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Pilot Pharmaceutical Take-Back Program Open Enrollment

Enrollment in DEC's pilot pharmaceutical take-back program is now open to all New York State health care entities such as:

  • retail chain and independent pharmacies,
  • hospitals and medical clinics with on-site pharmacies, and
  • authorized collectors of pharmaceuticals servicing long term care facilities (LTCFs).

The program will cover the costs of consumer drug collection boxes and disposal for two years. Health care entity locations that currently have a medication collection box are not eligible to apply.

Why is the New York State Department of Environmental Conservation implementing this pilot program?

Some of our lakes, rivers and streams contain low levels of pharmaceuticals, which may be attributed, in part, to years of consumers flushing unwanted drugs down the drain. Furthermore, prescription drug abuse has become epidemic across New York State and the nation. Health care entities can now provide a safe, convenient and effective way to collect unused drugs via a take-back program that can improve water quality, reduce potential adverse impacts to aquatic organisms, and dramatically reduce these public health and safety risks. See our page Drugs in New York's Waters for more information.

What are the eligibility requirements?

  1. Applicants must be located within New York State and be a pharmacy, a hospital or medical clinic with an on-site pharmacy, or a US Drug Enforcement Administration (DEA) authorized collector servicing LTCFs. Authorized collectors should review the information below about maintaining collection boxes at a LTCF before applying. LTCFs cannot apply on their own; only the authorized collector (pharmacy) servicing the LTCF can enroll on the LTCF's behalf.
  2. 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.
  3. Applicants cannot currently have a medication collection drop box at the applying location. The goal of the pilot program is to increase drop box locations within New York State; replacing an existing collection box will not serve that objective.

How does a health care entity apply for the pilot program?

Health care entities interested in applying to the pilot program must complete a short online application. A separate application must be completed for each location; retail pharmacy chains may submit up to 20 applications (locations). Only health care entities located within New York State are eligible to participate in this pilot program.

Applications will be accepted on a first-come, first-served basis. Given the potential interest in this pilot program and limited funding available, there is no guarantee that all interested health care entities will be accepted into the program. Every effort will be made to maximize program participation.

To participate in the program, fill out the open enrollment application (link leaves DEC website).

How will the pilot program work?

For accepted participants, the pilot pharmaceutical take-back program will cover the full cost of purchasing a DEA-compliant medication drop box, replacement inner liners, and the cost of pick up, transport and destruction of all collected waste pharmaceuticals by a DEA-registered reverse distributor for two years. DEC will purchase the medication drop box and have it shipped directly to participants. Participants will be required to install, operate and maintain the collection box according to DEA regulations (link leaves DEC website) for the two year pilot. DEC will hire a third party contractor who will either pick up, transport and destroy these waste drugs directly or will use a common carrier to undertake these activities.

How long will the pilot program be implemented?

The pilot program will cover the cost of drug disposal for two years. At that point, participants are required to continue with the program, and cover disposal costs at their own expense, for a minimum of six (6) months. If a participant is not interested in continuing after the required six (6) month period, DEC has the right to require that the medication drop box be removed from the participating location and placed in one that is interested in providing this service to its customers.

What are the participant's responsibilities?

  1. Once accepted into the pilot program, the participant must modify its DEA registration (link leaves DEC website) to become an authorized collector of controlled substances through an on-site take-back program. This is a free online process.
  2. The participant must install the medication collection box according to the third-party contractor's instructions and per federal DEA requirements (link leaves DEC website).
  3. The participant will be responsible for managing the collection box to ensure its proper operation. This includes periodic monitoring to determine when it is full, unlocking and removing the inner liner, and contacting the collection third-party contractor or common carrier to arrange for liner pickup. Please note that the participant must follow all DEA regulations related to unlocking the collection receptacle and removing the inner liner. The installation, removal, transfer and storage of full inner liners shall be performed by, or under the direct supervision of, two employees of the participating health care entity.
  4. The participant will replace inner liners when they are full. Inner liners will be sealed according to the included instructions for use, and given to the third-party contractor or common carrier for prepaid return transportation to the treatment facility. Upon removal, sealed inner liners must be stored at the participating pharmacy's registered location in a securely locked, substantially constructed cabinet or a securely locked room with controlled access until transfer to the common carrier.
  5. Participants must maintain all records as required by DEA regulations by filling out the Step Log provided by the drug disposal third-party contractor.
  6. Participants must ensure that signage is properly displayed on, or in close proximity to, the collection box. Signage and display information will be provided by the medication collection box third-party contractor.

The third-party contractor will be responsible for providing participants with training and support throughout the program.

Where should the medication collection box be installed within the participating health care entity?

The collection box must be installed in an area that can be easily and continuously monitored by the pharmacist, or pharmacy staff, and is accessible to the public.

How big are the DEA-compliant medication collection boxes?

DEC intends to offer a medication collection drop box that will hold between 33-42 gallons of waste pharmaceuticals. The collection box dimensions are estimated to be 43-54 inches tall by 20-25 inches wide by 19-23 inches deep.

What do DEA authorized collectors need to know to maintain medication collection boxes at LTCFs?

DEA authorized collectors applying to the pilot program on behalf of a Long Term Care Facility should carefully review §1317.80 of Title 21 Code of Federal Regulations before applying for the pilot program. Excerpts of this regulation are below:

(a) A long-term care facility may dispose of controlled substances in Schedules II, III, IV, and V on behalf of an ultimate user who resides, or has resided, at such long-term care facility by transferring those controlled substances into an authorized collection receptacle located at that long-term care facility. When disposing of such controlled substances by transferring those substances into a collection receptacle, such disposal shall occur immediately, but no longer than three business days after the discontinuation of use by the ultimate user. Discontinuation of use includes a permanent discontinuation of use as directed by the prescriber, as a result of the resident's transfer from the long-term care facility, or as a result of death.

(b) Only authorized retail pharmacies and hospitals/clinics with an on-site pharmacy may install, manage, and maintain collection receptacles at long-term care facilities and remove, seal, transfer, and store, or supervise the removal, sealing, transfer, and storage of sealed inner liners at long-term care facilities. Collectors authorized to install, manage, and maintain collection receptacles at long-term care facilities shall comply with all requirements of this chapter, including §§1317.60, 1317.75, and 1317.80.

(c) The installation, removal, transfer, and storage of inner liners shall be performed either: By or under the supervision of one employee of the authorized collector and one supervisor-level employee of the long-term care facility (e.g., a charge nurse or supervisor) designated by the authorized collector; or, by or under the supervision of two employees of the authorized collector.

(d) Upon removal, sealed inner liners may only be stored at the long-term care facility for up to three business days in a securely locked, substantially constructed cabinet or a securely locked room with controlled access until transfer in accordance with §1317.05(c)(2)(iv).

(e) Neither a hospital/clinic with an on-site pharmacy nor a retail pharmacy shall operate a collection receptacle at a long-term care facility until its registration has been modified in accordance with §1301.51 of this chapter.

Where can health care entities find additional resources related to pharmacy-based collection efforts in New York State?

The Product Stewardship Institute (PSI) has a number of valuable resources related to pharmacy-based collection programs implemented in New York and across the United States, including the "How-to Guide for Drug Take-Back: Managing a Pharmacy-Based Collection Program for Leftover Household Pharmaceuticals" (PDF, 2.92 MB). This guide was created as an outcome of a recently completed and successful pilot pharmacy-based medication collection program in Oneida and Lewis Counties. PSI also held a webinar on this pilot program and included the participating pharmacies as speakers. A recording of the webinar can be downloaded at PSI's website, Best Practices for Running Pharmacy-Based Drug Take-Back-Webinar Recording (link leaves DEC website).