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Title: Section 60-4.4 - Pharmacies Engaged in Drug Take Back

Effective Date

03/10/2021

Section 60-4.4. Pharmacies Engaged in Drug Take Back

Notwithstanding any provision of section 60-4.1, for the purposes of this section, a pharmacy shall also include any pharmacy located in the state and that, though not required to by Article 2-B of the Public Health Law, voluntarily participates in an authorized drug take back program.

Pharmacies participating in drug take back shall:

(a) Be properly registered under section 6808 of the Education Law or, in the case of non-resident pharmacies, be registered under section 6808-b of the Education Law.

(b) If maintaining an onsite collection receptacle, modify existing registration to obtain authorization from the DEA to be a collector.

(c) Comply with all federal laws and regulations concerning the disposal of controlled substances.

(d) Notify the Department and any contracted drug take back program operator, as applicable, within 30 days of drug take back program discontinuance or change of address of collection activity.

(e) If maintaining a collection receptacle:

(1) Utilize a collection receptacle that meets the requirements of section 60-4.5 of this Subpart and all applicable federal laws and regulations.

(2) Collection receptacle placement:

(i) Receptacles accessible to the public, shall be located in the immediate proximity of the registered pharmacy area where prescription drugs are stored and be easily and regularly monitored by the pharmacist or pharmacy staff; or

(ii) receptacles located in a residential health care facility shall be located in a secured area regularly monitored by residential health care facility employees.

(3) Ensure proper operation of the collection receptacle, which includes but is not limited to periodic monitoring to determine when it is full; removing and replacing the inner liner when it is full; and arranging for delivery of sealed inner liners and their contents to a reverse distributor’s registered location by common or contract carrier pickup or by reverse distributor pickup;

(4) Ensure that receptacle box liners that are removed are safely and securely stored until retrieved by the reverse distributor or by common or contract carrier;

(5) Ensure that pharmacy employees do not handle drugs for disposal, review the contents of the collection receptacle, remove, count, weigh, consume, repurpose, restock, redispense, resell, or touch items placed in the collection receptacle;

(6) Ensure the sealed inner liners and their contents are shipped to a reverse distributor's registered location by common or contract carrier or by licensed reverse distributor pick-up at the licensed pharmacy's or residential health care facility’s premises;

(f) Report to the Department immediately, and in any event within 24 hours of discovery of tampering with, or damage to, a collection receptacle, or diversion or theft of deposited contents, or any tampering with, damage to, or theft of a removed liner.

Statutory Authority

Public Health Law, Sections 291 and 3308

Volume

VOLUME A-1a (Title 10)

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