5 Questions
What did the Food, Drug and Cosmetic Act (FD&C) of 1938 establish?
Quality standards for food, drugs, medical devices, and cosmetics
What did the Durham Humphrey Amendment of 1951 define?
What was considered prescription and over-the-counter medications
What is required for a medication to be considered a 'Legend' according to the Durham Humphrey Amendment?
Prescription requirement and potential harm
What did the FD&C Act of 1938 prohibit in relation to medications?
False claims for medications
What was authorized by the Durham Humphrey Amendment in relation to prescriptions?
Verbal prescriptions and prescription refills
Study Notes
U.S. Law and Pharmacy History
- The Food and Drug Administration (FDA) is an agency of the Department of Health and Human Services.
FDA Responsibilities
- Oversee food, beverages, health supplements, tobacco, cosmetics, biologics, drugs, veterinary drugs, medical devices, and radiation-emitting products.
The Orange Book
- A list of all approved drug products and their equivalents.
- Can be accessed online at https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.
The Purple Book
- Lists approved biologics, bioequivalents, and biosimilars.
- Can be accessed online at https://purplebooksearch.fda.gov/.
Test your knowledge of the major outcomes from US pharmacy law throughout history and learn about medications exempt from the PPPA, Federal Anti-tampering Law, and patients’ HIPAA rights violations.
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