FDA In Brief: FDA Proposes Four Bulk Drug Substances for Inclusion, 19 Not to Be Included on 503B Bulks List for Use by Outsourcing Facilities

July 30, 2020

Media Inquiries

The following quote is attributed to Patrizia Cavazzoni, M.D., Acting Director of the FDA’s Center for Drug Evaluation and Research:

“As part of our oversight efforts to help ensure that Americans have access to compounded medicines, we are developing and evaluating a list of bulk drug substances that outsourcing facilities can use in compounding when it’s been determined that there is a clinical need. We believe that patients should have access to these drugs when their medical needs cannot be met by an FDA-approved drug.

“While compounded drugs do not undergo premarket review for safety, effectiveness and quality, we recognize they can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. As we develop the 503B bulks list, we are balancing these goals of patient protection and access to compounded drugs for patients who need them, particularly compounded drugs intended for use in health care systems, including use for office stock.

“Today, we’re proposing the addition of four drug substances to the 503B bulks list. If the proposal is finalized, outsourcing facilities would be authorized to use these substances in compounding as long as they meet the other conditions in section 503B. There are also 19 bulk drug substances the FDA has reviewed and proposes not to include on the 503B bulks list. For each of these proposals, we are seeking comments from the public before making a final decision. The FDA will continue to evaluate other bulk substances for inclusion on this list as part of our continuing efforts to help ensure availability for patients who require access to medically necessary compounded drug products.”

Today, the U.S. Food and Drug Administration proposed to include four bulk drug substances on the list of bulk drug substances (or active pharmaceutical ingredients) that outsourcing facilities may use in drug compounding consistent with section 503B of the Federal Food, Drug & Cosmetic Act. The four bulk drug substances are: diphenylcyclopropenone, glycolic acid, squaric acid dibutyl ester and trichloroacetic acid. These substances are not components of FDA-approved drug products.
The FDA also identified 19 bulk drug substances that the agency has considered and proposed not to include on the 503B bulks list. Based on the information reviewed, the agency did not find a clinical need for an outsourcing facility to compound drug products starting from these bulk drug substances, and therefore the statutory standard for adding these bulk drug substances to the 503B bulks list has not been met. The FDA is seeking public comment on this proposal before finalizing its decision.

Related Information

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.