Final answer:
The Durham Humphrey Amendment to the 1938 FDA act in 1951 created a clear distinction between prescription and over-the-counter medications, gave the FDA oversight of prescription drug advertising, and later led to requirements for proof of efficacy for new drugs.
Step-by-step explanation:
When Durham Humphrey amended the 1938 FDA act in 1951, significant changes were made to the regulation of pharmaceuticals. The amendment introduced a distinction between drugs that could be sold over-the-counter (OTC) and those requiring a prescription. This change necessitated that certain drugs could only be dispensed with a physician's prescription, and it gave the Food and Drug Administration (FDA) the authority to supervise prescription drug advertising, rather than leaving it in the hands of the Federal Trade Commission. As a result, consumer safety was enhanced by ensuring that potent medications would be used under the supervision of healthcare professionals. Moreover, the amendments mandated that drug manufacturers provide proof of efficacy for any new drug applications submitted to the FDA post-1962.
Prescription and Over-the-Counter (OTC) Drugs: The amendment established a distinction between prescription and over-the-counter drugs. It empowered physicians to prescribe medications that were deemed unsafe for use without medical supervision.
Labeling Requirements: The Durham-Humphrey Amendment introduced specific labeling requirements for prescription drugs. It mandated that prescription drugs include adequate directions for use and carry the cautionary statement, "Caution: Federal law prohibits dispensing without a prescription."
Oral Prescriptions: The amendment allowed for the verbal authorization of prescriptions by physicians, facilitating more accessible and timely access to necessary medications.