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The FDA Proposes Adding Five Of 31 Drug Substances To 503A Bulks List

 
• By Joanne S. Eglovitch

FDA proposal would allow traditional compounding from five drug substances based on medical need, but not from another 26.  

Smiling pharmacist and indian pharmacy technician posing in drugstore - Image
FDA Proposes To Disallow More Active Substances From Pharmacy Compounding • Source: Shutterstock

The US Food and Drug Administration proposed 5 September to place five more bulk drug substances on the list of those that traditional pharmacies can use in compounding drugs under Section 503A of the Food, Drug and Cosmetic Act, while also proposing to keep another 26 drug substances off the list.

The agency said there is a medical need for the five drug substances proposed for the list which is unmet...

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