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US Pharmacy Law History Quiz

Created by

@EvaluativeHope419

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Questions and Answers

What did the Food, Drug and Cosmetic Act (FD&C) of 1938 establish?

Exemption of pharmacies from regulation

Authorization for verbal prescriptions only

Mandatory prescription for all medications

Quality standards for food, drugs, medical devices, and cosmetics (correct)

What did the Durham Humphrey Amendment of 1951 define?

What was considered prescription and over-the-counter medications (correct)

The limitations on verbal prescriptions

The maximum dosage for over-the-counter medications

The manufacturing standards for prescription medications

What is required for a medication to be considered a 'Legend' according to the Durham Humphrey Amendment?

'Legend' status and verbal prescription authorization

'Legend' status and habit-forming nature

'Legend' status and exemption from FDA regulation

Prescription requirement and potential harm (correct)

What did the FD&C Act of 1938 prohibit in relation to medications?

<p>False claims for medications</p> Signup and view all the answers

What was authorized by the Durham Humphrey Amendment in relation to prescriptions?

<p>Verbal prescriptions and prescription refills</p> Signup and view all the answers

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/.

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Description

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.