FDA Releases New Compounding Regulations

In an ongoing effort to implement the provisions of the Drug Quality and Security Act, signed into law by President Obama in November 2013, the FDA released multiple documents further regulating compounding pharmacies.

The documents, released on July 1, 2014, include a final guidance for pharmacists and pharmacies intending to compound drugs under section 503A. In addition to restating the requirements of section 503A and describing the agency’s interim policies for certain provisions, the guidance lists the potential enforcement actions the FDA will take against compounding pharmacies and pharmacists who violate the Federal Food, Drug, and Cosmetic Act.

The new regulations also include draft interim guidance detailing the agency’s expectations for compliance with current good manufacturing practice requirements, focusing on sterility assurance and the safety of compounded drug products. The FDA also released a proposed rule that would revise the agency’s current list of drugs that cannot be compounded because they were found to be unsafe or ineffective and have been removed from the market. The rule would modify the description of 1 drug and add 25 new products to the list. The draft guidance and the proposed rule apply to both compounding pharmacies and facilities registered with the agency as outsourcing facilities.

In addition, in 2 Federal Register Notices, the FDA stated that it is reopening the nomination process for lists of bulk substances that may be used in compounding.

The draft interim guidance and proposed rule are available for public comment for 60 days, and the public can nominate bulk drug substances for compounding under section 503A or 503B for 90 days.