What did the Durham Humphrey Amendment establish?

The Durham-Humphrey Amendment, enacted in 1951, is significant because it established a clear distinction between over-the-counter (OTC) medications and prescription drugs. This amendment amended the Federal Food, Drug, and Cosmetic Act to specify that certain drugs must be dispensed only with a prescription from a licensed healthcare provider. It was crucial in shaping the framework by which drugs are categorized based on their safety and effectiveness when used without a physician's supervision.

This amendment also allowed for the practice of refills on prescriptions and set standards for labeling prescription medications, enhancing patient safety and ensuring proper use of these powerful substances. By creating this distinction, the Durham-Humphrey Amendment helped regulate access to drugs that required supervision and professional guidance, thus safeguarding public health.

The other options refer to different aspects of legislation or regulation that are not directly connected to the core purpose of the Durham-Humphrey Amendment. The focus on OTC versus prescription drugs is what makes this amendment particularly important in the context of pharmacy jurisprudence.