An Act to Clarify the Laws Regarding Pharmaceutical Product Stewardship
Maine Legislature, Session 131, LD 2021
Committee: Environment and Natural Resources
Sponsors: CARNEY
Amends: 38 MRSA §1612

Legislative Document
No. 2021
S.P. 849
In Senate, December 13, 2023
An Act to Clarify the Laws Regarding Pharmaceutical Product 
Stewardship
Submitted by the Department of Environmental Protection pursuant to Joint Rule 203.
Received by the Secretary of the Senate on December 11, 2023.  Referred to the Committee 
on Environment and Natural Resources pursuant to Joint Rule 308.2 and ordered printed.
DAREK M. GRANT
Secretary of the Senate
Presented by Senator CARNEY of Cumberland.
Be it enacted by the People of the State of Maine as follows:
Sec. 1.  38 MRSA §1612, sub-§1, ¶B, as enacted by PL 2021, c. 94, §2, is repealed.
Sec. 2.  38 MRSA §1612, sub-§1, ¶D, as enacted by PL 2021, c. 94, §2, is amended 
to read:
D.  "Covered drug" means any substance recognized as a drug under 21 United States 
Code, Section 321(g)(1), as amended, and any regulations adopted pursuant to that 
provision, that is sold, offered for sale or dispensed in the State, whether directly or 
through a wholesaler, in any form, including, but not limited to, prescription and 
nonprescription drugs, drugs in medical devices and combination products, brand name 
and generic drugs and drugs for veterinary use.
"Covered drug" does not include:
(1)  Vitamins or supplements;
(2)  Herbal-based remedies and homeopathic drugs, products or remedies;
(3)  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;
(4)  Pet pesticide products contained in pet collars, powders, shampoos, topical 
applications or other forms and prescription pet food;
(5)  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;
(6)  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;
(7)  Emptied syringes or emptied medical devices or the component parts or 
accessories of those products or devices;
(8)  Drugs that are used solely in a clinical setting; and
(9)  Dialysate drugs required to perform home kidney dialysis.
Sec. 3.  38 MRSA §1612, sub-§1, ¶K, as enacted by PL 2021, c. 94, §2, is amended 
to read:
K.  "Manufacturer" means:
(1)  A person that has legal ownership of the brand of a covered drug sold in or 
into the State; or
(1-A)  Except as provided in subparagraph (2), a manufacturer of a covered drug 
that is sold or offered for sale in or into the State; or
(2)  If the person to which subparagraph (1) applies manufacturer of a covered drug 
that is sold or offered for sale in or into the State has no physical presence in the 
United States and is not a participant in a stewardship program, a person that 
imports a covered drug that is branded by the person to which subparagraph (1) 
applies sold or offered for sale in or into the State.
"Manufacturer" does not include a wholesaler that sells or offers for sale in the State at 
wholesale a covered drug if the covered drug is manufactured by a manufacturer that 
is a participant in a stewardship program.
"Manufacturer" does not include a retailer that sells or offers for sale in the State at 
retail a covered drug under the retailer's brand or store label if the covered drug is 
manufactured by a manufacturer that is a participant in a stewardship program.
Sec. 4.  38 MRSA §1612, sub-§3, ¶B, as enacted by PL 2021, c. 94, §2, is amended 
to read:
B.  Contact information for the person submitting the plan to whom the department 
shall direct all related inquiries, a list of participating manufacturers and their brands 
covered drugs, contact information for each participating manufacturer and a list of the 
covered drugs manufactured by any participating manufacturer that are branded or 
labeled for sale in the State by a retailer under the retailer's own brand or store label;
SUMMARY
This bill clarifies that the entity that manufactures a drug is the regulated entity under 
the drug take-back stewardship program and that retailers are not regulated as 
manufacturers of generic drugs.