FDA Clarifies When Drug Compounders Must Register with the Agency

August 17, 2015

The FDA last week issued final guidance clarifying when large drug compounding facilities must register with the agency, making only a few changes to a draft version released in February.

According to the agency, compounders should register as outsourcing facilities only if all of their products are compounded according to FDA conditions and comply with good manufacturing practices. That means that the bulk substances and other ingredients they use meet FDA requirements, none of the compounded drugs  appears on a list of drugs withdrawn from the market for safety or efficacy reasons and the drugs haven’t been designated as difficult to compound, among criteria.

The guidance — one of four documents for compounders released for comment in February — applies to facilities that compound sterile drugs and does not affect compounders of nonsterile products and repackaging facilities. None of the other three drafts has been finalized.

The final version drops a reference to guidance explaining how outsourcing facilities should report the products they compound because it doesn’t directly relate to the issue of registration as an outsourcing facility.

The FDA also added references to guidance on registration, reporting and fees and on compounded animal drugs made from bulk drug substances.

To view the final guidance, go to www.fdanews.com/08-12-15-OutsourcingGuidance.pdf . — Kellen Owings