The New York State Drug Take Back Act (Act), which was signed into law on July 10, 2018, went into effect on January 6, 2019. However, due to statutory timelines, enforcement actions are unlikely to start until after October 2019. Nonetheless, drug manufacturers should continue to diligently work toward the various Act deadlines, as development of a drug take-back program will require an investment of manufacturer time and money.
By way of background, the Act imposes significant requirements on drug manufacturers to develop, implement, and pay for a statewide drug take-back program covering most prescription and over-the-counter drugs, whether for use by humans or animals, including controlled substances (covered drugs). Manufacturers may operate a program in one of three ways. First, programs may be operated individually or jointly with other manufacturers, but the program must first be proposed to and approved by the New York State Department of Health (Department). In the alternative, manufacturers may enter into an agreement with a “drug take-back organization,” and that organization can submit a proposal to the Department on behalf of the manufacturer or a group of manufacturers. The third statutory option is to enter into an agreement with the Department to operate a program on the manufacturer’s behalf. The Department has not yet published any explanatory information on this third option. Program proposals must be submitted by July 5, 2019.
After receiving a manufacturer’s program proposal (between now and July 5, 2019), the Department will review it within 60 days, consult with the New York State Department of Environmental Conservation to determine whether the program complies with the Act, and notify the applicant of approval or denial. Depending on when a manufacturer submits its plan, this would be September 3, 2019, at the latest. If the Department does not approve the program, the applicant must submit a revised proposal within 30 days. If the Department rejects the subsequent proposal, the manufacturer or drug take-back organization will be in violation of the Act and subject to enforcement, which could involve a potential fine of up to $2,000 per day of noncompliance. Overall, given the various deadlines, this process can stretch into October 2019.
Because implementation of the law is an ongoing process, and much of it is up to the discretion of the Department’s delegate, the New York Bureau of Narcotic Enforcement, stakeholders should ensure that they understand the state’s current regulatory plan to carry out the statutory mandate. Moreover, stakeholders should be aware that programs being proposed by drug take-back organizations might not be publicized for many months while they await Department approval. Accordingly, if stakeholders have questions about specific aspects of proposed programs, they may need to confer with the state regulators so that internal company procedures can be appropriately tailored to the Department’s expectations.