410 ILCS 720/ Drug Take-Back Act

(410 ILCS 720/1)

Sec. 1. Short title. This Act may be cited as the Drug Take-Back Act.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/5)

Sec. 5. Findings. The General Assembly finds that:

(1) A safe system for the collection and disposal of unused, unwanted, and expired medicines is a key element of a comprehensive strategy to prevent prescription drug abuse and pharmaceutical pollution. Home medicine cabinets are full of unused and expired prescription drugs, only a fraction of which get disposed of properly.

(2) Storing unused, unwanted, or expired medicines can lead to accidental poisoning, drug abuse, and even drug trafficking, but disposing of medicines by flushing them down the toilet or placing them in the garbage can contaminate groundwater and other bodies of water, contributing to long-term harm to the environment and animal life.

(3) Manufacturers of these drugs hold the ultimate responsibility for the lasting impacts of the drugs they produce.

(4) The General Assembly therefore finds that it is in the interest of public health and environmental protection to establish a single, uniform, statewide system of regulation for safe and secure collection and disposal of medicines through a uniform drug "take-back" program operated and funded by drug manufacturers.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/10)

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.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/15)

Sec. 15. Participation in a drug take-back program. Each covered manufacturer must, beginning January 1, 2024 or 6 months after becoming a covered manufacturer, whichever is later, individually or collectively implement an approved drug take-back program that complies with the requirements of this Act. A covered manufacturer must establish, fund, and implement a drug take-back program independently or as part of a group of covered manufacturers.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/20)

Sec. 20. Identification of covered manufacturers.

(a) No later than April 1, 2023, each pharmacy, private label distributor, and repackager that sells or offers for sale in Illinois, under its own label, a covered drug must provide written notification to the Agency identifying the covered manufacturer from which the covered drug is obtained.

(b) All covered manufacturers of covered drugs sold or offered for sale in Illinois must register with the Agency and pay to the Agency the annual registration fee as set forth under Section 60.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/25)

Sec. 25. Drug take-back program requirements.

(a) At least 120 days prior to submitting a proposal under Section 35, a manufacturer program operator must notify potential authorized collectors of the opportunity to serve as an authorized collector for the proposed drug take-back program. No later than 30 days after a potential authorized collector expresses interest in participating in a proposed program, the manufacturer program operator must commence good faith negotiations with the potential authorized collector regarding the collector's participation in the program.

(b) A person may serve as an authorized collector for a drug take-back program voluntarily or in exchange for compensation. Nothing in this Act requires any person to serve as an authorized collector for a drug take-back program.

(c) A pharmacy shall not be required to participate in a drug take-back program.

(d) A drug take-back program must include as a collector any person who (i) is a potential authorized collector and (ii) offers to participate in the program. The manufacturer program operator must include the person in the program as an authorized collector no later than 90 days after receiving a written offer to participate.

(e) A drug take-back program must pay for all administrative and operational costs of the drug take-back program, as outlined in subsection (a) of Section 55.

(f) An authorized collector operating a drug take-back program collection site must accept all covered drugs from consumers during the hours that the location used as a collection site is normally open for business to the public.

(g) A drug take-back program collection site must collect covered drugs and store them in compliance with State and federal law, including United States Drug Enforcement Administration regulations. The manufacturer program operator must provide for transportation and disposal of collected covered drugs in a manner that ensures each collection site is serviced as often as necessary to avoid reaching capacity and that collected covered drugs are transported to final disposal in a manner compliant with State and federal law, including a process for additional prompt collection service upon notification from the collection site. Covered drugs shall be disposed of at:

(1) a permitted hazardous waste facility that meets the requirements under 40 CFR 264 and 40 CFR 265;

(2) a permitted municipal waste incinerator that meets the requirements under 40 CFR 50 and 40 CFR 62; or

(3) a permitted hospital, medical, and infectious waste incinerator that meets the requirements under subpart HHH of 40 CFR part 62, an applicable State plan for existing hospital, medical, and infectious waste incinerators, or subpart Ec of 40 CFR part 60 for new hospital, medical, and infectious waste incinerators.

(h) Authorized collectors must comply with all State and federal laws and regulations governing the collection, storage, and disposal of covered drugs, including United States Drug Enforcement Administration regulations.

(i) A drug take-back program must provide for the collection, transportation, and disposal of covered drugs on an ongoing, year-round basis and must provide access for residents across the State as set forth in subsection (j).

(j) A drug take-back program shall provide, in every county with a potential authorized collector, one authorized collection site and a minimum of at least one additional collection site for every 50,000 county residents, provided that there are enough potential authorized collectors offering to participate in the drug take-back program.

All potential authorized collection sites that offer to participate in a drug take-back program shall be counted toward meeting the minimum number of authorized collection sites within a drug take-back program. Collection sites funded in part or in whole under a contract between a covered manufacturer and a pharmacy entered into on or before June 10, 2022 (the effective date of this Act) shall be counted toward the minimum requirements within this Section for so long as the contract continues.

(k) A drug take-back program may include mail-back distribution locations or periodic collection events for each county in the State. The manufacturer program operator shall consult with each county authority identified in the written notice prior to preparing the program plan to determine the role that mail-back distribution locations or periodic collection events will have in the drug take-back program.

The requirement to hold periodic collection events shall be deemed to be satisfied if a manufacturer program operator makes reasonable efforts to arrange periodic collection events but they cannot be scheduled due to lack of law enforcement availability.

A drug take-back program must permit a consumer who is a homeless, homebound, or disabled individual to request prepaid, preaddressed mailing envelopes. A manufacturer program operator shall accept the request through a website and toll-free telephone number that it must maintain to comply with the requests.

(Source: P.A. 102-1055, eff. 6-10-22; 103-154, eff. 6-30-23.)

(410 ILCS 720/30)

Sec. 30. Manufacturer program operator requirements. A manufacturer program operator shall:

(1) Adopt policies and procedures to be followed by persons handling covered drugs collected under the program to ensure compliance with State and federal laws, rules, and regulations, including regulations adopted by the United States Drug Enforcement Administration.

(2) Ensure the security of patient information on drug packaging during collection, transportation, recycling, and disposal.

(3) Promote the program by providing consumers, pharmacies, and other entities with educational and informational materials as required under Section 45.

(4) Consider:

(A) the use of existing providers of pharmaceutical waste transportation and disposal services;

(B) separation of covered drugs from packaging to reduce transportation and disposal costs; and

(C) recycling of drug packaging.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/35)

Sec. 35. Drug take-back program approval.

(a) By July 1, 2023, each covered manufacturer must individually or collectively submit to the Agency for review and approval a proposal for the establishment and implementation of a drug take-back program. The proposal must demonstrate that the drug take-back program will fulfill the requirements under Section 25. If the Agency receives more than one proposal for a drug take-back program, the Agency shall review all proposals in conjunction with one another to ensure the proposals are coordinated to achieve the authorized collection site coverage set forth in subsection (j) of Section 25.

(b) The Agency shall approve a proposed program if each covered manufacturer and manufacturer program operator participating in the program has registered and paid the fee under Section 60, the program proposal demonstrates the program fulfills the requirements under Section 25, and the proposal includes the following information on forms prescribed by the Agency:

(1) The identity and contact information for the manufacturer program operator and each participating covered manufacturer.

(2) The identity and contact information for the authorized collectors participating in the drug take-back program.

(3) The identity of transporters and waste disposal facilities that the program will use to transport and dispose of collected covered drugs.

(4) The identity of all potential authorized collectors that were notified of the opportunity to serve as an authorized collector, including how they were notified.

(c) Within 90 days after receiving a drug take-back program proposal, the Agency shall either approve, reject, or approve with modification the proposal in writing to the manufacturer program operator. During this 90-day period, the Agency shall provide a 30-day public comment period on the drug take-back program proposal. If the Agency rejects the proposal, it shall provide the reason for rejection in the written notification to the manufacturer program operator.

(d) No later than 90 days after receipt of a notice of rejection under subsection (c) of this Section, the manufacturer or manufacturers participating in the program shall submit a revised proposal to the Agency. Within 90 days of receipt of a revised proposal the Agency shall either approve or reject the revised proposal in writing to the manufacturer program operator. During this 90-day period, the Agency shall provide a 30-day public comment period on the revised proposal.

(e) After approval, covered manufacturers must, individually or collectively, initiate operation of a drug take-back program meeting the requirements under Section 25 no later than December 1, 2023.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/40)

Sec. 40. Changes or modifications to the approved manufacturer drug take-back program. A manufacturer program operator shall maintain records for 5 years of any changes to an approved drug take-back program. These include, but are not limited to, changes in:

(1) participating covered manufacturers;

(2) collection methods;

(3) collection site locations; or

(4) contact information for the program operator or authorized collectors.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/45)

Sec. 45. Drug take-back program promotion. Each drug take-back program must include a system of promotion, education, and public outreach about the proper collection and management of covered drugs. If there is more than one drug take-back program operated by more than one manufacturer program operator, the requirements of this Section shall be implemented by all drug take-back programs collectively using a single toll-free number and website and similar education, outreach, and promotional materials. This may include, but is not limited to, signage, written materials to be provided at the time of purchase or delivery of covered drugs, and advertising or other promotional materials. At a minimum, promotion, education, and public outreach must include the following:

(1) Promoting the proper management of drugs by residents and the collection of covered drugs through a drug take-back program.

(2) Discouraging residents from disposing of drugs in household waste, sewers, or septic systems.

(3) Promoting the use of the drug take-back program so that where and how to return covered drugs is readily understandable to residents.

(4) Maintaining a toll-free telephone number and website publicizing collection options and collection sites, and discouraging improper disposal practices for covered drugs, such as disposal in household waste, sewers, or septic systems.

(5) Preparing and distributing to program collection sites, for dissemination to consumers, the educational and outreach materials. The materials must use plain language and explanatory images to make collection services and discouraged disposal practices readily understandable by residents, including residents with limited English proficiency.

(6) Promotional materials prepared and distributed in conjunction with an approved drug take-back program under this Section may not be used to promote in-home disposal products of any kind, including, but not limited to, in-home disposal products of authorized collectors participating in a drug take-back program.

The program promotion requirements under this Section do not apply to any drug take-back program established prior to the effective date of this Act that provides promotional or educational materials to the public about the proper collection and management of covered drugs.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/50)

Sec. 50. Annual program report.

(a) By April 1, 2025, and each April 1 thereafter, a manufacturer program operator must submit to the Agency a report describing implementation of the drug take-back program during the previous calendar year. The report must include:

(1) a list of the covered manufacturers participating in the drug take-back program during the program year;

(2) the total amount, by weight, of covered drugs collected and the amount, by weight, from each collection method used during the program year, reported by county;

(3) the total amount, by weight, of covered drugs collected from each collection site during the prior year;

(4) the following details regarding the program's collection system:

(A) a list of collection sites, with addresses;

(B) collection sites where mailers to program collection sites, for dissemination to consumers, and education and outreach materials were made available to the public;

(C) dates and locations of collection events held; and

(D) the transporters and disposal facility or facilities used to dispose of the covered drugs collected;

(5) a description of the promotion, education, and public outreach activities implemented;

(6) a description of how collected packaging was recycled to the extent feasible; and

(7) an evaluation of the program's effectiveness in collecting covered drugs during the program year and of any program changes that have been implemented.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/55)

Sec. 55. Manufacturer drug take-back program funding.

(a) A covered manufacturer or group of covered manufacturers must pay all administrative and operational costs associated with establishing and implementing the drug take-back program in which it participates. Such administrative and operational costs include, but are not limited to:

(1) collection and transportation supplies for each collection site;

(2) purchase of collection receptacles for each collection site;

(3) ongoing maintenance or replacement of collection receptacles when requested by authorized collectors;

(4) costs related to prepaid, preaddressed mail;

(5) compensation of authorized collectors, if applicable;

(6) operation of periodic collection events, including, but not limited to, the cost of law enforcement staff time;

(7) transportation of all collected covered drugs to final disposal;

(8) proper disposal of all collected covered drugs in compliance with State and federal laws, rules, and regulations; and

(9) program promotion and outreach.

(b) A manufacturer program operator shall allocate to covered manufacturers participating in the drug take-back program the administration and operational costs of the programs. The method of cost allocation shall be included in the drug take-back program proposal required under Section 35.

(c) A manufacturer program operator, covered manufacturer, authorized collector, or other person may not charge:

(1) a specific point-of-sale fee to consumers to recoup the costs of a drug take-back program;

(2) a specific point-of-collection fee at the time covered drugs are collected from a person; or

(3) an increase in the cost of covered drugs to recoup the costs of a drug take-back program.

(d) A manufacturer program operator or covered manufacturer shall not charge any fee to an authorized collector or authorized collection site.

(e) The funding requirements in this Section shall not apply to a pharmacy location that is part of an existing contractual agreement entered into prior to the effective date of this Act between a pharmacy and a covered manufacturer to fund in part or whole the collection, transportation, or disposal of a covered drug so long as that contractual arrangement continues.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/60)

Sec. 60. Registration fee.

(a) By January 1, 2023, and by January 1 of each year thereafter, each covered manufacturer and manufacturer program operator shall register with the Agency and submit to the Agency a $2,500 registration fee.

(b) All fees collected under this Section must be deposited in the Solid Waste Management Fund to be used solely for the administration of this Act.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/65)

Sec. 65. Rules; enforcement; penalties.

(a) The Agency may adopt any rules it deems necessary to implement and administer this Act.

(b) Except as otherwise provided in this Act, any person who violates any provision of this Act is liable for a civil penalty of $7,000 per violation per day, provided that the penalty for failure to register or pay a fee under this Act shall be double the applicable registration fee.

(c) The penalties provided for in this Section may be recovered in a civil action brought in the name of the People of the State of Illinois by the State's Attorney of the county in which the violation occurred or by the Attorney General. Any penalties collected under this Section in an action in which the Attorney General has prevailed shall be deposited in the Environmental Protection Trust Fund.

(d) The Attorney General or the State's Attorney of a county in which a violation occurs may institute a civil action for an injunction, prohibitory or mandatory, to restrain violations of this Act or to require such actions as may be necessary to address violations of this Act.

(e) The penalties and injunctions provided in this Act are in addition to any penalties, injunctions, or other relief provided under any other law. Nothing in this Act bars a cause of action by the State for any other penalty, injunction, or other relief provided by any other law.

(f) Any person who knowingly makes a false, fictitious, or fraudulent material statement, orally or in writing, to the Agency, related to or required by this Act or any rule adopted under this Act commits a Class 4 felony, and each such statement or writing shall be considered a separate Class 4 felony. A person who, after being convicted under this subsection (f), violates this subsection (f) a second or subsequent time, commits a Class 3 felony.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/70)

Sec. 70. Antitrust immunity. The activities authorized by this Act require collaboration among covered manufacturers and among authorized collectors. These activities will enable safe and secure collection and disposal of covered drugs in Illinois and are therefore in the best interest of the public. The benefits of collaboration, together with active State supervision, outweigh potential adverse impacts. Therefore, the General Assembly intends to exempt from State antitrust laws, and provide immunity through the state action doctrine from federal antitrust laws, activities that are undertaken pursuant to this Act that might otherwise be constrained by such laws. The General Assembly does not intend and does not authorize any person or entity to engage in activities not provided for by this Act, and the General Assembly neither exempts nor provides immunity for such activities.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/75)

Sec. 75. Public disclosure. Proprietary information submitted to the Agency under this Act is exempted from disclosure as provided under paragraphs (g) and (mm) of subsection (1) of Section 7 of the Freedom of Information Act.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/90)

Sec. 90. Home rule.

(a) It is the intent of the General Assembly that, in order to ensure a uniform, statewide solution, on and after the effective date of this Act no unit of local government shall mandate that a new drug take-back or disposal program be created and no expansion or change of an existing program or program requirement by a unit of local government shall occur that is inconsistent with this Act.

(b) A home rule municipality may not regulate drug take-back programs in a manner inconsistent with the regulation by the State of drug take-back programs under this Act. This Section is a limitation under subsection (i) of Section 6 of Article VII of the Illinois Constitution on the concurrent exercise by home rule units of powers and functions exercised by the State.

(Source: P.A. 102-1055, eff. 6-10-22.)

(410 ILCS 720/95)

Sec. 95. (Amendatory provisions; text omitted).

(Source: P.A. 102-1055, eff. 6-10-22; text omitted.)

(410 ILCS 720/100)

Sec. 100. (Amendatory provisions; text omitted).

(Source: P.A. 102-1055, eff. 6-10-22; text omitted.)

(410 ILCS 720/999)

Sec. 999. Effective date. This Act takes effect upon becoming law.

(Source: P.A. 102-1055, eff. 6-10-22.)