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FDA Finalizes Guidance on 503B Bulks List

Posted 01 March 2019 | By Zachary Brennan 

FDA Finalizes Guidance on 503B Bulks List

Today, the US Food and Drug Administration (FDA) issued a final guidance for the drug compounding industry on the 503B Bulks List, which is a list of bulk drug substances for which there is a clinical need.

Drug products compounded using bulk drug substances on the 503B list qualify for certain exemptions from the Food, Drug, and Cosmetic Act (FD&C Act), provided certain conditions in section 503B are met.

This guidance addresses FDA policies for developing the 503B Bulks List, including the agency’s interpretation of what exactly bulk drug substances for which there is a clinical need means, and as it is used in section 503B.

As far as changes between the draft and final guidance, FDA said it received about 60 comments on the draft guidance.

“In response to received comments or on its own initiative, FDA made certain changes to the guidance. For example, FDA has further explained how Congress' limitation on bulk drug substances that can be used in compounding under section 503B helps to preserve the integrity of the new drug approval process and identified the process to request that FDA add or remove a bulk drug substance from the 503B Bulks List after the Agency has made a final determination with respect to that substance in the Federal Register,” FDA said.

In addition to the guidance, FDA also issued a Federal Register notice announcing that it has decided not to include two bulk drug substances that were nominated for the 503B bulks list: nicardipine hydrochloride and vasopressin. 

Endo International praised the move by FDA, as it owns the only vasopressin product approved by the FDA. 

And for one other bulk drug substance nominated last August, bumetanide, FDA said Friday it is not making a final determination. “This substance remains under consideration,” the agency said.

Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

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