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Annual Report With Monthly Production Totals Added To OTC Monograph Drug Firms' To-Do List

 
• By Malcolm Spicer

Firms making drugs available in US without pre-market approval, including homeopathics, got another annual reporting requirement under CARES Act.  “It's going to be a bit of a sea change for the industry, and they're going to need to be prepared for it,” says attorney Ann Begley.

• Source: Alamy

Manufacturers of OTC monograph drugs got more than a more efficient program controlling how their products are formulated and labeled under the Coronavirus Aid, Relief and Economic Security (CARES) Act Congress passed in 2020.

They, along with firms making homeopathics marketed in the US without pre-market approval and makers of some approved drugs, also...

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