Sec. 10. Definitions.
752 words·~3 min read·
/il/chapter-410/act-720/10A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Sec. 10. Definitions. In this Act:
"Agency" means the Environmental Protection Agency.
"Authorized collector" means any of the following who collect covered drugs through participation in a drug take-back program:
(1)a person who is registered with the United States Drug Enforcement Administration to
collect controlled substances for the purpose of destruction;
(2)a law enforcement agency;
(3)a unit of local government working in conjunction with a law enforcement agency; or
(4)a household waste drop-off point or one-day household waste collection event, as
those terms are defined in Section 22.55 of the Environmental Protection Act.
"Collection site" means the location where an authorized collector collects covered drugs as part of a drug take-back program under this Act.
"Consumer" means a person who possesses a covered drug for personal use or for the use of a member of the person's household.
"Covered drug" means a drug, legend drug, nonlegend drug, brand name drug, or generic drug. "Covered drug" does not include:
(1)a dietary supplement as defined by 21 U.S.C. 321 (ff);
(2)drugs that are defined as Schedule I controlled substances under the Illinois
Controlled Substances Act or the federal Controlled Substances Act;
(3)personal care products, including, but not limited to, cosmetics, shampoos,
sunscreens, lip balms, toothpastes, and antiperspirants, that are regulated as both cosmetics and nonprescription drugs under the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301;
(4)drugs for which manufacturers provide a pharmaceutical product stewardship or drug
take-back program as part of a federal managed risk evaluation and mitigation strategy under 21 U.S.C. 355-1;
(5)biological products, as defined by 42 U.S.C. 262(i)(l);
(6)drugs that are administered in a clinical setting;
(7)emptied injector products or emptied medical devices and their component parts or
accessories;
(8)needles or sharps;
(9)pet pesticide products contained in pet collars, powders, shampoos, topical
applications, or other forms;
(10)dialysate drugs or other saline solutions required to perform kidney dialysis;
(11)drugs sold at retail as a unit dose package; or
(12)homeopathic drugs.
"Covered manufacturer" means a manufacturer of a covered drug that is sold or offered for sale in Illinois.
"Drug" has the same meaning as defined in Section 2.4 of the Illinois Food, Drug and Cosmetic Act.
"Drug take-back program" means a program implemented under this Act by a manufacturer program operator for the collection, transportation, and disposal of covered drugs.
"Generic drug" means a drug determined to be therapeutically equivalent to a brand name drug by the United States Food and Drug Administration and that is available for substitution in Illinois in accordance with the Illinois Food, Drug and Cosmetic Act and the Pharmacy Practice Act.
"Legend drug" has the same meaning as defined in Section 3.23 of the Illinois Food, Drug and Cosmetic Act.
"Manufacturer program operator" means a covered manufacturer, a group of covered manufacturers, or an entity acting on behalf of a covered manufacturer or group of covered manufacturers, that implements a drug take-back program.
"Medical practitioner" has the same meaning as defined in Section 3.23 of the Illinois Food, Drug and Cosmetic Act.
"Nonlegend drug" means a drug that does not require dispensing by prescription and which is not restricted to use by practitioners only.
"Person" means any individual, partnership, co-partnership, firm, company, limited liability company, corporation, association, joint stock company, trust, estate, political subdivision, State agency, or any other legal entity, or their legal representative, agent, or assign.
"Pharmacy" has the meaning provided in Section 3 of the Pharmacy Practice Act. A "pharmacy" is not a covered manufacturer.
"Potential authorized collector" means a person who is eligible to be an authorized collector by participating in a drug take-back program.
"Prescription drug" has the same meaning as defined in Section 2.37 of the Illinois Food, Drug and Cosmetic Act.
"Private label distributor" has the same meaning as defined in 21 CFR 207.1. A private label distributor is not a covered manufacturer.
"Program year" means a calendar year, except that the first program year is from January 1, 2024 through December 31, 2024.
"Proprietary information" means information that is:
(1)submitted under this Act;
(2)a trade secret or commercial or financial information that is privileged or
confidential and is identified as such by the person providing the information; and
(3)not required to be disclosed under any other law, rule, or regulation affecting a
covered drug, covered manufacturer, or pharmacy.
"Repackager" means a repacker as that term is defined in 21 CFR 207.1. A repackager is not a covered manufacturer.