FDA Says No Need to Compound from Bumetanide, Nicardipine hydrochloride, and Vasopressin

News
Article

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.

Source: FDA

 

Recent Videos
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.
Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes