FDA Finalizes Bulk Drug substances Rule

The U.S. Food and Drug Administration (FDA) has issued a final rule under section 503A of the Federal Food Drug and Cosmetic Act, placing, for the first time, six bulk drug substances on the list of substances that compounders can use to compound drugs, known as the 503A bulks list. This rule also identifies four bulk drug substances that are not included on the 503A bulks list, and therefore cannot be used in compounding under section 503A. The rule establishes the criteria for evaluating nominated bulk drug substances for inclusion on the 503A bulks list. These criteria include the physical and chemical characterization of the substance, safety issues raised by use of the substance in compounded drug products, evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance and historical use of the substance in compounded drug products. This final rule applies to compounding by licensed pharmacists in state-licensed pharmacies or federal facilities, and licensed physicians.

"Balancing patient needs for compounded products with patient safety is critical. Patients still face too many risks when it comes to compounded drugs, which do not go through the premarket approval process. We’re taking a number of steps to help ensure that compounders do not unnecessarily put patients at risk by using a bulk drug substance that is not appropriate for compounding because of safety risks or other concerns," said FDA Commissioner Scott Gottlieb, M.D. "Today, we’re issuing a final rule that adds six bulk drug substances to the list of bulk substances that can be used by compounders not registered as outsourcing facilities. It also identifies four bulk drug substances that are not allowed. Developing the bulks lists for these compounders and outsourcing facilities remains a compounding priority and we look forward to continuing this work in 2019."

As the FDA works to develop the 503A bulks list, the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A provides information for state-licensed physicians and pharmacists regarding bulk drug substances nominated for the list that may be used in compounding. Since the FDA has issued the final rule regarding the inclusion of these 10 nominated substances, the interim policy no longer applies to these 10 substances. The agency continues its rulemaking efforts to propose and seek public comment on additional bulk drug substances nominated for the 503A bulks list.

The final rule goes into effect on March 21, 2019.

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