Pharmacy Law and Regulations

Question 1

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

Answer 1

Pure Food and Drug Act of 1906

Question 2

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.

Answer 2

Food, Drug, and Cosmetic Act of 1938

Question 3

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.

Answer 3

Manufacturer Drug Labeling

Question 4

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

Answer 4

Over-the-counter Package Labeling

Question 5

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.

Answer 5

Durham-Humphrey Act of 1951

Question 6

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

Answer 6

Kefauver-Harris Amendment

Question 7

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

Answer 7

Comprehensive Drug Abuse Prevention and Control Act of 1970