N.Y. Comp. Codes R. & Regs. tit. 10 § 80.51

Current through Register Vol. 46, No. 45, November 2, 2024

Section 80.51 - Surrender and disposal of controlled substances

(a) As described in this section, the destruction of controlled substances shall mean that the substances have been rendered totally unrecoverable and beyond reclamation.

(b) Single-unit doses or partial doses remaining after the administration or attempted administration of a portion of a liquid or solid unit dose of a controlled substance may be destroyed on the premises of an institutional dispenser by a pharmacist or nurse provided that:

(1) a notation is made on the administration record sheet; and

(2) the destruction is witnessed by a second pharmacist or nurse or other responsible person designated by the administrator.

(c) A person holding a Federal registration number, or who is licensed by the department under article 33 of the Public Health Law, or a person with lawful temporary custody possessing controlled substances, which are undesired, deteriorated, obsolete, or for any reason no longer needed shall:

(1) return such controlled substances to the licensed distributor or manufacturer from whom the controlled substances were purchased provided, that a manufacturer or distributor is required to accept only those full packages of controlled substances still in the sealed containers but may accept partial containers if it wishes to do so; or

(2) surrender such controlled substances to such other person approved by the Bureau of Narcotic Enforcement to receive controlled substances for destruction; or

(3) destroy the controlled substances in the presence of a witness who shall be a New York State licensed practitioner, pharmacist or nurse, provided that:

(i) the person shall request from the department permission to destroy controlled substances at least two weeks prior to the intended destruction. Such requests must be made in writing and must include the following information:

(a) an inventory of controlled substances to be destroyed;

(b) the specific method of destruction to be employed;

(c) the date, time and location of intended destruction;

(d) the identity of at least two persons to conduct and witness the destruction. Such witnesses shall be New York State-licensed practitioners, pharmacists or nurses; and

(e) the reason for the destruction;

(ii) the department shall determine whether or not to grant approval for the destruction by considering factors that include, but are not limited to:

(a) the record of compliance with article 33 of the Public Health Law by the licensee, its employees, and the persons designated to witness the destruction;

(b) the type, nature and schedule of the drugs proposed for destruction, including the potential for diversion of such drugs during the destruction process;

(c) the licensee's pattern and frequency of requests for approval to destroy and of surrenders of controlled substances to the department;

(iii) a person may destroy controlled substances only after receiving the written approval of the department which will include specific protocols for and methods of destruction;

(iv) if the department does not grant approval for the person to destroy controlled substances, the person shall surrender the controlled substances to the department by following the requirements in paragraph (4) of this subdivision; or

(4) surrender the controlled substances to the New York State Department of Health, Bureau of Narcotic Enforcement in the following manner:

(i) the person shall request a surrender date from the bureau on which to surrender the controlled substances to the bureau. Such a request shall be made on forms provided by the bureau and must include the following information:

(a) an inventory of all controlled substances to be surrendered;

(b) the identity of at least two persons who conducted the inventory of the controlled substances to be surrendered. Such persons shall be New York State licensed practitioners, pharmacists or nurses;

(c) the reason for the surrender of each controlled substance; and

(d) the proposed date of surrender and an alternative date;

(ii) a person may surrender controlled substances only after receiving a surrender date in writing from the bureau. The controlled substances must be shipped to the bureau no later than five days from the date the bureau has set as the surrender date. The bureau may set a date different than the date requested by the applicant;

(iii) all controlled substances to be surrendered to the bureau must be packaged in the following manner:

(a) all solid dosage forms of controlled substances must be packaged by placing each controlled substance in separate, individual, paper packaging only. The package must be properly labeled with the name of the licensee, DEA registration number and the name, strength and quantity of the controlled substance;

(b) all liquids, including injectable preparations and prefilled syringes, shall be emptied into individual plastic containers. A label shall be affixed to the container with the name of the licensee, DEA registration number and the name, strength and quantity of the controlled substance. Glass containers are prohibited;

(c) no needles or syringes shall be surrendered to the department for destruction; or

(5) surrender the controlled substances to the federal Drug Enforcement Administration, or its successor agency; or

(6) transfer such controlled substances into an authorized collection receptacle, located at the residential health care facility and maintained by a properly licensed and registered pharmacy, no longer than three business days after discontinuation.

(d) Recordkeeping requirements.

(1) Any person disposing of a controlled substance by returning it to the distributor or to the manufacturer, by destroying the controlled substance in the presence of a witness, or by surrendering it to the department, must maintain a written record containing:

(i) date of return or destruction;

(ii) name, form, quantity of the substance returned or destroyed;

(iii) name, address, registry number of the person making the return;

(iv) name, address, registry number of the supplier or manufacturer to whom the substances are returned or the name and license number of the persons performing and witnessing the destruction.

(2) Any distributor or manufacturer receiving such controlled substances shall keep a record of those controlled substances received and include:

(i) name, address, registry number of the person making the return;

(ii) name, form and quantity of the substance returned; and

(iii) date substance was received.

(3) Any person surrendering controlled substances to the Drug Enforcement Administration shall maintain records of such surrenders as may be required by that agency.

(4) Any record required to be kept under this section shall be kept for a period of five years.

(e) Persons licensed under article 33 of the Public Health Law as manufacturers or distributors may destroy controlled substances on their premises providing that Federal Drug Enforcement Administration approval is obtained and a copy of such approval is filed with the department within 30 days of the receipt of such approval.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 80.51

Amended New York State Register March 10, 2021/Volume XLIII, Issue 10, eff. 3/10/2021