FDA Outlines Enforcement Penalties for Compounders

Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to.

Compounders have told the FDA in their responses that they believe they are instead subject to oversight of their State Pharmacy Boards, not the FDA.

In general, compounded drugs are exempt from GMP requirements if the products are for a specific patient with a prescription, or are produced in limited quantities by a pharmacist. Compounders are allowed to distribute 5 percent of their prescription orders to other states, but must enter into agreements with the FDA to distribute larger quantities. The FDA issued guidance in August on when to register with the agency as a compounder.

The FDA’s final guidance puts compounders on equal GMP footing with other drugmakers. The FDA says it does not need to identify a particular safety problem before pursuing an enforcement action.

The agency also published two draft guidances — covering the interim regulatory policy on compounding bulk drug substances, which is restricted under Section 503A, and compounding by outsourcing facilities, which is restricted under Section 503B of the FD&C Act.

Roughly 2,950 substances were nominated for the 503B list, but 1,750 of them are biologicals, which are not eligible for the list. Roughly 740 substances were nominated for the 503A list, but 275 were already eligible for use in compounding and didn’t need to be on the list.

Read the final guidance on Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetics Act here: www.fdanews.com/10-15-FDA-Compounding1.pdf.

The draft guidances on Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act and Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act are here, respectively: www.fdanews.com/10-15-Compounding3.pdf and www.fdanews.com/10-15-FDA-Compounding2.pdf.