‘Sec. 1. 22 MRSA §2700, sub-§8 is enacted to read:
Sec. 2. 38 MRSA §1612 is enacted to read:
§ 1612. Drug take-back stewardship program
(1) A person, company, corporation or other entity registered with the United States Department of Justice, Drug Enforcement Administration to collect controlled substances and noncontrolled 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 household pharmaceutical waste and that are noncontrolled substances.
"Authorized collector" includes a mandatory pharmacy collector.
(1) Into which a person may deposit for disposal covered drugs that are household pharmaceutical waste and that is prominently labeled in a manner indicating that only such types of covered drugs may be deposited for disposal;
(2) That meets applicable federal standards for the use described in subparagraph (1); and
(3) That is located on the premises of an authorized collector participating in a stewardship program under this section.
"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;
(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.
For the purposes of this paragraph, "household" includes, but is not limited to, a single residential unit, a multifamily residential unit, an apartment and an independent living community. "Household" does not include a hospital, health clinic, hospice facility, skilled nursing facility or other long-term care facility, physician's office, pharmacy or veterinary office or clinic.
For the purposes of this paragraph, "pharmacy" has the same meaning as in Title 32, section 13702-A, subsection 24, except that "pharmacy" does not include a pharmacy that purchases drugs for and dispenses drugs to a limited, institutional patient population.
(1) A person that has legal ownership of the brand of a covered drug sold in or into the State; or
(2) If the person to which subparagraph (1) applies has no physical presence in the United States, a person that imports a covered drug that is branded by the person to which subparagraph (1) applies.
"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.
(1) A list of authorized collectors, collection locations and the collection methods available at each collection location, updated as necessary;
(2) General information regarding the purpose and scope of the stewardship program and the opportunities available to consumers under the program for the safe disposal of covered drugs that are household pharmaceutical waste; and
(3) A statement that the stewardship program is designed for the collection of covered drugs that are household pharmaceutical waste only;
(1) Ensure awareness of the program by 60% of residents of the State after one year of stewardship program implementation, by 70% of residents of the State after 2 years of implementation and by 90% of residents of the State after 4 years of implementation; and
(2) Discourage the use of improper disposal methods for covered drugs that are household pharmaceutical waste, such as flushing the drugs or placing them in the garbage;
When 2 or more manufacturers participate in a stewardship program, the costs of implementing, administering and operating the program must be fairly and reasonably allocated between each participating manufacturer so that the share of the costs that is allocated to each manufacturer is reasonably related to the market share of covered drugs that the manufacturer sells in the State.
(1) Mail-back envelopes made available to consumers of covered drugs upon request;
(2) Collection receptacles; or
(3) Any other method of collection that complies with applicable United States Department of Justice, Drug Enforcement Administration regulations under 21 Code of Federal Regulations, Part 1300, 1301, 1304, 1305, 1307 or 1317 and that has been approved by the department as a method of collection for use in the stewardship program, except that the department may not approve for use in any stewardship program under this section a method of home disposal involving packets, bottles or other containers that a person may use to render nonretrievable or destroy a covered drug that is household pharmaceutical waste by means of a chemical process.
A mandatory pharmacy collector that is a pharmacy not located in the State that provides covered drugs to residents in the State by mail shall provide for the safe collection of covered drugs that are household pharmaceutical waste through the use of mail-back envelopes and shall ensure that consumers in the State purchasing covered drugs from the pharmacy are provided with information regarding the availability of such envelopes upon request and instructions regarding how the customer can request an envelope.
The department shall charge a reasonable fee to be paid by a manufacturer or stewardship organization for review of a plan or amendments to an approved plan submitted under subsection 4. The department may establish a reasonable annual fee to cover the department's actual costs for annual report review, oversight, administration and enforcement of a stewardship program, except that the fee may not exceed the greater of $100,000 per year and 1% of total stewardship program costs, as verified through the independent 3rd-party audit required under subsection 10, paragraph J.
(1) Sixty days after the request for reimbursement under paragraph C, if the plaintiff manufacturer or stewardship organization did not request an independent audit under subparagraph (2); or
(2) Thirty days after completion of an independent audit, if the plaintiff manufacturer or stewardship organization requested an independent audit and the audit verified the validity of the reimbursement request.
As used in this subsection, "damages" means the actual, direct costs a plaintiff manufacturer or stewardship organization incurs in collecting, handling and disposing of covered drugs that are household pharmaceutical waste reasonably identified as having originated from a defendant manufacturer or manufacturers that are not in compliance with all applicable requirements of this section; punitive or exemplary damages not exceeding 3 times those incurred costs; and the plaintiff manufacturer's or stewardship organization's attorney's fees and costs of bringing the action under this subsection.
Sec. 3. 38 MRSA §1776, sub-§11, as enacted by PL 2013, c. 315, §7, is amended to read:
Sec. 4. 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 1612, individually or jointly with one or more manufacturers, or a drug take-back stewardship organization contracted by one or more manufacturers, shall submit to the Department of Environmental Protection for review a proposed drug take-back stewardship plan that meets the requirements of Title 38, section 1612, subsection 3.
Sec. 5. Appropriations and allocations. The following appropriations and allocations are made.
ENVIRONMENTAL PROTECTION, DEPARTMENT OF
Maine Environmental Protection Fund 0421
Initiative: Provides an allocation for one Environmental Specialist III position and associated costs.
|OTHER SPECIAL REVENUE FUNDS||2019-20||2020-21|
POSITIONS - LEGISLATIVE COUNT
|OTHER SPECIAL REVENUE FUNDS TOTAL||$0||$41,607|