N.M. Admin. Code § 16.19.37.9

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

Section 16.19.37.9 - OPERATIONAL STANDARDS

The following minimum standards shall apply to all outsourcing facilities and dual purpose facilities for which licenses have been issued by the board:

A. All drugs and chemicals used in the manufacturing process or held for sale shall conform to the Drug, Device and Cosmetic Act and shall be stored, preserved and disposed of as prescribed by laws regulating the labeling and manufacture of drugs. When necessary, and/or according to label requirements, all drugs and chemicals which require refrigeration shall be stored and preserved under proper temperature.

B. Facilities must comply with applicable FDA current good manufacturing practice requirements as set forth in title 21, CFR, Subsection 211.1 to 211.208 inclusive (or successor regulations). The defnitions and interpretations contained in Section 201 of the Federal Food and Drug Act shall be applicable.

C. Facilities must be in compliance with applicable DEA regulations.

D. Facilities must comply with applicable United States Pharmacopeia requirements.

N.M. Admin. Code § 16.19.37.9

Adopted by New Mexico Register, Volume XXVI, Issue 22, November 30, 2015, eff. 12/13/2015