N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 60-4.7

Current through Register Vol. 46, No. 42, October 16, 2024

Section 60-4.7 - General Requirements

(a) Recordkeeping requirements.

(1) Manufacturers, drug take back organizations, pharmacies and other authorized collectors shall maintain all records required by this Part for a period of five years.

(2) Records and invoices required by this Part shall be readily available and promptly produced for inspection and copying upon request by authorized representatives of the Department's Bureau of Narcotic Enforcement, or the Department of Environmental Conservation.

(b) Upon request by the Department, a wholesaler shall provide the Department with a list of manufacturers that produce the covered drugs it sells or distributes for resale in New York State.

(c) A manufacturer must notify the Department upon contracting with an organization to operate a drug take back program on its behalf, in a manner and in such form as determined by the Department; upon the manufacturer's discontinuance of participation in a drug take back program; upon the manufacturer's changing of participation from one drug take back program to another; and upon discontinuance of the sale of the manufacturer's covered drugs in the state. Such notices to the Department shall be in writing and may be electronic, and shall occur within 15 days of the date of the applicable action.

(d) A manufacturer who begins to offer a covered drug must notify the Department of its joining an existing approved drug take back program, or submit a proposal for a drug take back program within ninety days following the initial offer for sale of a covered drug.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 60-4.7

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