Date of Award

1975

Document Type

Thesis

Degree Name

Master of Science (M.S.)

Department

Pharmacy

First Advisor

James C. King

First Committee Member

Ravin Vasavada

Second Committee Member

Warren J. Schneider

Third Committee Member

K. Michael Mills

Abstract

It is the purpose of this thesis to develop a course of study for pharmacy schools on drug regulation by the Food and Drug Administration (FDA). A summarization of the history of the development of the Food and Drug Administration (FDA) and of pharmacy education reveals a lack of interface between the two. The necessity for the interface of pharmacy education and the agency which has significant control over the products forming the basis of the pharmacy profession will be made apparent. A period of residency through which the course of study on drug regulation by the FDA was to be developed, will be described. This description details the responsibilities and functions of the various segments of the FDA involved in the regulation of drugs as acquired through discussion with agency officials during the residency. It is intended to be used as the textual material for the didactic portion of the course of study to be offered at schools of pharmacy. Based upon the experience, recommendations will be made regarding the applicability of the course of study to include possible residencies for pharmacy students at the agency.

Pages

241

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