N.M. Admin. Code § 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.
Notes
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