Food and Drug Administration (FDA)

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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


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