New York establishes a no-cost pilot drug take-back program



July 25, 2017

Health Care Alert

Author(s): Libby Ford, QEP, CHMM, CEP, Peter J. Millock, Dana P. Stanton

Nationwide, 80% of lakes, rivers and streams now contain low levels of pharmaceuticals. Chronic exposure to low levels of medications in the environment, even expired medications, has been shown to harm the fertility of fish and other aquatic animals. Most current municipal wastewater treatment technology is ineffective in intercepting drugs when they are flushed down the toilet. Moreover, unwanted prescription drugs that remain in consumers’ homes are at risk of being abused. For these reasons, New York State is funding a one million dollar drug take-back program to encourage health care entities to provide for the safe, convenient and effective collection of unused drugs. Health care entities who sign up early can get the costs of their drug take-back programs covered for the first two years of operation. The creation of new take-back programs will not only improve water quality and reduce adverse impacts to aquatic organisms, but also dramatically reduce the public health and safety risks posed by the accessibility of unused and uncollected drugs.

Enrollment in the New York Department of Environmental Conservation’s (NYSDEC’s) pilot drug take-back program is now open to all New York State health care entities, including:

  • retail chain and independent pharmacies
  • hospitals and medical clinics with on-site pharmacies, and
  • U.S. Drug Enforcement Administration (DEA) authorized collectors of pharmaceuticals servicing Long-Term Care Facilities (LTCFs).

New York State will cover the costs of the consumer drug collection boxes and disposal for two years. Applications will be accepted on a first-come, first-served basis, but NYSDEC has stated that it will make every effort to maximize participation in this program. It will accept applications until the one million dollars is fully committed.

Eligibility requirements

  • Applicants must be located within New York State
  • Pharmacies, hospitals and medical clinics with on-site pharmacies and authorized collectors servicing LTCFs are eligible to apply. Authorized collectors should review the information on NYSDEC’s web page about maintaining collection boxes at an LTCF.
  • Applicants must agree to continue collection efforts, at their own expense, for a minimum of six (6) months after the two-year pilot program ends.
  • Applicants cannot currently have a medication collection drop box at the applying location.

Health care entities interested in applying to the pilot program must complete the open enrollment application. A separate application must be filled out for each location and retail pharmacy chains may submit applications for up to twenty locations.

Program mechanics

The pilot pharmaceutical take-back program covers the full cost of purchasing a DEA‑compliant medication drop box, replacement inner liners and the cost of pick up, transportation and destruction of all collected waste pharmaceuticals by a DEA-registered reverse distributor for two years. NYSDEC will ship the medication drop box directly to participants. Participants must install, operate and maintain the collection box according to DEA regulations. A third-party contractor or common carrier, hired by NYSDEC, will pick up, transport and destroy the collected pharmaceuticals.

Participant’s responsibilities

Program participants are responsible for:

  • modifying their DEA registration to become an authorized collector of controlled substances, and
  • installing and managing the medication collection box according to the third-party contractor’s instructions and DEA regulations.

More details are available on the NYSDEC Pilot Pharmaceutical Take-back Program web page.

Things to consider

New York State’s no-cost pilot program significantly reduces the red-tape, difficulty and expense of managing a consumer drug take-back program. Appreciating that the regulatory scheme for drug take-back programs is complicated and fraught with risks if not carefully complied with, New York State is using the “carrot approach” to incentivize the establishment of these programs. Behind the carrot, however, there will continue to be a big stick that can be yielded by the federal DEA and other law enforcement entities. The mishandling of unused and returned controlled substances is a serious crime with grave consequences. The improper handling of unused controlled substances is a violation of the New York State Public Health Law as well as the federal Controlled Substances Act and may result in misdemeanor and felony charges, as well as administrative enforcement proceedings. N.Y. Pub. Health Law § 12-b; 21 U.S.C. § 841 et seq.

The foregoing has been prepared for the general information of clients and friends of the firm. It is not meant to provide legal advice with respect to any specific matter and should not be acted upon without professional counsel. If you have any questions or require any further information regarding these or other related matters, please contact your regular Nixon Peabody LLP representative. This material may be considered advertising under certain rules of professional conduct.

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