Question

Which federal statute initiated that commercial containers for prescription medications requires "Rx only" or "Caution: Federal law prohibits dispensing without a prescription order"?

Answer 1

The federal statute that requires the inclusion of 'Rx only' or 'Caution: Federal law prohibits dispensing without a prescription order' on commercial containers for prescription medications is the Drug Amendments of 1962.

Step-by-step explanation:

The federal statute that initiated the requirement for commercial containers for prescription medications to include the phrases 'Rx only' or 'Caution: Federal law prohibits dispensing without a prescription order' is the Drug Amendments of 1962. These amendments were made to the Federal Food, Drug, and Cosmetic Act (FFDCA), which is enforced by the Food and Drug Administration (FDA).

The Drug Amendments of 1962 were implemented to enhance drug safety and regulation in response to the thalidomide tragedy. It required drug manufacturers to provide evidence of both the safety and efficacy of their products before they could be marketed. As part of this regulatory process, the FDA mandated the inclusion of the 'Rx only' or 'Caution' labeling on commercial containers to clearly indicate that the medication is intended for prescription use only.

This labeling requirement helps prevent misuse and ensures that prescription medications are dispensed under the supervision of a healthcare professional. It is an important measure to promote patient safety and prevent the unauthorized use of prescription drugs.