USA – FDA Revises 1989 Guidance on Drug Master Files

The revised draft guidance from the US Food and Drug Administration (FDA) on drug master files (DMFs) deals with submissions on confidential information about facilities, manufacturing, processing, packaging and storing drugs.

FDA said Friday that the update includes new procedures for DMFs referenced in abbreviated new drug applications (ANDAs), more detailed instructions on submitting original DMFs versus amendments, reference to the electronic submission requirements under section 745A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to certain DMFs, clarification and reorganization of material associated with Type III and Type IV DMFs and a change in FDA’s contact person for the guidance.

The 22-page draft, updated from September 1989, also discusses the four types of DMFs (Type I DMFs were discontinued in 2000):

  • Type II, which is for drug substance, drug substance intermediate and materials used in their preparation or drug product
  • Type III is for packaging material
  • Type IV is for excipient, colorant, flavor, essence or material used in their preparation
  • Type V is for FDA-accepted reference information…