Bill > S3641

Introduced Session

This bill requires drug manufacturers to establish drug take back programs, which will accept the return of covered drugs for disposal or destruction, and requires certain pharmacies to become authorized collection sites for covered drugs. As used in the bill, "covered drug" means any substance recognized as a drug pursuant to federal law, including prescription and nonprescription drugs and biological products, drugs and biological products in medical devices and combination products, brand name and generic drugs and biological products, and drugs and biological products for veterinary use. The term will not include vitamins or supplements, herbal-based or homeopathic products, various personal care products, pesticide products for animals, emptied injector products or medical devices, drugs that are used solely in a clinical setting, or any drug or biological product for which the manufacturer already provides a take back program. Each manufacturer will be permitted to: establish its own take back program, either on its own or jointly with other manufacturers; enter into an agreement with a drug take back organization to implement and operate a drug take back program on behalf of the manufacturer; or enter into an agreement with the division to operate a drug take back program on its behalf. At a minimum, each drug take back program will be required to: certify that the program will accept all covered drugs regardless of the manufacturer of the drug; designate a contact person to receive and respond to inquiries and communications; include a collection system that provides convenient, ongoing access to collection services; incorporate appropriate security plans and protocols, including tracking throughout the collection and disposal process; ensure compliance with applicable State and federal laws and regulations; include public education and outreach activities; and provide reimbursement to authorized collectors. The bill requires manufacturers to pay all administrative and operational fees associated with the drug take back program, including the cost of collecting, transporting, and disposing of covered drugs from participant pharmacies and other authorized collectors, the cost of recycling or other disposal of packing, packaging, and other materials collected with the covered drug, and the actual costs incurred by the State in the administration and enforcement of the drug take back program. In instances where manufacturers jointly conduct a drug take back program, the costs of administration and enforcement are to be fairly and reasonably allocated in a manner that ensures that the share of the costs allocated to each manufacturer is reasonably related to the volume or value of covered drugs that the manufacturer sells or distributes in the State. Manufacturers will be prohibited from charging a point-of-sale or other fee to consumers, or a fee that could be passed on to consumers, to recoup the cost of the manufacturer's program. Drug take back programs will be subject to approval by the Division of Consumer Affairs in the Department of Law and Public Safety in consultation with the Department of Environmental Protection. All manufacturers will be required to submit their proposed drug take back program plans to the division for approval no later than 180 days after the effective date of the bill. The division will provide written notice of its approval determination in writing within 60 days after the date a program plan is submitted; if a program plan is not approved, the manufacturer will have 30 days to submit a revised program plan. If the revised program plan is not approved, the manufacturer will be deemed noncompliant with the requirements of the bill. The division may hold a noticed public hearing prior to making a determination with regard to approval of a proposed program plan. Drug take back programs are to be reviewed and updated by the manufacturer, or the manufacturer's designated drug take back program operator, at least once every three years, which updates are subject to division approval. A manufacturer who begins to offer a covered drug in the State after the effective date of the bill will be required, within 90 days of the date the covered drug is first made available in the State, to join an existing drug take back program or submit a plan for its own drug take back program. Any proposed change to a drug take back program is to be submitted to the division in writing and will be subject to division approval. The division is to make a list of all approved drug take back programs that identifies the manufacturers participating in each program available on its Internet website. The list is to be updated at least annually. The operator or administrator of each drug take back program will be required to report to the division concerning the program's collection activities, including, but not limited to, the weight of covered drugs collected, the collection activities utilized and the weight of covered drugs collected using each method, the program's public education and outreach activities, and reimbursements paid to participant pharmacies, authorized collectors, and the State. The division will determine the form, manner, and frequency with which the program reports are to be submitted. The division will be required to submit an annual report to the Governor and to the Legislature detailing all program activities, including: the weight of covered drugs collected by each program; a description of each program's collection activities; the names and locations of all collection sites; a description of all public education and outreach activities undertaken by approved programs, and an assessment of the effectiveness of the various activities; an evaluation of the efficacy of the program and each collection method utilized; and the names of, and disciplinary actions taken against, manufacturers found to be in violation of the requirements of the bill. No later than 30 days after the effective date of the bill, each wholesaler that sells or distributes covered drugs in New Jersey is to provide the division with a list of manufacturers that produce covered drugs sold or dispensed by the wholesaler in New Jersey. The lists are to be updated upon request by the division. The bill additionally requires pharmacies that are part of a group of 10 or more establishments that conduct business under the same name or that operate under a common ownership or management or pursuant to a franchise agreement with the same franchisor, as well as out-of-State pharmacies that ship, mail, distribute, or deliver covered drugs into New Jersey, to become authorized collectors of covered drugs. In-State pharmacies are to offer drug collection through the use of on-site receptacles, mail-back collection using prepaid envelopes, or any other drug collection method approved by the federal Drug Enforcement Administration. In-State pharmacies providing for mail-back collection will be required to provide a voucher for a prepaid envelope upon dispensing a covered drug, which will include information concerning drug take back and safe drug disposal methods. In-State pharmacies are to additionally offer to furnish patients with a drug disposal product, which is a nontoxic composition that can be used to permanently sequester or deactivate unused, unwanted, or expired drugs for the purpose of safely disposing of the unused drug. Drug disposal products are to be furnished upon request without cost to the patient. In-State pharmacies are to display prominent signage advising consumers of the availability of drug collection and drug disposal products, which may identify the particular collection methods available through that pharmacy. Out-of-State pharmacies are to include a prepaid mail-back collection envelope with any drug delivered, along with written notice advising consumers of the availability of drug collection, including the use of mail-back collection using the enclosed prepaid envelope and a link to the list of collection sites on the division's Internet website. Out-of-State pharmacies will also be required to offer patients, at the time the patient orders a prescription for dispensing, to include with the dispensed drug a drug disposal product, which are to be furnished upon request at no additional cost. Drug take back program operators are to notify other potential authorized collectors of the opportunity to serve as an authorized collector for the drug take back program. Participation by authorized collectors, other than participant pharmacies, will be voluntary. For any municipality with a population of more than 100,000 according to the last decennial census, the division is to establish a distribution plan that ensures that on-site collection receptacles are placed in a manner that provides reasonable access for all residents of the municipality while maintaining cost-effectiveness for the program. An entity that violates the requirements of the bill will be subject to a civil penalty of $10,000 for a first violation and $20,000 for a second or subsequent violation. Each week during which a manufacturer does not have an approved program in place will constitute a separate violation.

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Joe Cryan (D)*, 

Introduced in the Senate, Referred to Senate Health, Human Services and Senior Citizens Committee (on 05/13/2019)

Official Document