This guidance is intended for those in industry whose approved applications for bulk antibiotic drug substances (i.e., bulk applications) were converted to Type II Drug Master Files (DMFs) when section 507 of the Federal Food, Drug, and Cosmetic Act was repealed as part of the enactment of section 125 of Title I of the Food and Drug Administration Modernization Act on November 21, 1997. This guidance explains the purpose of DMFs, discusses the type of information expected in a Type II DMF, outlines administrative procedures governing review of DMFs, and clarifies your responsibilities as a DMF holder. The information presented in this guidance is also relevant to the submission of new DMFs for bulk antibiotic drug substances.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.