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Regulatory Focus™ > News Articles > 2019 > 2 > FDA Kicks Off List of 503A Bulk Drug Substances List

FDA Kicks Off List of 503A Bulk Drug Substances List

Posted 15 February 2019 | By Ana Mulero 

FDA Kicks Off List of 503A Bulk Drug Substances List

Six bulk drug substances added to the US Food and Drug Administration (FDA) list of substances can, for the first time, be legally used to compound drugs under a final rule issued by FDA on Friday.

“Balancing patient needs for compounded products with patient safety is critical,” FDA Commissioner Scott Gottlieb said. “Patients still face too many risks when it comes to compounded drugs, which do not go through the premarket approval process.”

Licensed pharmacists, in-state licensed pharmacies or federal facilities and licensed physicians are safeguarded by the final rule for compounding the six bulk drug substances. These comprise the agency’s initial list of bulk drug substances, on what’s known as the 503A bulks list, that can be legally used to compound drugs products in accordance with the FD&C Act.

The agency’s newly added drug substances include Brilliant Blue G—otherwise known as Coomassie Brilliant Blue G-250—cantharidin (for topical use only), diphenylcyclopropenone (for topical use only), N-acetyl-D-glucosamine (NAG) (for topical use only), squaric acid dibutyl ester (for topical use only), as well as thymol iodide (for topical use only).

The rule establishes the criteria for evaluating nominated bulk drug substances for inclusion on the 503A bulks list. Four criteria were established relating to the physical and chemical characterization of the substance, safety issues raised by use of the substance in compounded drug products, evidence of effectiveness and historical use of the substance.

The agency’s final rule also identified a total of four bulk drug substances that are not permitted to be used for compounding drugs in the US. “Additional bulk drug substances are under evaluation and new substances may be added to the list through subsequent rulemaking,” the final rule noted.

Final rule

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