Final answer:
The Durham-Humphrey Amendment of 1951 to the FD&C Act allowed for oral prescriptions and refills, categorizing drugs into prescription and over-the-counter, and streamlining the drug approval process.
Step-by-step explanation:
The amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allowed for oral prescriptions and refills was the Durham-Humphrey Amendment of 1951. This amendment categorized drugs into two specific areas: prescription and over-the-counter (OTC). The passage of this amendment permitted oral prescriptions to be made by physicians and refills to be called into pharmacies, which was a significant change from the original 1906 Act that required a written prescription for any drug. This adjustment was essential in making drug dispensing more efficient and accessible for patients and healthcare providers. Moreover, the Durham-Humphrey Amendment facilitated the process by which new drugs could be classified either for prescription or OTC use by establishing a more streamlined drug approval process within the FDA.
The FDCA amendment that allowed for oral prescriptions and refills is the Prescription Drug Marketing Act of 1987. This amendment was enacted to prevent the sale of counterfeit, adulterated, misbranded, or expired prescription drugs in the market. One of the provisions of this act allowed oral prescriptions and refills under specific circumstances.