New Mexico Administrative Code
Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING
Chapter 19 - PHARMACISTS
Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION
Section 16.19.8.24 - MANUFACTURER REQUIREMENTS

Universal Citation: 16 NM Admin Code 16.19.8.24

Current through Register Vol. 35, No. 18, September 24, 2024

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.

Disclaimer: These regulations may not be the most recent version. New Mexico may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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