Pharmacy Laws/Amendments
Study online at https://quizlet.com/_hui65v
1. 1906- Pure Food and Drug Act: Enacted to stop the sale of inaccurately labeled drugs
-Manufacturers were required to provide truthful information on the label before a drug was sold & prove the drugs
effectiveness
2. 1914- Harrison Narcotics Act: Enacted to curb recreational use of opium
-No longer available without a prescription
-Records required for prescriptions
-Importation and distribution were restricted
3. 1938- Food, Drug, and Cosmetic Act: Enacted because the 1906 law was not worded strictly enough
and did not include cosmetics
-Required drug companies to include directions to the consumer regarding use of a drug, and also package inserts
-All addictive substances had to be labeled: "Warning: May be habit forming"
-Defined the exact labeling for products and defined misbranding and adulteration as illegal
-Requires: mandatory food labeling, standards of identity, information on imitation foods, nutritional information for
special dietary foods
-Provided the legal status for the Food and Drug Administration (FDA)
4. 1951 Durham-Humphrey Amendment: -Required label on prescription drugs: "Caution: Federa
law prohibits dispensing without a prescription."
-Required a doctor's order and supervision for certain drugs
-Made the initial distinction between legend drugs (by prescription only) and OTC drugs that do not require a doctor's
order (non-prescription drugs)
5. 1962- Kefauver-Harris Amendments: Enacted in an attempt to ensure the safety and effectiveness
of all new drugs on the market
-Burden put on manufacturers to ensure "good manufacturing practice" (GMP)
-Prevented the sale of thalidomide in the United States; children in Europe were born with birth defects after mothers
used drug during pregnancy
6. 1970- Comprehensive Drug Abuse Prevention and Control Act: Established the Drug
Enforcement Administration (DEA) to enforce the laws covering controlled substances and their distribution
-Created stair-step categories of controlled substances (Schedules I-V)
7. 1970- Poison Prevention Packaging Act: Required all medications to be placed in containers with
childproof caps or packaging (includes both OTC and legend drugs)
-Exceptions include: physician request for non-childproof cap, certain legend medications, hospitalized patients or
patient request
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Study online at https://quizlet.com/_hui65v
1. 1906- Pure Food and Drug Act: Enacted to stop the sale of inaccurately labeled drugs
-Manufacturers were required to provide truthful information on the label before a drug was sold & prove the drugs
effectiveness
2. 1914- Harrison Narcotics Act: Enacted to curb recreational use of opium
-No longer available without a prescription
-Records required for prescriptions
-Importation and distribution were restricted
3. 1938- Food, Drug, and Cosmetic Act: Enacted because the 1906 law was not worded strictly enough
and did not include cosmetics
-Required drug companies to include directions to the consumer regarding use of a drug, and also package inserts
-All addictive substances had to be labeled: "Warning: May be habit forming"
-Defined the exact labeling for products and defined misbranding and adulteration as illegal
-Requires: mandatory food labeling, standards of identity, information on imitation foods, nutritional information for
special dietary foods
-Provided the legal status for the Food and Drug Administration (FDA)
4. 1951 Durham-Humphrey Amendment: -Required label on prescription drugs: "Caution: Federa
law prohibits dispensing without a prescription."
-Required a doctor's order and supervision for certain drugs
-Made the initial distinction between legend drugs (by prescription only) and OTC drugs that do not require a doctor's
order (non-prescription drugs)
5. 1962- Kefauver-Harris Amendments: Enacted in an attempt to ensure the safety and effectiveness
of all new drugs on the market
-Burden put on manufacturers to ensure "good manufacturing practice" (GMP)
-Prevented the sale of thalidomide in the United States; children in Europe were born with birth defects after mothers
used drug during pregnancy
6. 1970- Comprehensive Drug Abuse Prevention and Control Act: Established the Drug
Enforcement Administration (DEA) to enforce the laws covering controlled substances and their distribution
-Created stair-step categories of controlled substances (Schedules I-V)
7. 1970- Poison Prevention Packaging Act: Required all medications to be placed in containers with
childproof caps or packaging (includes both OTC and legend drugs)
-Exceptions include: physician request for non-childproof cap, certain legend medications, hospitalized patients or
patient request
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