With More OTC Drugs On Radar, US FDA Reminds Industry Of Statement Of Identity Requirements

Consumer Self-Care Also Noted In Sodium, Potassium, Phosphorous Labeling Recommendations

Draft guidances published on statements of OTC drug identity and strength and on labeling of sodium, potassium and phosphorous levels. Recommendations come as agency and drug industry anticipate more OTC remedies becoming available through proposed ACNU rule and streamlined monograph program.

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The Food and Drug Administration galvanizes its work to make more drugs available OTC in the US with recommendations on compliance with labeling requirements for the content and format of statements of identity and strength.

The agency also torques its support for improving consumers’ self-care choices with recommendations on clearly stating the amounts contained in...

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