WASHINGTON, April 20 -- Food and Drug Administration has issued a notice called: Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on April 20 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Establishing Impurity Specifications for Antibiotics." The draft guidance provides recommendations regarding the establishment of specifications for organic impurities in antibiotics manufactured by fermentation and semi-synthesis. This draft guidance applies to antibiotic drugs ...