Term
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Definition
1906
Prohibited sale of adulterated or misbranded food or drugs
Required government pre-approval of all drugs |
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Term
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Definition
1914
Required all manufacturers, pharmacists, drug importers, and doctors who prescribe controls to be licensed a pay a tax |
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Term
| Food, Drug, Insecticide Administration |
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Definition
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Term
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Definition
1938
Created in response to poisoning of over 100 patients due to sulfanilamide
Required drugs to be proven safe before marketing |
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Term
| Alberty Food Products v. U.S. |
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Definition
1950
Stated purpose for which drug is used must be clearly printed on the label |
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Term
| Durham-Humphrey Amendment |
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Definition
1951
Defines what drugs require a prescription (legend drugs)
Required prescription drugs have legend on the label (says "Rx only" on it) |
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Term
| Kefauver-Harris Amendment |
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Definition
1962
All manufacturers must prove drugs are safe and effective before marketing or clinical testing
Required advertising for new drugs to disclose accurate information about side effects |
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Term
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Definition
1966
Required all drugs to be honestly and informatively labeled |
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Term
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Definition
1970
Required most drugs and all controls to have childproof packaging, unless otherwise requested by the patient or the prescribing physician |
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Term
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Definition
1970
Classified controls I-V based on abuse potential
Formed Drug Enforcement Administration (DEA) |
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Term
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Definition
1976
Required all medical devices to get pre-marked approval to ensure safety and effectiveness |
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Term
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Definition
1983
Provided grants to support medical research leading to the development of orphan drugs (drugs used to treat rare diseases) |
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Term
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Definition
1984
Allowed extension of patents
Allowed quicker induction of generics |
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Term
| Prescription Drug Marketing Act |
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Definition
1987
Restricted distribution of prescription drugs to legitamate commercial channels
Required prescription wholesalers to be licensed by the state |
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Term
| Omnibus Budget Reconcilliation Act |
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Definition
1990
Required pharmacists to offer counseling to all patients about their medications |
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Term
| Anabolic Steroid Control Act |
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Definition
1990
Passed to address abuse of steroids by athletes
Meant to prevent use by young people trying to emulate idols
Made anabolic steroids CIII |
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Term
| Health Insurance Portability and Accountability Act (HIPAA) |
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Definition
Described scope of which health care information can be shared with non-healthcare providers
Proveded regulations to protect patient privacy
Covers all forms of communication |
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