An Act To Support Collection and Proper Disposal of Unwanted Drugs
Sec. 1. 22 MRSA §2700, sub-§8 is enacted to read:
Sec. 2. 38 MRSA §1611 is enacted to read:
§ 1611. Drug take-back stewardship program
(1) A person, company, corporation or other entity that is registered with the United States Department of Justice, Drug Enforcement Administration to collect controlled substances for the purposes of safe disposal and destruction;
(2) A law enforcement agency; or
(3) A person, company, corporation or other entity authorized by the department to provide alternative collection methods for covered drugs that are not controlled substances.
(1) "Covered drug" does not include:
(a) Vitamins or supplements;
(b) Herbal-based remedies and homeopathic drugs, products or remedies;
(c) Cosmetics, soap with or without germicidal agents, laundry detergent, bleach, household cleaning products, shampoo, sunscreen, toothpaste, lip balm, antiperspirant or other personal care products that are regulated as both cosmetics and nonprescription drugs under the federal Food, Drug, and Cosmetic Act;
(d) Pet pesticide products contained in pet collars, powders, shampoos, topical applications or other forms;
(e) Drugs that are biological products as defined in 21 Code of Federal Regulations, Section 600.3(h) if the manufacturer provides a program to take back that drug;
(f) Drugs for which a manufacturer provides a program to take back those drugs as part of a United States Department of Health and Human Services, Food and Drug Administration managed risk evaluation and mitigation strategy;
(g) Emptied syringes or emptied medical devices or the component parts or accessories of those products or devices; and
(h) Drugs that are used solely in a clinical setting.
(1) Has legal ownership of the brand of a covered drug sold in or into the State;
(2) Imports a covered drug branded by a person that meets the requirements of subparagraph (1) and has no physical presence in the United States; or
(3) Sells a covered drug in the State at wholesale or retail, does not have legal ownership of the brand of the covered drug and elects to fulfill the responsibilities of the manufacturer for that covered drug.
When more than one manufacturer participates in a drug take-back stewardship program, the costs of administration and enforcement must be fairly and reasonably allocated so that the portion of costs allocated to each manufacturer is reasonably related to the market share of covered drugs that manufacturer sells in the State.
Disposal of a covered drug under a drug take-back stewardship program must be free to consumers. A manufacturer may not charge a point-of-sale fee to consumers, or a fee that could be passed on to consumers, to recoup the cost of implementing the stewardship program.
(1) On-site, publicly accessible and secure collection receptacles meeting federal standards;
(2) Mail-back collection by prepaid envelopes as authorized by federal law and regulation; and
(3) Other methods of collection approved by the United States Department of Justice, Drug Enforcement Administration.
(1) Sixty days after the request for reimbursement under paragraph C, if the plaintiff manufacturer or drug take-back stewardship organization did not request an independent audit under subparagraph (2); or
(2) Thirty days after completion of an audit, if the plaintiff manufacturer or drug take-back stewardship organization requested an independent audit and the audit confirmed the validity of the reimbursement request.
A civil action under this subsection may be brought against an individual manufacturer only if that manufacturer is individually implementing its own drug take-back stewardship program. A manufacturer participating in a stewardship program covering multiple manufacturers may not be sued individually for reimbursement. An action against a manufacturer participating in a stewardship program covering multiple manufacturers must be brought against the drug take-back stewardship organization implementing the stewardship program.
As used in this subsection, "damages" means the actual, direct costs a plaintiff manufacturer incurs in collecting, handling and disposing of covered drugs reasonably identified as having originated from a noncompliant manufacturer; punitive or exemplary damages not exceeding 3 times the costs incurred under this section; and the prevailing plaintiff manufacturer's attorney's fees and costs of bringing the action.
Sec. 3. Submittal of drug take-back stewardship plan. Within 180 days after the effective date of this Act, a manufacturer of a covered drug under the Maine Revised Statutes, Title 38, section 1611, individually or jointly with one or more manufacturers, or a drug take-back organization contracted by one or more manufacturers shall submit to the Department of Environmental Protection a proposed drug take-back stewardship plan that meets, at a minimum, the requirements of Title 38, section 1611, subsection 3.
This bill provides for the establishment of drug take-back stewardship programs. It requires certain drug manufacturers, as defined in the bill, to operate a drug take-back stewardship program to collect and dispose of certain drugs.