YAFI Online Programming // Law Related to Pharmacy Practice

Law

When is a Medication Not a Drug?

Educational Objectives

After participating in this activity, pharmacists will be able to:

  • Explain what it means to be a "drug"
  • Describe the approval processes for prescription and homeopathic drugs and dietary supplements.
  • Differentiate a drug and a dietary supplement
  • Explain recent regulatory concerns about homeopathic products and supplements
  • Describe the role of the pharmacist in helping consumers navigate the differences in FDA oversight among different drug products.

Session Offered

Release Date: March 15, 2020

Expiration Date: March 15, 2022

Course Fee

$7 for pharmacists

$4 for technicians

Session Codes

20YC22-XPC44 Pharmacist

20YC22-KZP68 Pharmacy Technician

Accreditation Hours

2.0 hours of CE

Abstract

A typical pharmacy carries many products, including prescription and OTC drugs, homeopathic products, and dietary supplements. The FDA has jurisdiction over all of these products, but the nature of approval and the degree of oversight differs among them. Prescription drugs are subject to the most rigorous oversight and regulation, but some products do not need pre-market approval. Many consumers and even health professionals have the misconception that all of these products are subject to the same level of control. This continuing education activity will describe the regulation of these products and consider recently proposed regulatory issues and safety concerns.

Accreditation Statements

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Pharmacists and pharmacy technicians are eligible to participate in this application-based activity and will receive up to 0.2 CEU (2 contact hours) for completing the activity, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor on- line system and your participation will be recorded with CPE Monitor within 72 hours of submission

ACPE UAN:
0009-0000-20-022-H03-P
0009-0000-20-022-H03-T

Grant funding: None.

Cost: $7 for pharmacists $4 for technicians

Initial Release Date: March 15, 2020
Expiration Date: March 15, 2022

To obtain CPE credit, visit the UConn Online CE Center

Use your NABP E-profile ID and the session code 20YC22-XPC44 for pharmacists or 20YC22-KZP68 for pharmacy technicians to access the online quiz and evaluation.

First- time users must pre-register in the Online CE Center. Test results will be displayed immediately and your participation will be recorded with CPE Mon- itor within 72 hours of completing the requirements.

For questions concerning the online CPE activities, email joanne.nault@uconn.edu

Faculty

Gerald Gianutsos, Ph.D., J.D., R.Ph., is an Emeritus Associate Professor of Pharmacology at the University of Connecticut, School of Pharmacy.

Faculty Disclosure

Dr. Gianutsos has no actual or potential conflicts of interest associated with this article.

Disclosure of Discussions of Off-label and Investigational Drug Use

This activity may contain discussion of off label/unapproved use of drugs. The content and views presented in this educational program are those of the faculty and do not necessarily represent those of the University of Connecticut School of Pharmacy. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Content

Introduction

What is a drug? If you asked a pharmacist or pharmacy technician this question, you would probably hear an answer something like “A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” This is, in fact, the U.S. Food and Drug Administration’s (FDA) legal definition of a drug.1 However, it may come as a surprise that another part of the definition is a “substance recognized by an official pharmacopoeia or formulary,”1 which would expand the definition of “drug” to include homeopathic products. Conversely, the legal description of a dietary supplement specifically excludes it from being defined as a drug. These descriptions affect the regulation and oversight of different substances found in pharmacies.

Pharmacists and technicians are at least generally knowledgeable about the requirement for rigorous testing, including extensive clinical trials and review, before the FDA grants approval for marketing a prescription drug. However, pharmacy staff may be less familiar with oversight of other classes of medicinal substances that are subject to different regulatory guidelines and which, overall, are subject to less stringent requirements than those for prescription products (see Table 1). Consumers and many health care practitioners are largely unaware of these differences and the degree of oversight the FDA provides2 and may look to pharmacy staff to provide guidance.

This continuing education activity will review and contrast the regulation of prescription drugs, homeopathic drugs, and dietary supplements. It will highlight some recently proposed regulatory changes that could impact the promotion and approval of these products.

 

References

Full List of References

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