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PHM1140 De More3

PHM1140 Law & Ethics for Pharmacy Techs, Federal Regulation, Chapter 3, De More

adulteration tampering with or contaminating a substance
fraud the intentional use of deceit to deprive another person of his or her money, property or rights
fraudulent deceitful; intending to deceive
investigational drugs used to provide detailed inquiry or systematic examination of their effects
legend drug prescription drug
misbranding fraudulent or misleading labeling or marking
National Drug Code (NDC) the federal code tha identifies a drug's manufacturer or distributer , its formulation, and the size and type pf packaging
orphan drug drug used to treat diseases that affect fewer than 200,000 people in the United States
over-the-counter (OTC) non-prescription drug
phocomelia a severe birth defect also known as "seal limbs" involving the malformation or non formation of the arms and legs; it was caused by the drug thalidomide
teratogenic causing genetic defects
Pure Food and Drug Act 1906 Prohibited interstate commerce in adulterated or misbranded food, drink & drugs.
Harrison Narcotics Tax Act 1914 implemented to regulate and tak the distribution, importation and production of opiates; required that manufacturers, importers, pharmacists and physicians prescribing
Food Drug and Cosmetic Act 1938 manufacturers have to ensure the purity, strength, safety and packaging of drugs; ensures approved drugs are safe and effective.
Durham-Humphrey Amendment 1951 Defines what drugs require a prescription by a licensed practitioner, and requires a legend on the label, such as 'RX Only'
Kefauver-Harris Amendment 1963 Requires drug manufacturers to provide proof of safety and effectiveness before marketing the drug
Poison Prevention Packaging Act 1970 Requires child proof packaging on all controlled and most RX drugs dispensed by pharmacies. Non-child proof can only be used when patient requests.
Orphan Drug Act 1983 Provides incentives to promote research, approval and marketing of drugs needed for treatment of rare diseases.
Health Insurance Portability and Accountability Act (HIPPA) 1996 Defined the scope of health information that may and may not be shared among health providers without patient consent and provided for broad and stringent regulations to protect patients' right to privacy.
Recalls Class I: serious adverse effects or death; Class II: cause temporary but reversible effects; Class III: not likely to cause adverse effects
Thalidomide Tragedy of 1962 Thalidomide had been widely tested around the world as a tranquilizer, sedative and anti-nauseant during pregnancy, but was found to be teratogenic and cause phocomelia when used during pregnancy. It was withdrawn from the market in late 1961.
Comprehensive Drug Abuse Prevention and Control Act of 1970 requires the pharmaceutical industry to maintain physical security ans strict record keeping for many types of drugs. It classifies the levels of drugs that have potential for abuse into 5 schedules, from highest (Schedule I) to least (Schedule V).
Occupational Safety and Health Act (OSHA) of 1970 requires all employers to ensure employee safety and health; includes regulations for physical workplaces, machinery and equipment, first aid and job related materials; intended to require safe workplace conditions.
Drug Listing Act of 1972 each new drug is assigned a unique and permanent drug code that the FDA uses to maintain records of drugs by their use, manufacturer and active ingredients.
Medical Device Amendment of 1976 the safety and effectiveness of life-sustaining and life-supporting devices were now required to have pre-market approval of the FDA
Resource Conservation and Recovery Act of 1976 regulates the handling of solid waste and authorizes the governmental agencies to handke cleanup of contaminated sites and regulates solid waste landfills; also focuses on reducing and eliminating pollution
Drug Regulation Reform Act of 1978 - Provisions increase consumer protection; encourage drug innovation; increase consumer info; protect patient rights; improve FDA enforcement; promote competition/cost savings w/generics; increase FDA accountabiliy; make more drugs available; encourage research/traing
Drug Price Competition and Patent Term Restoration Act of 1984 gave marketers of a generic drug the ability to file abbreviate dnew drug applications to seek new approval of the generic drug; created in order to offset time and money required to bring new innovative drugs to market.
Prescription Drug Marketing Act of 1987 . It's designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs. It was passed in response to the development of a wholesale sub-market for prescription drugs
Omnibus Budget Reconciliation Act of 1990 Reduce Medicaid cost by reducing inappropriate drug use; Pharmacists must offer counseling their patients; manufacturers must offer lowest prices - rebate diff between avg and lowest avail price.
FDA Safe Medical Devices Act of 1990 gives FDA ability to regulate medical devices and products used for medical diagnosis; requires medical device reports be filed on a timely basis; established procedure for new devices prior to market availability and increased penalties for violations
Anabolic Steroids Control Act 1990 allowed Controlled Substances Act of 1990 to regulate anabolic steroids; offered harsher penalties for abuse and misuse of anabolic steroids by athletes
Americans With Disabilities Act 1990 prohibits discrimination against disabled persons; focuses on issues and rights - areas that concern employment, public services, transportation, commercial facilities telecommunications, and more; oversees what's needed to live as normally as possible
Dietary Supplement Health and Education Act of 1994 the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed.
FDA Modernization Act Act 1997 passed to improve the FDA regulation of drugs, biological products, food and medical devices - main aim was speeding up the process; addressed changing technologies of marketing products.
Medicare Prescription Drug, Improvement and Modernization Act of 2003 introduced tax breaks and subsidies for prescription drugs; ; presents new Medicare Advatage plans that offered patients better choices about their terms of care, providers, other types of coverage, and federal reimbursements
Isotretinoin Safety and Risk Management Act (Proposal Only) of 2005 proposed (but not passed); designed to restrict the distribution of isotretinoin (Accutane) because of the drug's side effects (severe birth defects, fetal death, depression, psychosis and suicide)
Created by: MrsAFlaherty



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