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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 transition when they are deemed as biologics: human chorionic gonadotropin...

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