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Questions and Answers
What did the Food, Drug and Cosmetic Act (FD&C) of 1938 establish?
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 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?
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?
What did the FD&C Act of 1938 prohibit in relation to medications?
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What was authorized by the Durham Humphrey Amendment in relation to prescriptions?
What was authorized by the Durham Humphrey Amendment in relation to prescriptions?
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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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