NAC585.530. Stability of finished drugs.

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The stability of finished drugs must be ensured. The stability must be:

     1. Determined by reliable, meaningful and specific methods of testing;

     2. Determined on drugs in the same system of container and closure in which they are marketed;

     3. Determined on any dry drug that is to be reconstituted at the time of dispensing (as directed on its labeling) as well as on the reconstituted drug.

     4. Recorded and maintained in such a manner that the data on stability may be used to establish expiration dates for the drug.

[Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.6-4.6.1.4, eff. 5-15-78]

                    
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