Bill Text: IL SB0600 | 2021-2022 | 102nd General Assembly | Introduced
Bill Title: Creates the Prescription Drug Repository Program Act. Requires the Department of Public Health to, by rule, establish a prescription drug repository program, under which a donor 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 uninsured and underinsured individuals shall be given priority over other eligible persons for drugs and supplies donated under the Act. 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. Contains other provisions. Amends the Pharmacy Practice Act, the Wholesale Drug Distribution Licensing Act, the Senior Pharmaceutical Assistance Act, the Illinois Food, Drug and Cosmetic 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.
Spectrum: Partisan Bill (Republican 2-0)
Status: (Introduced - Dead) 2021-04-16 - Rule 3-9(a) / Re-referred to Assignments [SB0600 Detail]
Download: Illinois-2021-SB0600-Introduced.html
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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.
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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 | ||||||||||||||||||||||||
13 | of 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, | ||||||||||||||||||||||||
17 | pharmacies, dispensers, clinics, surgical or health centers, | ||||||||||||||||||||||||
18 | detention and rehabilitation centers, laboratories, medical or | ||||||||||||||||||||||||
19 | pharmacy schools, prescribers or other health care | ||||||||||||||||||||||||
20 | professionals, or health care facilities. "Donor" includes | ||||||||||||||||||||||||
21 | government agencies and entities that are federally authorized | ||||||||||||||||||||||||
22 | to possess medicine, including, but not limited to, drug | ||||||||||||||||||||||||
23 | manufacturers, repackagers, relabelers, outsourcing |
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1 | facilities, Veterans Affairs hospitals, and prisons. | ||||||
2 | "Pharmacist" means an individual licensed to engage in the | ||||||
3 | practice of pharmacy under the Pharmacy Practice Act. | ||||||
4 | "Practitioner" means a person licensed in this State to | ||||||
5 | prescribe and administer drugs or licensed in another state | ||||||
6 | and recognized by this State as a person authorized to | ||||||
7 | prescribe and administer drugs. | ||||||
8 | "Prescription drug" means any prescribed drug that may be | ||||||
9 | legally dispensed by a pharmacy. | ||||||
10 | "Program" means the prescription drug repository program | ||||||
11 | established under this Act. | ||||||
12 | "Recipient pharmacy" means a pharmacy licensed under the | ||||||
13 | Pharmacy Practice Act that receives a donated prescription | ||||||
14 | drug or supplies needed to administer a prescription drug | ||||||
15 | under this Act.
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16 | Section 10. Prescription drug repository program. The | ||||||
17 | Department shall, by rule, establish and maintain a | ||||||
18 | prescription drug repository program, under which a donor may | ||||||
19 | donate a prescription drug or supplies needed to administer a | ||||||
20 | prescription drug for use by an individual who meets | ||||||
21 | appropriate eligibility criteria. The Department shall adopt | ||||||
22 | the rules within one year after the effective date of this Act. | ||||||
23 | A recipient pharmacy may charge an individual who receives a | ||||||
24 | prescription drug or supplies needed to administer a | ||||||
25 | prescription drug under this Act a handling fee that may not |
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1 | exceed an appropriate amount. A recipient pharmacy may | ||||||
2 | distribute the prescription drug or supplies to another | ||||||
3 | eligible recipient pharmacy for use under the program or to | ||||||
4 | another state's drug repository program.
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5 | Section 15. Priority. Uninsured and underinsured | ||||||
6 | individuals shall be given priority over other eligible | ||||||
7 | persons for drugs and supplies donated under this Act.
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8 | Section 20. Requirements for accepting and dispensing | ||||||
9 | prescription drugs and supplies. A prescription drug or | ||||||
10 | supplies needed to administer a prescription drug may be | ||||||
11 | accepted and dispensed under the program only if all of the | ||||||
12 | following requirements are met:
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13 | (1) The prescription drug or supplies needed to | ||||||
14 | administer a prescription drug are in their original, | ||||||
15 | unopened, sealed, and tamper-evident packaging or, if | ||||||
16 | packaged in single-unit doses, the single-unit-dose | ||||||
17 | packaging is unopened.
A prescription drug or supplies | ||||||
18 | needed to administer a prescription drug originally packed | ||||||
19 | by a pharmacy, whether or not it is a recipient pharmacy, | ||||||
20 | is acceptable for donation. | ||||||
21 | (2) The prescription drug is not expired.
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22 | (3) The prescription drug or supplies needed to | ||||||
23 | administer a prescription drug are not adulterated or | ||||||
24 | misbranded, as determined by a pharmacist employed by, or |
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1 | under contract with, the pharmacy, whether or not it is a | ||||||
2 | recipient pharmacy, where the drug or supplies needed to | ||||||
3 | administer a prescription drug are accepted or dispensed. | ||||||
4 | The pharmacist must inspect the drug or supplies needed to | ||||||
5 | administer a prescription drug before the drug or supplies | ||||||
6 | needed to administer a prescription drug are dispensed.
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7 | (4) The prescription drug or supplies needed to | ||||||
8 | administer a prescription drug are prescribed by a | ||||||
9 | practitioner for use by an eligible individual.
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10 | (5) The prescription drug is not a controlled | ||||||
11 | substance. | ||||||
12 | (6) If the prescription drug can be dispensed only to | ||||||
13 | a patient registered with the drug's manufacturer in | ||||||
14 | accordance with federal Food and Drug Administration | ||||||
15 | requirements, the prescription drug may not be dispensed | ||||||
16 | through the program unless the patient receiving the drug | ||||||
17 | is registered with the manufacturer at the time the drug | ||||||
18 | is dispensed and the amount dispensed does not exceed the | ||||||
19 | duration of the registration period. | ||||||
20 | (7) The recipient pharmacy maintains a written or | ||||||
21 | electronic record of a donation made under this Act | ||||||
22 | consisting of the name, strength, and quantity of each | ||||||
23 | accepted drug and the name, address, and telephone number | ||||||
24 | of the donor. No other record of a donation is required.
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25 | Section 25. Resale of donated drugs or supplies |
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1 | prohibited. No prescription drug or supplies needed to | ||||||
2 | administer a prescription drug that are donated for use under | ||||||
3 | this Act may be resold.
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4 | Section 30. Participation in program not required. Nothing | ||||||
5 | in this Act requires that a pharmacy or pharmacist participate | ||||||
6 | in the prescription drug repository program.
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7 | Section 35. Immunity. | ||||||
8 | (a) A manufacturer of a drug or supply acting reasonably | ||||||
9 | and in good faith is not subject to criminal or civil liability | ||||||
10 | for injury, death, or loss to a person or property for matters | ||||||
11 | related to the donation, acceptance, or dispensing of a | ||||||
12 | prescription drug or supply manufactured by the manufacturer | ||||||
13 | that is donated by any person under this Act.
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14 | (b) A person acting reasonably and in good faith, | ||||||
15 | including a pharmacist or other health professional, is immune | ||||||
16 | from civil liability for injury to or the death of the | ||||||
17 | individual to whom the prescription drug or supply is | ||||||
18 | dispensed and may not be found guilty of unprofessional | ||||||
19 | conduct for his or her acts or omissions related to donating, | ||||||
20 | accepting, distributing, or dispensing a prescription drug or | ||||||
21 | supply under this Act. The immunity granted under this | ||||||
22 | subsection does not apply to acts or omissions outside the | ||||||
23 | scope of the program.
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1 | Section 90. The Pharmacy Practice Act is amended by | ||||||
2 | changing Section 4 as follows:
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3 | (225 ILCS 85/4) (from Ch. 111, par. 4124)
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4 | (Section scheduled to be repealed on January 1, 2023)
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5 | Sec. 4. Exemptions. Nothing contained in any Section of | ||||||
6 | this Act shall
apply
to, or in any manner interfere with:
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7 | (a) the lawful practice of any physician licensed to | ||||||
8 | practice medicine in
all of its branches, dentist, | ||||||
9 | podiatric physician,
veterinarian, or therapeutically or | ||||||
10 | diagnostically certified optometrist within
the limits of
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11 | his or her license, or prevent him or her from
supplying to | ||||||
12 | his
or her
bona fide patients
such drugs, medicines, or | ||||||
13 | poisons as may seem to him appropriate;
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14 | (b) the sale of compressed gases;
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15 | (c) the sale of patent or proprietary medicines and | ||||||
16 | household remedies
when sold in original and unbroken | ||||||
17 | packages only, if such patent or
proprietary medicines and | ||||||
18 | household remedies be properly and adequately
labeled as | ||||||
19 | to content and usage and generally considered and accepted
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20 | as harmless and nonpoisonous when used according to the | ||||||
21 | directions
on the label, and also do not contain opium or | ||||||
22 | coca leaves, or any
compound, salt or derivative thereof, | ||||||
23 | or any drug which, according
to the latest editions of the | ||||||
24 | following authoritative pharmaceutical
treatises and | ||||||
25 | standards, namely, The United States |
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1 | Pharmacopoeia/National
Formulary (USP/NF), the United | ||||||
2 | States Dispensatory, and the Accepted
Dental Remedies of | ||||||
3 | the Council of Dental Therapeutics of the American
Dental | ||||||
4 | Association or any or either of them, in use on the | ||||||
5 | effective
date of this Act, or according to the existing | ||||||
6 | provisions of the Federal
Food, Drug, and Cosmetic Act and | ||||||
7 | Regulations of the Department of Health
and Human | ||||||
8 | Services, Food and Drug Administration, promulgated | ||||||
9 | thereunder
now in effect, is designated, described or | ||||||
10 | considered as a narcotic,
hypnotic, habit forming, | ||||||
11 | dangerous, or poisonous drug;
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12 | (d) the sale of poultry and livestock remedies in | ||||||
13 | original and unbroken
packages only, labeled for poultry | ||||||
14 | and livestock medication;
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15 | (e) the sale of poisonous substances or mixture of | ||||||
16 | poisonous substances,
in unbroken packages, for | ||||||
17 | nonmedicinal use in the arts or industries
or for | ||||||
18 | insecticide purposes; provided, they are properly and | ||||||
19 | adequately
labeled as to content and such nonmedicinal | ||||||
20 | usage, in conformity
with the provisions of all applicable | ||||||
21 | federal, state and local laws
and regulations promulgated | ||||||
22 | thereunder now in effect relating thereto
and governing | ||||||
23 | the same, and those which are required under such | ||||||
24 | applicable
laws and regulations to be labeled with the | ||||||
25 | word "Poison", are also labeled
with the word "Poison" | ||||||
26 | printed
thereon in prominent type and the name of a |
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1 | readily obtainable antidote
with directions for its | ||||||
2 | administration;
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3 | (f) the delegation of limited prescriptive authority | ||||||
4 | by a physician
licensed to
practice medicine in all its | ||||||
5 | branches to a physician assistant
under Section 7.5 of the | ||||||
6 | Physician Assistant Practice Act of 1987. This
delegated | ||||||
7 | authority under Section 7.5 of the Physician Assistant | ||||||
8 | Practice Act of 1987 may, but is not required to, include | ||||||
9 | prescription of
controlled substances, as defined in | ||||||
10 | Article II of the
Illinois Controlled Substances Act, in | ||||||
11 | accordance with a written supervision agreement;
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12 | (g) the delegation of prescriptive authority by a | ||||||
13 | physician
licensed to practice medicine in all its | ||||||
14 | branches or a licensed podiatric physician to an advanced | ||||||
15 | practice
registered nurse in accordance with a written | ||||||
16 | collaborative
agreement under Sections 65-35 and 65-40 of | ||||||
17 | the Nurse Practice Act; and
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18 | (g-5) the donation or acceptance, or the packaging, | ||||||
19 | repackaging, or labeling, of prescription drugs to the | ||||||
20 | extent permitted or required under the Prescription Drug | ||||||
21 | Repository Program Act; and | ||||||
22 | (h) the sale or distribution of dialysate or devices | ||||||
23 | necessary to perform home peritoneal renal dialysis for | ||||||
24 | patients with end-stage renal disease, provided that all | ||||||
25 | of the following conditions are met: | ||||||
26 | (1) the dialysate, comprised of dextrose or |
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1 | icodextrin, or devices are approved or cleared by the | ||||||
2 | federal Food and Drug Administration, as required by | ||||||
3 | federal law; | ||||||
4 | (2) the dialysate or devices are lawfully held by | ||||||
5 | a manufacturer or the manufacturer's agent, which is | ||||||
6 | properly registered with the Board as a manufacturer, | ||||||
7 | third-party logistics provider, or wholesaler; | ||||||
8 | (3) the dialysate or devices are held and | ||||||
9 | delivered to the manufacturer or the manufacturer's | ||||||
10 | agent in the original, sealed packaging from the | ||||||
11 | manufacturing facility; | ||||||
12 | (4) the dialysate or devices are delivered only | ||||||
13 | upon receipt of a physician's prescription by a | ||||||
14 | licensed pharmacy in which the prescription is | ||||||
15 | processed in accordance with provisions set forth in | ||||||
16 | this Act, and the transmittal of an order from the | ||||||
17 | licensed pharmacy to the manufacturer or the | ||||||
18 | manufacturer's agent; and | ||||||
19 | (5) the manufacturer or the manufacturer's agent | ||||||
20 | delivers the dialysate or devices directly to: (i) a | ||||||
21 | patient with end-stage renal disease, or his or her | ||||||
22 | designee, for the patient's self-administration of the | ||||||
23 | dialysis therapy or (ii) a health care provider or | ||||||
24 | institution for administration or delivery of the | ||||||
25 | dialysis therapy to a patient with end-stage renal | ||||||
26 | disease. |
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1 | This paragraph (h) does not include any other drugs | ||||||
2 | for peritoneal dialysis, except dialysate, as described in | ||||||
3 | item (1) of this paragraph (h). All records of sales and | ||||||
4 | distribution of dialysate to patients made pursuant to | ||||||
5 | this paragraph (h) must be retained in accordance with | ||||||
6 | Section 18 of this Act. | ||||||
7 | (Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18; | ||||||
8 | 100-863, eff. 8-14-18; 101-420, eff. 8-16-19 .)
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9 | Section 95. The Wholesale Drug Distribution Licensing Act | ||||||
10 | is amended by changing Section 15 as follows:
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11 | (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
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12 | (Section scheduled to be repealed on January 1, 2023)
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13 | Sec. 15. Definitions. As used in this Act:
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14 | "Authentication" means the affirmative verification, | ||||||
15 | before any wholesale distribution of a prescription drug | ||||||
16 | occurs, that each transaction listed on the pedigree has | ||||||
17 | occurred. | ||||||
18 | "Authorized distributor of record" means a wholesale | ||||||
19 | distributor with whom a manufacturer has established an | ||||||
20 | ongoing relationship to distribute the manufacturer's | ||||||
21 | prescription drug. An ongoing relationship is deemed to exist | ||||||
22 | between a wholesale distributor and a manufacturer when the | ||||||
23 | wholesale distributor, including any affiliated group of the | ||||||
24 | wholesale distributor, as defined in Section 1504 of the |
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1 | Internal Revenue Code, complies with the following: | ||||||
2 | (1) The wholesale distributor has a written agreement | ||||||
3 | currently in effect with the manufacturer evidencing the | ||||||
4 | ongoing relationship; and | ||||||
5 | (2) The wholesale distributor is listed on the | ||||||
6 | manufacturer's current list of authorized distributors of | ||||||
7 | record, which is updated by the manufacturer on no less | ||||||
8 | than a monthly basis.
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9 | "Blood" means whole blood collected from a single donor | ||||||
10 | and processed
either for transfusion or further manufacturing.
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11 | "Blood component" means that part of blood separated by | ||||||
12 | physical or
mechanical means.
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13 | "Board" means the State Board of Pharmacy of the | ||||||
14 | Department of
Professional Regulation.
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15 | "Chain pharmacy warehouse" means a physical location for | ||||||
16 | prescription drugs that acts as a central warehouse and | ||||||
17 | performs intracompany sales or transfers of the drugs to a | ||||||
18 | group of chain or mail order pharmacies that have the same | ||||||
19 | common ownership and control. Notwithstanding any other | ||||||
20 | provision of this Act, a chain pharmacy warehouse shall be | ||||||
21 | considered part of the normal distribution channel. | ||||||
22 | "Co-licensed partner or product" means an instance where | ||||||
23 | one or more parties have the right to engage in the | ||||||
24 | manufacturing or marketing of a prescription drug, consistent | ||||||
25 | with the FDA's implementation of the Prescription Drug | ||||||
26 | Marketing Act.
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1 | "Department" means the Department of Financial and
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2 | Professional Regulation.
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3 | "Drop shipment" means the sale of a prescription drug to a | ||||||
4 | wholesale distributor by the manufacturer of the prescription | ||||||
5 | drug or that manufacturer's co-licensed product partner, that | ||||||
6 | manufacturer's third party logistics provider, or that | ||||||
7 | manufacturer's exclusive distributor or by an authorized | ||||||
8 | distributor of record that purchased the product directly from | ||||||
9 | the manufacturer or one of these entities whereby the | ||||||
10 | wholesale distributor or chain pharmacy warehouse takes title | ||||||
11 | but not physical possession of such prescription drug and the | ||||||
12 | wholesale distributor invoices the pharmacy, chain pharmacy | ||||||
13 | warehouse, or other person authorized by law to dispense or | ||||||
14 | administer such drug to a patient and the pharmacy, chain | ||||||
15 | pharmacy warehouse, or other authorized person receives | ||||||
16 | delivery of the prescription drug directly from the | ||||||
17 | manufacturer, that manufacturer's third party logistics | ||||||
18 | provider, or that manufacturer's exclusive distributor or from | ||||||
19 | an authorized distributor of record that purchased the product | ||||||
20 | directly from the manufacturer or one of these entities.
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21 | "Drug sample" means a unit of a prescription drug that is | ||||||
22 | not intended to
be sold and is intended to promote the sale of | ||||||
23 | the drug.
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24 | "Facility" means a facility of a wholesale distributor | ||||||
25 | where prescription drugs are stored, handled, repackaged, or | ||||||
26 | offered for sale, or a facility of a third-party logistics |
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1 | provider where prescription drugs are stored or handled. | ||||||
2 | "FDA" means the United States Food and Drug | ||||||
3 | Administration.
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4 | "Manufacturer" means a person licensed or approved by the | ||||||
5 | FDA to engage in the manufacture of drugs or devices, | ||||||
6 | consistent with the definition of "manufacturer" set forth in | ||||||
7 | the FDA's regulations and guidances implementing the | ||||||
8 | Prescription Drug Marketing Act. "Manufacturer" does not | ||||||
9 | include anyone who is engaged in the packaging, repackaging, | ||||||
10 | or labeling of prescription drugs only to the extent required | ||||||
11 | under the Prescription Drug Repository Program Act. | ||||||
12 | "Manufacturer's exclusive distributor" means anyone who | ||||||
13 | contracts with a manufacturer to provide or coordinate | ||||||
14 | warehousing, distribution, or other services on behalf of a | ||||||
15 | manufacturer and who takes title to that manufacturer's | ||||||
16 | prescription drug, but who does not have general | ||||||
17 | responsibility to direct the sale or disposition of the | ||||||
18 | manufacturer's prescription drug. A manufacturer's exclusive | ||||||
19 | distributor must be licensed as a wholesale distributor under | ||||||
20 | this Act and, in order to be considered part of the normal | ||||||
21 | distribution channel, must also be an authorized distributor | ||||||
22 | of record.
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23 | "Normal distribution channel" means a chain of custody for | ||||||
24 | a prescription drug that goes, directly or by drop shipment, | ||||||
25 | from (i) a manufacturer of the prescription drug, (ii) that | ||||||
26 | manufacturer to that manufacturer's co-licensed partner, (iii) |
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1 | that manufacturer to that manufacturer's third party logistics | ||||||
2 | provider, or (iv) that manufacturer to that manufacturer's | ||||||
3 | exclusive distributor to: | ||||||
4 | (1) a pharmacy or to other designated persons | ||||||
5 | authorized by law to dispense or administer the drug to a | ||||||
6 | patient; | ||||||
7 | (2) a wholesale distributor to a pharmacy or other | ||||||
8 | designated persons authorized by law to dispense or | ||||||
9 | administer the drug to a patient; | ||||||
10 | (3) a wholesale distributor to a chain pharmacy | ||||||
11 | warehouse to that chain pharmacy warehouse's intracompany | ||||||
12 | pharmacy to a patient or other designated persons | ||||||
13 | authorized by law to dispense or administer the drug to a | ||||||
14 | patient; | ||||||
15 | (4) a chain pharmacy warehouse to the chain pharmacy | ||||||
16 | warehouse's intracompany pharmacy or other designated | ||||||
17 | persons authorized by law to dispense or administer the | ||||||
18 | drug to the patient; | ||||||
19 | (5) an authorized distributor of record to one other | ||||||
20 | authorized distributor of record to an office-based health | ||||||
21 | care practitioner authorized by law to dispense or | ||||||
22 | administer the drug to the patient; or | ||||||
23 | (6) an authorized distributor to a pharmacy or other | ||||||
24 | persons licensed to dispense or administer the drug. | ||||||
25 | "Pedigree" means a document or electronic file containing | ||||||
26 | information that records each wholesale distribution of any |
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1 | given prescription drug from the point of origin to the final | ||||||
2 | wholesale distribution point of any given prescription drug.
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3 | "Person" means and includes a natural person, partnership, | ||||||
4 | association,
corporation, or any other legal business entity.
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5 | "Pharmacy distributor" means any pharmacy licensed in this | ||||||
6 | State or
hospital pharmacy that is engaged in the delivery or | ||||||
7 | distribution of
prescription drugs either to any other | ||||||
8 | pharmacy licensed in this State or
to any other person or | ||||||
9 | entity including, but not limited to, a wholesale
drug | ||||||
10 | distributor engaged in the delivery or distribution of | ||||||
11 | prescription
drugs who is involved in the actual, | ||||||
12 | constructive, or attempted transfer of
a drug in this State to | ||||||
13 | other than the ultimate consumer except as
otherwise provided | ||||||
14 | for by law.
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15 | "Prescription drug" means any human drug, including any | ||||||
16 | biological product (except for blood and blood components | ||||||
17 | intended for transfusion or biological products that are also | ||||||
18 | medical devices), required by federal law or
regulation to be | ||||||
19 | dispensed only by a prescription, including finished
dosage | ||||||
20 | forms and bulk drug substances
subject to Section
503 of the | ||||||
21 | Federal Food, Drug and Cosmetic Act.
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22 | "Repackage" means repackaging or otherwise changing the | ||||||
23 | container, wrapper, or labeling to further the distribution of | ||||||
24 | a prescription drug, excluding that completed by the | ||||||
25 | pharmacist responsible for dispensing the product to a | ||||||
26 | 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. | ||||||
9 | "Wholesale distribution"
means the distribution
of | ||||||
10 | prescription drugs to persons other than a consumer or | ||||||
11 | patient, but does
not include any of the following:
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12 | (1)
Intracompany sales of prescription drugs, meaning | ||||||
13 | (i) any transaction or transfer
between any division, | ||||||
14 | subsidiary, parent, or affiliated or related company
under | ||||||
15 | the common ownership and control of a corporate entity or | ||||||
16 | (ii) any transaction or transfer between co-licensees of a | ||||||
17 | co-licensed product.
| ||||||
18 | (2) The sale, purchase, distribution, trade, or | ||||||
19 | transfer of a prescription drug or offer to sell, | ||||||
20 | purchase, distribute, trade, or transfer a prescription | ||||||
21 | drug for emergency medical reasons.
| ||||||
22 | (3) The distribution of prescription drug samples by | ||||||
23 | manufacturers' representatives. | ||||||
24 | (4) Drug returns, when conducted by a hospital, health | ||||||
25 | care entity, or charitable institution in accordance with | ||||||
26 | federal regulation. |
| |||||||
| |||||||
1 | (5) The sale of minimal quantities of prescription | ||||||
2 | drugs by licensed pharmacies to licensed practitioners for | ||||||
3 | office use or other licensed pharmacies. | ||||||
4 | (6) The sale, purchase, or trade of a drug, an offer to | ||||||
5 | sell, purchase, or trade a drug, or the dispensing of a | ||||||
6 | drug pursuant to a prescription. | ||||||
7 | (7) The sale, transfer, merger, or consolidation of | ||||||
8 | all or part of the business of a pharmacy or pharmacies | ||||||
9 | from or with another pharmacy or pharmacies, whether | ||||||
10 | accomplished as a purchase and sale of stock or business | ||||||
11 | assets. | ||||||
12 | (8) The sale, purchase, distribution, trade, or | ||||||
13 | transfer of a prescription drug from one authorized | ||||||
14 | distributor of record to one additional authorized | ||||||
15 | distributor of record when the manufacturer has stated in | ||||||
16 | writing to the receiving authorized distributor of record | ||||||
17 | that the manufacturer is unable to supply the prescription | ||||||
18 | drug and the supplying authorized distributor of record | ||||||
19 | states in writing that the prescription drug being | ||||||
20 | supplied had until that time been exclusively in the | ||||||
21 | normal distribution channel. | ||||||
22 | (9) The delivery of or the offer to deliver a | ||||||
23 | prescription drug by a common carrier solely in the common | ||||||
24 | carrier's usual course of business of transporting | ||||||
25 | prescription drugs when the common carrier does not store, | ||||||
26 | warehouse, or take legal ownership of the prescription |
| |||||||
| |||||||
1 | drug. | ||||||
2 | (10) The sale or transfer from a retail pharmacy, mail | ||||||
3 | order pharmacy, or chain pharmacy warehouse of expired, | ||||||
4 | damaged, returned, or recalled prescription drugs to the | ||||||
5 | original manufacturer, the originating wholesale | ||||||
6 | distributor, or a third party returns processor.
| ||||||
7 | (11) The donation of prescription drugs to the extent | ||||||
8 | permitted under the Prescription Drug Repository Program | ||||||
9 | Act.
| ||||||
10 | "Wholesale drug distributor" means anyone
engaged in the
| ||||||
11 | wholesale distribution of prescription drugs into, out of, or | ||||||
12 | within the State, including without limitation
manufacturers; | ||||||
13 | repackers; own label distributors; jobbers; private
label | ||||||
14 | distributors; brokers; warehouses, including manufacturers' | ||||||
15 | and
distributors' warehouses; manufacturer's exclusive | ||||||
16 | distributors; and authorized distributors of record; drug | ||||||
17 | wholesalers or distributors; independent wholesale drug | ||||||
18 | traders; specialty wholesale distributors; and retail | ||||||
19 | pharmacies that conduct wholesale distribution; and chain | ||||||
20 | pharmacy warehouses that conduct wholesale distribution. In | ||||||
21 | order to be considered part of the normal distribution | ||||||
22 | channel, a wholesale distributor must also be an authorized | ||||||
23 | distributor of record.
| ||||||
24 | (Source: P.A. 101-420, eff. 8-16-19.)
| ||||||
25 | Section 100. The Senior Pharmaceutical Assistance Act is |
| |||||||
| |||||||
1 | amended by changing Section 10 as follows:
| ||||||
2 | (320 ILCS 50/10)
| ||||||
3 | Sec. 10. Definitions. In this Act:
| ||||||
4 | "Manufacturer" includes:
| ||||||
5 | (1) An entity that is engaged in (a) the production, | ||||||
6 | preparation,
propagation, compounding, conversion, or | ||||||
7 | processing of prescription drug
products (i) directly or | ||||||
8 | indirectly by extraction from substances of natural
| ||||||
9 | origin,
(ii) independently by means of chemical synthesis, | ||||||
10 | or (iii) by combination of
extraction
and chemical | ||||||
11 | synthesis; or (b) the packaging, repackaging, labeling or
| ||||||
12 | re-labeling, or distribution of prescription drug | ||||||
13 | products.
| ||||||
14 | (2) The entity holding legal title to or possession of | ||||||
15 | the national
drug code number for the covered prescription | ||||||
16 | drug.
| ||||||
17 | The term does not include a wholesale distributor of | ||||||
18 | drugs,
drugstore chain organization, or retail pharmacy | ||||||
19 | licensed by the State. The term also does not include anyone | ||||||
20 | who is engaged in the packaging, repackaging, or labeling of | ||||||
21 | prescription drugs only to the extent required under the | ||||||
22 | Prescription Drug Repository Program Act.
| ||||||
23 | "Prescription drug" means a drug that may be dispensed | ||||||
24 | only upon
prescription by an authorized prescriber and that is | ||||||
25 | approved for safety and
effectiveness as a prescription drug |
| |||||||
| |||||||
1 | under Section 505 or 507 of the Federal
Food, Drug and Cosmetic | ||||||
2 | Act.
| ||||||
3 | "Senior citizen" or "senior" means a person 65 years of | ||||||
4 | age or
older.
| ||||||
5 | (Source: P.A. 92-594, eff. 6-27-02.)
| ||||||
6 | Section 105. The Illinois Food, Drug and Cosmetic Act is | ||||||
7 | amended by changing Section 16 as follows:
| ||||||
8 | (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
| ||||||
9 | Sec. 16. (a) The Director is hereby authorized to | ||||||
10 | promulgate
regulations exempting from any labeling or | ||||||
11 | packaging requirement of this
Act drugs and devices which are | ||||||
12 | (i) , in accordance with the practice of the
trade, to be | ||||||
13 | processed, labeled or repacked in substantial quantities at
| ||||||
14 | establishments other than those where originally processed or | ||||||
15 | packaged on
condition that such drugs and devices are not | ||||||
16 | adulterated or misbranded
under the provisions of this Act | ||||||
17 | upon removal from such processing,
labeling or repacking | ||||||
18 | establishment or (ii) packaged, repackaged, or labeled to the | ||||||
19 | extent required under the Prescription Drug Repository Program | ||||||
20 | Act .
| ||||||
21 | (b) Drugs and device labeling or packaging exemptions | ||||||
22 | adopted under the
Federal Act and supplements thereto or | ||||||
23 | revisions thereof shall apply to
drugs and devices in Illinois | ||||||
24 | except insofar as modified or rejected by
regulations |
| |||||||
| |||||||
1 | promulgated by the Director.
| ||||||
2 | (c) A drug intended for use by man which (A) is a | ||||||
3 | habit-forming drug to
which Section 15 (d) applies; or (B) | ||||||
4 | because of its toxicity or other
potentiality for harmful | ||||||
5 | effect or the method of its use or the collateral
measures | ||||||
6 | necessary to its use is not safe for use except under the
| ||||||
7 | supervision of a practitioner licensed by law to administer | ||||||
8 | such drug; or
(C) is limited by an approved application under | ||||||
9 | Section 505 of the Federal
Act or Section 17 of this Act to use | ||||||
10 | under the professional supervision of
a practitioner licensed | ||||||
11 | by law to administer such drug, shall be dispensed
only in | ||||||
12 | accordance with the provisions of the "Illinois Controlled
| ||||||
13 | Substances Act". The act of dispensing a drug contrary to the | ||||||
14 | provisions of
this paragraph shall be deemed to be an act which | ||||||
15 | results in a drug being
misbranded while held for sale.
| ||||||
16 | (d) Any drug dispensed by filling or refilling a written
| ||||||
17 | or oral prescription of a practitioner licensed by law to | ||||||
18 | administer such
drug shall be exempt from the requirements of | ||||||
19 | Section 15, except
subsections (a), (k) and (l) and clauses | ||||||
20 | (2) and (3) of subsection (i), and
the packaging requirements | ||||||
21 | of
subsections (g), (h) and (q), if the drug bears a label | ||||||
22 | containing the
proprietary name or names, or if there is none, | ||||||
23 | the established name or
names of the drugs, the dosage and | ||||||
24 | quantity, unless the prescribing
practitioner, in the interest | ||||||
25 | of the health of the patient, directs
otherwise in writing, | ||||||
26 | the name and address of the dispenser, the serial
number and |
| |||||||
| |||||||
1 | date of the prescription or of its filling, the name of the
| ||||||
2 | prescriber and, if stated in the prescription, the name of the | ||||||
3 | patient, and
the directions for use and the cautionary | ||||||
4 | statements, if any, contained in
such prescription. This | ||||||
5 | exemption shall not apply to any drug dispensed in
the course | ||||||
6 | of the conduct of business of dispensing drugs pursuant to
| ||||||
7 | diagnosis by mail, or to a drug dispensed in violation of | ||||||
8 | subsection (a) of
this Section.
| ||||||
9 | (e) The Director may by regulation remove drugs subject to
| ||||||
10 | Section 15 (d) and Section 17 from the requirements of | ||||||
11 | subsection (c) of
this Section when such requirements are not | ||||||
12 | necessary for the protection of
the public health.
| ||||||
13 | (f) A drug which is subject to subsection (c) of this | ||||||
14 | Section
shall be deemed to be misbranded if at any time before | ||||||
15 | dispensing its label
fails to bear the statement "Caution: | ||||||
16 | Federal Law Prohibits Dispensing Without
Prescription" or | ||||||
17 | "Caution: State Law Prohibits Dispensing Without
| ||||||
18 | Prescription". A drug to which subsection (c) of this Section | ||||||
19 | does not apply
shall be deemed to be misbranded if at any time | ||||||
20 | prior to dispensing its
label bears the caution statement | ||||||
21 | quoted in the preceding sentence.
| ||||||
22 | (g) Nothing in this Section shall be construed to relieve
| ||||||
23 | any person from any requirement prescribed by or under | ||||||
24 | authority of law
with respect to controlled substances now | ||||||
25 | included or which may hereafter
be included within the | ||||||
26 | classifications of controlled substances cannabis as
defined |
| |||||||
| |||||||
1 | in applicable Federal laws relating to controlled substances | ||||||
2 | or
cannabis or the Cannabis Control Act.
| ||||||
3 | (Source: P.A. 84-1308.)
| ||||||
4 | Section 110. The Cannabis and Controlled Substances Tort | ||||||
5 | Claims Act is amended by changing Section 3 as follows:
| ||||||
6 | (740 ILCS 20/3) (from Ch. 70, par. 903)
| ||||||
7 | Sec. 3. Definitions. As used in this Act, unless the | ||||||
8 | context otherwise
requires:
| ||||||
9 | "Cannabis" includes marihuana, hashish, and other | ||||||
10 | substances that
are identified as including any parts of the | ||||||
11 | plant Cannabis Sativa, whether
growing or not, the seeds of | ||||||
12 | that plant, the resin extracted from any part of
that plant, | ||||||
13 | and any compound, manufacture, salt, derivative, mixture, or
| ||||||
14 | preparation of that plant, its seeds, or resin, including
| ||||||
15 | tetrahydrocannabinol (THC) and all other cannabinol | ||||||
16 | derivatives, including
its naturally occurring or | ||||||
17 | synthetically produced ingredients, whether
produced directly | ||||||
18 | or indirectly by extraction, independently by means of
| ||||||
19 | chemical synthesis, or by a combination of extraction and | ||||||
20 | chemical
synthesis. "Cannabis" does not include the mature | ||||||
21 | stalks of that plant, fiber
produced from those stalks, oil or | ||||||
22 | cake made from the seeds of that plant,
any other compound, | ||||||
23 | manufacture, salt, derivative, mixture, or preparation
of | ||||||
24 | mature stalks (except the extracted resin), fiber, oil
or |
| |||||||
| |||||||
1 | cake, or the sterilized seeds of that plant that are incapable | ||||||
2 | of
germination.
| ||||||
3 | "Controlled substance" means a drug, substance, or | ||||||
4 | immediate precursor in
the Schedules of Article II of the | ||||||
5 | Illinois Controlled Substances Act.
| ||||||
6 | "Counterfeit substance" means a controlled substance or | ||||||
7 | the container or
labeling of a controlled substance that, | ||||||
8 | without authorization, bears the
trademark, trade name, or | ||||||
9 | other identifying mark, imprint, number, device,
or any | ||||||
10 | likeness thereof of a manufacturer, distributor, or dispenser | ||||||
11 | other
than the person who in fact manufactured, distributed, | ||||||
12 | or dispensed the
substance.
| ||||||
13 | "Deliver" or "delivery" means the actual, constructive, or | ||||||
14 | attempted
transfer of possession of a controlled substance or | ||||||
15 | cannabis, with or
without consideration, whether or not there | ||||||
16 | is an agency relationship. "Deliver" or "delivery" does not | ||||||
17 | include the donation of prescription drugs to the extent | ||||||
18 | permitted under the Prescription Drug Repository Program Act.
| ||||||
19 | "Manufacture" means the production, preparation, | ||||||
20 | propagation,
compounding, conversion, or processing of a | ||||||
21 | controlled substance, either
directly or indirectly, by | ||||||
22 | extraction from substances of natural origin,
independently by | ||||||
23 | means of chemical synthesis, or by a combination of
extraction | ||||||
24 | and chemical synthesis, and includes any packaging or
| ||||||
25 | repackaging of the substance or labeling of its container, | ||||||
26 | except that the
term does not include:
|
| |||||||
| |||||||
1 | (1) by an ultimate user, the preparation or | ||||||
2 | compounding of a
controlled substance for his own use;
| ||||||
3 | (2) by a practitioner or his authorized agent under | ||||||
4 | his supervision,
the preparation, compounding, packaging, | ||||||
5 | or labeling of a controlled substance:
| ||||||
6 | (A) as an incident to his administering or | ||||||
7 | dispensing of a controlled
substance in the course of | ||||||
8 | his professional practice; or
| ||||||
9 | (B) as an incident to lawful research, teaching or | ||||||
10 | chemical analysis
and not for sale; or
| ||||||
11 | (3) the preparation, compounding, packaging, or | ||||||
12 | labeling of cannabis
as an incident to lawful research, | ||||||
13 | teaching, or chemical analysis and not
for sale ; or .
| ||||||
14 | (4) the packaging, repackaging, or labeling of | ||||||
15 | prescription drugs only to the extent required under the | ||||||
16 | Prescription Drug Repository Program Act.
| ||||||
17 | "Owner" means a person who has possession of or any | ||||||
18 | interest
whatsoever in the property involved.
| ||||||
19 | "Person" means an individual, a corporation, a government,
| ||||||
20 | a governmental subdivision or agency, a business trust, an | ||||||
21 | estate, a trust,
a partnership or association, or any other | ||||||
22 | entity.
| ||||||
23 | "Production" means planting, cultivating, tending, or | ||||||
24 | harvesting.
| ||||||
25 | "Property" means real property, including things growing | ||||||
26 | on,
affixed to, and found in land, and tangible or intangible |
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
1 | personal
property, including rights, services, privileges, | |||||||||||||||||||||||||
2 | interests, claims,
and securities.
| |||||||||||||||||||||||||
3 | (Source: P.A. 96-328, eff. 8-11-09.)
| |||||||||||||||||||||||||
|