Drugmakers Seek Improvements in Inactive Ingredient Database

The FDA should establish searchable names and correct incomplete entries in its inactive ingredient database to enhance its accuracy and usability, generic drug and excipients makers say.

GPhA and IPEC want the FDA to establish searchable names with unique identifiers for excipients that are consistent with other regulatory databases, including the agency’s Substance Registration System.

The agency also needs to assess the database to identify and correct incomplete entries, GPhA says, noting some lack key information, such as trade names, chemical abstracts service registries and unique ingredient identifiers.

The comments are among 23 submitted following the FDA’s August request for input on improving the database. The feedback will be used to inform future guidance on use of the database (Generic Line, Sept. 2).

USP says the FDA could avoid confusion and facilitate search capabilities by cross-referencing the United States Pharmacopeia-National Formulary official title to substances’ UNII number and brand and proprietary names for excipients and their mixtures.

IPEC takes issue with the database’s maximum potency data element, saying it’s inadequate because it doesn’t indicate dosage amount or frequency of administration. The database should also include the maximum daily amount of excipient that can be safely ingested, the group says.

Read all of the comments on docket no. FDA-2015-N-2986 at www.regulations.gov. — Jonathon Shacat



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