New Rules for Compounding Pharmacies in 2016

USP 797 Sampling Swabs

After a string on contamination issues in compounding pharmacies, the FDA has expanded some of it’s definitions and adopted some changes that seek to improve patient outcomes. One of the biggest changes in 2016 has been adopting a new broader definition of compounding which before was defined by Federal Food, Drug and Cosmetic Act which did not contain important elements of compounding such as mixing and reconstituting.

In addition, A new term, “in-use time,” which describes a time before the compounded product must be used after it has been opened. There are also some additional environmental control requirements including surface sampling on a monthly basis to detect any kind of microbial contamination present.

You can learn more by reading this article by Kenneth Maxik in Infection Control Today.

Berkshire offers sampling swabs that are USP 797 complaint.

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