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FDA Releases Draft Interim Guidance on Bulk Drug Substances in Compounding Under Sections 503A and 503B of FDCA

The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more

FDA Announces Draft Guidance on Outsourcing Facility Sales

The U.S. Food and Drug Administration (FDA) issued a draft guidance document, June 27, that describes FDA’s current thinking on the prohibition of wholesaling human drugs by a 503B outsourcing facility under the Food, Drugs,...more

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