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List of Bulk Drug Substances That Can Be Used Compound Drug Products in Accordance With Section 503A of the Federal Food Drug and Cosmetic Act Final Regulatory Impact Analysis

List of Bulk Drug Substances That Can Be Used Compound Drug Products in Accordance With Section 503A of the Federal Food Drug and Cosmetic Act Final Regulatory Impact Analysis

We evaluated ten bulk drug substances for this final rule.  We will place six bulk drug substances on the 503A Bulks List and we will not place four substances on the 503A Bulks List.  We expect that the rule will affect compounding pharmacies and other producers that market the affected substances or drug products made from the affected substances, consumers of drug products containing the affected substances, and payers that cover these drug products or alternative treatments.  Because we lack sufficient information to quantify most of the costs and benefits of this final rule, we also include a qualitative description of potential benefits and potential costs.

Regulatory Impact Analysis

List of Bulk Drug Substances That Can Be Used Compound Drug Products in Accordance With Section 503A of the Federal Food Drug and Cosmetic Act Final Regulatory Impact Analysis (PDF - 226KB)

Federal Register: 84 FR 4696, February 19, 2019

Docket: FDA-2016-N-3464