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Earlier this month, the FDA issued two documents of interest to compounding pharmacies.  The publications related to the Drug Quality and Security Act of 2013 (DQSA).  The DQSA created two categories of compounding entities: (1) traditional compounding pharmacies, which compound drug products for an identified individual patient, and (2) outsourcing facilities, which compound sterile drugs, need not obtain prescriptions for identified individual patients, and need not be licensed pharmacies.

Outsourcing facilities fall under Section 503B of the Food, Drug, and Cosmetic Act.  They must register with the FDA and are subject to rigorous federal oversight.

Traditional compounding pharmacies fall under Section 503A of the Food, Drug, and Cosmetic Act.  They will continue to be primarily regulated by State agencies.

The new FDA publications are:

Guidance for Pharmacy Compounding of Human Drug Products Under Section 503A

Draft Guidance on Current Good Manufacturing Practice for Outsourcing Facilities Under Section 503B

In addition, last December, the FDA issued Draft Guidance for Registration of Outsourcing Facilities  and Draft Guidance for Product Reporting by Outsourcing Facilities.

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