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FDA Statement Addresses Drug Compounding and Outsourcing Facilities

Commissioner Scott Gottlieb’s announcement takes a step forward in implementing DQSA and section 503B; directs agency to develop 503B bulks list.

FDA Commissioner Scott Gottlieb, M.D., announced that the agency was “taking a key step forward in implementing the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. Among other things, these provisions limit the bulk drug substances that outsourcing facilities can use in compounding. It directs the FDA to develop a list of bulk drug substances for which there is a clinical need—the 503B bulks list.”

The March 23, 2018 statement looks at how that list will be formulated, and what bulk drug substances the outsourcing facilities can use to compound drugs. Some key points:

• Compounding can be critical for advancing the health of patients who have specific medical needs that cannot be met by FDA-approved drugs.

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