March CPE Article Evolution of the Federal Legal Framework for Regulation of Medications Authors: Joseph L. Fink III, B.S.Pharm., J.D., D.Sc.(Hon.), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington. The author declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest. Goal: To educate pharmacists and pharmacy technicians about evolution of the federal statutes and regulations related to production and distribution of medications in the U.S. thereby enhancing the readers’ understanding of the legal environment of professional practice. Universal Activity #0143-0000-21-003-H03-P &T Contact Hour (1.0 CEU) Expires:4/15/2024
KPERF offers all CE articles to members online at www.kphanet.org
Learning Objectives: At the conclusion of this knowledge-based article, the reader should be able to: 1.
Distinguish the bases of legal authority to regulate pharmacists, pharmacies and pharmaceuticals
between the federal and state governments; 2.
Identify the impetus for the 1906 Federal Pure Food and Drug Act;
3.
Identify the impetus for the Federal Food, Drug and Cosmetic Act of 1938; and
4.
Identify the impetus for Kefauver-Harris Amendments of 1963.
Introduction Taken together, when one looks at both federal and state level statutes and regulations, pharmaceuticals are among the most highly regulated products in the U.S. marketplace. They require pre-marketing approval and, if the product presents a potential for abuse, it may have an additional layer of regulation limiting its availability. Authority to regulate medications at the federal level of government comes from the Commerce Clause of the U.S. Constitution: The United States Congress shall have power “to regulate commerce with foreign Nations, and among the several States, and with the Indian Tribes.”1 Having medicinal agents that move across state lines or are composed of ingredients or packaging that did so invokes this provision in the law. At the state level the authority is rooted in what is known as the “Police Power” of state government – the authority to enact and enforce statutes and regulations related to the public health, safety and welfare. |20| Kentucky Pharmacists Association | March/April 2021
