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FDA Adds the First Four Bulk Drug Substances to the 503B Bulks List |
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As part of FDA’s efforts to help ensure Americans have access to compounded medicines when a patient’s medical needs cannot be met by an FDA-approved drug, FDA has added the first four bulk drug substances to the list of bulk drug substances that may be used in compounding by outsourcing facilities (503B Bulks List). The bulk drug substances include: diphenylcyclopropenone (DPCP) for topical use , glycolic acid for topical use in concentrations up to 70 percent, squaric acid dibutyl ester (SADBE) for topical use, and trichloroacetic acid (TCA) for topical use. These bulk drug substances are not components of any currently FDA-approved drugs. FDA also determined that eight bulk drug substances will not be added to the list at this time.
FDA’s dedicated clinicians and researchers have implemented a careful and deliberative process to consider whether a bulk drug substance should be included in the 503B Bulks List. This process is also informed by external research partners, feedback from industry stakeholders, and other public commenters. As development of the 503B Bulks List progresses, nominations of bulk drug substances that are adequately supported will continue to undergo the thorough FDA vetting necessary to protect patients while balancing access to compounded drugs to meet patient needs. To mitigate patient access concerns, FDA’s Interim Policy on Compounding Using Bulk Drug Substances is set forth in guidance and addresses compounding from certain bulk drug substances while the agency conducts its clinical need evaluations.
Federal law places conditions on compounded drugs that qualify for the exemptions in section 503B of the Federal Food, Drug, and Cosmetic Act. One of these conditions is that a drug must be compounded by an outsourcing facility that only compounds drugs using bulk drug substances for which the FDA has determined there is a clinical need (the 503B Bulks List) unless the compounded drug appears on the FDA’s drug shortage list at the time of compounding, distribution and dispensing. FDA will continue to balance patient protection and access to compounded drugs for patients who need them.
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