N.M. Admin. Code § 16.19.8.24

Current through Register Vol. 35, No. 19, October 8, 2024

Section 16.19.8.24 - MANUFACTURER REQUIREMENTS

A.Product tracing, product identifier, and verification: Manufacturers shall comply with the requirements for tracing products through the distribution system as defined in Sections 353 and 360eee, et seq., of the DSCSA, 21 U.S.C. 301, et seq., and successor FDA regulations, with respect to the role of such manufacturer including any requirements with respect to: transaction history, transaction information, or transaction statement of a product as such product changes ownership in the supply chain, or verification, investigation, disposition, notification, or recordkeeping relating to such systems, including paper or electronic pedigree systems or for tracking and tracing drugs throughout the distribution system.

B.Authorized trading partners: The trading partners of a manufacturer may be only authorized trading partners.

C.Compliance with federal, state, and local law: Manufacturers shall operate in compliance with applicable federal, state, and local laws and regulations. Manufacturers that deal in controlled substances shall register with the board and with the DEA, and shall comply with all applicable state, local and DEA regulations.

N.M. Admin. Code § 16.19.8.24

Adopted by New Mexico Register, Volume XXVIII, Issue 22, November 28, 2017, eff. 11/28/2017