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Title: Section 80.23 - Records and reports

Effective Date

02/25/2009

80.23 Records and reports.

(a) Manufacturer records. Manufacturers shall keep records of all controlled substances manufactured, received, disposed of or distributed by them, which shall include date of manufacture, type and quantity of drug manufactured.

(1) Records of drugs received shall indicate date of receipt, type and quantity of drug received, and name and address of supplier of such drug.

(2) Records of drugs disposed of or distributed shall indicate date of disposal or distribution, name and address of the person receiving such drugs and type and quantity of such drugs.

(b) Distributors, importers and exporters records. Distributors, importers and exporters shall keep records of all controlled substances received, disposed of or distributed by them.

(1) Records of drugs received shall indicate the date of receipt, type and quantity of drug received, and the name and address of supplier of such drug.

(2) Record of drugs disposed of or distributed shall indicate the name and address of persons receiving such drugs and the type and quantity of such drugs.

(c) Purchase requests. Manufacturers or distributors may sell schedule III, IV and V controlled substances to authorized practitioners, pharmacies, institutional dispensers or other authorized persons on a written request submitted by the purchaser on his professional or business stationery or on a written order submitted by a representative of the vendor. All such purchase requests shall indicate the name and address of the vendor, the name and address of the vendee, Drug Enforcement Administration registration number, date of the order, type and quantity of drug ordered. Schedule I and II drugs shall be ordered on an official Federal order form only.

(d) Invoice required. The manufacturer or distributor shall furnish the vendee with each shipment of controlled substances an invoice in duplicate, or separate itemized list of all such drugs sold, which shall include the name and address of the vendor, the name and address of the vendee, date of shipment or delivery, type and quantity of drug sold.

(e) Record maintenance. Manufacturers and distributors shall maintain all required records of controlled substances in a separate file or in such a manner as will make them readily available for inspection by authorized representatives of the Bureau of Narcotic Enforcement, New York State Department of Health.

(f) Reports. Manufacturers and distributors shall report to the Department, in a manner approved by the Department, information from the sale of controlled substances. Such information shall be filed electronically with the Bureau of Narcotic Enforcement, utilizing a transmission format acceptable to the Department. The information filed with the Department shall include, but not be limited to:

(i) the manufacturer's or distributor's name, address, phone number, DEA registration number and controlled substance license number issued by the Department;

(ii) the name, address and DEA registration number of the entity to whom the controlled substance was sold;

(iii) the date of the sale of the controlled substance;

(iv) the name and National Drug Code (NDC) of the controlled substance sold; and

(v) the number of containers and the strength and metric quantity of controlled substance in each container of controlled substance sold.

Volume

VOLUME A-1a (Title 10)

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