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29 Cards in this Set
- Front
- Back
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Pure Drug and Food Act of 1906
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prohibits the interstate transportation or sale of adulterated & misbranded food or drugs
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Food, Drug, & Cosmetic Act of 1938 (FDCA 1938)
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req'd that all new drug apps. be filed w/ the FDA
defined adulteration defined misbranding of food & drug products |
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Durham-Humphrey Act of 1951
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amendment to FDCA 1938
req. adequate directions made OTC (nonlegend) & Rx (legend) Rx needs supervision of a doc. allows refills to be called in from doc's office |
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Kefauver-Harris Amendment of 1962
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reqs. All meds in the U.S.to be pure, safe, & effective)
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Comprehensive Drug Abuse Prevention & Control Act of 1970
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DEA created; under supervision of the Dept. of Justice
created 5 schedules based on potential for abuse |
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Poison Prevention Packagin Act of 1970
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reqs. Most OTC & legend drugs to be packaged in child resistant containers
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Occupational Safety & Health Act of 1970 (OSHA of 1970)
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created OSHA
ensures safe & healthful workplace for employees |
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Drug Listing Act of 1972
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each drug gets an NDC
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Omnibus Budget Reconciliation Act of 1987
(OBRA-87) |
prevents importation of a drug from someone other than manufacturer in a foreign company
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Anabolic Steroid Control Act of 1990
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harsher penalties for the abuse of anabolic steroids by athletes
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Omnibus Budget Reconciliation Act of 1990
(OBRA-90) |
reqs. That manufacturer provide lowest prices to any customer/Medicaid
"offer to counsel" patient profiles |
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FDA Safe Medical Devices Act of 1990
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all medical devices be tracked
records be maintained for durable medical equip. (i.e. infusion pumps) |
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Americans with Disabilities Act (ADA) of 1990
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prevent discrimination against potential employees who may possess a disability
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Orphan Drug Act of 1983
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orphan drugs- meds. for treatment of diseases which have than 200,000 cases
makes tax incentives & exclusive living |
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Drug Price Competition & Patent Term Restoration Act of 1984
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encouraged creation of both generic & new meds by streamling drug approval & extending licenses
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Resource Conservation & Recovery Act
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EPA (Environmental Protection Agency) made fed. Guidelines & disposal of hazardous materials
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FDA Modernization Act
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Rx means fed. Law prohibit dist. Of drug w/o prescription
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Dietary Supplement Health & Education Act of 1994
(DSHEA of 1994) |
herbal products are dietary supplements
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Health Insurance Portability & Accountability of 1996
(HIPPA of 1996) |
improve portability & continuity of health coverage
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Isotretinoin Safety & Risk Management Act of 2004
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mandatory registry of pharmD & patients
education only for severe nodular acne certification of med. Offices 30 days of pills for refills preg. Testing |
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Anabolic Steroid Control Act of 2004
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increased anabolic steroids to 59 substances
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Any Willing Provider Law
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allows any pharmacy to participate in a benefit plan as long as the pharm. Agrees to their terms
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Freedom of Choice Law
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allows a member of an Rx plan to select any pharm. As long as the pharm. Agrees to the plan
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Freedom of Choice With Regard to Long-term Care
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long-term care residents may choose an outside pharm. For their meds. if the pharm. Services is not in their contract
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Prescription Drug Equity Law
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prohibits a Rx plan from req. mail order prescription
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Medicare Drug, Improvement, & Modernization Act of 2003
(MPDIMA of 2003) |
Medicare Part D Rx plan allows beneficiaries to enroll in either regional or national insurance programs
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Combat Methamphetamine Epidemic Act of 2005
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law that puts ephedrine, psuedoephedrine, & phenylpropanolamine in the Controlled Substances Act category "scheduled listed chemical products"
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Medicaid Tamper-resistant Prescription Act
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When Medicaid pays:
1.feature to prevent copying of form 2. prevents erasure 3. counterfeit form production |
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USP <797>
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Addresses: (for sterile products)
microbial contamination risk levels: low, medium, & high personnel training clean rooms environmental monitoring |
