Food and Drug Administration (FDA)
What did the Virus, Serum, and Toxin Act of 1913 do?
gave pre-market authority for animal biological drugs
What are Schedule I drugs?
they have no acceptable medical use and a high potential for abuse
What are biological drugs?
vaccines, blood and blood products, extracts of living cells, and other drugs
What are examples of Schedule IV drugs?
xanax, Ativan, ambien
What did "Elixir Sulfanilaminde" contain?
DEG- antifreeze
Which law stopped cheap generic drugs from being marketed as new expensive drugs?
Kefauver-Harris Amendment of 1962
What are examples of Schedule V drugs?
Robitussin AC or Lyrica
What did the Durham-Humphrey Amendment of 1951 do?
-defined two categories of drugs: prescription and OTC -requires that any drug that is habit-forming or harmful be dispensed under the supervision of a health practitioner
What did the Food, Drug and Cosmetic Act of 1938 do?
-gave the FDA authority to oversee safety of food, drugs, and cosmetics -required that drugs be labeled with directions -prohibited false therapeutic claims for drugs
What is the Keauver-Harris Amendment of 1962?
-it mandated efficacy as well as safety before a drug could be marketed -it instituted stricter control over drug trials -made drug advertising disclose side effects and efficacy -required adverse drug reactions to be reported to the FDA
What are examples of Schedule III drugs?
Vicodin, tylenol with codeine, ketamine
What caused the Biological Act of 1902?
children dying from contaminated vaccines in 1901
What are examples of Schedule II drugs?
cocaine, meth, methadone, oxycotin, adderall
What did the Comprehensive Drug Abuse Prevention and Control Act do?
created the Controlled Substance Act and the Importation and Exportation, Criminal Forfeiture and Drug Law Amendments
What are Schedule III drugs?
drug that have a moderate to low potential for physical and psychological dependence
What are Schedule V drugs?
drugs have the least potential for abuse and contain limited quantities of narcotics
What are Schedule IV drugs?
drugs that have a low potential for abuse and a low risk of dependence
What are Schedule II drugs?
drugs with high potential or abuse and are also considered dangerous but have medical use
What are examples of Schedule I drugs?
heroin, ecstasy, marijuana, and LSD
What does the Biologics Control Act of 1902 do?
requires that federal government grant premarket approval for every biological drug and for the process and facility of those drugs
What did the Pure Food and Drug Act of 1906 do?
stopped misbranding and adulteration and made products have truth in labeling
