Legislative Document No. 1460 S.P. 445 In Senate, April 2, 2019
An Act To Support Collection and Proper Disposal of Unwanted Drugs
Reference to the Committee on Environment and Natural Resources suggested and ordered printed.
DAREK M. GRANT Secretary of the Senate
Presented by Senator GRATWICK of Penobscot. Cosponsored by Representative HYMANSON of York and Senators: BLACK of Franklin, CLAXTON of Androscoggin, DAVIS of Piscataquis, DILL of Penobscot, President JACKSON of Aroostook, SANBORN, L. of Cumberland, VITELLI of Sagadahoc, Representative: MADIGAN of Waterville.
Printed on recycled paper 1 Be it enacted by the People of the State of Maine as follows:
2 Sec. 1. 22 MRSA §2700, sub-§8 is enacted to read: 3 8. Drug take-back stewardship program participation. Nothing in this section 4 prohibits a law enforcement agency from participating as an authorized collector in a 5 drug take-back stewardship program implemented under Title 38, section 1611.
6 Sec. 2. 38 MRSA §1611 is enacted to read: 7 §1611. Drug take-back stewardship program
8 1. Definitions. As used in this section, unless the context otherwise indicates, the 9 following terms have the following meanings. 10 A. "Authorized collector" means: 11 (1) A person, company, corporation or other entity that is registered with the 12 United States Department of Justice, Drug Enforcement Administration to collect 13 controlled substances for the purposes of safe disposal and destruction; 14 (2) A law enforcement agency; or 15 (3) A person, company, corporation or other entity authorized by the department 16 to provide alternative collection methods for covered drugs that are not controlled 17 substances. 18 B. "Brand" means a name, symbol, word or mark that identifies a covered drug, 19 rather than its components, and attributes a covered drug to the owner of the brand. 20 C. "Closed-shop pharmacy" means a pharmacy that purchases drugs for and 21 dispenses drugs to a limited, institutional patient population. 22 D. "Covered drug" means any substance recognized as a drug under 21 United States 23 Code, Section 321(g)(1), as amended, and any regulations adopted pursuant to that 24 provision that is sold, offered for sale or dispensed in the State, whether directly or 25 through a wholesaler, in any form, including prescription and nonprescription drugs, 26 drugs in medical devices and combination products, brand and generic drugs and 27 drugs for veterinary use. 28 (1) "Covered drug" does not include: 29 (a) Vitamins or supplements; 30 (b) Herbal-based remedies and homeopathic drugs, products or remedies; 31 (c) Cosmetics, soap with or without germicidal agents, laundry detergent, 32 bleach, household cleaning products, shampoo, sunscreen, toothpaste, lip 33 balm, antiperspirant or other personal care products that are regulated as both 34 cosmetics and nonprescription drugs under the federal Food, Drug, and 35 Cosmetic Act; 36 (d) Pet pesticide products contained in pet collars, powders, shampoos, 37 topical applications or other forms;
Page 1 - 129LR0206(01)-1 1 (e) Drugs that are biological products as defined in 21 Code of Federal 2 Regulations, Section 600.3(h) if the manufacturer provides a program to take 3 back that drug; 4 (f) Drugs for which a manufacturer provides a program to take back those 5 drugs as part of a United States Department of Health and Human Services, 6 Food and Drug Administration managed risk evaluation and mitigation 7 strategy; 8 (g) Emptied syringes or emptied medical devices or the component parts or 9 accessories of those products or devices; and 10 (h) Drugs that are used solely in a clinical setting. 11 E. "Drug take-back stewardship organization" or "stewardship organization" means a 12 corporation, nonprofit organization or other legal entity created by one or more 13 manufacturers to implement a drug take-back stewardship program. 14 F. "Drug take-back stewardship plan" or "plan" means a plan designed by a 15 manufacturer or drug take-back stewardship organization for the establishment of a 16 drug take-back stewardship program. 17 G. "Drug take-back stewardship program" or "stewardship program" means a system 18 implemented for the collection, transportation and disposal of covered drugs in 19 accordance with a drug take-back stewardship plan approved by the department under 20 subsection 4. 21 H. "Mandatory pharmacy collector" means a pharmacy registered with the Maine 22 Board of Pharmacy that is part of a group of 10 or more establishments that conduct 23 business under the same name or operate under a common ownership or management 24 or pursuant to a franchise agreement with the same franchisor and a nonresident 25 pharmacy registered with the Maine Board of Pharmacy that provides covered drugs 26 to residents in the State by mail. "Mandatory pharmacy collector" does not include a 27 closed-shop pharmacy. 28 I. "Manufacturer" means an entity that: 29 (1) Has legal ownership of the brand of a covered drug sold in or into the State; 30 (2) Imports a covered drug branded by a person that meets the requirements of 31 subparagraph (1) and has no physical presence in the United States; or 32 (3) Sells a covered drug in the State at wholesale or retail, does not have legal 33 ownership of the brand of the covered drug and elects to fulfill the 34 responsibilities of the manufacturer for that covered drug. 35 J. "Operator" means a manufacturer or drug take-back stewardship organization that 36 implements and operates a drug take-back stewardship program. 37 2. Drug take-back stewardship program. A manufacturer shall: 38 A. Individually or jointly with one or more manufacturers, operate a drug take-back 39 stewardship program approved by the department;
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