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25 Cards in this Set
- Front
- Back
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Pure Food and Drug Act of 1906
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originally used to forbid the interstate distribution for sale of adulterated and misbranded food and drugs. in 1937 the need for new legislation was exposed when people died from a sulfa drug that contained diethylene glycol, anti-freeze
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Food, Drug, and Cosmetic Act of 1938
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this act created the FDA and required pharmaceutical manufacturers to file a New Drug Application with the FDA. Any adverse reaction to a drug should be reported to the FDA.
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Durham-Humphrey Amendment of 1951
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states that drug containers do not have to include "adequate directions for use," as long as they bear the legend "Caution: Federal law prohibits dispensing without a prescription." established the difference btween legend (prescription) drugs and OTC drugs
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Kefauver-Harris Amendment of 1962
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passed in response to reports of severe birth defects in infants born to mothers who had taken the tranquilizer thalidomide. it extended the FDA's requirement that drug products, both prescription and nonprescription, be shown to be effective and safe
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Comprehensive Drug Abuse Prevention and Control Act of 1970
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Controlled Substance Act (CSA). controls the manufacture, importation, sale, and distribution of drugs that have the potential for addiction and abuse. under this act, drugs are classified with potential for abuse into five types.
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Poison Prevention Packaging Act of 1970
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the Poison Prevention Packaging Act of 1970 required that the majority of OTC and prescription drugs be packaged in child-resistant containers
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Occupational Safety and Health Act of 1970
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Occupational Safety and Health Act (OSHA) IN 1970. general purpose of requiring all employers to ensure employee safety and health, OSHA regulates actual workplaces, first-aid, job-related materials, equipment and machinery. it also established the Occupational Safety and Health Administration (OSHA)
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Drug Listing Act of 1972
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under this act, each new drug is assigned a unique and permanent product code, known as a National Drug Code (NDC) that identifies the manufacturer or distributor, the drug formulation, and the size and type of its packaging.
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Medical Device Amendments of 1976
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Medical Device Amendments of 1976 classified medical devices into three regulatory classes. These classes depended upon how each device actually functioned. Class III devices, such as those used for life-sustaining and life-supporting measures, were required to have premarket approval from the FDA
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Resource Conservation and Recovery Act of 1976
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also known as the Solid Waste Disposal Act, the Resource Conservation and Recovery Act (RCRA) of 1976 regulates how solid wastes are handled and authorizes environmental agencies for the proper cleanup of contaminated sites
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Drug Regulation Reform Act of 1978
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Enacted to permit a shorter period for the investigation of new drugs, the Drug Regulation Reform Act of 1978 allows quicker consumer access
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Orphan Drug Act of 1983
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it offers federal financial incentives to commercial and nonprofit organizations to develop and market drugs previously unavailable in the United States. it can be used to treat a rare disease that affects fewer than 200,000 people in the US. it offers tax breaks and a seven-year monopoly on drug sales encourage companies to undertake the development manufacture of such drugs
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Drug Price Competition and Patent Term Restoration Act of 1984
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it encouraged the creation of both generic (those not protected by trademark) and innovative new drugs. The act streamlined the process for generic drug approval and extended patent license as a function of the time required for the drug application approval process
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Prescription Drug Marketing Act of 1987
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it deals with safety and competition issues that secondary markets raised for drugs and prohibits the re-importation of a drug into the US by anyone except the manufacturer
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Omnibus Budget Reconciliation Act of 1990 (OBRA-90)
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requires pharmacists to offer to discuss information about new and refill prescriptions with each patient:
1) name and description of medication 2) dosage form, dosage, route of administration, and duration of drug therapy 3) common severe side effects and adverse effects 4) interactions (with other drugs or food) and therapeutic contraindications 5) self-monitoring of the medication therapy 6) proper storage 7) action in the event of a missed dose 8) special directions and precautions that the patient should take |
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FDA Safe Medical Devices Act of 1990 (SMDA of 1990)
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it increase the FDA's ability to regulate medical devices and products used in medical diagnostic procedures. anyone who violates this policy faces increased civil penalties
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Anabolic Steroid Control Act of 1990
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it was in response to reports of athletes abusing anabolic steroids to increase their physical performance. it increased the CSA's powers to regulate anabolic steroids, hormonal substances that promote muscle growth. under the terms of this act, anabolic steroids are now listed in Schedule III of the CSA
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Americans with Disabilities Act (ADA) of 1990
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it prohibits discrimination of people with disabilities
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Dietary Supplement Health and Education Act (DSHEA) of 1994
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it amended the FD&C Act to increase regulations on dietary supplements and how they are labeled. Dietary supplements are foods, not drugs, and manufacturers are responsible for ensuring that their supplements are safe to use
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Health Insurance Portability and Accountability Act (HIPPA) of 1996
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it was designed with many goals in mind; limiting administrative costs of health care and privacy issues and preventing fraud and abuse were of primary importance. the law also had to provide security and confidentiality guarantees for each individual patient. extensive privacy rules, including the use of unique identifiers, have shaped the law. all health-care organizations that transmit any health information electronically must comply with this.
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FDA Modernization Act (FDAMA) of 1997
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reforming regulation of cosmetics, foods, and medical products, this act affected user fees, compounding in the pharmacy, safety, and medical device regulation. it also gave manufacturers six-month extension on new pediatric drugs that had undergone drug trials and required risk assessment reviews of all drugs and foods containing mercury.
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Medicare Prescription Drug, Improvement, and Modernization Act of 2003
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extensively overhauling Medicare, it introduced prescription drug tax breaks and subsidies. it also offered new Medicare "Advantage" plans with increased choices about care, providers, coverages, and federal reimbursements.
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Isotretinoin (Accutane) Safety and Risk Management Act (Proposal only) of 2004
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it was not passed, but it proposed the restriction of drugs containing isotretinoin as a result of severe, adverse effects. used for the treatment of acne, isotretinoin was shown to cause severe birth defects in the fetuses of patients who took the drug during the pregnancy. isotretinoin has also been lined to spontaneous abortions of fetuses, depression, psychosis, and suicide. FDA instituted the System to Manage Accutane-Related Tertogenicity (SMART). to this date the SMART program has unfortunately not been passed
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Combat Methamphetamine Epidemic Act of 2005
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An extension of the Patriot Act, it focused on the methamphetamine provisions with more intensity to stop illegal methamphetamine use, especially as it related to the funding of terrorist activities. the gov't can confiscate the property of anyone involved in methamphetamine-financed terrorism. it controls other drugs such as crack cocaine when involved in funding terrorism
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Medical Tamper-Resistant Prescription Act of 2008
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it requires written prescriptions for Medicaid-covered outpatient drugs to be executed on a tamper-resistant prescription. To be considered tamper-resistant, a prescription must have the following three characteristics:
1) one or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form 2) one or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription pad by the prescriber 3) one or more industry-recognized features designed to prevent the use of counterfeit prescription forms |
