Beyond use dating usp 795

Reprocessing of repackaged unit-dose containers (i.e., removing dosage unit from one unit-dose container and placing dosage unit into another unit-dose container) shall not be done.However, reprocessing of the secondary package (e.g., removing the blister card from the cardboard carrier and placing the blister card into another cardboard carrier) is allowed provided that the original expiration date is maintained.

A refrigerator or freezer shall not be considered to be a humidity-controlled environment.Reading USP chapters requires paying special attention to the words “should,” “shall” and “must.” “Shall” and “must” are requirements for compliance with the chapter, while “should” is a recommendation.A number of topics are prescriptive in telling you how to comply, but there are aspects of the chapter that are left up to you to determine what is appropriate based on the compounding done in your practice.While many have considered this a standard of practice for nonsterile preparations, it wasn’t defined in the current version of the chapter.Acceptable variability in strength in the new It is important to consider how each step of the compounding process affects the final potency and to have standard operating procedures addressing the use of certificates of analysis, base/salt conversions, minimum accurately weighable quantity for your balance, specificity in mixing instructions and many other factors.

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