- The Food and Drug Administration is seeking to exclude three bulk drug substances from its list of permitted compounds for outsourcing facilities, known as the Section 503B bulks list.
- The agency issued a Federal Register notice to seek public comment and outline its proposal, which is based on the rationale that there are approved drugs that can be used or adapted instead of bumetanide, nicardipine hydrochloride and vasopressin.
- This is the first time the FDA has issued such a proposal since the Drug Quality and Security Act (DQSA) was passed in 2013.
Compounding can play an important role in treating certain groups of patients whose needs aren't met by existing products, like those allergic to certain excipients or in need a specific combination of drug and diluent in an intravenous infusion.
There are risks to making drugs outside of an FDA-approved facility. After a fungal meningitis outbreak in a Massachusetts compounding pharmacy killed 76 people in 2012, the DQSA was passed, giving the FDA more authority to regulate compounded drugs.
"Compounded drug products can serve an important medical need for patients, but they don’t meet the same standards as FDA-approved drugs," FDA Commissioner Scott Gottlieb said in an Aug. 27 statement.
According to an FDA release, in the case of bumetanide, nicardipine hydrochloride and vasopressin, "the nominations did not give any reason why the FDA-approved drug products containing these substances could not be either used or adapted instead of compounding new drug products using bulk drug substances."
Because of this, the FDA did not find clinical need for an outsourcing facility to use these bulk drug substances to compound finished products and proposed to exclude them from the Section 503B bulks list.
The FDA also plans to release revised versions of a draft Memorandum of Understanding with states on a more flexible approach to certain compounders, a draft guidance on insanitary conditions at compounding facilities, and a guidance on current good manufacturing practice requirements for outsourcing facilities.
Last month, the FDA continued stepping up its regulation on compounded drugs with a risk alert on cesium chloride. The agency said it intended to move cesium chloride from category 1 to category 2, which includes substances with significant safety risks.