Acts
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each of the black spaces below before clicking
on it to display the answer.
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| Pure food and drug act of 1906 | -Prohibit the intrastate transportation or sale of adulterated and misbranded food or drugs
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| Food, Drug, and Cosmetic Act of 1938 (FDCA 1938) | -FDA created
-All new drug applications be filed with FDA
-Clearly defines Aldulterated and misbranding
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| Durham-Humphrey act of 1951 | -"Caution: Federal Law prohibits dispensing without a prescription"
-Legend and non-legend (OTC)
-Allows verbal prescriptions/refills over the phone
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| Kefauver-Harris Amendment of 1962 | -Requires all drugs in US to be pure and safe
-Establishes procedures to both drug applications and investigation drugs
-Drug manufacturers are to use Good Manufacturing Process
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| Comprehensive Drug Abuse Prevention and Control Act of 1970 | -DEA created
-Drug Classes were made I(no medical use) to IV
-DEA Forms:
224-New Pharm
222-Ordering class II Narcs
041-Destruction of Class II
106-Theft of Controls
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| Poison Prevention Packaging act of 1970 | -Reduce chances of children being poisoned
-Safety caps inwhich 80% of children cannot open but 90% adults can
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| Occupational Safety and Health Act of 1970 | -OSHA was created
-Ensures safe working environments for workforce
-Safety Data Sheets (SDS) are used
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| Drug Listing Act of 1972 | -NDC (11-digit number)
-Manufactor-Drug-Package
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| Federal Privacy Act of 1974 | -Protects Health Information from the government
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| Orphan Drug Act of 1983 | -Orphan drugs inwhich that are fewer than 200,000 patients with a disease/condition
-Provides incentives to produce and manufacture
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| Hatch-Waxman (Drug Price Competition and Patent Term Restoration Act of 1984) | -Encourages creation of both generic and new meds by streamlining the process
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| Prescription Drug Marketing Act of 1987 | -Prohibits the re importation of a dug into the Us by anyone except the Manufacturer
-Prohibits sell/samples to anyone other than a licensed prescriber
- "Caution: Federal Law restricts this drug to be use by or on an order of a licensed veterinarian"
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| Omnibus Budget Reconciliation Act of | -Establishes extensive revisions to Medicare and Medicaid Conditions of Participation regarding long-term care facilities and pharmacy.
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| Anabolic Steroid Control Act of 1990 | -Enacted harsher penalties for the abuse of anabolic steroids and their misuse by athletes
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| Omnibus Budget Reconciliation Act of 1990 | -Review drug use with 3 cats
1: Prospective drug use review
2: Retrospective drug use review
3: Educational programs
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| Food and Drug Administration Safe Medical Devices Act of 1990 | -All medical devices are to be tracked and records maintained for durable medical equipment
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| Resource Conservation and Recovery Act | -Medical Waste Management
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| Dietary Supplement Health and Education Act of 1994 | -Herbal products are dietary supplements rather than drugs
-make health claims but not disease claims
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| Health Insurance Portability and Accountability Act of 1996 | -Improve portability and continuity of health coverage in groups/individual markets
-Combat waste
-Reduce Fraud
-Reduce Health care abuse
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| Medicare Prescription Drug Improvement and Modernization Act of 2003 | -Provides voluntary prescription drug benefit to Medicare Beneficiaries
-Preventive medical benefits for senior citizens
-Lowers reimbursement rates for durable medical equipment
-changed the way Medicare pays for outpatient Part B drugs
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| Isotretnoin Safety and Risk Management Act of 2004 | -Curve the misuse and abuse of this very powerful acne medication.
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| Anabolic Steroid Control Act of 2004 | -Amended the Controlled Substances Act and added a new definition for Anabolic steroids
-Changed them to Class III
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| Combat Methamphetamine Epidemic Act of 2005 | -Placed Ephedrine, Pseudeephedrine and Phenylpropanolamine in the controlled substances Act
-Specifies 3.6G/day, 9g/30-day
-Logbook implemented
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| Medicaid Tamper-Resistant prescription Act | -Applies to all Prescriptions in writing,
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