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No Change To US FDA’s Risk-Based Homeopathic Enforcement From Its OTC Monograph Overhaul

 
• By Malcolm Spicer

Final guidance presents same descriptions of six "categories of homeopathic drug products ... potentially posing higher risks to public health” agency stated in 2019 revised draft. Agency adds reference to monograph reform in explanation of how homeopathics aren't GRASE.  

FDA final guidance presents same descriptions of six areas of enforcement priorities – “certain categories of homeopathic drug products marketed without the required FDA approval as potentially posing higher risks to public health” – agency stated in a 2019 revised draft guidance. • Source: Shutterstock

Adding a statement that an overhaul of its OTC drug monograph program didn’t affect the US Food and Drug Administration’s oversight of homeopathic drugs is the biggest change between the agency’s draft and final guidances on regulating the Rx and OTC products.

The guidance the FDA published on 7 November presents the same descriptions of six areas of enforcement priorities – “certain categories of homeopathic drug products marketed without the required...

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