FDA in Brief: FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound drugs using nine bulk drug substances

August 30, 2019

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“Access to compounded medicines is important for patients whose medical needs cannot be met by an FDA-approved drug. It is also important to recognize that compounded drugs do not meet the same standards as FDA-approved drugs and do not undergo premarket review for safety, effectiveness and quality.” said Donald D. Ashley, director of compliance for the FDA's Center for Drug Evaluation and Research. “As part of our compounding oversight efforts, we are developing a list of bulk drug substances for which there is a clinical need and that outsourcing facilities can use in compounding, which is known as the 503B bulks list. Today, we’re providing our preliminary assessment for nine substances nominated for inclusion on this list. Based on our review, we have not found a clinical need for outsourcing facilities to compound drugs from these nine bulk drug substances. We’re issuing a Federal Register notice outlining our proposal and seeking comments from the public before making a final decision. We’ll continue to evaluate other bulk substances for inclusion on this list.”

Today, the U.S. Food and Drug Administration issued a Federal Register notice identifying nine bulk drug substances that the agency has considered and is proposing not to include on the list of bulk drug substances (or active pharmaceutical ingredients) that outsourcing facilities may use in drug compounding under section 503B of the Federal Food, Drug & Cosmetic Act. The nine bulk drug substances are: dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue, and vecuronium bromide.

Each of these substances is an ingredient of one or more FDA-approved drug products. The nominations for these substances did not provide a reason why the FDA-approved drug products containing these substances could not be either used or adapted instead of compounding new drug products using bulk drug substances. To date, the agency has not found a clinical need for an outsourcing facility to use these bulk drug substances to compound finished products, which is the statutory standard for adding a bulk drug substance to the 503B bulks list. Therefore, the FDA is proposing to not include these substances on the 503B bulks list and we are seeking public comment before finalizing our decision.

The agency’s final guidance on this issue provides information regarding the analysis and processes the FDA intends to use to evaluate whether a bulk substance should be used by outsourcing facilities in compounding. As the FDA evaluates bulk drug substances, the agency intends to publish notices for public comment in the Federal Register that describe the FDA’s proposed position on each substance along with the rationale for that position.

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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.