Section I. THE FOOD, DRUG, AND COSMETIC ACT OF 1938
The original Food, Drug, and Cosmetic Act was passed in 1906 and served to
protect the public from unethical practices of irresponsible drug manufacturers. In 1938,
this Act was revised to expand its coverage. Although this Act was passed in 1938,
some elements of it should be very familiar to you. Furthermore, the Act still has great
impact upon the practice of pharmacy.
SECTIONS OF THE FOOD, DRUG, AND COSMETIC ACT OF 1938
a. Section I. The first major section of the Act pertains to adulterations of drug
products. Adulterating a product refers to changing the quality of a product by adding or
taking away ingredients. Hence, this section focuses on the quality of products. A
product is considered to be adulterated if any one of the following situations occurs:
A decomposed substance is present in the product.
(2) The product is listed in an official reference (for example, USP/NF) as a
specific strength (concentration), but an analysis of the product shows that its strength
is not equal to the required strength.
The item has been packaged under unsanitary conditions.
b. Section II. The second section of the Act concerns misbranding or errors in
labeling, examples of misbranding are:
(1) Labels that contain false or misleading information. For example, some
products might be labeled as "cure-alls" for every disease. this is illegal.
(2) Labels that lack required information. For example, a label must contain
certain types of information like the manufacturer's name and address, the name and
strength of the drug, and the amount or quality of the drug in the container.
(3) Labels on habit-forming. Labels on habit-forming drugs that are not
clearly marked as habit-forming.
c. Section III. The third section pertains to new drugs. Before a new drug is
marketed, it must be tested, proven safe, and approved by the Food and Drug