Division of Nonprescription Regulation Development
Goals: The purpose of this rotation is to familiarize the student with the role of the Food and Drug Administration (FDA) in determining the safety and efficacy of over-the-counter (OTC) drug products. This rotation will also offer experience in providing an overview of FDA’s drug development, review, and post-marketing surveillance of prescription and non-prescription drug products.
I. Learning Objectives: Upon completion of this rotation, the student will be able to:
- Describe FDA’s role in the regulatory and administrative approval process of OTC drug products.
- Distinguish between OTC drug products that are marketed under a new drug application (NDA) versus the monograph system.
- Discuss the OTC drug review and monograph development.
- Knowledgeable of key legal and drug regulatory statues that affect OTC drug products.
- Outline the OTC drug monograph labeling requirements
- Become familiar with health literacy issues as related to OTC drug products as well as written formats of consumer-friendly medication information (i.e. medication guides).
- Utilize ONP and FDA resources such as CDER guidance documents, Federal Register, DailyMed, Drugs@FDA, Electronic Orange Book, PubMed, Micromedex, and the Unified Agenda.
- Answer questions with the laws, regulations, and guidance documents governing drugs.
- Answer drug information request.
II. Student Requirements:
- Be familiar with current drug news in the media and provide weekly summary reports.
- Give a 30 min presentation with a minimum of 3-presentation learning objects and 5- review questions or conduct a project assigned by preceptor.
- Draft a “Drug Facts Label” for a OTC monograph drug product.
- Attend FDA’s Pharmacy Student Lecture Series within the Office of the Commissioner and the Center for Drug Evaluation and Research.
- Fulfill required hours.