The FDA is developing a list of bulk drug substances (active ingredients) that can be used to compound drug products in accordance with the FD&C Act. The FDA previously solicited nominations for the list, but some of the nominated substances were not supported by sufficient information for the FDA to evaluate them. The FDA is establishing a public docket where these substances can be renominated with sufficient supporting information or to receive nominations of bulk drug substances that were not previously nominated for consideration for inclusion on the 503B bulks list. Comments can be submitted at any time.

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