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  5. Draft guidances for industry on FDA’s interim policy on compounding using bulk drug substances under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
  1. Human Drug Compounding

Draft guidances for industry on FDA’s interim policy on compounding using bulk drug substances under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

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Under section 503A of the FD&C Act, bulk drug substances used in compounding must either be components of FDA-approved drug products, the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, or appear on a list established by FDA through rulemaking of bulk drug substances that can be used in compounding. This draft guidance sets forth FDA’s proposed policy regarding the conditions under which the Agency does not intend to take action against a licensed pharmacist in a State-licensed pharmacy or Federal facility, or a licensed physician, for compounding drug products using bulk drug substances that are not components of FDA-approved drug products or the subject of an applicable USP or NF monograph, while FDA develops the list of bulk drug substances that can be used in compounding under this section.

Under section 503B of the FD&C Act, bulk drug substances used in compounding must either appear on a list published by FDA in the Federal Register of bulk drug substances for which there is a clinical need, or they must be used to compound drug products that appear on FDA’s drug shortage list at the time of compounding, distribution, and dispensing.  This draft guidance sets forth FDA’s proposed policy regarding the conditions under which the Agency does not intend to take action against an outsourcing facility for using bulk drug substances to compound drug products that do not appear on the FDA drug shortage list at the time of compounding, distribution, and dispensing, while FDA develops the list of bulk drug substances that can be used in compounding under this section.

FDA has also opened two public dockets (FDA-2015-N-3534 and FDA-2015-N-3469) where interested persons can nominate bulk drug substances for inclusion on the lists of bulk drug substances that can be used to compound drug products under sections 503A and 503B of the FD&C Act.  Re-nominations for substances that were previously nominated without sufficient supporting information and new nominations for substances that were not previously nominated can be submitted to these dockets.
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