof shall apply to
drugs and devices in Illinois | 3 | | except insofar as modified or rejected by
regulations | 4 | | promulgated by the Director.
| 5 | | (c) A drug intended for use by man which (A) is a | 6 | | habit-forming drug to
which Section 15 (d) applies; or (B) | 7 | | because of its toxicity or other
potentiality for harmful | 8 | | effect or the method of its use or the collateral
measures | 9 | | necessary to its use is not safe for use except under the
| 10 | | supervision of a practitioner licensed by law to administer | 11 | | such drug; or
(C) is limited by an approved application under | 12 | | Section 505 of the Federal
Act or Section 17 of this Act to use | 13 | | under the professional supervision of
a practitioner licensed | 14 | | by law to administer such drug, shall be dispensed
only in | 15 | | accordance with the provisions of the "Illinois Controlled
| 16 | | Substances Act". The act of dispensing a drug contrary to the | 17 | | provisions of
this paragraph shall be deemed to be an act which | 18 | | results in a drug being
misbranded while held for sale.
| 19 | | (d) Any drug dispensed by filling or refilling a written
or | 20 | | oral prescription of a practitioner licensed by law to | 21 | | administer such
drug shall be exempt from the requirements of | 22 | | Section 15, except
subsections (a), (k) and (l) and clauses (2) | 23 | | and (3) of subsection (i), and
the packaging requirements of
| 24 | | subsections (g), (h) and (q), if the drug bears a label | 25 | | containing the
proprietary name or names, or if there is none, | 26 | | the established name or
names of the drugs, the dosage and |
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| 1 | | quantity, unless the prescribing
practitioner, in the interest | 2 | | of the health of the patient, directs
otherwise in writing, the | 3 | | name and address of the dispenser, the serial
number and date | 4 | | of the prescription or of its filling, the name of the
| 5 | | prescriber and, if stated in the prescription, the name of the | 6 | | patient, and
the directions for use and the cautionary | 7 | | statements, if any, contained in
such prescription. This | 8 | | exemption shall not apply to any drug dispensed in
the course | 9 | | of the conduct of business of dispensing drugs pursuant to
| 10 | | diagnosis by mail, or to a drug dispensed in violation of | 11 | | subsection (a) of
this Section.
| 12 | | (e) The Director may by regulation remove drugs subject to
| 13 | | Section 15 (d) and Section 17 from the requirements of | 14 | | subsection (c) of
this Section when such requirements are not | 15 | | necessary for the protection of
the public health.
| 16 | | (f) A drug which is subject to subsection (c) of this | 17 | | Section
shall be deemed to be misbranded if at any time before | 18 | | dispensing its label
fails to bear the statement "Caution: | 19 | | Federal Law Prohibits Dispensing Without
Prescription" or | 20 | | "Caution: State Law Prohibits Dispensing Without
| 21 | | Prescription". A drug to which subsection (c) of this Section | 22 | | does not apply
shall be deemed to be misbranded if at any time | 23 | | prior to dispensing its
label bears the caution statement | 24 | | quoted in the preceding sentence.
| 25 | | (g) Nothing in this Section shall be construed to relieve
| 26 | | any person from any requirement prescribed by or under |
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| 1 | | authority of law
with respect to controlled substances now | 2 | | included or which may hereafter
be included within the | 3 | | classifications of controlled substances cannabis as
defined | 4 | | in applicable Federal laws relating to controlled substances or
| 5 | | cannabis or the Cannabis Control Act.
| 6 | | (Source: P.A. 84-1308.)
| 7 | | Section 110. The Illinois Controlled Substances Act is | 8 | | amended by changing Section 102 as follows: | 9 | | (720 ILCS 570/102) (from Ch. 56 1/2, par. 1102) | 10 | | Sec. 102. Definitions. As used in this Act, unless the | 11 | | context
otherwise requires:
| 12 | | (a) "Addict" means any person who habitually uses any drug, | 13 | | chemical,
substance or dangerous drug other than alcohol so as | 14 | | to endanger the public
morals, health, safety or welfare or who | 15 | | is so far addicted to the use of a
dangerous drug or controlled | 16 | | substance other than alcohol as to have lost
the power of self | 17 | | control with reference to his or her addiction.
| 18 | | (b) "Administer" means the direct application of a | 19 | | controlled
substance, whether by injection, inhalation, | 20 | | ingestion, or any other
means, to the body of a patient, | 21 | | research subject, or animal (as
defined by the Humane | 22 | | Euthanasia in Animal Shelters Act) by:
| 23 | | (1) a practitioner (or, in his or her presence, by his | 24 | | or her authorized agent),
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| 1 | | (2) the patient or research subject pursuant to an | 2 | | order, or
| 3 | | (3) a euthanasia technician as defined by the Humane | 4 | | Euthanasia in
Animal Shelters Act.
| 5 | | (c) "Agent" means an authorized person who acts on behalf | 6 | | of or at
the direction of a manufacturer, distributor, | 7 | | dispenser, prescriber, or practitioner. It does not
include a | 8 | | common or contract carrier, public warehouseman or employee of
| 9 | | the carrier or warehouseman.
| 10 | | (c-1) "Anabolic Steroids" means any drug or hormonal | 11 | | substance,
chemically and pharmacologically related to | 12 | | testosterone (other than
estrogens, progestins, | 13 | | corticosteroids, and dehydroepiandrosterone),
and includes:
| 14 | | (i) 3[beta],17-dihydroxy-5a-androstane, | 15 | | (ii) 3[alpha],17[beta]-dihydroxy-5a-androstane, | 16 | | (iii) 5[alpha]-androstan-3,17-dione, | 17 | | (iv) 1-androstenediol (3[beta], | 18 | | 17[beta]-dihydroxy-5[alpha]-androst-1-ene), | 19 | | (v) 1-androstenediol (3[alpha], | 20 | | 17[beta]-dihydroxy-5[alpha]-androst-1-ene), | 21 | | (vi) 4-androstenediol | 22 | | (3[beta],17[beta]-dihydroxy-androst-4-ene), | 23 | | (vii) 5-androstenediol | 24 | | (3[beta],17[beta]-dihydroxy-androst-5-ene), | 25 | | (viii) 1-androstenedione | 26 | | ([5alpha]-androst-1-en-3,17-dione), |
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| 1 | | (ix) 4-androstenedione | 2 | | (androst-4-en-3,17-dione), | 3 | | (x) 5-androstenedione | 4 | | (androst-5-en-3,17-dione), | 5 | | (xi) bolasterone (7[alpha],17a-dimethyl-17[beta]- | 6 | | hydroxyandrost-4-en-3-one), | 7 | | (xii) boldenone (17[beta]-hydroxyandrost- | 8 | | 1,4,-diene-3-one), | 9 | | (xiii) boldione (androsta-1,4- | 10 | | diene-3,17-dione), | 11 | | (xiv) calusterone (7[beta],17[alpha]-dimethyl-17 | 12 | | [beta]-hydroxyandrost-4-en-3-one), | 13 | | (xv) clostebol (4-chloro-17[beta]- | 14 | | hydroxyandrost-4-en-3-one), | 15 | | (xvi) dehydrochloromethyltestosterone (4-chloro- | 16 | | 17[beta]-hydroxy-17[alpha]-methyl- | 17 | | androst-1,4-dien-3-one), | 18 | | (xvii) desoxymethyltestosterone | 19 | | (17[alpha]-methyl-5[alpha] | 20 | | -androst-2-en-17[beta]-ol)(a.k.a., madol), | 21 | | (xviii) [delta]1-dihydrotestosterone (a.k.a. | 22 | | '1-testosterone') (17[beta]-hydroxy- | 23 | | 5[alpha]-androst-1-en-3-one), | 24 | | (xix) 4-dihydrotestosterone (17[beta]-hydroxy- | 25 | | androstan-3-one), | 26 | | (xx) drostanolone (17[beta]-hydroxy-2[alpha]-methyl- |
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| 1 | | 5[alpha]-androstan-3-one), | 2 | | (xxi) ethylestrenol (17[alpha]-ethyl-17[beta]- | 3 | | hydroxyestr-4-ene), | 4 | | (xxii) fluoxymesterone (9-fluoro-17[alpha]-methyl- | 5 | | 1[beta],17[beta]-dihydroxyandrost-4-en-3-one), | 6 | | (xxiii) formebolone (2-formyl-17[alpha]-methyl-11[alpha], | 7 | | 17[beta]-dihydroxyandrost-1,4-dien-3-one), | 8 | | (xxiv) furazabol (17[alpha]-methyl-17[beta]- | 9 | | hydroxyandrostano[2,3-c]-furazan), | 10 | | (xxv) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one, | 11 | | (xxvi) 4-hydroxytestosterone (4,17[beta]-dihydroxy- | 12 | | androst-4-en-3-one), | 13 | | (xxvii) 4-hydroxy-19-nortestosterone (4,17[beta]- | 14 | | dihydroxy-estr-4-en-3-one), | 15 | | (xxviii) mestanolone (17[alpha]-methyl-17[beta]- | 16 | | hydroxy-5-androstan-3-one), | 17 | | (xxix) mesterolone (1amethyl-17[beta]-hydroxy- | 18 | | [5a]-androstan-3-one), | 19 | | (xxx) methandienone (17[alpha]-methyl-17[beta]- | 20 | | hydroxyandrost-1,4-dien-3-one), | 21 | | (xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]- | 22 | | dihydroxyandrost-5-ene), | 23 | | (xxxii) methenolone (1-methyl-17[beta]-hydroxy- | 24 | | 5[alpha]-androst-1-en-3-one), | 25 | | (xxxiii) 17[alpha]-methyl-3[beta], 17[beta]- | 26 | | dihydroxy-5a-androstane, |
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| 1 | | (xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy | 2 | | -5a-androstane, | 3 | | (xxxv) 17[alpha]-methyl-3[beta],17[beta]- | 4 | | dihydroxyandrost-4-ene), | 5 | | (xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]- | 6 | | methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one), | 7 | | (xxxvii) methyldienolone (17[alpha]-methyl-17[beta]- | 8 | | hydroxyestra-4,9(10)-dien-3-one), | 9 | | (xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]- | 10 | | hydroxyestra-4,9-11-trien-3-one), | 11 | | (xxxix) methyltestosterone (17[alpha]-methyl-17[beta]- | 12 | | hydroxyandrost-4-en-3-one), | 13 | | (xl) mibolerone (7[alpha],17a-dimethyl-17[beta]- | 14 | | hydroxyestr-4-en-3-one), | 15 | | (xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone | 16 | | (17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]- | 17 | | androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl- | 18 | | 1-testosterone'), | 19 | | (xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one), | 20 | | (xliii) 19-nor-4-androstenediol (3[beta], 17[beta]- | 21 | | dihydroxyestr-4-ene), | 22 | | (xliv) 19-nor-4-androstenediol (3[alpha], 17[beta]- | 23 | | dihydroxyestr-4-ene), | 24 | | (xlv) 19-nor-5-androstenediol (3[beta], 17[beta]- | 25 | | dihydroxyestr-5-ene), | 26 | | (xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]- |
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| 1 | | dihydroxyestr-5-ene), | 2 | | (xlvii) 19-nor-4,9(10)-androstadienedione | 3 | | (estra-4,9(10)-diene-3,17-dione), | 4 | | (xlviii) 19-nor-4-androstenedione (estr-4- | 5 | | en-3,17-dione), | 6 | | (xlix) 19-nor-5-androstenedione (estr-5- | 7 | | en-3,17-dione), | 8 | | (l) norbolethone (13[beta], 17a-diethyl-17[beta]- | 9 | | hydroxygon-4-en-3-one), | 10 | | (li) norclostebol (4-chloro-17[beta]- | 11 | | hydroxyestr-4-en-3-one), | 12 | | (lii) norethandrolone (17[alpha]-ethyl-17[beta]- | 13 | | hydroxyestr-4-en-3-one), | 14 | | (liii) normethandrolone (17[alpha]-methyl-17[beta]- | 15 | | hydroxyestr-4-en-3-one), | 16 | | (liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy- | 17 | | 2-oxa-5[alpha]-androstan-3-one), | 18 | | (lv) oxymesterone (17[alpha]-methyl-4,17[beta]- | 19 | | dihydroxyandrost-4-en-3-one), | 20 | | (lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene- | 21 | | 17[beta]-hydroxy-(5[alpha]-androstan-3-one), | 22 | | (lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy- | 23 | | (5[alpha]-androst-2-eno[3,2-c]-pyrazole), | 24 | | (lviii) stenbolone (17[beta]-hydroxy-2-methyl- | 25 | | (5[alpha]-androst-1-en-3-one), | 26 | | (lix) testolactone (13-hydroxy-3-oxo-13,17- |
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| 1 | | secoandrosta-1,4-dien-17-oic | 2 | | acid lactone), | 3 | | (lx) testosterone (17[beta]-hydroxyandrost- | 4 | | 4-en-3-one), | 5 | | (lxi) tetrahydrogestrinone (13[beta], 17[alpha]- | 6 | | diethyl-17[beta]-hydroxygon- | 7 | | 4,9,11-trien-3-one), | 8 | | (lxii) trenbolone (17[beta]-hydroxyestr-4,9, | 9 | | 11-trien-3-one).
| 10 | | Any person who is otherwise lawfully in possession of an | 11 | | anabolic
steroid, or who otherwise lawfully manufactures, | 12 | | distributes, dispenses,
delivers, or possesses with intent to | 13 | | deliver an anabolic steroid, which
anabolic steroid is | 14 | | expressly intended for and lawfully allowed to be
administered | 15 | | through implants to livestock or other nonhuman species, and
| 16 | | which is approved by the Secretary of Health and Human Services | 17 | | for such
administration, and which the person intends to | 18 | | administer or have
administered through such implants, shall | 19 | | not be considered to be in
unauthorized possession or to | 20 | | unlawfully manufacture, distribute, dispense,
deliver, or | 21 | | possess with intent to deliver such anabolic steroid for
| 22 | | purposes of this Act.
| 23 | | (d) "Administration" means the Drug Enforcement | 24 | | Administration,
United States Department of Justice, or its | 25 | | successor agency.
| 26 | | (d-5) "Clinical Director, Prescription Monitoring Program" |
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| 1 | | means a Department of Human Services administrative employee | 2 | | licensed to either prescribe or dispense controlled substances | 3 | | who shall run the clinical aspects of the Department of Human | 4 | | Services Prescription Monitoring Program and its Prescription | 5 | | Information Library. | 6 | | (d-10) "Compounding" means the preparation and mixing of | 7 | | components, excluding flavorings, (1) as the result of a | 8 | | prescriber's prescription drug order or initiative based on the | 9 | | prescriber-patient-pharmacist relationship in the course of | 10 | | professional practice or (2) for the purpose of, or incident | 11 | | to, research, teaching, or chemical analysis and not for sale | 12 | | or dispensing. "Compounding" includes the preparation of drugs | 13 | | or devices in anticipation of receiving prescription drug | 14 | | orders based on routine, regularly observed dispensing | 15 | | patterns. Commercially available products may be compounded | 16 | | for dispensing to individual patients only if both of the | 17 | | following conditions are met: (i) the commercial product is not | 18 | | reasonably available from normal distribution channels in a | 19 | | timely manner to meet the patient's needs and (ii) the | 20 | | prescribing practitioner has requested that the drug be | 21 | | compounded. | 22 | | (e) "Control" means to add a drug or other substance, or | 23 | | immediate
precursor, to a Schedule whether by
transfer from | 24 | | another Schedule or otherwise.
| 25 | | (f) "Controlled Substance" means (i) a drug, substance, | 26 | | immediate
precursor, or synthetic drug in the Schedules of |
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| 1 | | Article II of this Act or (ii) a drug or other substance, or | 2 | | immediate precursor, designated as a controlled substance by | 3 | | the Department through administrative rule. The term does not | 4 | | include distilled spirits, wine, malt beverages, or tobacco, as | 5 | | those terms are
defined or used in the Liquor Control Act of | 6 | | 1934 and the Tobacco Products Tax
Act of 1995.
| 7 | | (f-5) "Controlled substance analog" means a substance: | 8 | | (1) the chemical structure of which is substantially | 9 | | similar to the chemical structure of a controlled substance | 10 | | in Schedule I or II; | 11 | | (2) which has a stimulant, depressant, or | 12 | | hallucinogenic effect on the central nervous system that is | 13 | | substantially similar to or greater than the stimulant, | 14 | | depressant, or hallucinogenic effect on the central | 15 | | nervous system of a controlled substance in Schedule I or | 16 | | II; or | 17 | | (3) with respect to a particular person, which such | 18 | | person represents or intends to have a stimulant, | 19 | | depressant, or hallucinogenic effect on the central | 20 | | nervous system that is substantially similar to or greater | 21 | | than the stimulant, depressant, or hallucinogenic effect | 22 | | on the central nervous system of a controlled substance in | 23 | | Schedule I or II. | 24 | | (g) "Counterfeit substance" means a controlled substance, | 25 | | which, or
the container or labeling of which, without | 26 | | authorization bears the
trademark, trade name, or other |
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| 1 | | identifying mark, imprint, number or
device, or any likeness | 2 | | thereof, of a manufacturer, distributor, or
dispenser other | 3 | | than the person who in fact manufactured, distributed,
or | 4 | | dispensed the substance.
| 5 | | (h) "Deliver" or "delivery" means the actual, constructive | 6 | | or
attempted transfer of possession of a controlled substance, | 7 | | with or
without consideration, whether or not there is an | 8 | | agency relationship.
"Deliver" or "delivery" does not include | 9 | | the donation of prescription drugs to the extent permitted | 10 | | under the Prescription Drug Repository Program Act.
| 11 | | (i) "Department" means the Illinois Department of Human | 12 | | Services (as
successor to the Department of Alcoholism and | 13 | | Substance Abuse) or its successor agency.
| 14 | | (j) (Blank).
| 15 | | (k) "Department of Corrections" means the Department of | 16 | | Corrections
of the State of Illinois or its successor agency.
| 17 | | (l) "Department of Financial and Professional Regulation" | 18 | | means the Department
of Financial and Professional Regulation | 19 | | of the State of Illinois or its successor agency.
| 20 | | (m) "Depressant" means any drug that (i) causes an overall | 21 | | depression of central nervous system functions, (ii) causes | 22 | | impaired consciousness and awareness, and (iii) can be | 23 | | habit-forming or lead to a substance abuse problem, including | 24 | | but not limited to alcohol, cannabis and its active principles | 25 | | and their analogs, benzodiazepines and their analogs, | 26 | | barbiturates and their analogs, opioids (natural and |
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| 1 | | synthetic) and their analogs, and chloral hydrate and similar | 2 | | sedative hypnotics.
| 3 | | (n) (Blank).
| 4 | | (o) "Director" means the Director of the Illinois State | 5 | | Police or his or her designated agents.
| 6 | | (p) "Dispense" means to deliver a controlled substance to | 7 | | an
ultimate user or research subject by or pursuant to the | 8 | | lawful order of
a prescriber, including the prescribing, | 9 | | administering, packaging,
labeling, or compounding necessary | 10 | | to prepare the substance for that
delivery.
| 11 | | (q) "Dispenser" means a practitioner who dispenses.
| 12 | | (r) "Distribute" means to deliver, other than by | 13 | | administering or
dispensing, a controlled substance.
| 14 | | (s) "Distributor" means a person who distributes.
| 15 | | (t) "Drug" means (1) substances recognized as drugs in the | 16 | | official
United States Pharmacopoeia, Official Homeopathic | 17 | | Pharmacopoeia of the
United States, or official National | 18 | | Formulary, or any supplement to any
of them; (2) substances | 19 | | intended for use in diagnosis, cure, mitigation,
treatment, or | 20 | | prevention of disease in man or animals; (3) substances
(other | 21 | | than food) intended to affect the structure of any function of
| 22 | | the body of man or animals and (4) substances intended for use | 23 | | as a
component of any article specified in clause (1), (2), or | 24 | | (3) of this
subsection. It does not include devices or their | 25 | | components, parts, or
accessories.
| 26 | | (t-3) "Electronic health record" or "EHR" means an |
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| 1 | | electronic record of health-related information on an | 2 | | individual that is created, gathered, managed, and consulted by | 3 | | authorized health care clinicians and staff. | 4 | | (t-4) "Emergency medical services personnel" has the | 5 | | meaning ascribed to it in the Emergency Medical Services (EMS) | 6 | | Systems Act. | 7 | | (t-5) "Euthanasia agency" means
an entity certified by the | 8 | | Department of Financial and Professional Regulation for the
| 9 | | purpose of animal euthanasia that holds an animal control | 10 | | facility license or
animal
shelter license under the Animal | 11 | | Welfare Act. A euthanasia agency is
authorized to purchase, | 12 | | store, possess, and utilize Schedule II nonnarcotic and
| 13 | | Schedule III nonnarcotic drugs for the sole purpose of animal | 14 | | euthanasia.
| 15 | | (t-10) "Euthanasia drugs" means Schedule II or Schedule III | 16 | | substances
(nonnarcotic controlled substances) that are used | 17 | | by a euthanasia agency for
the purpose of animal euthanasia.
| 18 | | (u) "Good faith" means the prescribing or dispensing of a | 19 | | controlled
substance by a practitioner in the regular course of | 20 | | professional
treatment to or for any person who is under his or | 21 | | her treatment for a
pathology or condition other than that | 22 | | individual's physical or
psychological dependence upon or | 23 | | addiction to a controlled substance,
except as provided herein: | 24 | | and application of the term to a pharmacist
shall mean the | 25 | | dispensing of a controlled substance pursuant to the
| 26 | | prescriber's order which in the professional judgment of the |
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| 1 | | pharmacist
is lawful. The pharmacist shall be guided by | 2 | | accepted professional
standards including, but not limited to | 3 | | the following, in making the
judgment:
| 4 | | (1) lack of consistency of prescriber-patient | 5 | | relationship,
| 6 | | (2) frequency of prescriptions for same drug by one | 7 | | prescriber for
large numbers of patients,
| 8 | | (3) quantities beyond those normally prescribed,
| 9 | | (4) unusual dosages (recognizing that there may be | 10 | | clinical circumstances where more or less than the usual | 11 | | dose may be used legitimately),
| 12 | | (5) unusual geographic distances between patient, | 13 | | pharmacist and
prescriber,
| 14 | | (6) consistent prescribing of habit-forming drugs.
| 15 | | (u-0.5) "Hallucinogen" means a drug that causes markedly | 16 | | altered sensory perception leading to hallucinations of any | 17 | | type. | 18 | | (u-1) "Home infusion services" means services provided by a | 19 | | pharmacy in
compounding solutions for direct administration to | 20 | | a patient in a private
residence, long-term care facility, or | 21 | | hospice setting by means of parenteral,
intravenous, | 22 | | intramuscular, subcutaneous, or intraspinal infusion.
| 23 | | (u-5) "Illinois State Police" means the State
Police of the | 24 | | State of Illinois, or its successor agency. | 25 | | (v) "Immediate precursor" means a substance:
| 26 | | (1) which the Department has found to be and by rule |
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| 1 | | designated as
being a principal compound used, or produced | 2 | | primarily for use, in the
manufacture of a controlled | 3 | | substance;
| 4 | | (2) which is an immediate chemical intermediary used or | 5 | | likely to
be used in the manufacture of such controlled | 6 | | substance; and
| 7 | | (3) the control of which is necessary to prevent, | 8 | | curtail or limit
the manufacture of such controlled | 9 | | substance.
| 10 | | (w) "Instructional activities" means the acts of teaching, | 11 | | educating
or instructing by practitioners using controlled | 12 | | substances within
educational facilities approved by the State | 13 | | Board of Education or
its successor agency.
| 14 | | (x) "Local authorities" means a duly organized State, | 15 | | County or
Municipal peace unit or police force.
| 16 | | (y) "Look-alike substance" means a substance, other than a | 17 | | controlled
substance which (1) by overall dosage unit | 18 | | appearance, including shape,
color, size, markings or lack | 19 | | thereof, taste, consistency, or any other
identifying physical | 20 | | characteristic of the substance, would lead a reasonable
person | 21 | | to believe that the substance is a controlled substance, or (2) | 22 | | is
expressly or impliedly represented to be a controlled | 23 | | substance or is
distributed under circumstances which would | 24 | | lead a reasonable person to
believe that the substance is a | 25 | | controlled substance. For the purpose of
determining whether | 26 | | the representations made or the circumstances of the
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| 1 | | distribution would lead a reasonable person to believe the | 2 | | substance to be
a controlled substance under this clause (2) of | 3 | | subsection (y), the court or
other authority may consider the | 4 | | following factors in addition to any other
factor that may be | 5 | | relevant:
| 6 | | (a) statements made by the owner or person in control | 7 | | of the substance
concerning its nature, use or effect;
| 8 | | (b) statements made to the buyer or recipient that the | 9 | | substance may
be resold for profit;
| 10 | | (c) whether the substance is packaged in a manner | 11 | | normally used for the
illegal distribution of controlled | 12 | | substances;
| 13 | | (d) whether the distribution or attempted distribution | 14 | | included an
exchange of or demand for money or other | 15 | | property as consideration, and
whether the amount of the | 16 | | consideration was substantially greater than the
| 17 | | reasonable retail market value of the substance.
| 18 | | Clause (1) of this subsection (y) shall not apply to a | 19 | | noncontrolled
substance in its finished dosage form that was | 20 | | initially introduced into
commerce prior to the initial | 21 | | introduction into commerce of a controlled
substance in its | 22 | | finished dosage form which it may substantially resemble.
| 23 | | Nothing in this subsection (y) prohibits the dispensing or | 24 | | distributing
of noncontrolled substances by persons authorized | 25 | | to dispense and
distribute controlled substances under this | 26 | | Act, provided that such action
would be deemed to be carried |
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| 1 | | out in good faith under subsection (u) if the
substances | 2 | | involved were controlled substances.
| 3 | | Nothing in this subsection (y) or in this Act prohibits the | 4 | | manufacture,
preparation, propagation, compounding, | 5 | | processing, packaging, advertising
or distribution of a drug or | 6 | | drugs by any person registered pursuant to
Section 510 of the | 7 | | Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
| 8 | | (y-1) "Mail-order pharmacy" means a pharmacy that is | 9 | | located in a state
of the United States that delivers, | 10 | | dispenses or
distributes, through the United States Postal | 11 | | Service or other common
carrier, to Illinois residents, any | 12 | | substance which requires a prescription.
| 13 | | (z) "Manufacture" means the production, preparation, | 14 | | propagation,
compounding, conversion or processing of a | 15 | | controlled substance other than methamphetamine, either
| 16 | | directly or indirectly, by extraction from substances of | 17 | | natural origin,
or independently by means of chemical | 18 | | synthesis, or by a combination of
extraction and chemical | 19 | | synthesis, and includes any packaging or
repackaging of the | 20 | | substance or labeling of its container, except that
this term | 21 | | does not include:
| 22 | | (1) by an ultimate user, the preparation or compounding | 23 | | of a
controlled substance for his or her own use; or
| 24 | | (2) by a practitioner, or his or her authorized agent | 25 | | under his or her
supervision, the preparation, | 26 | | compounding, packaging, or labeling of a
controlled |
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| 1 | | substance:
| 2 | | (a) as an incident to his or her administering or | 3 | | dispensing of a
controlled substance in the course of | 4 | | his or her professional practice; or
| 5 | | (b) as an incident to lawful research, teaching or | 6 | | chemical
analysis and not for sale ; or .
| 7 | | (3) the packaging, repackaging, or labeling of | 8 | | prescription drugs only to the extent required under the | 9 | | Prescription Drug Repository Program Act.
| 10 | | (z-1) (Blank).
| 11 | | (z-5) "Medication shopping" means the conduct prohibited | 12 | | under subsection (a) of Section 314.5 of this Act. | 13 | | (z-10) "Mid-level practitioner" means (i) a physician | 14 | | assistant who has been delegated authority to prescribe through | 15 | | a written delegation of authority by a physician licensed to | 16 | | practice medicine in all of its branches, in accordance with | 17 | | Section 7.5 of the Physician Assistant Practice Act of 1987, | 18 | | (ii) an advanced practice registered nurse who has been | 19 | | delegated authority to prescribe through a written delegation | 20 | | of authority by a physician licensed to practice medicine in | 21 | | all of its branches or by a podiatric physician, in accordance | 22 | | with Section 65-40 of the Nurse Practice Act, (iii) an advanced | 23 | | practice registered nurse certified as a nurse practitioner, | 24 | | nurse midwife, or clinical nurse specialist who has been | 25 | | granted authority to prescribe by a hospital affiliate in | 26 | | accordance with Section 65-45 of the Nurse Practice Act, (iv) |
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| 1 | | an animal euthanasia agency, or (v) a prescribing psychologist. | 2 | | (aa) "Narcotic drug" means any of the following, whether | 3 | | produced
directly or indirectly by extraction from substances | 4 | | of vegetable origin,
or independently by means of chemical | 5 | | synthesis, or by a combination of
extraction and chemical | 6 | | synthesis:
| 7 | | (1) opium, opiates, derivatives of opium and opiates, | 8 | | including their isomers, esters, ethers, salts, and salts | 9 | | of isomers, esters, and ethers, whenever the existence of | 10 | | such isomers, esters, ethers, and salts is possible within | 11 | | the specific chemical designation; however the term | 12 | | "narcotic drug" does not include the isoquinoline | 13 | | alkaloids of opium;
| 14 | | (2) (blank);
| 15 | | (3) opium poppy and poppy straw;
| 16 | | (4) coca leaves, except coca leaves and extracts of | 17 | | coca leaves from which substantially all of the cocaine and | 18 | | ecgonine, and their isomers, derivatives and salts, have | 19 | | been removed;
| 20 | | (5) cocaine, its salts, optical and geometric isomers, | 21 | | and salts of isomers; | 22 | | (6) ecgonine, its derivatives, their salts, isomers, | 23 | | and salts of isomers; | 24 | | (7) any compound, mixture, or preparation which | 25 | | contains any quantity of any of the substances referred to | 26 | | in subparagraphs (1) through (6). |
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| 1 | | (bb) "Nurse" means a registered nurse licensed under the
| 2 | | Nurse Practice Act.
| 3 | | (cc) (Blank).
| 4 | | (dd) "Opiate" means any substance having an addiction | 5 | | forming or
addiction sustaining liability similar to morphine | 6 | | or being capable of
conversion into a drug having addiction | 7 | | forming or addiction sustaining
liability.
| 8 | | (ee) "Opium poppy" means the plant of the species Papaver
| 9 | | somniferum L., except its seeds.
| 10 | | (ee-5) "Oral dosage" means a tablet, capsule, elixir, or | 11 | | solution or other liquid form of medication intended for | 12 | | administration by mouth, but the term does not include a form | 13 | | of medication intended for buccal, sublingual, or transmucosal | 14 | | administration. | 15 | | (ff) "Parole and Pardon Board" means the Parole and Pardon | 16 | | Board of
the State of Illinois or its successor agency.
| 17 | | (gg) "Person" means any individual, corporation, | 18 | | mail-order pharmacy,
government or governmental subdivision or | 19 | | agency, business trust, estate,
trust, partnership or | 20 | | association, or any other entity.
| 21 | | (hh) "Pharmacist" means any person who holds a license or | 22 | | certificate of
registration as a registered pharmacist, a local | 23 | | registered pharmacist
or a registered assistant pharmacist | 24 | | under the Pharmacy Practice Act.
| 25 | | (ii) "Pharmacy" means any store, ship or other place in | 26 | | which
pharmacy is authorized to be practiced under the Pharmacy |
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| 1 | | Practice Act.
| 2 | | (ii-5) "Pharmacy shopping" means the conduct prohibited | 3 | | under subsection (b) of Section 314.5 of this Act. | 4 | | (ii-10) "Physician" (except when the context otherwise | 5 | | requires) means a person licensed to practice medicine in all | 6 | | of its branches. | 7 | | (jj) "Poppy straw" means all parts, except the seeds, of | 8 | | the opium
poppy, after mowing.
| 9 | | (kk) "Practitioner" means a physician licensed to practice | 10 | | medicine in all
its branches, dentist, optometrist, podiatric | 11 | | physician,
veterinarian, scientific investigator, pharmacist, | 12 | | physician assistant,
advanced practice registered nurse,
| 13 | | licensed practical
nurse, registered nurse, emergency medical | 14 | | services personnel, hospital, laboratory, or pharmacy, or | 15 | | other
person licensed, registered, or otherwise lawfully | 16 | | permitted by the
United States or this State to distribute, | 17 | | dispense, conduct research
with respect to, administer or use | 18 | | in teaching or chemical analysis, a
controlled substance in the | 19 | | course of professional practice or research.
| 20 | | (ll) "Pre-printed prescription" means a written | 21 | | prescription upon which
the designated drug has been indicated | 22 | | prior to the time of issuance; the term does not mean a written | 23 | | prescription that is individually generated by machine or | 24 | | computer in the prescriber's office.
| 25 | | (mm) "Prescriber" means a physician licensed to practice | 26 | | medicine in all
its branches, dentist, optometrist, |
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| 1 | | prescribing psychologist licensed under Section 4.2 of the | 2 | | Clinical Psychologist Licensing Act with prescriptive | 3 | | authority delegated under Section 4.3 of the Clinical | 4 | | Psychologist Licensing Act, podiatric physician, or
| 5 | | veterinarian who issues a prescription, a physician assistant | 6 | | who
issues a
prescription for a controlled substance
in | 7 | | accordance
with Section 303.05, a written delegation, and a | 8 | | written collaborative agreement required under Section 7.5
of | 9 | | the
Physician Assistant Practice Act of 1987, an advanced | 10 | | practice registered
nurse with prescriptive authority | 11 | | delegated under Section 65-40 of the Nurse Practice Act and in | 12 | | accordance with Section 303.05, a written delegation,
and a | 13 | | written
collaborative agreement under Section 65-35 of the | 14 | | Nurse Practice Act, an advanced practice registered nurse | 15 | | certified as a nurse practitioner, nurse midwife, or clinical | 16 | | nurse specialist who has been granted authority to prescribe by | 17 | | a hospital affiliate in accordance with Section 65-45 of the | 18 | | Nurse Practice Act and in accordance with Section 303.05, or an | 19 | | advanced practice registered nurse certified as a nurse | 20 | | practitioner, nurse midwife, or clinical nurse specialist who | 21 | | has full practice authority pursuant to Section 65-43 of the | 22 | | Nurse Practice Act.
| 23 | | (nn) "Prescription" means a written, facsimile, or oral | 24 | | order, or an electronic order that complies with applicable | 25 | | federal requirements,
of
a physician licensed to practice | 26 | | medicine in all its branches,
dentist, podiatric physician or |
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| 1 | | veterinarian for any controlled
substance, of an optometrist in | 2 | | accordance with Section 15.1 of the Illinois Optometric | 3 | | Practice Act of 1987, of a prescribing psychologist licensed | 4 | | under Section 4.2 of the Clinical Psychologist Licensing Act | 5 | | with prescriptive authority delegated under Section 4.3 of the | 6 | | Clinical Psychologist Licensing Act, of a physician assistant | 7 | | for a
controlled substance
in accordance with Section 303.05, a | 8 | | written delegation, and a written collaborative agreement | 9 | | required under
Section 7.5 of the
Physician Assistant Practice | 10 | | Act of 1987, of an advanced practice registered
nurse with | 11 | | prescriptive authority delegated under Section 65-40 of the | 12 | | Nurse Practice Act who issues a prescription for a
controlled | 13 | | substance in accordance
with
Section 303.05, a written | 14 | | delegation, and a written collaborative agreement under | 15 | | Section 65-35 of the Nurse Practice Act, of an advanced | 16 | | practice registered nurse certified as a nurse practitioner, | 17 | | nurse midwife, or clinical nurse specialist who has been | 18 | | granted authority to prescribe by a hospital affiliate in | 19 | | accordance with Section 65-45 of the Nurse Practice Act and in | 20 | | accordance with Section 303.05 when required by law, or of an | 21 | | advanced practice registered nurse certified as a nurse | 22 | | practitioner, nurse midwife, or clinical nurse specialist who | 23 | | has full practice authority pursuant to Section 65-43 of the | 24 | | Nurse Practice Act.
| 25 | | (nn-5) "Prescription Information Library" (PIL) means an | 26 | | electronic library that contains reported controlled substance |
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| 1 | | data. | 2 | | (nn-10) "Prescription Monitoring Program" (PMP) means the | 3 | | entity that collects, tracks, and stores reported data on | 4 | | controlled substances and select drugs pursuant to Section 316. | 5 | | (oo) "Production" or "produce" means manufacture, | 6 | | planting,
cultivating, growing, or harvesting of a controlled | 7 | | substance other than methamphetamine.
| 8 | | (pp) "Registrant" means every person who is required to | 9 | | register
under Section 302 of this Act.
| 10 | | (qq) "Registry number" means the number assigned to each | 11 | | person
authorized to handle controlled substances under the | 12 | | laws of the United
States and of this State.
| 13 | | (qq-5) "Secretary" means, as the context requires, either | 14 | | the Secretary of the Department or the Secretary of the | 15 | | Department of Financial and Professional Regulation, and the | 16 | | Secretary's designated agents. | 17 | | (rr) "State" includes the State of Illinois and any state, | 18 | | district,
commonwealth, territory, insular possession thereof, | 19 | | and any area
subject to the legal authority of the United | 20 | | States of America.
| 21 | | (rr-5) "Stimulant" means any drug that (i) causes an | 22 | | overall excitation of central nervous system functions, (ii) | 23 | | causes impaired consciousness and awareness, and (iii) can be | 24 | | habit-forming or lead to a substance abuse problem, including | 25 | | but not limited to amphetamines and their analogs, | 26 | | methylphenidate and its analogs, cocaine, and phencyclidine |
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| 1 | | and its analogs. | 2 | | (rr-10) "Synthetic drug" includes, but is not limited to, | 3 | | any synthetic cannabinoids or piperazines or any synthetic | 4 | | cathinones as provided for in Schedule I. | 5 | | (ss) "Ultimate user" means a person who lawfully possesses | 6 | | a
controlled substance for his or her own use or for the use of | 7 | | a member of his or her
household or for administering to an | 8 | | animal owned by him or her or by a member
of his or her | 9 | | household.
| 10 | | (Source: P.A. 99-78, eff. 7-20-15; 99-173, eff. 7-29-15; | 11 | | 99-371, eff. 1-1-16; 99-480, eff. 9-9-15; 99-642, eff. 7-28-16; | 12 | | 100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513, eff. | 13 | | 1-1-18; 100-789, eff. 1-1-19; 100-863, eff. 8-14-18 .)
| 14 | | Section 115. The Cannabis and Controlled Substances Tort | 15 | | Claims Act is amended by changing Section 3 as follows:
| 16 | | (740 ILCS 20/3) (from Ch. 70, par. 903)
| 17 | | Sec. 3. Definitions. As used in this Act, unless the | 18 | | context otherwise
requires:
| 19 | | "Cannabis" includes marihuana, hashish, and other | 20 | | substances that
are identified as including any parts of the | 21 | | plant Cannabis Sativa, whether
growing or not, the seeds of | 22 | | that plant, the resin extracted from any part of
that plant, | 23 | | and any compound, manufacture, salt, derivative, mixture, or
| 24 | | preparation of that plant, its seeds, or resin, including
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| 1 | | tetrahydrocannabinol (THC) and all other cannabinol | 2 | | derivatives, including
its naturally occurring or | 3 | | synthetically produced ingredients, whether
produced directly | 4 | | or indirectly by extraction, independently by means of
chemical | 5 | | synthesis, or by a combination of extraction and chemical
| 6 | | synthesis. "Cannabis" does not include the mature stalks of | 7 | | that plant, fiber
produced from those stalks, oil or cake made | 8 | | from the seeds of that plant,
any other compound, manufacture, | 9 | | salt, derivative, mixture, or preparation
of mature stalks | 10 | | (except the extracted resin), fiber, oil
or cake, or the | 11 | | sterilized seeds of that plant that are incapable of
| 12 | | germination.
| 13 | | "Controlled substance" means a drug, substance, or | 14 | | immediate precursor in
the Schedules of Article II of the | 15 | | Illinois Controlled Substances Act.
| 16 | | "Counterfeit substance" means a controlled substance or | 17 | | the container or
labeling of a controlled substance that, | 18 | | without authorization, bears the
trademark, trade name, or | 19 | | other identifying mark, imprint, number, device,
or any | 20 | | likeness thereof of a manufacturer, distributor, or dispenser | 21 | | other
than the person who in fact manufactured, distributed, or | 22 | | dispensed the
substance.
| 23 | | "Deliver" or "delivery" means the actual, constructive, or | 24 | | attempted
transfer of possession of a controlled substance or | 25 | | cannabis, with or
without consideration, whether or not there | 26 | | is an agency relationship. "Deliver" or "delivery" does not |
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| 1 | | include the donation of prescription drugs to the extent | 2 | | permitted under the Prescription Drug Repository Program Act.
| 3 | | "Manufacture" means the production, preparation, | 4 | | propagation,
compounding, conversion, or processing of a | 5 | | controlled substance, either
directly or indirectly, by | 6 | | extraction from substances of natural origin,
independently by | 7 | | means of chemical synthesis, or by a combination of
extraction | 8 | | and chemical synthesis, and includes any packaging or
| 9 | | repackaging of the substance or labeling of its container, | 10 | | except that the
term does not include:
| 11 | | (1) by an ultimate user, the preparation or compounding | 12 | | of a
controlled substance for his own use;
| 13 | | (2) by a practitioner or his authorized agent under his | 14 | | supervision,
the preparation, compounding, packaging, or | 15 | | labeling of a controlled substance:
| 16 | | (A) as an incident to his administering or | 17 | | dispensing of a controlled
substance in the course of | 18 | | his professional practice; or
| 19 | | (B) as an incident to lawful research, teaching or | 20 | | chemical analysis
and not for sale; or
| 21 | | (3) the preparation, compounding, packaging, or | 22 | | labeling of cannabis
as an incident to lawful research, | 23 | | teaching, or chemical analysis and not
for sale ; or .
| 24 | | (4) the packaging, repackaging, or labeling of | 25 | | prescription drugs only to the extent required under the | 26 | | Prescription Drug Repository Program Act.
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| 1 | | "Owner" means a person who has possession of or any | 2 | | interest
whatsoever in the property involved.
| 3 | | "Person" means an individual, a corporation, a government,
| 4 | | a governmental subdivision or agency, a business trust, an | 5 | | estate, a trust,
a partnership or association, or any other | 6 | | entity.
| 7 | | "Production" means planting, cultivating, tending, or | 8 | | harvesting.
| 9 | | "Property" means real property, including things growing | 10 | | on,
affixed to, and found in land, and tangible or intangible | 11 | | personal
property, including rights, services, privileges, | 12 | | interests, claims,
and securities.
| 13 | | (Source: P.A. 96-328, eff. 8-11-09.)".
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