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24 Cards in this Set
- Front
- Back
- 3rd side (hint)
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Introduced Federal inspection of meat products.
Prohibited adulterated food and poisonous patent medicines.
Last authority to ban unsafe drugs or demand proper drug labeling. |
Pure Food and Drug Act of 1906 |
Did not regulate cosmetics. |
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Prohibited labeling medicines with false therapeutic claims to deceive consumers. |
Sherley Amendment of 1912 |
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Regulated drug labeling and prescribing of Legend (prescription-only) drugs. Limited interstate commerce of drugs to those deemed safe and effective. Prompted by the sulfanilamide disaster of 1937 |
Food, Drug, and Cosmetic Act of 1938 (FDCA) |
Established the Food and Drug Administration (FDA) |
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Required prescription drugs to bear the legend, "Caution: Federal law prohibits dispensing without a prescription. Subsequent Amendment replaced it with the legend, "Rx only." |
Durham-Humphrey Amendment of 1951 |
Also known as the Prescription Drug Amendment. |
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Authorized FDA to regulate hazardous substances. Covers toxic, corrosive, irritants, sensitizers, flammable, and pressure-generating items. |
Federal Hazardous Substance Labeling Act (FHSA) - 1960 |
Requires labels caution and consumers of potential hazards. |
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Created procedures for New Drug Applications (NDAs) and investigational drugs.
Advertising of RX drugs under FDA supervision.
Required proof of new drug Effectiveness and safety before marketing.
Established Good Manufacturing Practices. (GMPs) |
Kefauver-Harris Amendment- 1962 |
Also known as the Drug Effiacy Amendment. |
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Consolidated federal laws related to narcotics, stimulants, depressants, and designer drugs. Establishment of the Drug Enforcement Administration (DEA) |
Controlled Substances Act of 1970 |
Creation of five controlled substance schedules based on abuse potential. |
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Law that pertains to pharmacy practice. Sets standards for pharmacy practice. May add restrictions to federal laws. |
State Pharmacy Law |
Licenses pharmacies and professionals. |
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Law that focuses on pharmaceutical manufacturing, marketing, and distribution. |
Federal Pharmacy Law |
Law that aims for uniformity among states' medical regulations. |
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Mandates childproof packaging for most legend and controlled drugs. Exceptions: Sublingual nitroglycerin, contraceptives, inpatient hospital drugs, certain emergency medications, and others. |
Poison Prevention Packaging Act (PPPA) 1970 |
Childproof containers require a written request for alternative packaging. |
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Amended the Federal Food, Drug, and Cosmetic Act of 1938. Mandated drug manufacturers, repackagers, and distributors to register their products with the FDA. |
Drug Listing Act of 1972 |
Introduced the National Dtug Code (NDC) as a unique product code. |
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Requires premarket approval from the FDA for life-sustaining and life-supporting medical devices. |
Medical Device Amendment of 1976 |
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Stimulate drug development for rare diseases (affecting<200,000 people) |
Orphan Drug Act of 1983 |
Very Very Very Rare Diseases |
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Manufacturers can seek Abbreviated New Drug Applications (ANDAs) for generic versions of drugs with expiring patents. |
Drug Price Competition and Patent Term Restoration Act 1984 (Hatch-Waxman Act) |
Established modern system of generic drugs. |
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Aims to prevent mislabeled, sub-potent, adulterated, expired, and counterfeit drugs from entering the distribution system. |
Prescription Drug Marketing Act (PDMA) 1987 |
Addresses prescription drug marketing practices. |
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Placed anabolic steroids in Schedule III of the Controlled Substances Act (CSA). |
Anabolic Steroid Control Act (1990) |
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Focused on Medicare and Medicaid federal funding. Mandated pharmacists to perform drug utilization reviews (DURs) and provide patient counseling. |
Omnibus Budget Reconciliation Act (OBRA '90) |
Increased the demand for pharmacy technicians. |
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Defined dietary supplements and their ingredients. Provided guidelines for literature display where supplements are sold. |
Dietary Supplement Health and Education Act of 1994 |
Required ingredient and nutrition labeling. |
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Simplified FDA regulations and procedures. Streamlined drug approval and access to investigational medicines. |
FDA Modernization Act of 1997 |
Changed federal legend to "Rx only" for prescription drugs. |
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Àllows certain physicians to prescribe to pre-approved C-III, C-IV, and C-V medications for opioid addiction treatment. Requires physicians to complete a training course, register with the DEA, and treat a limited number of patients. |
Drug Addiction Treatment Act of 2000 |
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Significant change to Medicare, the insurance program for seniors. Introduced Medicare Part D, a voluntary prescription drug benefit plan for seniors. |
Medicare Modernization Act of 2003 |
Added options for Medicare Advantage. |
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Established first enforceable standards for sterile compounding. |
USP Chapter <797> (2004) |
Outlines procedures and practices for sterile preparations. |
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Address the methamphetamine epidemic by regulating OTC sales of certain products. |
Combat Methamphetamine Epidemic Act of 2005 (CMEA) |
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Ensure prescription safety and prevent fraud in Medicaid-covered outpatient drugs. |
Medicaid Tamper-Resistant Prescription Pad Law of 2008 |
Written prescriptions must use tamper-resistant prescription pads. |
