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Acts

QuestionAnswer
Pure food and drug act of 1906 -Prohibit the intrastate transportation or sale of adulterated and misbranded food or drugs
Food, Drug, and Cosmetic Act of 1938 (FDCA 1938) -FDA created -All new drug applications be filed with FDA -Clearly defines Aldulterated and misbranding
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
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
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
Poison Prevention Packaging act of 1970 -Reduce chances of children being poisoned -Safety caps inwhich 80% of children cannot open but 90% adults can
Occupational Safety and Health Act of 1970 -OSHA was created -Ensures safe working environments for workforce -Safety Data Sheets (SDS) are used
Drug Listing Act of 1972 -NDC (11-digit number) -Manufactor-Drug-Package
Federal Privacy Act of 1974 -Protects Health Information from the government
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
Hatch-Waxman (Drug Price Competition and Patent Term Restoration Act of 1984) -Encourages creation of both generic and new meds by streamlining the process
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"
Omnibus Budget Reconciliation Act of -Establishes extensive revisions to Medicare and Medicaid Conditions of Participation regarding long-term care facilities and pharmacy.
Anabolic Steroid Control Act of 1990 -Enacted harsher penalties for the abuse of anabolic steroids and their misuse by athletes
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
Food and Drug Administration Safe Medical Devices Act of 1990 -All medical devices are to be tracked and records maintained for durable medical equipment
Resource Conservation and Recovery Act -Medical Waste Management
Dietary Supplement Health and Education Act of 1994 -Herbal products are dietary supplements rather than drugs -make health claims but not disease claims
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
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
Isotretnoin Safety and Risk Management Act of 2004 -Curve the misuse and abuse of this very powerful acne medication.
Anabolic Steroid Control Act of 2004 -Amended the Controlled Substances Act and added a new definition for Anabolic steroids -Changed them to Class III
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
Medicaid Tamper-Resistant prescription Act -Applies to all Prescriptions in writing,
Created by: zulim1