Laws Affecting Prescription Dispensing

Question 1

Food and Drug Administration (FDA)

Answer 1

-Governing body over meds sold in the U.S.
-Branch of U.S. Department of Health and Human Services
-Responsible for approval of prescription and over-the-counter meds, drug labeling, and standards for drug manufacturing.

Question 2

Centers for Disease Control and Prevention (CDC):

Answer 2

-Provides regulation for infection control
-Publishes annual vaccination and immunization requirements for children, adolescents, and adults.
-Involved with national health issues (HIV/AIDS)

Question 3

Drug Enforcement Administration (DEA):

Answer 3

-Enforces laws/regulations surrounding controlled/illegal substances
-Sets requirements for dispensing and refilling controlled substances

Question 4

The Pure Food and Drug Act of 1906:

Answer 4

-First law to regulate meds
-prohibits falsely labeling pharmaceutical products (misbranding)
Prohibits sale of contaminated products or those with unknown contents (adulteration)

Question 5

Food, Drug, & Cosmetic Act of 1938:

Answer 5

-Created amendments to pure food and drug act of 1906
-expanded role of FDA (authority to approve/deny new drugs coming on the market)
-requires drug manufacturers to prove a drug’s purity, strength, and safety before it can be sold

Question 6

Durham-Humphrey Amendment of 1951:

Answer 6

-created 2 classes of meds: prescription (legend) and nonprescription (OTC)
-“RX Only” must be labeled
-OTC labeling must contain active ingredients, purpose/uses, warnings, dosage instructions

Question 7

Child-resistant packaging:

Answer 7

-can’t be opened by 80% of kids younger than 5
-can be opened by 90% of adults