Governor Cuomo signed into law on Tuesday, July 10, 2018 the New York State Drug Take Back Act (“Act”). New York joins the State of Washington as the first two states to adopt statewide drug take back programs for unwanted drugs from households. In 2016, Massachusetts created a narrower take back stewardship program that focused on the safe and proper collection and disposal of opioids and benzodiazepines from households. TThe New York law also follows numerous West Coast city and county-level measures adopted in recent years targeting the management of unwanted medicines.

The Act requires drug manufacturers to develop, implement, and pay for a statewide drug take back program for unwanted household drugs. The Act will go into effect on January 6, 2019 (180 days from the date it was signed into law); it is codified at New York Public Health Law, Article 2-B. Drug manufacturers have until early July 2019 to submit proposed drug take back programs to the State of New York Department of Public Health (“Department”) for approval.

Covered Drugs

“Covered Drugs” under the Act are defined broadly and generally include brand name and generic prescription drugs and non-prescription drugs, drugs in medical devices and combination products, and drugs for veterinary use. Covered Drugs do not include, among other things, (1) vitamins or supplements, (2) herbal based remedies and homeopathic drugs, products or remedies, (3) drugs that are biological products if the manufacturer already provides a take back program as part of a FDA managed risk evaluation and mitigation strategy (RIMS), (4) emptied injector products or emptied medical devices and their component parts or accessories, and (5) drugs that are used solely in a clinical setting. The Act does not generally apply to sharps that do not contain Covered Drugs.

Drug Manufacturers

Under the Act, a “Manufacturer” of a Covered Drug includes a person, company, corporation, or other entity engaged in the manufacture of a Covered Drug sold, offered for sale, or dispensed in New York State. It does not include a wholesaler or re-packager.

Manufacturers of Covered Drugs must (1) operate a drug take back program approved by the New York State Department of Health individually or jointly with other manufacturers, (2) enter into an agreement with a drug take back organization which shall operate an approved drug take back program, or (3) enter into an agreement with the Department to operate a drug take back program on the manufacturer’s behalf.

Drug Take Back Program

Within 180 days of the Act’s effective date, a Manufacturer or a drug take back organization acting on behalf of a manufacturer or manufacturers must submit to the Department a proposed Drug Take Back Program (“Program”). A Program must satisfy eight requirements for Department approval:

1. Certify that the Program will accept all Covered Drugs, regardless of who produced them;
2. Provide contact information for the Program contact to whom the Department will direct all inquiries;
3. Detail a collection system to provide convenient, ongoing collection services to all persons seeking to dispose Covered Drugs, that is geographically distributed in a way to ensure access in rural and underserved areas;
4. Describe other collection methods by which Covered Drugs shall be collected by authorized collectors;
5. Explain how Covered Drugs will be safely and securely tracked from collection through final disposal and destruction and policies to ensure security and compliance with all applicable laws and regulations;
6. Describe public education and outreach efforts, which shall include advertising of collection location on a website and through use of signage and other written materials, and how effectiveness will be evaluated;
7. Detail how the costs of pharmacy collection will be reimbursed and the required plan for a fair and reasonable cost allocation; and
8. Provide further information as deemed appropriate by the Department.

The Department must, within 60 days of receiving a proposed Program, consult with the New York State Department of Environmental Conservation to determine whether the Program complies with the Act, and notify the applicant of the Department’s determination. The Department may conduct a noticed public hearing. If the drug take back program is not approved, the Department shall notify the applicant in writing and the applicant has 30 days to submit a revised program. If the Department rejects the subsequent proposal, the manufacturer or manufacturers at issue shall be out of compliance with the Drug Take Back Act. Following approval by the Department, a Program must be updated, including an updated proposal, at least every three years.

Role of Pharmacies and Law Enforcement Agencies

All pharmacies that are part of a group of at least ten establishments and operate under the same name or management or ownership, i.e., chain pharmacies, and all non-resident pharmacies that provide drugs to New York State residents by mail are required to participate in a drug take back program. Plan operators are required to notify other potential collectors of the opportunity to participate. All other pharmacies, as well as law enforcement agencies may participate voluntarily.

Participating pharmacies must provide for the safe collection of drugs, including offering drug collection by one or more of the following methods:

• Onsite dropbox or receptacle meeting federal law and regulation;
• Mail-back collection with prepaid envelopes as authorized by federal law and regulation; or
• Other Drug Enforcement Agency (DEA) approved methods of collection.

Participating pharmacies providing for mail-back collection must provide a voucher for a prepaid envelope upon dispensing a Covered Drug. Such voucher shall include information on drug take back and safe drug disposal methods.

Disposal

All Covered Drugs collected under an approved program shall be managed in compliance with all applicable laws and regulations, including disposal and destruction at a permitted waste disposal facility meeting federal requirements. Accordingly, the Act authorizes disposal at municipal solid waste combustion facilities or medical waste incineration facilities.

Costs

Manufacturers of Covered Drugs are responsible for payment or reimbursement of all costs associated with an approved drug take back program. For instance, all costs incurred by participating pharmacies and other collectors must be paid or reimbursed by Manufacturers. Reimbursement of pharmacies participating in the program and other collectors shall include costs retroactive to the effective date of the legislation (six months before a plan is due).

Where more than one manufacturer will be involved in a program, the participating manufacturers must establish a plan for a fair and reasonable manner of allocating costs among the participants such that the costs paid by each manufacturer are reasonably related to the volume or value of Covered Drugs sold in the State.

Convenience Standard

The collection system established by a Program must “provide convenient, ongoing collection services to all persons” seeking to dispose of Covered Drugs and be “geographically distributed in a way to ensure access in rural and underserved areas”. With regard to any city in New York State with a population of 125,000 or more (New York City, Buffalo, Syracuse, Rochester and Yonkers), the Department shall by regulation establish a distribution plan that ensures that “collection receptacle or dropbox placement” shall be reasonably accessible to all residents and that it provides for program cost efficiency.

Preemption

The Act provides that any provision of any local law or ordinance, or any rule or regulation, pertaining to drug disposal promulgated “prior to, or upon the effective date” shall be preempted.

Enforcement

Civil actions for violations of the Act can be brought for penalties not to exceed $2,000 for every violation. A penalty may be increased to an amount not to exceed $5,000 for a subsequent violation if the person committed the same violation, with respect to the same or any other person or persons, within twelve months of the initial violation for which a penalty was assessed and said violations were a serious threat to the health and safety of an individual or individuals.

Reporting

Each approved drug take back program shall report to the Department at a date and manner set by the Department. The Department is required to submit an annual report to the Governor, Speaker of the Assembly and Temporary President of the Senate by January 1st of the relevant year detailing all program activities, the weight collected by each program, a description of collection activities, the name and location of all collection sites, public education and outreach activities, and an evaluation of the efficacy of the program and each collection method, and any manufacturer out of compliance or subject to penalties under the Act. The Department is also authorized to adopt regulations necessary to implement and enforce the Act.

Beveridge & Diamond’s Pharmaceuticals and Health Care industry group assists pharmaceutical companies on a wide range of environmental and product-related matters in the US and overseas. For more information, please contact the authors.