FDA Finalizes Compounding Guidance

On June 9, 2016, FDA published three final guidance documents regarding the compounding of drug products. The guidance documents address the regulation of firms that compound drugs and the compounding of bulk drug substances by FDA-registered outsourcing facilities.

Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act details FDA’s enforcement of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C), which has been amended by Congress to remove advertising and solicitation provisions. The guidance states a Pharmacy Compounding Advisory Committee must rule and consult on parts of 503A before they can be implemented. The guidance “explains how the provisions will be applied pending those consultations and rulemaking. This guidance also describes some of the possible enforcement actions FDA can bring against individuals or firms that compound drugs in violation of the FD&C Act.”

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act “describes FDA’s interim regulatory policy for licensed pharmacists in State-licensed pharmacies and Federal facilities and for licensed physicians that compound human drug products using bulk drug substances while the list is being developed.” FD&C Act section 503A includes restrictions on bulk drug substances that compounders may use. FDA prepared this guidance to be used while it is developing its list of 503A bulk drug substances.

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act presents FDA’s interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA is developing a list of bulk drug substances that can be compounded under section 503B of the FD&C Act. Section 503B of the FD&C Act restricts certain bulk drug substances that outsourcing facilities can use in compounding.

More information on the interim policy and the guidance documents can be found on FDA's website.

Source: FDA