FDA issues two draft guidance documents regarding bulk drug substances used in compounding drug products
[10/26/2015] FDA today issued two draft guidance documents regarding the use of bulk drug substances in compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- Draft Guidance for Industry, “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act”
- Draft Guidance for Industry, “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act”
Bulk drug substances used in compounding under sections 503A and 503B must meet certain criteria, and both sections 503A and 503B direct FDA to develop lists of bulk drug substances that can be used in compounding under each of these sections. FDA is in the process of developing these lists. In the interim, these draft guidance documents set forth FDA’s proposed policies regarding the conditions under which the Agency does not intend to take action against State-licensed pharmacies, Federal facilities, and licensed physicians (under section 503A) or outsourcing facilities (under section 503B) that compound drug products from bulk drug substances that cannot otherwise be used in compounding under these sections.
FDA is issuing these draft guidance documents to avoid unnecessary disruption to patient treatment while FDA considers the bulk drug substances nominated for use in compounding under sections 503A and 503B of the FD&C Act and to clarify the process by which FDA is evaluating the nominated bulk drug substances.
In addition, FDA has established two public dockets to receive nominations for bulk drug substances for inclusion on the lists of bulk drug substances that can be used in compounding under sections 503A and 503B of the FD&C Act. FDA is establishing these public dockets to receive re-nominations for substances that were previously nominated without sufficient supporting information and new nominations for substances that were not previously nominated.
Both guidance documents are available for public comment.
Resources for You
- Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket
- Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket
- Regulatory Policy Information
- Draft guidances for industry on FDAâs interim policy on compounding using bulk drug substances under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act