Under amended sections 503A and 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act, to avoid submitting a new drug application (NDA), “a compounder must obtain a prescription for an individually identified patient,” said the FDA in a letter to US congressmen.
Congressman Morgan Griffith (R-VA) and 30 other members of the House of Representatives had written to the FDA to ask how it implements laws on “office use” of compounded medications by doctors and hospitals “within their practice settings.”
The FDA said Congress has not changed the part of the November 2013 Drug Quality and Security Act (DQSA) which required a prescription, and that the Administration “has issued Warning Letters to firms that were not getting prescriptions for individually identified patients.”
The FDA also said it “has begun to review its policies with respect to compounding and repackaging of drug products, including biological products, taking into consideration the best interest of patients and the recent passage of the DQSA.”
How far compounding pharmacies should be regulated, in comparison with more restricted contract manufacturing organisations (CMOs) has been a matter of much debate.
Griffith was one of the Congressmen introducing the unsuccessful bipartisan Compounding Clarity Act of 2013 (HR 3089), which led to the passage of the DQSA. The bills were in part a response to the deaths of 64 patients in 2012, who had received steroid injections contaminated with fungal meningitis from a compounding pharmacy.
The supervising pharmacist at New England Compounding Center, Glenn Chin, was arrested earlier this month in connection with the outbreak.
Two other compounding pharmacies received FDA warning letters three weeks ago for using unapproved APIs (active pharmaceutical ingredients), bacterial contamination, and violating GMP (good manufacturing practice) rules.
An amendment by the FDA to the DQSA in July this year allows drug compounders to register as CMOs, binding them to stricter rules and inspections, but for now the option is voluntary.