1. 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.
2. B. Authorized trading partners: The trading partners of a manufacturer may be only authorized trading partners.

3. 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.

   HISTORY OF 16.19.8 NMAC:

   Pre NMAC History: The material in this part was derived from that previously filed with the state records center and archives:

   BOP 69-2, Rules and Regulations of the State Board of Pharmacy, filed 6/13/1969.

   BOP 69-3, New Mexico Laws and Regulations, Pharmacy Act, Drug and Cosmetic Act, Narcotic Drug Act, Poisons Act, Board of Pharmacy Rules and Regulations, filed 8/15/1969.

   BOP 72-1, New Mexico Board of Pharmacy Rules and Regulations Promulgated Pursuant to New Mexico Drug and Cosmetic Act, Pharmacy Act, Controlled Substances Act, filed 7/31/1972.

   Regulation No. 8, Minimum Standards For Wholesalers, filed 2/07/1980.

   Regulation No. 8, Minimum Standards For Wholesalers, filed 10/23/1985.

   Regulation No. 8, Minimum Standards For Wholesalers, filed 2/02/1987.

   Regulation No. 8, Minimum Standards For Wholesalers, filed 7/27/1990.

   Regulation No. 8, Wholesale Prescription Drug Distribution, filed 5/14/1992.

   History of Repealed Material:

   BOP 72-1, New Mexico Board of Pharmacy Rules and Regulations Promulgated Pursuant to New Mexico Drug and Cosmetic Act, Pharmacy Act, Controlled Substances Act (filed 7/31/1972) repealed 10/29/1985.

   16.19.8 NMAC, Wholesale Prescription Drug Distribution (filed 2/02/1996 and 3/1/2002) repealed 12/02/2009.

   16.19.8 NMAC, Wholesale Prescription Drug Distribution, filed 11-03-2009, repealed 11/28/2017.

   Other History:

   Regulation No. 8, Wholesale Prescription Drug Distribution (filed 5/14/1992) was renumbered, reformatted, amended and replaced by 16 NMAC 19.8, Pharmacists - Wholesale Prescription Drug Distribution, effective 2/15/1996.

   16 NMAC 19.8, Pharmacists - Wholesale Prescription Drug Distribution (filed 2/02/1996) was reformatted and renumbered to 16.19.8 NMAC, Wholesale Prescription Drug Distribution, effective 3/30/2002.

   16.19.8 NMAC, Wholesale Prescription Drug Distribution (filed 2/02/1996 and 3/01/2002) replaced by 16.19.8 NMAC, Wholesale Prescription Drug Distribution, effective 12/02/2009.

[16.19.8.24 NMAC - Rp, 16.19.8.24 NMAC, 11/28/2017]