FDA issues rules for sterile compounding pharmacies

Some pharmacies may be exempt from certain federal requirements

NEW YORK — Compounding pharmacies that produce sterile drugs can register as outsourcing facilities and may be exempt from certain Food and Drug Administration approval requirements, according to a document published on the FDA's website.

The document, issued under the Drug Quality and Security Act, signed into law last week by president Barack Obama, states that once a sterile compounding pharmacy has been registered as an outsourcing facility, it must meet certain conditions in order to be exempt from the Federal Food, Drug and Cosmetic Act's approval requirements and the requirement to label products with adequate directions for use. The drugs must be compounded in compliance with the agency-defined current good manufacturing practices, or CGMP, either by licensed pharmacist or under the pharmacist's supervision.

The outsourcing facility must also report information such as a list of all products compounded during the past six months and where it got the ingredients it used to compound, as well as reporting adverse side effects.


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