FDA In Brief: FDA Provides Preliminary Assessment on Five Bulk Drug Substances for Use by Outsourcing Facilities

March 23, 2021

Media Inquiries

The following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research:

“As part of our compounding oversight efforts, we have been developing a list of clinically needed bulk drug substances for outsourcing facilities to use in compounding, sometimes referred to as the 503B bulks list. Today, we’re providing our preliminary assessment for five additional substances nominated for inclusion on this list.

Based on our review, we have preliminarily found a clinical need for outsourcing facilities to compound drugs from one additional bulk drug substance. Access to compounded medicines is important for patients whose 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.

As we continue to develop the 503B bulks list, we are balancing the goal of patient protection against the goal of assuring access to compounded drugs for patients who need them, particularly compounded drugs intended for use in health care systems, including for office stock. The Federal Register notice we’ve issued outlines today’s proposal and we are seeking comments from the public before making a final decision. We’ll continue to evaluate other bulk substances for inclusion on this list as part of our continuing efforts to help ensure compounded drugs are available for patients who need them."

Additional Information:

Today, the U.S. Food and Drug Administration proposed to include one additional bulk drug substance 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 and Cosmetic Act. The bulk drug substance, quinacrine hydrochloride, is not a component of an FDA-approved drug. The agency nominated quinacrine HCl to compound oral products for the treatment of cutaneous lupus erythematosus (CLE).
The FDA also identified four bulk drug substances—bromfenac sodium, mitomycin–C, nepafenac and hydroxychloroquine sulfate—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 drugs starting from these bulk drug substances, and therefore proposed that the statutory standard for adding these bulk drug substances to the 503B bulks list has not been met

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.