An OTC drug products (except a dermatological, dentifrice, insulin, or lozenge merchandise) for retail sale that is not packaged in a very tamper-resistant package deal or that isn't correctly labeled less than this area is adulterated beneath segment 501 of the act or misbranded less than area 502 of the act, or the two.(b) Valid in-process specs
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Laboratory controls should be followed and documented at time of performance. Any departures from the above-explained techniques really should be documented and discussed.All generation, Command, and distribution records really should be retained for a minimum of 1 calendar year following the expiry date on the batch. For APIs with retest dates, re
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