Proposed rule also addresses criteria for evaluating bulk drug substances and four bulk drug substances not proposed for inclusion on the 503A bulks list
[12/15/2016] Today FDA issued a proposed rule, List of Bulk Drug Substances that can be used to Compound Drug Products, addressing six bulk drug substances the agency has evaluated and is proposing for inclusion on a list of bulk drug substances that can be used in compounding under section 503A of the Food, Drug, and Cosmetic Act. The proposed rule also proposes that four other bulk drug substances that FDA evaluated not be included on the 503A bulks list.
If the proposed rule is finalized, the six bulk drug substances proposed for inclusion will be the first ones included on the 503A bulks list.
FDA also proposes to use the following criteria when evaluating nominated substances for inclusion on the list:
- The physical and chemical characterization of the substance;
- Any safety issues raised by the use of the substance in compounded drug products;
- The available evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists; and
- Historical use of the substance in compounded drug products, including information about the medical condition(s) the substance has been used to treat and any references in peer-reviewed medical literature.
FDA proposes to consider each criterion in the context of the others and balance them, on a substance-by-substance basis, to decide whether a particular substance is appropriate for inclusion on the 503A bulks list. The Federal Register notice announcing the proposed rule provides additional details about the kind of information proposed to be considered for each criterion and how FDA proposes to weigh the information.
Substances proposed for inclusion on the 503A bulks list
The FDA applied the proposed criteria for evaluating bulk drug substances for the 503A bulks list. Based on its evaluation, as well as consultation with the Pharmacy Compounding Advisory Committee, FDA is proposing to include six bulk drug substances on the list:
- Brilliant Blue G, also known as Coomassie Brilliant Blue G-250
- cantharidin (for topical use only)
- diphenylcyclopropenone (for topical use only)
- N-acetyl-D-glucosamine (for topical use only)
- squaric acid dibutyl ester (for topical use only)
- thymol iodide (for topical use only)
Substances not proposed for inclusion on the 503A bulks list
FDA is proposing that the following four substances not be included on the list:
- silver protein mild
The public comment period on the proposed rule closes in 90 days. The Federal Register notice has information on how to submit comments.