Questions: A client asks the health care practitioner if there are any regulations concerning nonprescription medicines. The health care practitioner explains that nonprescription medicines are governed by which act? a. The Pure Food and Drug Act. b. The Omnibus Budget Reconciliation Act. c. The Federal Food, Drug, and Cosmetic Act. d. The Controlled Substance Act.

The answer is c. The Federal Food, Drug, and Cosmetic Act.

The Pure Food and Drug Act of 1906 was one of the first significant consumer protection laws, which led to the creation of the Food and Drug Administration (FDA). It focused on prohibiting the sale of misbranded or adulterated food and drugs. However, it did not specifically govern nonprescription medicines.

The Omnibus Budget Reconciliation Act (OBRA) primarily deals with budgetary and fiscal issues, including changes to Medicare and Medicaid. It does not specifically address the regulation of nonprescription medicines.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 is the primary law under which the FDA operates. It provides the legal framework for the regulation of food, drugs, and cosmetics, including nonprescription (over-the-counter) medicines. This act requires that drugs be proven safe and effective before they can be marketed.

The Controlled Substance Act (CSA) is a law that regulates the manufacture, importation, possession, use, and distribution of certain substances. It primarily deals with drugs that have a potential for abuse and dependence, such as narcotics and other controlled substances, rather than nonprescription medicines.