Search Results for drug substances

Showing 1 – 2

FDA Considers WHO Scheduling Change for 17 Drug Substances By Zachary Brennan - Published 11 August 2017

The US Food and Drug Administration (FDA) on Friday sought public comments to help prepare a response to the World Health Organization (WHO) regarding the abuse liability and diversion of 17 drug substances, many of which are opioids and similar to fentanyl. WHO will consider whether to recommend certain international restrictions be placed on the drugs.

Categories: News, US, FDA, WHO, Crisis management, Drugs, Government affairs

Tags: drug substances, fentanyl, opioids, cannabis

FDA Proposes New Rule on Bulk Substances Used to Compound Drugs By Zachary Brennan - Published 15 December 2016

The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Manufacturing, Quality

Tags: drug compounding, 503A bulks list, bulk drug substances, APIs