Recent Drug Legislation in the United States

Abstract

It is now apparent that the 1962 amendments to the Federal Food, Drug, and Cosmetic Act represent a substantial improvement in legal control over therapeutically useful but potentially hazardous drugs. Amendments relating to drugs require establishing the effectiveness of new drugs, progress reports on clinical investigations, accurate labeling, maintaining up-to-date standards of manufacturing, and registration of manufacturers. Provisions are made for marketing a drug only after it has met Food and Drug Administration requirements and for withdrawing or suspending a drug if findings suggest it is hazardous or ineffective.

These and other pertinent aspects of the amendments are discussed in this article.