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US Regulatory SUNSET Misses FDA’s OTC Drug Regulations, But Reaches Supplement Rules

 
• By Eileen Francis

Expiration dates in HHS’ final SUNSET rule exclude OTC drugs after CCHPA and other groups argue the rule would create more problems than it would solve. But dietary supplement regulations are subject to the rule.

US regulations for OTC drugs were exempted from expiration dates under a Department of Health and Human Services final rule on trimming federal regulations after the industry argued that eliminating rules would create problems more than it would reduce regulatory burden.

The HHS’ final Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule stated that in addition to OTC drug regulations, it exempts some device and food regulations and also extends from two to five calendar years the deadline for assessing and reviewing regulations more

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