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Flashcards in Pharmacy Law and Regulations Deck (7)
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1
Q

Enacted in 1906 to prohibit the interstate transportation or sale of adulterated and misbranded food or drugs

A

Pure Food and Drug Act of 1906

2
Q

Requires that all new drug application be filed with the FDA, which was created under this act.
Clearly defined adulteration and misbranding of drugs and food products.

A

Food, Drug, and Cosmetic Act of 1938

3
Q

name and place of business of manufacturer or distributor, NDC #, directions for use, no misleading statements, statement of ingredients, expiration date, manufacturer lot or control number.

A

Manufacturer Drug Labeling

4
Q

drug name and place of busincess, ndc #, active ingredient, established name of a drug, inactive ingrediants, “purpose”. “warnings”, “directions”, “questions of comments”

A

Over-the-counter Package Labeling

5
Q

Separated drugs into two categories, legend and nonlegend (OTC) . Allows verbal prescriptions over the telephone. Allows refills to be called in from a physicians office.

A

Durham-Humphrey Act of 1951

6
Q

Requires all meds to be pure, safe, and effective. Established procedures for both drug applications and investigational drugs. Drug manufactueres required to be responsible for Good Manufacturing Process

A

Kefauver-Harris Amendment

7
Q

Controlled substances are placed in one of five categories based on potential of abuse and accepted medical use in the US

A

Comprehensive Drug Abuse Prevention and Control Act of 1970