Drugs, Brain, & Behavior (Midterm 1-3)

Drug Importation Act

-1848

Pure Food and Drugs Act

-1906 -Required manufacturers to indicate the amounts of alcohol, morphine, opium, cocaine, heroin, and marijuana extract on the label of each product

Food, Drug, and Cosmetics Act

-1938 -In response to Elixir Sulfanilamide -Gave FDA control over drug safety -Defined drugs as products that affected the bodily structure or function even in the absence of disease. -Companies had to file applications with the government for all new drugs showing that they were safe for use as described -Eliminated Sherley Amendment requirement to prove intent to defraud in drug misbranding cases. -Allowed drug manufacturer to determine whether drug was to be labeled as prescription or nonprescription

Kefauver- Harris Amendments

-1962 -Strengthened the governments regulation of both the introduction of new drugs and the production and sale of existing drugs -FDA can retract approval of a drug that was already being marketed

Comprehensive Drug Abuse Prevention and Control Act

-1970 -Replaced previous laws and categorized drugs based on abuse and addiction potential as well as therapeutic value

Prescription Drug User Fee Act (PDUFA)

-1992 -Requires drug manufacturers to par fees to the FDA for the evaluation of New Drug Applications (NDA) -Congress requires FDA to use these fees to hire more reviewers so as to expedite the reviews.

Schedule II Drugs

-The drug or other substance has a high potential for abuse -The drug or other substance has a currently accepted medical use in treatment in the US or a currently accepted medical use with severe restrictions -Abuse of the drug or other substance may lead to severe psychological or physical dependence. -Examples: Cocaine, Cocaine base, Fentanyl, Methamphetamine, PCP

Schedule I Drugs

-The drug or other substance has a high potential for abuse -The drug or other substance has no currently accepted medical use in treatment in the US -There is a lack of accepted safety for use of the drug or other substance under medical supervision -Examples: Fentanyl analog, Heroin, LSD, Marijuana, Hashish, Hashish oil

Schedule IV Drugs

-The drug or other substance has a low abuse potential -The drug or other substance has a currently accepted medical use in the US -Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or substances in schedules I-III

Schedule V Drugs

-The drug or other substance has a low abuse potential -The drug or other substance has a currently accepted medical use in the US -Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or substances in schedules I-IV.

Schedule III Drugs

-The drug or other substance has relatively less abuse potential -The drug or other substance has a currently accepted medical use in treatment in the US -Abuse of the drug or other substance may lead to moderate or low physical or high psychological dependence

Thalidomide Incident

-Used in Europe as a sedative for pregnant women -There are two approximately 24- hour intervals early in pregnancy when the drug can alter the development of arms and legs in the embryo -Distributed more than 2 million tablets in US