Pharmacy Technician Federal Laws

Front 1

Pure Food & Drug Act (1906)

Back 1

prohibits interstate transportation or sale of adulterated and misbranded food/drugs

Front 2

Food, Drug & Cosmetic Act of 1938 (FDCA 1938)

Back 2

-created FDA
-all drug applications must be filed with the FDA
-clearly defines adulteration and misbranding of food/drugs

Front 3

Durham-Humphrey Act (1951)

Back 3

-all products need directions for use, unless they have the label: "caution federal law prohibits dispensing w/o a prescription
-creates two categories of drugs (1) legend and (2) non-legend (OTC drugs)
-can file prescriptions and order refills via telephone

Front 4

Kefauver-Harris Amendment (1962)

Back 4

requires all medications in the US to be pure, safe, and effective

Front 5

Comprehensive Drug Abuse Prevention and Control Act (1970)

Back 5

-created Drug Enforcement Agency (DEA) and 5 schedules of drugs

Front 6

Schedule I drugs

Back 6

NO MEDICAL USE-high potential for abuse, e.g. "crack" cocaine, meth, marijuana, rohypnol

Front 7

Schedule II drugs

Back 7

medical use, but high abuse potential w/severe psychological dependency e.g. cocaine, methadone, oxycodone

Front 8

Schedule III drugs

Back 8

medical use, abuse potential less than schedule I & II

Front 9

Schedule IV drugs

Back 9

medical use, abuse less than schedule III but may lead to limited psychological/physical dependencies

Front 10

Schedule V drugs

Back 10

abuse potential less than schedule IV, includes exempt narcotics