APPROVED CHAPTER
FEBRUARY 20, 2024 504
BY GOVERNOR PUBLIC LAW
STATE OF MAINE
_____
IN THE YEAR OF OUR LORD
TWO THOUSAND TWENTY-FOUR
_____
S.P. 849 - L.D. 2021
An Act to Clarify the Laws Regarding Pharmaceutical Product Stewardship
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Sec. 1. 38 MRSA §1612, sub-§1, ¶B, as enacted by PL 2021, c. 94, §2, is repealed.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;
Page 1 - 131LR2666(03)
 (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;
Page 2 - 131LR2666(03)


Statutes affected:
Bill Text LD 2021, SP 849: 38.1612
Bill Text ACTPUB , Chapter 504: 38.1612