Geschäft · 20.7.20151 Min. Lesezeit
List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Extension of Nomination Period
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is extending the nomination period for the notice that appeared in the Federal Register of May 19, 2015. In the notice, FDA requested nominations for a list of bulk drug substances that may be used by facilities registered as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs from bulk substances, in accordance with FDA's draft guidance for industry (GIF) #230, "Compounding Animal Drugs from Bulk Drug Substances." The FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit nominations.