OR WAIT null SECS
FDA proposed in a Federal Register notice that bumetanide, nicardipine hydrochloride, and vasopressin should not be included on the list of bulk drug substances that outsourcing facilities may use in compounding.
On Aug. 27, 2018, FDA announced through a Federal Register notice that it was proposing that bumetanide, nicardipine hydrochloride, and vasopressin not be included on the list of bulk drug substances that drug compounders may use in compounding under section 503B of the Federal Food, Drug & Cosmetic Act (FD&C). The agency is seeking public comment before finalizing its decision.
The FD&C permits drug compounding with limitations, which include the use of bulk drug substances. Because compounded drugs are not evaluated by FDA for safety, effectiveness, or quality, the agency states compounded drugs should only be used when an FDA-approved drug is not available.
FDA found that bumetanide, nicardipine hydrochloride, and vasopressin are ingredients in drugs already approved by FDA. The agency felt that there was no reason why drugs already approved that contained these ingredients “could not be either used or adapted instead of compounding new drug products using bulk drug substances.”
“Our preliminary assessment is that the FDA-approved drug products containing these substances can either be used or adapted to treat patients instead of compounding new drugs from bulk drug substances as proposed by the nominations. So, at this point, we don’t see a clinical need for outsourcing facilities to compound from these bulk substances,” FDA Commissioner Scott Gottlieb, MD, said in a press release.