FDA Seeks Comment Preliminary Finding of Lack of Clinical Need for Outsourcing Facilities to Compound from Three Bulk Drug Substances that are Ingredients in FDA-approved Drugs
The U.S. Food and Drug Administration (FDA) is seeking comment on a proposal not to include three bulk drug substances, bumetanide, nicardipine hydrochloride, and vasopressin, on the list of bulk drug substances (or active pharmaceutical ingredients) that outsourcing facilities may use in compounding under section 503B of the Federal Food, Drug & Cosmetic Act (503B bulks list).
This is the first time since the passage of the Drug Quality and Security Act (DQSA) that the FDA has issued a proposal regarding whether to include bulk drug substances to the 503B bulks list. Each of these substances is an ingredient of one or more FDA-approved drug products.
The FDA states that it has not found clinical need for an outsourcing facility to use these bulk drug substances to compound finished products, which is the statutory standard for adding a bulk drug substance to the 503B bulks list. Therefore, the FDA is proposing to exclude these substances from the 503B bulks list and we are seeking public comment before finalizing our decision.
Follow the link below to review the proposed changes. The proposed rule will be published in the Federal Register on Thursday August 28, 2018 and commend will be accepted for sixty days thereafter.
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