Final Guidance on 503A Pharmacy Compounding

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA has released a final guidance on prescription requirements for compounding pharmacies operating under section 503A of the FD&C Act. Some clarifications were made to the draft issued in April 2016. The guidance covers compounding both before and after receiving a prescription for an individual patient and for office use. The guidance does not apply to drugs compounded for use in animals, to biological products subject to licensure in a biologics license application, or to repackaged drug products. Additional information on human drug compounding can be found here.
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