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22 Cards in this Set
- Front
- Back
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Pure Food and Drug Act of 1906
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Passed to prohibit adulteration and misbranding of foods in interstate commerce
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Pure Food and Drug Act of 1912
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Amendment was prompted to prohibit false and misleading claims
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Food, Drug and Cosmetic Act 1938
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No new drug could be marketed until it was proved safe, labeled properly and approved by FDA
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Durham-Humphrey Amendment
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Established two classes of drugs (over-the-counter and prescription drugs)
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Food Additive Amendment of 1958
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Food additives must get pre-market approval
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Color Additive Amendment of 1960
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Color additives to food, drugs and cosmetics must get pre-market approval
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Kefauver-Harris Amendment
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1. Requires drugs to be effective
2. Requires informed consent from research subjects participating in clinical trials. 3.Established GMP Requirements |
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Poison Prevention Packaging Act
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Requires special packaging to protect children from harmful accidents
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PPPA
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Is under jurisdiction of the Consumer Product Safety Commission (CPSC)
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PPPA Test
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Package will fail if:
>20% kids <5 can open package in 10 minutes or if 90% of 100 adults can open and close in 5 minutes and do so again within one minute |
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Medical Device Amendments
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Gave FDA authority to regulate drug devices;Requires pre-market approval
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Federal Anti-Tampering Act
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Requires OTC drugs, cosmetics and devices manufactured in tamper-evident packages; Regulated by FBI and the USDA
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Orphan Drug Act
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Encourage drug companies to develop drugs (Type V) affecting fewer than 200,000 people in the U.S.
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Orphan Drug Act
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drug companies can receive tax incentives, exclusive marketing rights and/or Faster NDA approval for developing orphan drugs
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Drug Price Competition and Patent-Term Restoration Act
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Streamlined the drug approval process for generic companies
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Drug Price Competition and Patent-Term Restoration Act
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Gave 1st generic company180 day market exclusivity; Gave drug companies five year market exclusivity after NDA has been approved
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Prescription Drug Marketing Act
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Prohibits retail pharmacies from selling, receiving, possessing or trading drug samples
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Prescription Drug Marketing Act
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Requires Shippers and Wholesaler to be licensed
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Omnibus Budget Reconciliation Act
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Requires pharmacies to use the Drug Utilization Review to improve health care and minimize medication errors for medicaid patients
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Prescription Drug User Fee
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Allows FDA to charge drug companies to review drug applications
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Dietary Supplement Health and Education Act
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Required FDA to regulate dietary supplements more like food than drugs
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Food and Drug Administration Modernization Act
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1. Streamlined the regulatory procedures to expedite the review process by:
a. Establishing a fast track program for serious or life threatening diseases b. No longer requiring the “Caution federal law and replaced w Rx only c. No long required substances to have the warning “may be habit forming” |
