FDA Works To Encourage Office-Use Compounding In Advance Of Legislation

27 Sep 2017

FDA looks to carve out a place for office-use compounding within Section 503B, the new framework created after deadly fungal contamination of products, while industry supports efforts in Congress to allow it under the traditional Section 503A.

FDA and Congress are working on separate approaches to facilitating local compounding of physician office stocks in advance of receiving prescriptions, which Title I of the November 2013 Drug Quality and Security Act made more difficult.

DQSA clarified that traditional compounding pharmacies regulated under Section 503A of the Food, Drug and Cosmetic Act are state regulated...