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| | 102ND GENERAL ASSEMBLY
State of Illinois
2021 and 2022 HB0119 Introduced 1/14/2021, by Rep. Will Guzzardi SYNOPSIS AS INTRODUCED: |
| | Creates the Prescription Drug Repository Program Act. Requires the Department of Public Health to, by rule, establish a prescription drug repository program, under which any person may donate a prescription drug or supplies needed to administer a prescription drug for use by an individual who meets eligibility criteria specified by the Department. Sets forth requirements that prescription drugs or supplies must meet in order to be accepted and dispensed under the program. Provides that no drugs or supplies donated under the prescription drug repository program may be resold. Provides that nothing in the Act requires that a pharmacy or pharmacist participate in the prescription drug repository program. Provides for civil and criminal immunity for drug and supply manufacturers and individuals in relation to the donation, acceptance, or dispensing of prescription drugs or supplies under the prescription drug repository program. Imposes conditions on any rulemaking authority. Amends the Pharmacy Practice Act, the Wholesale Drug Distribution Licensing Act, the Senior Pharmaceutical Assistance Act, the Illinois Food, Drug and Cosmetic Act, the Illinois Controlled Substances Act, and the Cannabis and Controlled Substances Tort Claims Act to provide that persons engaged in donating or accepting, or packaging, repackaging, or labeling, prescription drugs to the extent permitted or required under the Prescription Drug Repository Program Act are exempt from provisions of those other Acts that might prohibit or otherwise regulate such activity.
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| | | FISCAL NOTE ACT MAY APPLY | |
| | A BILL FOR |
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1 | | AN ACT concerning health.
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2 | | Be it enacted by the People of the State of Illinois,
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3 | | represented in the General Assembly:
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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 | | "Pharmacist" means an individual licensed to engage in the |
13 | | practice of pharmacy under the Pharmacy Practice Act. |
14 | | "Pharmacy" means a pharmacy registered in this State under |
15 | | the Pharmacy Practice Act. |
16 | | "Practitioner" means a person licensed in this State to |
17 | | prescribe and administer drugs or licensed in another state |
18 | | and recognized by this State as a person authorized to |
19 | | prescribe and administer drugs. |
20 | | "Prescription drug" means any prescribed drug that may be |
21 | | legally dispensed by a pharmacy. "Prescription drug" does not |
22 | | include drugs for the treatment of cancer that can only be |
23 | | dispensed to a patient registered with the drug manufacturer |
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1 | | in accordance with federal Food and Drug Administration |
2 | | requirements. |
3 | | "Program" means the prescription drug repository program |
4 | | established under this Act. |
5 | | Section 10. Prescription drug repository program. The |
6 | | Department shall, by rule, establish and maintain a |
7 | | prescription drug repository program, under which any person |
8 | | may donate a prescription drug or supplies needed to |
9 | | administer a prescription drug for use by an individual who |
10 | | meets appropriate eligibility criteria. Donations may be made |
11 | | on the premises of a pharmacy that elects to participate in the |
12 | | program and meets appropriate requirements. The pharmacy may |
13 | | charge an individual who receives a prescription drug or |
14 | | supplies needed to administer a prescription drug under this |
15 | | Act a handling fee that may not exceed an appropriate amount. A |
16 | | pharmacy that receives a donated prescription drug or supplies |
17 | | needed to administer a prescription drug under this Act may |
18 | | distribute the prescription drug or supplies to another |
19 | | eligible pharmacy for use under the program.
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20 | | Section 15. Requirements for accepting and dispensing |
21 | | prescription drugs and supplies. A prescription drug or |
22 | | supplies needed to administer a prescription drug may be |
23 | | accepted and dispensed under the program only if all of the |
24 | | following requirements are met:
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1 | | (1) The prescription drug or supplies needed to |
2 | | administer a prescription drug are in their original, |
3 | | unopened, sealed, and tamper-evident unit-dose packaging |
4 | | or, if packaged in single-unit doses, the single-unit-dose |
5 | | packaging is unopened.
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6 | | (2) The prescription drug bears an expiration date |
7 | | that is later than 6 months after the date that the drug |
8 | | was donated.
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9 | | (3) The prescription drug or supplies needed to |
10 | | administer a prescription drug are not adulterated or |
11 | | misbranded, as determined by a pharmacist employed by, or |
12 | | under contract with, the pharmacy where the drug or |
13 | | supplies are accepted or dispensed. The pharmacist must |
14 | | inspect the drug or supplies before the drug or supplies |
15 | | are dispensed.
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16 | | (4) The prescription drug or supplies needed to |
17 | | administer a prescription drug are prescribed by a |
18 | | practitioner for use by an eligible individual.
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19 | | (5) The prescription drug is not a controlled |
20 | | substance. |
21 | | Section 20. Resale of donated drugs or supplies |
22 | | prohibited. No prescription drug or supplies needed to |
23 | | administer a prescription drug that are donated for use under |
24 | | this Act may be resold.
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1 | | Section 25. Participation in program not required. Nothing |
2 | | in this Act requires that a pharmacy or pharmacist participate |
3 | | in the prescription drug repository program.
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4 | | Section 30. Immunity. |
5 | | (a) A manufacturer of a drug or supply acting reasonably |
6 | | and in good faith is not subject to criminal or civil liability |
7 | | for injury, death, or loss to a person or property for matters |
8 | | related to the donation, acceptance, or dispensing of a |
9 | | prescription drug or supply manufactured by the manufacturer |
10 | | that is donated by any person under this Act.
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11 | | (b) A person acting reasonably and in good faith, |
12 | | including a pharmacist or other health professional, is immune |
13 | | from civil liability for injury to or the death of the |
14 | | individual to whom the prescription drug or supply is |
15 | | dispensed and may not be found guilty of unprofessional |
16 | | conduct for his or her acts or omissions related to donating, |
17 | | accepting, distributing, or dispensing a prescription drug or |
18 | | supply under this Act. The immunity granted under this |
19 | | subsection does not apply to acts or omissions outside the |
20 | | scope of the program. |
21 | | Section 90. The Pharmacy Practice Act is amended by |
22 | | changing Section 4 as follows:
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23 | | (225 ILCS 85/4) (from Ch. 111, par. 4124)
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1 | | (Section scheduled to be repealed on January 1, 2023)
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2 | | Sec. 4. Exemptions. Nothing contained in any Section of |
3 | | this Act shall
apply
to, or in any manner interfere with:
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4 | | (a) the lawful practice of any physician licensed to |
5 | | practice medicine in
all of its branches, dentist, |
6 | | podiatric physician,
veterinarian, or therapeutically or |
7 | | diagnostically certified optometrist within
the limits of
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8 | | his or her license, or prevent him or her from
supplying to |
9 | | his
or her
bona fide patients
such drugs, medicines, or |
10 | | poisons as may seem to him appropriate;
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11 | | (b) the sale of compressed gases;
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12 | | (c) the sale of patent or proprietary medicines and |
13 | | household remedies
when sold in original and unbroken |
14 | | packages only, if such patent or
proprietary medicines and |
15 | | household remedies be properly and adequately
labeled as |
16 | | to content and usage and generally considered and accepted
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17 | | as harmless and nonpoisonous when used according to the |
18 | | directions
on the label, and also do not contain opium or |
19 | | coca leaves, or any
compound, salt or derivative thereof, |
20 | | or any drug which, according
to the latest editions of the |
21 | | following authoritative pharmaceutical
treatises and |
22 | | standards, namely, The United States |
23 | | Pharmacopoeia/National
Formulary (USP/NF), the United |
24 | | States Dispensatory, and the Accepted
Dental Remedies of |
25 | | the Council of Dental Therapeutics of the American
Dental |
26 | | Association or any or either of them, in use on the |
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1 | | effective
date of this Act, or according to the existing |
2 | | provisions of the Federal
Food, Drug, and Cosmetic Act and |
3 | | Regulations of the Department of Health
and Human |
4 | | Services, Food and Drug Administration, promulgated |
5 | | thereunder
now in effect, is designated, described or |
6 | | considered as a narcotic,
hypnotic, habit forming, |
7 | | dangerous, or poisonous drug;
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8 | | (d) the sale of poultry and livestock remedies in |
9 | | original and unbroken
packages only, labeled for poultry |
10 | | and livestock medication;
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11 | | (e) the sale of poisonous substances or mixture of |
12 | | poisonous substances,
in unbroken packages, for |
13 | | nonmedicinal use in the arts or industries
or for |
14 | | insecticide purposes; provided, they are properly and |
15 | | adequately
labeled as to content and such nonmedicinal |
16 | | usage, in conformity
with the provisions of all applicable |
17 | | federal, state and local laws
and regulations promulgated |
18 | | thereunder now in effect relating thereto
and governing |
19 | | the same, and those which are required under such |
20 | | applicable
laws and regulations to be labeled with the |
21 | | word "Poison", are also labeled
with the word "Poison" |
22 | | printed
thereon in prominent type and the name of a |
23 | | readily obtainable antidote
with directions for its |
24 | | administration;
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25 | | (f) the delegation of limited prescriptive authority |
26 | | by a physician
licensed to
practice medicine in all its |
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1 | | branches to a physician assistant
under Section 7.5 of the |
2 | | Physician Assistant Practice Act of 1987. This
delegated |
3 | | authority under Section 7.5 of the Physician Assistant |
4 | | Practice Act of 1987 may, but is not required to, include |
5 | | prescription of
controlled substances, as defined in |
6 | | Article II of the
Illinois Controlled Substances Act, in |
7 | | accordance with a written supervision agreement;
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8 | | (g) the delegation of prescriptive authority by a |
9 | | physician
licensed to practice medicine in all its |
10 | | branches or a licensed podiatric physician to an advanced |
11 | | practice
registered nurse in accordance with a written |
12 | | collaborative
agreement under Sections 65-35 and 65-40 of |
13 | | the Nurse Practice Act; and
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14 | | (g-5) the donation or acceptance, or the packaging, |
15 | | repackaging, or labeling, of prescription drugs to the |
16 | | extent permitted or required under the Prescription Drug |
17 | | Repository Program Act; and |
18 | | (h) the sale or distribution of dialysate or devices |
19 | | necessary to perform home peritoneal renal dialysis for |
20 | | patients with end-stage renal disease, provided that all |
21 | | of the following conditions are met: |
22 | | (1) the dialysate, comprised of dextrose or |
23 | | icodextrin, or devices are approved or cleared by the |
24 | | federal Food and Drug Administration, as required by |
25 | | federal law; |
26 | | (2) the dialysate or devices are lawfully held by |
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1 | | a manufacturer or the manufacturer's agent, which is |
2 | | properly registered with the Board as a manufacturer, |
3 | | third-party logistics provider, or wholesaler; |
4 | | (3) the dialysate or devices are held and |
5 | | delivered to the manufacturer or the manufacturer's |
6 | | agent in the original, sealed packaging from the |
7 | | manufacturing facility; |
8 | | (4) the dialysate or devices are delivered only |
9 | | upon receipt of a physician's prescription by a |
10 | | licensed pharmacy in which the prescription is |
11 | | processed in accordance with provisions set forth in |
12 | | this Act, and the transmittal of an order from the |
13 | | licensed pharmacy to the manufacturer or the |
14 | | manufacturer's agent; and |
15 | | (5) the manufacturer or the manufacturer's agent |
16 | | delivers the dialysate or devices directly to: (i) a |
17 | | patient with end-stage renal disease, or his or her |
18 | | designee, for the patient's self-administration of the |
19 | | dialysis therapy or (ii) a health care provider or |
20 | | institution for administration or delivery of the |
21 | | dialysis therapy to a patient with end-stage renal |
22 | | disease. |
23 | | This paragraph (h) does not include any other drugs |
24 | | for peritoneal dialysis, except dialysate, as described in |
25 | | item (1) of this paragraph (h). All records of sales and |
26 | | distribution of dialysate to patients made pursuant to |
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1 | | this paragraph (h) must be retained in accordance with |
2 | | Section 18 of this Act. |
3 | | (Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18; |
4 | | 100-863, eff. 8-14-18; 101-420, eff. 8-16-19 .)
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5 | | Section 95. The Wholesale Drug Distribution Licensing Act |
6 | | is amended by changing Section 15 as follows:
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7 | | (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
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8 | | (Section scheduled to be repealed on January 1, 2023)
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9 | | Sec. 15. Definitions. As used in this Act:
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10 | | "Authentication" means the affirmative verification, |
11 | | before any wholesale distribution of a prescription drug |
12 | | occurs, that each transaction listed on the pedigree has |
13 | | occurred. |
14 | | "Authorized distributor of record" means a wholesale |
15 | | distributor with whom a manufacturer has established an |
16 | | ongoing relationship to distribute the manufacturer's |
17 | | prescription drug. An ongoing relationship is deemed to exist |
18 | | between a wholesale distributor and a manufacturer when the |
19 | | wholesale distributor, including any affiliated group of the |
20 | | wholesale distributor, as defined in Section 1504 of the |
21 | | Internal Revenue Code, complies with the following: |
22 | | (1) The wholesale distributor has a written agreement |
23 | | currently in effect with the manufacturer evidencing the |
24 | | ongoing relationship; and |
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1 | | (2) The wholesale distributor is listed on the |
2 | | manufacturer's current list of authorized distributors of |
3 | | record, which is updated by the manufacturer on no less |
4 | | than a monthly basis.
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5 | | "Blood" means whole blood collected from a single donor |
6 | | and processed
either for transfusion or further manufacturing.
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7 | | "Blood component" means that part of blood separated by |
8 | | physical or
mechanical means.
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9 | | "Board" means the State Board of Pharmacy of the |
10 | | Department of
Professional Regulation.
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11 | | "Chain pharmacy warehouse" means a physical location for |
12 | | prescription drugs that acts as a central warehouse and |
13 | | performs intracompany sales or transfers of the drugs to a |
14 | | group of chain or mail order pharmacies that have the same |
15 | | common ownership and control. Notwithstanding any other |
16 | | provision of this Act, a chain pharmacy warehouse shall be |
17 | | considered part of the normal distribution channel. |
18 | | "Co-licensed partner or product" means an instance where |
19 | | one or more parties have the right to engage in the |
20 | | manufacturing or marketing of a prescription drug, consistent |
21 | | with the FDA's implementation of the Prescription Drug |
22 | | Marketing Act.
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23 | | "Department" means the Department of Financial and
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24 | | Professional Regulation.
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25 | | "Drop shipment" means the sale of a prescription drug to a |
26 | | wholesale distributor by the manufacturer of the prescription |
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1 | | drug or that manufacturer's co-licensed product partner, that |
2 | | manufacturer's third party logistics provider, or that |
3 | | manufacturer's exclusive distributor or by an authorized |
4 | | distributor of record that purchased the product directly from |
5 | | the manufacturer or one of these entities whereby the |
6 | | wholesale distributor or chain pharmacy warehouse takes title |
7 | | but not physical possession of such prescription drug and the |
8 | | wholesale distributor invoices the pharmacy, chain pharmacy |
9 | | warehouse, or other person authorized by law to dispense or |
10 | | administer such drug to a patient and the pharmacy, chain |
11 | | pharmacy warehouse, or other authorized person receives |
12 | | delivery of the prescription drug directly from the |
13 | | manufacturer, that manufacturer's third party logistics |
14 | | provider, or that manufacturer's exclusive distributor or from |
15 | | an authorized distributor of record that purchased the product |
16 | | directly from the manufacturer or one of these entities.
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17 | | "Drug sample" means a unit of a prescription drug that is |
18 | | not intended to
be sold and is intended to promote the sale of |
19 | | the drug.
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20 | | "Facility" means a facility of a wholesale distributor |
21 | | where prescription drugs are stored, handled, repackaged, or |
22 | | offered for sale, or a facility of a third-party logistics |
23 | | provider where prescription drugs are stored or handled. |
24 | | "FDA" means the United States Food and Drug |
25 | | Administration.
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26 | | "Manufacturer" means a person licensed or approved by the |
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1 | | FDA to engage in the manufacture of drugs or devices, |
2 | | consistent with the definition of "manufacturer" set forth in |
3 | | the FDA's regulations and guidances implementing the |
4 | | Prescription Drug Marketing Act. "Manufacturer" does not |
5 | | include anyone who is engaged in the packaging, repackaging, |
6 | | or labeling of prescription drugs only to the extent required |
7 | | under the Prescription Drug Repository Program Act. |
8 | | "Manufacturer's exclusive distributor" means anyone who |
9 | | contracts with a manufacturer to provide or coordinate |
10 | | warehousing, distribution, or other services on behalf of a |
11 | | manufacturer and who takes title to that manufacturer's |
12 | | prescription drug, but who does not have general |
13 | | responsibility to direct the sale or disposition of the |
14 | | manufacturer's prescription drug. A manufacturer's exclusive |
15 | | distributor must be licensed as a wholesale distributor under |
16 | | this Act and, in order to be considered part of the normal |
17 | | distribution channel, must also be an authorized distributor |
18 | | of record.
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19 | | "Normal distribution channel" means a chain of custody for |
20 | | a prescription drug that goes, directly or by drop shipment, |
21 | | from (i) a manufacturer of the prescription drug, (ii) that |
22 | | manufacturer to that manufacturer's co-licensed partner, (iii) |
23 | | that manufacturer to that manufacturer's third party logistics |
24 | | provider, or (iv) that manufacturer to that manufacturer's |
25 | | exclusive distributor to: |
26 | | (1) a pharmacy or to other designated persons |
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1 | | authorized by law to dispense or administer the drug to a |
2 | | patient; |
3 | | (2) a wholesale distributor to a pharmacy or other |
4 | | designated persons authorized by law to dispense or |
5 | | administer the drug to a patient; |
6 | | (3) a wholesale distributor to a chain pharmacy |
7 | | warehouse to that chain pharmacy warehouse's intracompany |
8 | | pharmacy to a patient or other designated persons |
9 | | authorized by law to dispense or administer the drug to a |
10 | | patient; |
11 | | (4) a chain pharmacy warehouse to the chain pharmacy |
12 | | warehouse's intracompany pharmacy or other designated |
13 | | persons authorized by law to dispense or administer the |
14 | | drug to the patient; |
15 | | (5) an authorized distributor of record to one other |
16 | | authorized distributor of record to an office-based health |
17 | | care practitioner authorized by law to dispense or |
18 | | administer the drug to the patient; or |
19 | | (6) an authorized distributor to a pharmacy or other |
20 | | persons licensed to dispense or administer the drug. |
21 | | "Pedigree" means a document or electronic file containing |
22 | | information that records each wholesale distribution of any |
23 | | given prescription drug from the point of origin to the final |
24 | | wholesale distribution point of any given prescription drug.
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25 | | "Person" means and includes a natural person, partnership, |
26 | | association,
corporation, or any other legal business entity.
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1 | | "Pharmacy distributor" means any pharmacy licensed in this |
2 | | State or
hospital pharmacy that is engaged in the delivery or |
3 | | distribution of
prescription drugs either to any other |
4 | | pharmacy licensed in this State or
to any other person or |
5 | | entity including, but not limited to, a wholesale
drug |
6 | | distributor engaged in the delivery or distribution of |
7 | | prescription
drugs who is involved in the actual, |
8 | | constructive, or attempted transfer of
a drug in this State to |
9 | | other than the ultimate consumer except as
otherwise provided |
10 | | for by law.
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11 | | "Prescription drug" means any human drug, including any |
12 | | biological product (except for blood and blood components |
13 | | intended for transfusion or biological products that are also |
14 | | medical devices), required by federal law or
regulation to be |
15 | | dispensed only by a prescription, including finished
dosage |
16 | | forms and bulk drug substances
subject to Section
503 of the |
17 | | Federal Food, Drug and Cosmetic Act.
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18 | | "Repackage" means repackaging or otherwise changing the |
19 | | container, wrapper, or labeling to further the distribution of |
20 | | a prescription drug, excluding that completed by the |
21 | | pharmacist responsible for dispensing the product to a |
22 | | patient. |
23 | | "Secretary" means the Secretary of Financial and |
24 | | Professional Regulation. |
25 | | "Third-party logistics provider" means anyone who |
26 | | contracts with a prescription drug manufacturer to provide or |
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1 | | coordinate warehousing, distribution, or other services on |
2 | | behalf of a manufacturer, but does not take title to the |
3 | | prescription drug or have general responsibility to direct the |
4 | | prescription drug's sale or disposition. |
5 | | "Wholesale distribution"
means the distribution
of |
6 | | prescription drugs to persons other than a consumer or |
7 | | patient, but does
not include any of the following:
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8 | | (1)
Intracompany sales of prescription drugs, meaning |
9 | | (i) any transaction or transfer
between any division, |
10 | | subsidiary, parent, or affiliated or related company
under |
11 | | the common ownership and control of a corporate entity or |
12 | | (ii) any transaction or transfer between co-licensees of a |
13 | | co-licensed product.
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14 | | (2) The sale, purchase, distribution, trade, or |
15 | | transfer of a prescription drug or offer to sell, |
16 | | purchase, distribute, trade, or transfer a prescription |
17 | | drug for emergency medical reasons.
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18 | | (3) The distribution of prescription drug samples by |
19 | | manufacturers' representatives. |
20 | | (4) Drug returns, when conducted by a hospital, health |
21 | | care entity, or charitable institution in accordance with |
22 | | federal regulation. |
23 | | (5) The sale of minimal quantities of prescription |
24 | | drugs by licensed pharmacies to licensed practitioners for |
25 | | office use or other licensed pharmacies. |
26 | | (6) The sale, purchase, or trade of a drug, an offer to |
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1 | | sell, purchase, or trade a drug, or the dispensing of a |
2 | | drug pursuant to a prescription. |
3 | | (7) The sale, transfer, merger, or consolidation of |
4 | | all or part of the business of a pharmacy or pharmacies |
5 | | from or with another pharmacy or pharmacies, whether |
6 | | accomplished as a purchase and sale of stock or business |
7 | | assets. |
8 | | (8) The sale, purchase, distribution, trade, or |
9 | | transfer of a prescription drug from one authorized |
10 | | distributor of record to one additional authorized |
11 | | distributor of record when the manufacturer has stated in |
12 | | writing to the receiving authorized distributor of record |
13 | | that the manufacturer is unable to supply the prescription |
14 | | drug and the supplying authorized distributor of record |
15 | | states in writing that the prescription drug being |
16 | | supplied had until that time been exclusively in the |
17 | | normal distribution channel. |
18 | | (9) The delivery of or the offer to deliver a |
19 | | prescription drug by a common carrier solely in the common |
20 | | carrier's usual course of business of transporting |
21 | | prescription drugs when the common carrier does not store, |
22 | | warehouse, or take legal ownership of the prescription |
23 | | drug. |
24 | | (10) The sale or transfer from a retail pharmacy, mail |
25 | | order pharmacy, or chain pharmacy warehouse of expired, |
26 | | damaged, returned, or recalled prescription drugs to the |
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1 | | original manufacturer, the originating wholesale |
2 | | distributor, or a third party returns processor.
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3 | | (11) The donation of prescription drugs to the extent |
4 | | permitted under the Prescription Drug Repository Program |
5 | | Act.
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6 | | "Wholesale drug distributor" means anyone
engaged in the
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7 | | wholesale distribution of prescription drugs into, out of, or |
8 | | within the State, including without limitation
manufacturers; |
9 | | repackers; own label distributors; jobbers; private
label |
10 | | distributors; brokers; warehouses, including manufacturers' |
11 | | and
distributors' warehouses; manufacturer's exclusive |
12 | | distributors; and authorized distributors of record; drug |
13 | | wholesalers or distributors; independent wholesale drug |
14 | | traders; specialty wholesale distributors; and retail |
15 | | pharmacies that conduct wholesale distribution; and chain |
16 | | pharmacy warehouses that conduct wholesale distribution. In |
17 | | order to be considered part of the normal distribution |
18 | | channel, a wholesale distributor must also be an authorized |
19 | | distributor of record.
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20 | | (Source: P.A. 101-420, eff. 8-16-19.)
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21 | | Section 100. The Senior Pharmaceutical Assistance Act is |
22 | | amended by changing Section 10 as follows:
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23 | | (320 ILCS 50/10)
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24 | | Sec. 10. Definitions. In this Act:
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1 | | "Manufacturer" includes:
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2 | | (1) An entity that is engaged in (a) the production, |
3 | | preparation,
propagation, compounding, conversion, or |
4 | | processing of prescription drug
products (i) directly or |
5 | | indirectly by extraction from substances of natural
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6 | | origin,
(ii) independently by means of chemical synthesis, |
7 | | or (iii) by combination of
extraction
and chemical |
8 | | synthesis; or (b) the packaging, repackaging, labeling or
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9 | | re-labeling, or distribution of prescription drug |
10 | | products.
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11 | | (2) The entity holding legal title to or possession of |
12 | | the national
drug code number for the covered prescription |
13 | | drug.
|
14 | | The term does not include a wholesale distributor of |
15 | | drugs,
drugstore chain organization, or retail pharmacy |
16 | | licensed by the State. The term also does not include anyone |
17 | | who is engaged in the packaging, repackaging, or labeling of |
18 | | prescription drugs only to the extent required under the |
19 | | Prescription Drug Repository Program Act.
|
20 | | "Prescription drug" means a drug that may be dispensed |
21 | | only upon
prescription by an authorized prescriber and that is |
22 | | approved for safety and
effectiveness as a prescription drug |
23 | | under Section 505 or 507 of the Federal
Food, Drug and Cosmetic |
24 | | Act.
|
25 | | "Senior citizen" or "senior" means a person 65 years of |
26 | | age or
older.
|
|
| | HB0119 | - 19 - | LRB102 04093 CPF 14109 b |
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|
1 | | (Source: P.A. 92-594, eff. 6-27-02.)
|
2 | | Section 105. The Illinois Food, Drug and Cosmetic Act is |
3 | | amended by changing Section 16 as follows:
|
4 | | (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
|
5 | | Sec. 16. (a) The Director is hereby authorized to |
6 | | promulgate
regulations exempting from any labeling or |
7 | | packaging requirement of this
Act drugs and devices which are |
8 | | (i) , in accordance with the practice of the
trade, to be |
9 | | processed, labeled or repacked in substantial quantities at
|
10 | | establishments other than those where originally processed or |
11 | | packaged on
condition that such drugs and devices are not |
12 | | adulterated or misbranded
under the provisions of this Act |
13 | | upon removal from such processing,
labeling or repacking |
14 | | establishment or (ii) packaged, repackaged, or labeled to the |
15 | | extent required under the Prescription Drug Repository Program |
16 | | Act .
|
17 | | (b) Drugs and device labeling or packaging exemptions |
18 | | adopted under the
Federal Act and supplements thereto or |
19 | | revisions thereof shall apply to
drugs and devices in Illinois |
20 | | except insofar as modified or rejected by
regulations |
21 | | promulgated by the Director.
|
22 | | (c) A drug intended for use by man which (A) is a |
23 | | habit-forming drug to
which Section 15 (d) applies; or (B) |
24 | | because of its toxicity or other
potentiality for harmful |
|
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|
1 | | effect or the method of its use or the collateral
measures |
2 | | necessary to its use is not safe for use except under the
|
3 | | supervision of a practitioner licensed by law to administer |
4 | | such drug; or
(C) is limited by an approved application under |
5 | | Section 505 of the Federal
Act or Section 17 of this Act to use |
6 | | under the professional supervision of
a practitioner licensed |
7 | | by law to administer such drug, shall be dispensed
only in |
8 | | accordance with the provisions of the "Illinois Controlled
|
9 | | Substances Act". The act of dispensing a drug contrary to the |
10 | | provisions of
this paragraph shall be deemed to be an act which |
11 | | results in a drug being
misbranded while held for sale.
|
12 | | (d) Any drug dispensed by filling or refilling a written
|
13 | | or oral prescription of a practitioner licensed by law to |
14 | | administer such
drug shall be exempt from the requirements of |
15 | | Section 15, except
subsections (a), (k) and (l) and clauses |
16 | | (2) and (3) of subsection (i), and
the packaging requirements |
17 | | of
subsections (g), (h) and (q), if the drug bears a label |
18 | | containing the
proprietary name or names, or if there is none, |
19 | | the established name or
names of the drugs, the dosage and |
20 | | quantity, unless the prescribing
practitioner, in the interest |
21 | | of the health of the patient, directs
otherwise in writing, |
22 | | the name and address of the dispenser, the serial
number and |
23 | | date of the prescription or of its filling, the name of the
|
24 | | prescriber and, if stated in the prescription, the name of the |
25 | | patient, and
the directions for use and the cautionary |
26 | | statements, if any, contained in
such prescription. This |
|
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|
1 | | exemption shall not apply to any drug dispensed in
the course |
2 | | of the conduct of business of dispensing drugs pursuant to
|
3 | | diagnosis by mail, or to a drug dispensed in violation of |
4 | | subsection (a) of
this Section.
|
5 | | (e) The Director may by regulation remove drugs subject to
|
6 | | Section 15 (d) and Section 17 from the requirements of |
7 | | subsection (c) of
this Section when such requirements are not |
8 | | necessary for the protection of
the public health.
|
9 | | (f) A drug which is subject to subsection (c) of this |
10 | | Section
shall be deemed to be misbranded if at any time before |
11 | | dispensing its label
fails to bear the statement "Caution: |
12 | | Federal Law Prohibits Dispensing Without
Prescription" or |
13 | | "Caution: State Law Prohibits Dispensing Without
|
14 | | Prescription". A drug to which subsection (c) of this Section |
15 | | does not apply
shall be deemed to be misbranded if at any time |
16 | | prior to dispensing its
label bears the caution statement |
17 | | quoted in the preceding sentence.
|
18 | | (g) Nothing in this Section shall be construed to relieve
|
19 | | any person from any requirement prescribed by or under |
20 | | authority of law
with respect to controlled substances now |
21 | | included or which may hereafter
be included within the |
22 | | classifications of controlled substances cannabis as
defined |
23 | | in applicable Federal laws relating to controlled substances |
24 | | or
cannabis or the Cannabis Control Act.
|
25 | | (Source: P.A. 84-1308.)
|
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| | HB0119 | - 22 - | LRB102 04093 CPF 14109 b |
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|
1 | | Section 110. The Illinois Controlled Substances Act is |
2 | | amended by changing Section 102 as follows: |
3 | | (720 ILCS 570/102) (from Ch. 56 1/2, par. 1102) |
4 | | Sec. 102. Definitions. As used in this Act, unless the |
5 | | context
otherwise requires:
|
6 | | (a) "Addict" means any person who habitually uses any |
7 | | drug, chemical,
substance or dangerous drug other than alcohol |
8 | | so as to endanger the public
morals, health, safety or welfare |
9 | | or who is so far addicted to the use of a
dangerous drug or |
10 | | controlled substance other than alcohol as to have lost
the |
11 | | power of self control with reference to his or her addiction.
|
12 | | (b) "Administer" means the direct application of a |
13 | | controlled
substance, whether by injection, inhalation, |
14 | | ingestion, or any other
means, to the body of a patient, |
15 | | research subject, or animal (as
defined by the Humane |
16 | | Euthanasia in Animal Shelters Act) by:
|
17 | | (1) a practitioner (or, in his or her presence, by his |
18 | | or her authorized agent),
|
19 | | (2) the patient or research subject pursuant to an |
20 | | order, or
|
21 | | (3) a euthanasia technician as defined by the Humane |
22 | | Euthanasia in
Animal Shelters Act.
|
23 | | (c) "Agent" means an authorized person who acts on behalf |
24 | | of or at
the direction of a manufacturer, distributor, |
25 | | dispenser, prescriber, or practitioner. It does not
include a |
|
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|
1 | | common or contract carrier, public warehouseman or employee of
|
2 | | the carrier or warehouseman.
|
3 | | (c-1) "Anabolic Steroids" means any drug or hormonal |
4 | | substance,
chemically and pharmacologically related to |
5 | | testosterone (other than
estrogens, progestins, |
6 | | corticosteroids, and dehydroepiandrosterone),
and includes:
|
7 | | (i) 3[beta],17-dihydroxy-5a-androstane, |
8 | | (ii) 3[alpha],17[beta]-dihydroxy-5a-androstane, |
9 | | (iii) 5[alpha]-androstan-3,17-dione, |
10 | | (iv) 1-androstenediol (3[beta], |
11 | | 17[beta]-dihydroxy-5[alpha]-androst-1-ene), |
12 | | (v) 1-androstenediol (3[alpha], |
13 | | 17[beta]-dihydroxy-5[alpha]-androst-1-ene), |
14 | | (vi) 4-androstenediol |
15 | | (3[beta],17[beta]-dihydroxy-androst-4-ene), |
16 | | (vii) 5-androstenediol |
17 | | (3[beta],17[beta]-dihydroxy-androst-5-ene), |
18 | | (viii) 1-androstenedione |
19 | | ([5alpha]-androst-1-en-3,17-dione), |
20 | | (ix) 4-androstenedione |
21 | | (androst-4-en-3,17-dione), |
22 | | (x) 5-androstenedione |
23 | | (androst-5-en-3,17-dione), |
24 | | (xi) bolasterone (7[alpha],17a-dimethyl-17[beta]- |
25 | | hydroxyandrost-4-en-3-one), |
26 | | (xii) boldenone (17[beta]-hydroxyandrost- |
|
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|
1 | | 1,4,-diene-3-one), |
2 | | (xiii) boldione (androsta-1,4- |
3 | | diene-3,17-dione), |
4 | | (xiv) calusterone (7[beta],17[alpha]-dimethyl-17 |
5 | | [beta]-hydroxyandrost-4-en-3-one), |
6 | | (xv) clostebol (4-chloro-17[beta]- |
7 | | hydroxyandrost-4-en-3-one), |
8 | | (xvi) dehydrochloromethyltestosterone (4-chloro- |
9 | | 17[beta]-hydroxy-17[alpha]-methyl- |
10 | | androst-1,4-dien-3-one), |
11 | | (xvii) desoxymethyltestosterone |
12 | | (17[alpha]-methyl-5[alpha] |
13 | | -androst-2-en-17[beta]-ol)(a.k.a., madol), |
14 | | (xviii) [delta]1-dihydrotestosterone (a.k.a. |
15 | | '1-testosterone') (17[beta]-hydroxy- |
16 | | 5[alpha]-androst-1-en-3-one), |
17 | | (xix) 4-dihydrotestosterone (17[beta]-hydroxy- |
18 | | androstan-3-one), |
19 | | (xx) drostanolone (17[beta]-hydroxy-2[alpha]-methyl- |
20 | | 5[alpha]-androstan-3-one), |
21 | | (xxi) ethylestrenol (17[alpha]-ethyl-17[beta]- |
22 | | hydroxyestr-4-ene), |
23 | | (xxii) fluoxymesterone (9-fluoro-17[alpha]-methyl- |
24 | | 1[beta],17[beta]-dihydroxyandrost-4-en-3-one), |
25 | | (xxiii) formebolone (2-formyl-17[alpha]-methyl-11[alpha], |
26 | | 17[beta]-dihydroxyandrost-1,4-dien-3-one), |
|
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|
1 | | (xxiv) furazabol (17[alpha]-methyl-17[beta]- |
2 | | hydroxyandrostano[2,3-c]-furazan), |
3 | | (xxv) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one, |
4 | | (xxvi) 4-hydroxytestosterone (4,17[beta]-dihydroxy- |
5 | | androst-4-en-3-one), |
6 | | (xxvii) 4-hydroxy-19-nortestosterone (4,17[beta]- |
7 | | dihydroxy-estr-4-en-3-one), |
8 | | (xxviii) mestanolone (17[alpha]-methyl-17[beta]- |
9 | | hydroxy-5-androstan-3-one), |
10 | | (xxix) mesterolone (1amethyl-17[beta]-hydroxy- |
11 | | [5a]-androstan-3-one), |
12 | | (xxx) methandienone (17[alpha]-methyl-17[beta]- |
13 | | hydroxyandrost-1,4-dien-3-one), |
14 | | (xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]- |
15 | | dihydroxyandrost-5-ene), |
16 | | (xxxii) methenolone (1-methyl-17[beta]-hydroxy- |
17 | | 5[alpha]-androst-1-en-3-one), |
18 | | (xxxiii) 17[alpha]-methyl-3[beta], 17[beta]- |
19 | | dihydroxy-5a-androstane, |
20 | | (xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy |
21 | | -5a-androstane, |
22 | | (xxxv) 17[alpha]-methyl-3[beta],17[beta]- |
23 | | dihydroxyandrost-4-ene), |
24 | | (xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]- |
25 | | methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one), |
26 | | (xxxvii) methyldienolone (17[alpha]-methyl-17[beta]- |
|
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|
1 | | hydroxyestra-4,9(10)-dien-3-one), |
2 | | (xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]- |
3 | | hydroxyestra-4,9-11-trien-3-one), |
4 | | (xxxix) methyltestosterone (17[alpha]-methyl-17[beta]- |
5 | | hydroxyandrost-4-en-3-one), |
6 | | (xl) mibolerone (7[alpha],17a-dimethyl-17[beta]- |
7 | | hydroxyestr-4-en-3-one), |
8 | | (xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone |
9 | | (17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]- |
10 | | androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl- |
11 | | 1-testosterone'), |
12 | | (xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one), |
13 | | (xliii) 19-nor-4-androstenediol (3[beta], 17[beta]- |
14 | | dihydroxyestr-4-ene), |
15 | | (xliv) 19-nor-4-androstenediol (3[alpha], 17[beta]- |
16 | | dihydroxyestr-4-ene), |
17 | | (xlv) 19-nor-5-androstenediol (3[beta], 17[beta]- |
18 | | dihydroxyestr-5-ene), |
19 | | (xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]- |
20 | | dihydroxyestr-5-ene), |
21 | | (xlvii) 19-nor-4,9(10)-androstadienedione |
22 | | (estra-4,9(10)-diene-3,17-dione), |
23 | | (xlviii) 19-nor-4-androstenedione (estr-4- |
24 | | en-3,17-dione), |
25 | | (xlix) 19-nor-5-androstenedione (estr-5- |
26 | | en-3,17-dione), |
|
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|
1 | | (l) norbolethone (13[beta], 17a-diethyl-17[beta]- |
2 | | hydroxygon-4-en-3-one), |
3 | | (li) norclostebol (4-chloro-17[beta]- |
4 | | hydroxyestr-4-en-3-one), |
5 | | (lii) norethandrolone (17[alpha]-ethyl-17[beta]- |
6 | | hydroxyestr-4-en-3-one), |
7 | | (liii) normethandrolone (17[alpha]-methyl-17[beta]- |
8 | | hydroxyestr-4-en-3-one), |
9 | | (liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy- |
10 | | 2-oxa-5[alpha]-androstan-3-one), |
11 | | (lv) oxymesterone (17[alpha]-methyl-4,17[beta]- |
12 | | dihydroxyandrost-4-en-3-one), |
13 | | (lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene- |
14 | | 17[beta]-hydroxy-(5[alpha]-androstan-3-one), |
15 | | (lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy- |
16 | | (5[alpha]-androst-2-eno[3,2-c]-pyrazole), |
17 | | (lviii) stenbolone (17[beta]-hydroxy-2-methyl- |
18 | | (5[alpha]-androst-1-en-3-one), |
19 | | (lix) testolactone (13-hydroxy-3-oxo-13,17- |
20 | | secoandrosta-1,4-dien-17-oic |
21 | | acid lactone), |
22 | | (lx) testosterone (17[beta]-hydroxyandrost- |
23 | | 4-en-3-one), |
24 | | (lxi) tetrahydrogestrinone (13[beta], 17[alpha]- |
25 | | diethyl-17[beta]-hydroxygon- |
26 | | 4,9,11-trien-3-one), |
|
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|
1 | | (lxii) trenbolone (17[beta]-hydroxyestr-4,9, |
2 | | 11-trien-3-one).
|
3 | | Any person who is otherwise lawfully in possession of an |
4 | | anabolic
steroid, or who otherwise lawfully manufactures, |
5 | | distributes, dispenses,
delivers, or possesses with intent to |
6 | | deliver an anabolic steroid, which
anabolic steroid is |
7 | | expressly intended for and lawfully allowed to be
administered |
8 | | through implants to livestock or other nonhuman species, and
|
9 | | which is approved by the Secretary of Health and Human |
10 | | Services for such
administration, and which the person intends |
11 | | to administer or have
administered through such implants, |
12 | | shall not be considered to be in
unauthorized possession or to |
13 | | unlawfully manufacture, distribute, dispense,
deliver, or |
14 | | possess with intent to deliver such anabolic steroid for
|
15 | | purposes of this Act.
|
16 | | (d) "Administration" means the Drug Enforcement |
17 | | Administration,
United States Department of Justice, or its |
18 | | successor agency.
|
19 | | (d-5) "Clinical Director, Prescription Monitoring Program" |
20 | | means a Department of Human Services administrative employee |
21 | | licensed to either prescribe or dispense controlled substances |
22 | | who shall run the clinical aspects of the Department of Human |
23 | | Services Prescription Monitoring Program and its Prescription |
24 | | Information Library. |
25 | | (d-10) "Compounding" means the preparation and mixing of |
26 | | components, excluding flavorings, (1) as the result of a |
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|
1 | | prescriber's prescription drug order or initiative based on |
2 | | the prescriber-patient-pharmacist relationship in the course |
3 | | of professional practice or (2) for the purpose of, or |
4 | | incident to, research, teaching, or chemical analysis and not |
5 | | for sale or dispensing. "Compounding" includes the preparation |
6 | | of drugs or devices in anticipation of receiving prescription |
7 | | drug orders based on routine, regularly observed dispensing |
8 | | patterns. Commercially available products may be compounded |
9 | | for dispensing to individual patients only if both of the |
10 | | following conditions are met: (i) the commercial product is |
11 | | not reasonably available from normal distribution channels in |
12 | | a timely manner to meet the patient's needs and (ii) the |
13 | | prescribing practitioner has requested that the drug be |
14 | | compounded. |
15 | | (e) "Control" means to add a drug or other substance, or |
16 | | immediate
precursor, to a Schedule whether by
transfer from |
17 | | another Schedule or otherwise.
|
18 | | (f) "Controlled Substance" means (i) a drug, substance, |
19 | | immediate
precursor, or synthetic drug in the Schedules of |
20 | | Article II of this Act or (ii) a drug or other substance, or |
21 | | immediate precursor, designated as a controlled substance by |
22 | | the Department through administrative rule. The term does not |
23 | | include distilled spirits, wine, malt beverages, or tobacco, |
24 | | as those terms are
defined or used in the Liquor Control Act of |
25 | | 1934 and the Tobacco Products Tax
Act of 1995.
|
26 | | (f-5) "Controlled substance analog" means a substance: |
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|
1 | | (1) the chemical structure of which is substantially |
2 | | similar to the chemical structure of a controlled |
3 | | substance in Schedule I or II; |
4 | | (2) which has a stimulant, depressant, or |
5 | | hallucinogenic effect on the central nervous system that |
6 | | is substantially similar to or greater than the stimulant, |
7 | | depressant, or hallucinogenic effect on the central |
8 | | nervous system of a controlled substance in Schedule I or |
9 | | II; or |
10 | | (3) with respect to a particular person, which such |
11 | | person represents or intends to have a stimulant, |
12 | | depressant, or hallucinogenic effect on the central |
13 | | nervous system that is substantially similar to or greater |
14 | | than the stimulant, depressant, or hallucinogenic effect |
15 | | on the central nervous system of a controlled substance in |
16 | | Schedule I or II. |
17 | | (g) "Counterfeit substance" means a controlled substance, |
18 | | which, or
the container or labeling of which, without |
19 | | authorization bears the
trademark, trade name, or other |
20 | | identifying mark, imprint, number or
device, or any likeness |
21 | | thereof, of a manufacturer, distributor, or
dispenser other |
22 | | than the person who in fact manufactured, distributed,
or |
23 | | dispensed the substance.
|
24 | | (h) "Deliver" or "delivery" means the actual, constructive |
25 | | or
attempted transfer of possession of a controlled substance, |
26 | | with or
without consideration, whether or not there is an |
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|
1 | | agency relationship.
"Deliver" or "delivery" does not include |
2 | | the donation of prescription drugs to the extent permitted |
3 | | under the Prescription Drug Repository Program Act.
|
4 | | (i) "Department" means the Illinois Department of Human |
5 | | Services (as
successor to the Department of Alcoholism and |
6 | | Substance Abuse) or its successor agency.
|
7 | | (j) (Blank).
|
8 | | (k) "Department of Corrections" means the Department of |
9 | | Corrections
of the State of Illinois or its successor agency.
|
10 | | (l) "Department of Financial and Professional Regulation" |
11 | | means the Department
of Financial and Professional Regulation |
12 | | of the State of Illinois or its successor agency.
|
13 | | (m) "Depressant" means any drug that (i) causes an overall |
14 | | depression of central nervous system functions, (ii) causes |
15 | | impaired consciousness and awareness, and (iii) can be |
16 | | habit-forming or lead to a substance abuse problem, including |
17 | | but not limited to alcohol, cannabis and its active principles |
18 | | and their analogs, benzodiazepines and their analogs, |
19 | | barbiturates and their analogs, opioids (natural and |
20 | | synthetic) and their analogs, and chloral hydrate and similar |
21 | | sedative hypnotics.
|
22 | | (n) (Blank).
|
23 | | (o) "Director" means the Director of the Illinois State |
24 | | Police or his or her designated agents.
|
25 | | (p) "Dispense" means to deliver a controlled substance to |
26 | | an
ultimate user or research subject by or pursuant to the |
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|
1 | | lawful order of
a prescriber, including the prescribing, |
2 | | administering, packaging,
labeling, or compounding necessary |
3 | | to prepare the substance for that
delivery.
|
4 | | (q) "Dispenser" means a practitioner who dispenses.
|
5 | | (r) "Distribute" means to deliver, other than by |
6 | | administering or
dispensing, a controlled substance.
|
7 | | (s) "Distributor" means a person who distributes.
|
8 | | (t) "Drug" means (1) substances recognized as drugs in the |
9 | | official
United States Pharmacopoeia, Official Homeopathic |
10 | | Pharmacopoeia of the
United States, or official National |
11 | | Formulary, or any supplement to any
of them; (2) substances |
12 | | intended for use in diagnosis, cure, mitigation,
treatment, or |
13 | | prevention of disease in man or animals; (3) substances
(other |
14 | | than food) intended to affect the structure of any function of
|
15 | | the body of man or animals and (4) substances intended for use |
16 | | as a
component of any article specified in clause (1), (2), or |
17 | | (3) of this
subsection. It does not include devices or their |
18 | | components, parts, or
accessories.
|
19 | | (t-3) "Electronic health record" or "EHR" means an |
20 | | electronic record of health-related information on an |
21 | | individual that is created, gathered, managed, and consulted |
22 | | by authorized health care clinicians and staff. |
23 | | (t-4) "Emergency medical services personnel" has the |
24 | | meaning ascribed to it in the Emergency Medical Services (EMS) |
25 | | Systems Act. |
26 | | (t-5) "Euthanasia agency" means
an entity certified by the |
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|
1 | | Department of Financial and Professional Regulation for the
|
2 | | purpose of animal euthanasia that holds an animal control |
3 | | facility license or
animal
shelter license under the Animal |
4 | | Welfare Act. A euthanasia agency is
authorized to purchase, |
5 | | store, possess, and utilize Schedule II nonnarcotic and
|
6 | | Schedule III nonnarcotic drugs for the sole purpose of animal |
7 | | euthanasia.
|
8 | | (t-10) "Euthanasia drugs" means Schedule II or Schedule |
9 | | III substances
(nonnarcotic controlled substances) that are |
10 | | used by a euthanasia agency for
the purpose of animal |
11 | | euthanasia.
|
12 | | (u) "Good faith" means the prescribing or dispensing of a |
13 | | controlled
substance by a practitioner in the regular course |
14 | | of professional
treatment to or for any person who is under his |
15 | | or her treatment for a
pathology or condition other than that |
16 | | individual's physical or
psychological dependence upon or |
17 | | addiction to a controlled substance,
except as provided |
18 | | herein: and application of the term to a pharmacist
shall mean |
19 | | the dispensing of a controlled substance pursuant to the
|
20 | | prescriber's order which in the professional judgment of the |
21 | | pharmacist
is lawful. The pharmacist shall be guided by |
22 | | accepted professional
standards including, but not limited to |
23 | | the following, in making the
judgment:
|
24 | | (1) lack of consistency of prescriber-patient |
25 | | relationship,
|
26 | | (2) frequency of prescriptions for same drug by one |
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1 | | prescriber for
large numbers of patients,
|
2 | | (3) quantities beyond those normally prescribed,
|
3 | | (4) unusual dosages (recognizing that there may be |
4 | | clinical circumstances where more or less than the usual |
5 | | dose may be used legitimately),
|
6 | | (5) unusual geographic distances between patient, |
7 | | pharmacist and
prescriber,
|
8 | | (6) consistent prescribing of habit-forming drugs.
|
9 | | (u-0.5) "Hallucinogen" means a drug that causes markedly |
10 | | altered sensory perception leading to hallucinations of any |
11 | | type. |
12 | | (u-1) "Home infusion services" means services provided by |
13 | | a pharmacy in
compounding solutions for direct administration |
14 | | to a patient in a private
residence, long-term care facility, |
15 | | or hospice setting by means of parenteral,
intravenous, |
16 | | intramuscular, subcutaneous, or intraspinal infusion.
|
17 | | (u-5) "Illinois State Police" means the State
Police of |
18 | | the State of Illinois, or its successor agency. |
19 | | (v) "Immediate precursor" means a substance:
|
20 | | (1) which the Department has found to be and by rule |
21 | | designated as
being a principal compound used, or produced |
22 | | primarily for use, in the
manufacture of a controlled |
23 | | substance;
|
24 | | (2) which is an immediate chemical intermediary used |
25 | | or likely to
be used in the manufacture of such controlled |
26 | | substance; and
|
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1 | | (3) the control of which is necessary to prevent, |
2 | | curtail or limit
the manufacture of such controlled |
3 | | substance.
|
4 | | (w) "Instructional activities" means the acts of teaching, |
5 | | educating
or instructing by practitioners using controlled |
6 | | substances within
educational facilities approved by the State |
7 | | Board of Education or
its successor agency.
|
8 | | (x) "Local authorities" means a duly organized State, |
9 | | County or
Municipal peace unit or police force.
|
10 | | (y) "Look-alike substance" means a substance, other than a |
11 | | controlled
substance which (1) by overall dosage unit |
12 | | appearance, including shape,
color, size, markings or lack |
13 | | thereof, taste, consistency, or any other
identifying physical |
14 | | characteristic of the substance, would lead a reasonable
|
15 | | person to believe that the substance is a controlled |
16 | | substance, or (2) is
expressly or impliedly represented to be |
17 | | a controlled substance or is
distributed under circumstances |
18 | | which would lead a reasonable person to
believe that the |
19 | | substance is a controlled substance. For the purpose of
|
20 | | determining whether the representations made or the |
21 | | circumstances of the
distribution would lead a reasonable |
22 | | person to believe the substance to be
a controlled substance |
23 | | under this clause (2) of subsection (y), the court or
other |
24 | | authority may consider the following factors in addition to |
25 | | any other
factor that may be relevant:
|
26 | | (a) statements made by the owner or person in control |
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1 | | of the substance
concerning its nature, use or effect;
|
2 | | (b) statements made to the buyer or recipient that the |
3 | | substance may
be resold for profit;
|
4 | | (c) whether the substance is packaged in a manner |
5 | | normally used for the
illegal distribution of controlled |
6 | | substances;
|
7 | | (d) whether the distribution or attempted distribution |
8 | | included an
exchange of or demand for money or other |
9 | | property as consideration, and
whether the amount of the |
10 | | consideration was substantially greater than the
|
11 | | reasonable retail market value of the substance.
|
12 | | Clause (1) of this subsection (y) shall not apply to a |
13 | | noncontrolled
substance in its finished dosage form that was |
14 | | initially introduced into
commerce prior to the initial |
15 | | introduction into commerce of a controlled
substance in its |
16 | | finished dosage form which it may substantially resemble.
|
17 | | Nothing in this subsection (y) prohibits the dispensing or |
18 | | distributing
of noncontrolled substances by persons authorized |
19 | | to dispense and
distribute controlled substances under this |
20 | | Act, provided that such action
would be deemed to be carried |
21 | | out in good faith under subsection (u) if the
substances |
22 | | involved were controlled substances.
|
23 | | Nothing in this subsection (y) or in this Act prohibits |
24 | | the manufacture,
preparation, propagation, compounding, |
25 | | processing, packaging, advertising
or distribution of a drug |
26 | | or drugs by any person registered pursuant to
Section 510 of |
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1 | | the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
|
2 | | (y-1) "Mail-order pharmacy" means a pharmacy that is |
3 | | located in a state
of the United States that delivers, |
4 | | dispenses or
distributes, through the United States Postal |
5 | | Service or other common
carrier, to Illinois residents, any |
6 | | substance which requires a prescription.
|
7 | | (z) "Manufacture" means the production, preparation, |
8 | | propagation,
compounding, conversion or processing of a |
9 | | controlled substance other than methamphetamine, either
|
10 | | directly or indirectly, by extraction from substances of |
11 | | natural origin,
or independently by means of chemical |
12 | | synthesis, or by a combination of
extraction and chemical |
13 | | synthesis, and includes any packaging or
repackaging of the |
14 | | substance or labeling of its container, except that
this term |
15 | | does not include:
|
16 | | (1) by an ultimate user, the preparation or |
17 | | compounding of a
controlled substance for his or her own |
18 | | use; or
|
19 | | (2) by a practitioner, or his or her authorized agent |
20 | | under his or her
supervision, the preparation, |
21 | | compounding, packaging, or labeling of a
controlled |
22 | | substance:
|
23 | | (a) as an incident to his or her administering or |
24 | | dispensing of a
controlled substance in the course of |
25 | | his or her professional practice; or
|
26 | | (b) as an incident to lawful research, teaching or |
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1 | | chemical
analysis and not for sale ; or .
|
2 | | (3) the packaging, repackaging, or labeling of |
3 | | prescription drugs only to the extent required under the |
4 | | Prescription Drug Repository Program Act.
|
5 | | (z-1) (Blank).
|
6 | | (z-5) "Medication shopping" means the conduct prohibited |
7 | | under subsection (a) of Section 314.5 of this Act. |
8 | | (z-10) "Mid-level practitioner" means (i) a physician |
9 | | assistant who has been delegated authority to prescribe |
10 | | through a written delegation of authority by a physician |
11 | | licensed to practice medicine in all of its branches, in |
12 | | accordance with Section 7.5 of the Physician Assistant |
13 | | Practice Act of 1987, (ii) an advanced practice registered |
14 | | nurse who has been delegated authority to prescribe through a |
15 | | written delegation of authority by a physician licensed to |
16 | | practice medicine in all of its branches or by a podiatric |
17 | | physician, in accordance with Section 65-40 of the Nurse |
18 | | Practice Act, (iii) an advanced practice registered nurse |
19 | | certified as a nurse practitioner, nurse midwife, or clinical |
20 | | nurse specialist who has been granted authority to prescribe |
21 | | by a hospital affiliate in accordance with Section 65-45 of |
22 | | the Nurse Practice Act, (iv) an animal euthanasia agency, or |
23 | | (v) a prescribing psychologist. |
24 | | (aa) "Narcotic drug" means any of the following, whether |
25 | | produced
directly or indirectly by extraction from substances |
26 | | of vegetable origin,
or independently by means of chemical |
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1 | | synthesis, or by a combination of
extraction and chemical |
2 | | synthesis:
|
3 | | (1) opium, opiates, derivatives of opium and opiates, |
4 | | including their isomers, esters, ethers, salts, and salts |
5 | | of isomers, esters, and ethers, whenever the existence of |
6 | | such isomers, esters, ethers, and salts is possible within |
7 | | the specific chemical designation; however the term |
8 | | "narcotic drug" does not include the isoquinoline |
9 | | alkaloids of opium;
|
10 | | (2) (blank);
|
11 | | (3) opium poppy and poppy straw;
|
12 | | (4) coca leaves, except coca leaves and extracts of |
13 | | coca leaves from which substantially all of the cocaine |
14 | | and ecgonine, and their isomers, derivatives and salts, |
15 | | have been removed;
|
16 | | (5) cocaine, its salts, optical and geometric isomers, |
17 | | and salts of isomers; |
18 | | (6) ecgonine, its derivatives, their salts, isomers, |
19 | | and salts of isomers; |
20 | | (7) any compound, mixture, or preparation which |
21 | | contains any quantity of any of the substances referred to |
22 | | in subparagraphs (1) through (6). |
23 | | (bb) "Nurse" means a registered nurse licensed under the
|
24 | | Nurse Practice Act.
|
25 | | (cc) (Blank).
|
26 | | (dd) "Opiate" means any substance having an addiction |
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1 | | forming or
addiction sustaining liability similar to morphine |
2 | | or being capable of
conversion into a drug having addiction |
3 | | forming or addiction sustaining
liability.
|
4 | | (ee) "Opium poppy" means the plant of the species Papaver
|
5 | | somniferum L., except its seeds.
|
6 | | (ee-5) "Oral dosage" means a tablet, capsule, elixir, or |
7 | | solution or other liquid form of medication intended for |
8 | | administration by mouth, but the term does not include a form |
9 | | of medication intended for buccal, sublingual, or transmucosal |
10 | | administration. |
11 | | (ff) "Parole and Pardon Board" means the Parole and Pardon |
12 | | Board of
the State of Illinois or its successor agency.
|
13 | | (gg) "Person" means any individual, corporation, |
14 | | mail-order pharmacy,
government or governmental subdivision or |
15 | | agency, business trust, estate,
trust, partnership or |
16 | | association, or any other entity.
|
17 | | (hh) "Pharmacist" means any person who holds a license or |
18 | | certificate of
registration as a registered pharmacist, a |
19 | | local registered pharmacist
or a registered assistant |
20 | | pharmacist under the Pharmacy Practice Act.
|
21 | | (ii) "Pharmacy" means any store, ship or other place in |
22 | | which
pharmacy is authorized to be practiced under the |
23 | | Pharmacy Practice Act.
|
24 | | (ii-5) "Pharmacy shopping" means the conduct prohibited |
25 | | under subsection (b) of Section 314.5 of this Act. |
26 | | (ii-10) "Physician" (except when the context otherwise |
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1 | | requires) means a person licensed to practice medicine in all |
2 | | of its branches. |
3 | | (jj) "Poppy straw" means all parts, except the seeds, of |
4 | | the opium
poppy, after mowing.
|
5 | | (kk) "Practitioner" means a physician licensed to practice |
6 | | medicine in all
its branches, dentist, optometrist, podiatric |
7 | | physician,
veterinarian, scientific investigator, pharmacist, |
8 | | physician assistant,
advanced practice registered nurse,
|
9 | | licensed practical
nurse, registered nurse, emergency medical |
10 | | services personnel, hospital, laboratory, or pharmacy, or |
11 | | other
person licensed, registered, or otherwise lawfully |
12 | | permitted by the
United States or this State to distribute, |
13 | | dispense, conduct research
with respect to, administer or use |
14 | | in teaching or chemical analysis, a
controlled substance in |
15 | | the course of professional practice or research.
|
16 | | (ll) "Pre-printed prescription" means a written |
17 | | prescription upon which
the designated drug has been indicated |
18 | | prior to the time of issuance; the term does not mean a written |
19 | | prescription that is individually generated by machine or |
20 | | computer in the prescriber's office.
|
21 | | (mm) "Prescriber" means a physician licensed to practice |
22 | | medicine in all
its branches, dentist, optometrist, |
23 | | prescribing psychologist licensed under Section 4.2 of the |
24 | | Clinical Psychologist Licensing Act with prescriptive |
25 | | authority delegated under Section 4.3 of the Clinical |
26 | | Psychologist Licensing Act, podiatric physician, or
|
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1 | | veterinarian who issues a prescription, a physician assistant |
2 | | who
issues a
prescription for a controlled substance
in |
3 | | accordance
with Section 303.05, a written delegation, and a |
4 | | written collaborative agreement required under Section 7.5
of |
5 | | the
Physician Assistant Practice Act of 1987, an advanced |
6 | | practice registered
nurse with prescriptive authority |
7 | | delegated under Section 65-40 of the Nurse Practice Act and in |
8 | | accordance with Section 303.05, a written delegation,
and a |
9 | | written
collaborative agreement under Section 65-35 of the |
10 | | Nurse Practice Act, an advanced practice registered nurse |
11 | | certified as a nurse practitioner, nurse midwife, or clinical |
12 | | nurse specialist who has been granted authority to prescribe |
13 | | by a hospital affiliate in accordance with Section 65-45 of |
14 | | the Nurse Practice Act and in accordance with Section 303.05, |
15 | | or an advanced practice registered nurse certified as a nurse |
16 | | practitioner, nurse midwife, or clinical nurse specialist who |
17 | | has full practice authority pursuant to Section 65-43 of the |
18 | | Nurse Practice Act.
|
19 | | (nn) "Prescription" means a written, facsimile, or oral |
20 | | order, or an electronic order that complies with applicable |
21 | | federal requirements,
of
a physician licensed to practice |
22 | | medicine in all its branches,
dentist, podiatric physician or |
23 | | veterinarian for any controlled
substance, of an optometrist |
24 | | in accordance with Section 15.1 of the Illinois Optometric |
25 | | Practice Act of 1987, of a prescribing psychologist licensed |
26 | | under Section 4.2 of the Clinical Psychologist Licensing Act |
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1 | | with prescriptive authority delegated under Section 4.3 of the |
2 | | Clinical Psychologist Licensing Act, of a physician assistant |
3 | | for a
controlled substance
in accordance with Section 303.05, |
4 | | a written delegation, and a written collaborative agreement |
5 | | required under
Section 7.5 of the
Physician Assistant Practice |
6 | | Act of 1987, of an advanced practice registered
nurse with |
7 | | prescriptive authority delegated under Section 65-40 of the |
8 | | Nurse Practice Act who issues a prescription for a
controlled |
9 | | substance in accordance
with
Section 303.05, a written |
10 | | delegation, and a written collaborative agreement under |
11 | | Section 65-35 of the Nurse Practice Act, of an advanced |
12 | | practice registered nurse certified as a nurse practitioner, |
13 | | nurse midwife, or clinical nurse specialist who has been |
14 | | granted authority to prescribe by a hospital affiliate in |
15 | | accordance with Section 65-45 of the Nurse Practice Act and in |
16 | | accordance with Section 303.05 when required by law, or of an |
17 | | advanced practice registered nurse certified as a nurse |
18 | | practitioner, nurse midwife, or clinical nurse specialist who |
19 | | has full practice authority pursuant to Section 65-43 of the |
20 | | Nurse Practice Act.
|
21 | | (nn-5) "Prescription Information Library" (PIL) means an |
22 | | electronic library that contains reported controlled substance |
23 | | data. |
24 | | (nn-10) "Prescription Monitoring Program" (PMP) means the |
25 | | entity that collects, tracks, and stores reported data on |
26 | | controlled substances and select drugs pursuant to Section |
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1 | | 316. |
2 | | (oo) "Production" or "produce" means manufacture, |
3 | | planting,
cultivating, growing, or harvesting of a controlled |
4 | | substance other than methamphetamine.
|
5 | | (pp) "Registrant" means every person who is required to |
6 | | register
under Section 302 of this Act.
|
7 | | (qq) "Registry number" means the number assigned to each |
8 | | person
authorized to handle controlled substances under the |
9 | | laws of the United
States and of this State.
|
10 | | (qq-5) "Secretary" means, as the context requires, either |
11 | | the Secretary of the Department or the Secretary of the |
12 | | Department of Financial and Professional Regulation, and the |
13 | | Secretary's designated agents. |
14 | | (rr) "State" includes the State of Illinois and any state, |
15 | | district,
commonwealth, territory, insular possession thereof, |
16 | | and any area
subject to the legal authority of the United |
17 | | States of America.
|
18 | | (rr-5) "Stimulant" means any drug that (i) causes an |
19 | | overall excitation of central nervous system functions, (ii) |
20 | | causes impaired consciousness and awareness, and (iii) can be |
21 | | habit-forming or lead to a substance abuse problem, including |
22 | | but not limited to amphetamines and their analogs, |
23 | | methylphenidate and its analogs, cocaine, and phencyclidine |
24 | | and its analogs. |
25 | | (rr-10) "Synthetic drug" includes, but is not limited to, |
26 | | any synthetic cannabinoids or piperazines or any synthetic |
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1 | | cathinones as provided for in Schedule I. |
2 | | (ss) "Ultimate user" means a person who lawfully possesses |
3 | | a
controlled substance for his or her own use or for the use of |
4 | | a member of his or her
household or for administering to an |
5 | | animal owned by him or her or by a member
of his or her |
6 | | household.
|
7 | | (Source: P.A. 99-78, eff. 7-20-15; 99-173, eff. 7-29-15; |
8 | | 99-371, eff. 1-1-16; 99-480, eff. 9-9-15; 99-642, eff. |
9 | | 7-28-16; 100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513, |
10 | | eff. 1-1-18; 100-789, eff. 1-1-19; 100-863, eff. 8-14-18 .)
|
11 | | Section 115. The Cannabis and Controlled Substances Tort |
12 | | Claims Act is amended by changing Section 3 as follows:
|
13 | | (740 ILCS 20/3) (from Ch. 70, par. 903)
|
14 | | Sec. 3. Definitions. As used in this Act, unless the |
15 | | context otherwise
requires:
|
16 | | "Cannabis" includes marihuana, hashish, and other |
17 | | substances that
are identified as including any parts of the |
18 | | plant Cannabis Sativa, whether
growing or not, the seeds of |
19 | | that plant, the resin extracted from any part of
that plant, |
20 | | and any compound, manufacture, salt, derivative, mixture, or
|
21 | | preparation of that plant, its seeds, or resin, including
|
22 | | tetrahydrocannabinol (THC) and all other cannabinol |
23 | | derivatives, including
its naturally occurring or |
24 | | synthetically produced ingredients, whether
produced directly |
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1 | | or indirectly by extraction, independently by means of
|
2 | | chemical synthesis, or by a combination of extraction and |
3 | | chemical
synthesis. "Cannabis" does not include the mature |
4 | | stalks of that plant, fiber
produced from those stalks, oil or |
5 | | cake made from the seeds of that plant,
any other compound, |
6 | | manufacture, salt, derivative, mixture, or preparation
of |
7 | | mature stalks (except the extracted resin), fiber, oil
or |
8 | | cake, or the sterilized seeds of that plant that are incapable |
9 | | of
germination.
|
10 | | "Controlled substance" means a drug, substance, or |
11 | | immediate precursor in
the Schedules of Article II of the |
12 | | Illinois Controlled Substances Act.
|
13 | | "Counterfeit substance" means a controlled substance or |
14 | | the container or
labeling of a controlled substance that, |
15 | | without authorization, bears the
trademark, trade name, or |
16 | | other identifying mark, imprint, number, device,
or any |
17 | | likeness thereof of a manufacturer, distributor, or dispenser |
18 | | other
than the person who in fact manufactured, distributed, |
19 | | or dispensed the
substance.
|
20 | | "Deliver" or "delivery" means the actual, constructive, or |
21 | | attempted
transfer of possession of a controlled substance or |
22 | | cannabis, with or
without consideration, whether or not there |
23 | | is an agency relationship. "Deliver" or "delivery" does not |
24 | | include the donation of prescription drugs to the extent |
25 | | permitted under the Prescription Drug Repository Program Act.
|
26 | | "Manufacture" means the production, preparation, |
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1 | | propagation,
compounding, conversion, or processing of a |
2 | | controlled substance, either
directly or indirectly, by |
3 | | extraction from substances of natural origin,
independently by |
4 | | means of chemical synthesis, or by a combination of
extraction |
5 | | and chemical synthesis, and includes any packaging or
|
6 | | repackaging of the substance or labeling of its container, |
7 | | except that the
term does not include:
|
8 | | (1) by an ultimate user, the preparation or |
9 | | compounding of a
controlled substance for his own use;
|
10 | | (2) by a practitioner or his authorized agent under |
11 | | his supervision,
the preparation, compounding, packaging, |
12 | | or labeling of a controlled substance:
|
13 | | (A) as an incident to his administering or |
14 | | dispensing of a controlled
substance in the course of |
15 | | his professional practice; or
|
16 | | (B) as an incident to lawful research, teaching or |
17 | | chemical analysis
and not for sale; or
|
18 | | (3) the preparation, compounding, packaging, or |
19 | | labeling of cannabis
as an incident to lawful research, |
20 | | teaching, or chemical analysis and not
for sale ; or .
|
21 | | (4) the packaging, repackaging, or labeling of |
22 | | prescription drugs only to the extent required under the |
23 | | Prescription Drug Repository Program Act.
|
24 | | "Owner" means a person who has possession of or any |
25 | | interest
whatsoever in the property involved.
|
26 | | "Person" means an individual, a corporation, a government,
|
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1 | | a governmental subdivision or agency, a business trust, an |
2 | | estate, a trust,
a partnership or association, or any other |
3 | | entity.
|
4 | | "Production" means planting, cultivating, tending, or |
5 | | harvesting.
|
6 | | "Property" means real property, including things growing |
7 | | on,
affixed to, and found in land, and tangible or intangible |
8 | | personal
property, including rights, services, privileges, |
9 | | interests, claims,
and securities.
|
10 | | (Source: P.A. 96-328, eff. 8-11-09.)
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| 1 | |
INDEX
| 2 | |
Statutes amended in order of appearance
| | 3 | | New Act | | | 4 | | 225 ILCS 85/4 | from Ch. 111, par. 4124 | | 5 | | 225 ILCS 120/15 | from Ch. 111, par. 8301-15 | | 6 | | 320 ILCS 50/10 | | | 7 | | 410 ILCS 620/16 | from Ch. 56 1/2, par. 516 | | 8 | | 720 ILCS 570/102 | from Ch. 56 1/2, par. 1102 | | 9 | | 740 ILCS 20/3 | from Ch. 70, par. 903 |
|
|