As a pharmacy technician it is important to be familiar with laws and regulations that pertain to your industry, so we will continue to look at these different laws. Today we are going to look at the Food, Drug, and Cosmetic Act of 1938.
At the turn of the 20th century, there were no federal regulations to protect the public from dangerous drugs. John Swann, Ph.D., a historian at the Food and Drug Administration in Rockville, MD stated, “It was a menacing marketplace filled with products such as William Radam’s Microbe Killer and Benjamin Bye’s Soothing Balmy Oils to cure cancer. Products like these were, at minimum, useless remedies that picked the pocket of the user, but they could also be downright harmful.”
The U.S. Congress passed the first of a series of landmark 20th century laws to regulate the development, compounding, distribution, storage, and dispensing of drugs in 1906. The purpose of the Pure Food and Drug Act of 1906 was to prohibit the interstate transportation or sale of adulterated and misbranded food and drugs. This act required that the labels not contain false information about the drugs’ strength and purity. The act, although amended, proved unenforceable, and new legislation was later required.
The Food, Drug, and Cosmetic (FDC) Act of 1938 is one of the most important pieces of legislation in pharmaceutical history. It created the Food and Drug Administration (FDA) and required pharmaceutical manufacturers to file a new drug application (NDA) with each new drug before marketing. Manufacturers needed to prove that the product was safe for use by humans. In addition to proving safety, each new prescription and nonprescription drug had to be approved by the FDA. Pharmaceutical manufacturers were required to conduct and submit the results of toxicological studies on animals followed by clinical trials with human beings to determine the degree of toxicity and the effect of the drug in humans, respectively. The NDA must detail the chemical composition of the drug and the processes used to manufacture it.
Under this act, the FDA had the power to not only approve or deny new drug applications (NDAs) but also to conduct inspections of manufacturing plants to ensure compliance. The Supreme Court later held that the act applied to interstate transactions as well as intrastate transactions, including those within pharmacies. Unfortunately, the act required only that drugs be safe for human consumption, not that they be effective or useful for the purpose for which they were sold.