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FDA’s Revised Draft For Compounding Pharmacies Opens Door To Compounding For Office Use

 
• By Joanne S. Eglovitch

FDA’s revised draft guidance on GMPs for outsourcing pharmacy compounding operations responds to calls to allow the compounding of small quantities of drugs presumably for office use. The IACP applauds the move.

capsules in blue glass container on yellow background

To encourage additional compounders to register as outsourcing facilities, FDA has revised its draft guidance with a promise to enforce only a small subset of good manufacturing practice requirements when they produce small batches, as when compounding physicians’ office supplies in advance of receiving prescriptions.

The revision also adds guidance on non-sterile drug compounding, something industry complained was lacking in the first draft.

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