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Compounders Complain They Can’t Make These Four Drugs Once They’re Deemed Biologics

 
• By Joanne S. Eglovitch

After 23 March, the US FDA won’t allow any more bulk compounding of four oft-compounded drug substances, disrupting patient care, compounders say.

Smiling pharmacist and indian pharmacy technician posing in drugstore - Image
FDA's Announcement To Shift Four Drug Substances Over To Biologics Raising Resistance • Source: Shutterstock

Major disruptions in patient access to compounded versions of four bulk drug substances may result from the US Food and Drug Administration’s decision, announced 5 March, to regulate them beginning 23 March as biologics licensed under the Public Health Service Act, drug compounding industry groups say.

The announcement said outsourcing facilities complained four substances on the FDA’s preliminary list would be affected by the...

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
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More from Compliance

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By Sue Sutter

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EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

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