NAC585.500. Precautions respecting penicillin.

     1. If penicillin is being manufactured on the same premises or with the same equipment as is being used to manufacture products subject to NAC 585.010 to 585.640, inclusive, and the products may reasonably be regarded as susceptible to contamination by penicillin, the licensee shall provide for testing the products to determine whether any of them have become contaminated by the penicillin.

     2. A licensee shall not market such products if they are intended for use in humans and they are contaminated with an amount of penicillin:

     (a) Equivalent to 0.05 unit or more of penicillin G per maximum single dose recommended in the labeling of a drug intended for parenteral administration; or

     (b) Equivalent to 0.5 unit or more of penicillin G per maximum single dose recommended in the labeling of a drug intended for oral use.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.5.11 & 4.5.11.1, eff. 5-15-78]