Pharmacy Federal Law

This law prohibited foods and drugs that were distributed through interstate commerce to be adulterated or mis-branded.

This law fell short of protecting the public since it did not require manufacturers to list on the label the ingredients or directions for use of a product. It also did not regulate cosmetic or products or medical devices.

This law required, for the first time in the US, that any new drug could not be marketed unless it had first been proven to be safe when used according to directions on the label. It also required that labels include adequate instructions for use and warnings about habit-forming drugs contained in the product; also the first law that applied cosmetic products, medical devices, food and drug products.

In 1937, 107 deaths caused by the mistaken use of diethylene glycol (automobile anti-freeze), as a vehicle in a sulfanilamide elixir resulted in the passage of a landmark piece of federal regulation.

Drug products marketed prior to 1938 were exempted or "grand fathered" and did not, therefore, have to be labeled or proven safe under the Food, Drug and Cosmetic Act.

A. True
B. False

Many of the drug products covered by the 1938 FDCA Act were not safe to use without medical supervision. This amendment to the FDCA was enacted to regulate these products and established two classes of drugs; those that required medical supervision to be used safely (i.e. Legend drugs), and products that did not require medical supervision (i.e. OTC drugs).