Module 6

04/10/2024

57

OTC drug products - USA

• As with Europe - very important

● Reduces healthcare costs for individuals for treatment of more trivial conditions

The Organisation for Professionals in Regulatory Affairs

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58

USA – OTC Regulatory History…

 Durham-Humphrey amendment (1951)

 Not safe for self-administration if: ▪ Habit-forming ▪ Too much potential for harmful effects ▪ Not suitable for self-diagnosis and treatment  OTC products can be sold if: ▪ They are exempt due to OTC review / monograph ▪ Exempt from prescription sale under NDA

The Organisation for Professionals in Regulatory Affairs

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