Licensure & Personnel — Federal Law

It prohibited interstate commerce in adulterated or misbranded foods and drugs. It did not require any premarket proof of safety or effectiveness before a drug could be sold.

The Elixir Sulfanilamide disaster, in which a sulfanilamide product dissolved in diethylene glycol killed more than 100 people. Congress responded by requiring manufacturers to prove a new drug safe before marketing.

It required a new drug application showing the drug was safe for its labeled use before it could be marketed. Proof of effectiveness was not added until 1962.

It divided drugs into prescription (legend) drugs, which require a practitioner's supervision to use safely, and over-the-counter drugs that can be labeled for safe self-use. Prescription drugs had to carry a federal legend.

It authorized pharmacists to accept oral prescriptions from practitioners and to refill prescriptions when the prescriber authorizes refills. Both remain the federal baseline for non-controlled legend drugs.

The thalidomide birth-defect tragedy abroad, which FDA largely kept out of the U.S. market. Congress then tightened drug approval standards.