FDA Considers Compounding Pharmacy Regulations

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The Federal Drug Administration (FDA) is planning changes to their current regulations that guide compounding pharmacies, potentially removing some scrutiny from smaller 503A pharmacies.

The FDA is working towards a policy aimed at encouraging more compounding pharmacies to register under the Drug Quality and Security Act (DQSA). Under the DQSA, there were two types of compounding pharmacies created: 503A and 503B. 503B compounding pharmacies must register with the FDA, while 503A’s do not have to.

There are currently only around 70 pharmacies registered as 503B compounding pharmacies, while there are about 7,500 pharmacies specializing in compounding. To encourage higher registration, the FDA is considered creating levels of enforcement based on facility size and the danger of the drugs it compounds.

There are arguments against this though. The International Academy of Compounding Pharmacists (IACP) say that the FDA is overstepping Congress’s intent. Other pharmacy organizations are wary of the FDA’s interpretation of the DQSA.

The draft guidance on new FDA rules will be released in the next two months.


Link to full article here.