Pharmacy Laws & Regulations Flashcards
Prescription drug advertising is regulated primarily by the ____.
FDA
OTC drug advertising is regulated primarily by the Consumer Product Safety Commission, which is under the _____.
FTC (Federal Trade Commission)
The FDA’s minimum requirements for what an advertisement must contain are the following 3 points:
- ______
- ______
- ______
- At least 1 approved use
- The generic name
- Brief summary or major statement or “adequate provision” of the drug’s risks (adequate provision means a way for the audience to find the drug’s important safety information)
Any false or misleading statements about a drug in an advertisement could be considered ______.
Misbranding
The _________ of 1890 attempted to outlaw monopolies that blocked competition by nefarious methods, such as price-fixing, deceptive marketing practices, and excluding competition from markets.
Sherman Antitrust Act of 1890
The Pure Food and Drug Act of 1906 is also known as the ____.
Wiley Act
The ______ Act requires that no adulterated or misbranded drug’s could be sent through interstate commerce.
The Pure Food and Drug Act of 1906
______ means that the drug itself is bad (drug quality is not up to standard).
A. Adulteration
B. Misbranding
A. Adulteration
______ means the label is inaccurate.
Misbranding
This act mandated accurate product labeling, and required the ingredients used in drugs meet the standards of strength, quality, and purity in the USP/NF
The Pure Food and Drug Act of 1906 (The Wiley Act)
This act required the food or drug label could not be false or misleading, and the presence and amount of 11 dangerous ingredients (including alcohol, heroin, and cocaine) had to be listed.
The Pure Food and Drug Act of 1906 (The Wiley Act)
This act required that the manufacturer prove the safety of a drug before it could be marketed.
The Food, Drug, and Cosmetic Act (FDCA) of 1938
Due to this act in 1938, drug claims from that point forward must be accurate and all ingredients must be list d on the label so that the public is aware of what they are ingesting.
The Food, Drug, and Cosmetic Act (FDCA) of 1938
True or False: Under the FDCA of 1938, drugs only have to be proven safe, NOT effective.
True
True or False: the Durham-Humphrey Amendment of 1951 was an amendment to the FDCA that established 2 classes of drugs.
True
This act, established in 1944, required that biologics be approved for purity, potency, and safety.
Public Health Service Act of 1944
Biologics are NOT approved under an NDA, but rather, under a _____ application.
Biologics License Application (BLA)
Another term used for prescription drugs are ____ drugs.
Legend
The _____ made a clear distinction between OTC and prescription dugs by classifying 3 conditions that would make drug available only by prescription.
The Durham-Humphrey Amendment of 1951
The Durham-Humphrey Amendment was established in this year.
1951
What are the 3 conditions established by the Durham-Humphrey Amendment of 1951 that make a drug available only by prescription?
- Drugs that are habit-forming
- Drugs considered unsafe for use except under expert supervision due to toxicity concerns
- Drugs limited to prescription use only under a manufacturer’s NDA
This amendment to the FDCA required drugs to be safe AND effective.
Kefauver-Harris Amendment of 1962
