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Rep. Marcus C. Evans, Jr.
Filed: 3/14/2019
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1 | | AMENDMENT TO HOUSE BILL 3232
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2 | | AMENDMENT NO. ______. Amend House Bill 3232 by replacing |
3 | | everything after the enacting clause with the following:
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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 | | "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.
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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:
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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.
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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.
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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.
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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.
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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.
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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.
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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:
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8 | | (225 ILCS 85/4) (from Ch. 111, par. 4124)
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9 | | (Section scheduled to be repealed on January 1, 2020)
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10 | | Sec. 4. Exemptions. Nothing contained in any Section of |
11 | | this Act shall
apply
to, or in any manner interfere with:
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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
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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;
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19 | | (b) the sale of compressed gases;
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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;
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18 | | (d) the sale of poultry and livestock remedies in |
19 | | original and unbroken
packages only, labeled for poultry |
20 | | and livestock medication;
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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
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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;
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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;
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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
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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
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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.)
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14 | | Section 95. The Wholesale Drug Distribution Licensing Act |
15 | | is amended by changing Section 15 as follows:
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16 | | (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
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17 | | (Section scheduled to be repealed on January 1, 2023)
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18 | | Sec. 15. Definitions. As used in this Act:
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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.
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14 | | "Blood" means whole blood collected from a single donor and |
15 | | processed
either for transfusion or further manufacturing.
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16 | | "Blood component" means that part of blood separated by |
17 | | physical or
mechanical means.
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18 | | "Board" means the State Board of Pharmacy of the Department |
19 | | of
Professional Regulation.
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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.
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6 | | "Department" means the Department of Financial and
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7 | | Professional Regulation.
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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.
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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.
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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.
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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.
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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.
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5 | | "Person" means and includes a natural person, partnership, |
6 | | association,
corporation, or any other legal business entity.
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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.
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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.
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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:
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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.
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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.
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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.
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10 | | (11) The donation of prescription drugs to the extent |
11 | | permitted under the Prescription Drug Repository Program |
12 | | Act.
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13 | | "Wholesale drug distributor" means anyone
engaged in the
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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.)
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2 | | Section 100. The Senior Pharmaceutical Assistance Act is |
3 | | amended by changing Section 10 as follows:
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4 | | (320 ILCS 50/10)
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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
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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
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3 | | (3) a euthanasia technician as defined by the Humane |
4 | | Euthanasia in
Animal Shelters Act.
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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).
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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.
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23 | | (d) "Administration" means the Drug Enforcement |
24 | | Administration,
United States Department of Justice, or its |
25 | | successor agency.
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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.
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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.
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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.
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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).
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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.
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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.
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3 | | (n) (Blank).
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4 | | (o) "Director" means the Director of the Illinois State |
5 | | Police or his or her designated agents.
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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.
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11 | | (q) "Dispenser" means a practitioner who dispenses.
|
12 | | (r) "Distribute" means to deliver, other than by |
13 | | administering or
dispensing, a controlled substance.
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14 | | (s) "Distributor" means a person who distributes.
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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.)".
|