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Compounding: FDA Stepping Up Enforcement With Warning Letters?

 
• By Derrick Gingery

FDA calls North Carolina compounder’s products misbranded and adulterated after the company did not receive valid prescriptions for a number of products it made and agency found several GMP violations.

A compounder’s inability to obtain proper prescriptions for its products allowed FDA to issue a warning letter for a number of violations of Good Manufacturing Practices and other regulations.

The letter may be another indication of the route the agency could take to force compounders to adhere to more stringent manufacturing practices without a legislative remedy.

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