Module 6

04/10/2024

75

Labeling • OTC drug labeling ● ALL labels as well as written, printed or graphic matter accompanying the product ❑ Needs a label comprehension study ● Regulated by FDA ● Standard “Drug Facts” format ❑ Similar to “Nutrition Facts” / “Supplement Facts”

• OTC drug advertising ● Regulated by FTC

The Organisation for Professionals in Regulatory Affairs

75

76

The Organisation for Professionals in Regulatory Affairs

76

38