Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Drug Master Files for Bulk Antibiotic Drug Substances
Origin/Publisher:	FDA Office of Enforcement, HFC-200, 5600 Fishers Lane, Rockville, MD 20857, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Content:	This FDA Guideline deals specifically with Drug Master Files for antibiotics.
Document Type:	FDA Guidance for Industry