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List of Bulk Drug Substances that can be used to Compound Drug Products in Accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule)

This proposed rule proposes criteria for evaluating substances for inclusion on the 503A Bulks List and identifies six substances the Secretary proposes to place on the list. This proposed rule would allow these six substances to be used to compound drug products under the exemptions provided by section 503A of the FD&C Act. The Agency considered four other substances and is proposing not to include those substances on the 503A Bulks List. Drug products compounded with the four bulk drug substances that we propose not to include on the 503A Bulks List would not be eligible for the exemptions provided by section 503A of the FD&C Act. Additional substances are under evaluation, and new substances may be added to the list through subsequent rulemaking.

Regulatory Impact Analysis

List of Bulk Drug Substances that can be used to Compound Drug Products in Accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) (PDF - 80KB)

Federal Register: 81 FR 91071, December 16, 2016

Docket: FDA-2016-N-3464