header bg

Question:

Which of these laws states that all medication products must have directions for use and appropriate safety warnings?

A Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA, FDCA, or FD&C)
Explaination

The FFDCA requires all products to include a list of ingredients, directions, and safety warnings. It also states that all drugs must be approved by the FDA prior to being marketed and used by patients. The FFDCA improved upon the Pure Food and Drug Act by adding the safety requirements that the Pure Food and Drug Act was missing. The Isotretinoin Safety and Risk Management Act of 2004 addresses the need for Risk Evaluation and Mitigation Strategy (REMS) criteria and specific monitoring of patients using medications with potentially serious adverse effects. The PPPA describes the security requirements for medication packaging to prevent children from accessing the medication.