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pharmacy laws

pharmacy laws and their definitions

Pure food and drug act of 1906 prohibited foreign and interstate traffic in adulterated and misbranded food and drugs; required that the active ingredients be listed on the label and drugs could not fall below purity levels established by the USP or national formulary
Harrison narcotic act of 1914 first use of federal criminal law in the US to deal with the non medical use of drugs
Food Drug and Cosmetic act of 1938 clearly defined adulteration and misbranding of drugs and food products
Comprehensive Drug Abuse Prevention and Control act of 1938 required that all narcotics be labeled "warning; may be habit forming"
Durham-Humphrey Act of 1950 defining which drugs can and cannot be dispensed without a valid prescription and must include federal legend :"caution: federal law prohibits use without prescription" or "rx only" on the label and allows phone prescriptions
Kefauver-Harris Act of 1950 mandated that manufacturer must provide proof of safety and effectiveness before marketing new drugs.
Social Security Act of 1965 established Medicare
Fair Packaging and Labeling Act of 1966 all consumer products must be honestly and informatively labeled
Comprehensive Drug Abuse Prevention and Control Act of 1970 (controlled Substance Act) created under the DEA; controlled substances were placed in one of 5 categories and must be labeled : "Warning: May be habit forming"
Occupational Safety and Health Act of 1970 (OSHA) ensured a safe and healthful workplace for employees; created SDS
Poison Prevention Act of 1970 child resistant caps to reduce poisoning in children and permits certain meds not to be dispensed in child resistant containers
Consumer Products Safety Commission enforces the Poison Prevention Act
Drug Listing Act of 1972 created the National Drug Code: 11 digit number that identifies the manufacturer, product, and package size
Orphan Drug Act of 1983 provides incentives to promote research, approval and marketing of drugs needed for treatment of rare diseases by streamlining the drug development process
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman) allows for extension of drug patents and quicker introduction of lower-cost generics
Omnibus Budget Reconciliation Act of 1987 (OBRA87) establishes revisions to Medicare and Medicaid regarding long term care facilities including: meds must be labeled' pt regimen must be free of unnecessary meds, antipsychotic meds' consultant RPH, and routine and emergency meds provided
Prescription Drug Marketing Act of 1987 prohibits re-importation of a drug by anyone but the manufacturer
Omnibus Budget Reconciliation Act of 1990 (OBRA90) requires all pharmacies to maintain profiles on patients (DUE/DUR)
Dietary Supplemental Health and Education Act of 1994 required all herbal products to be labeled as a dietary supplement
Health Insurance Portability and Accountability Act 1996 (HIPAA 96) was concerned with insurance reform, patient confidentiality, and security of computer system; PHI-PROTECTED HEALTH INFORMATION
Medicare Drug Improvement and Modernization Act of 2003 provided voluntary prescription drug benefits to Medicare beneficiaries, added for seniors, lowered reimbursement rates for Medicare payment for med equip., discount card program
MTM Medication Therapy Management and tax free savings
Anabolic Steroid Control Act of 2004 provided requirements for handling substances defined as anabolic steroids (schedule 3 drugs)
Isotretinoin Safety and Risk Management Act of 2004 the rx must be hand written and dispensed within 7 days after being written and limits the dispensing to a 30 day supply with no refills: refills can not be called into the pharmacy
Combat Methamphetamine Epidemic Act of 2005 the maximum allowed amount of pseudoephedrine that may be purchased in a single day is 3.6 g; maximum in a 30 day period is 9g. must be locked and id required for purchase
Patient Protection and Affordable Care Act of 2010 health care reform for the uninsured; reduced the amount that may be set aside for a flexible spending account
Prescription Drug Equity Law assured equitable treatment in health care coverage of prescription drugs under group health plans , health insurance coverage, medicare and Medicaid, medigap, and health plans under the federal employees health benefits program
Freedom Choice Law permits an enrollee to obtain reimbursable health care services from any qualified provider even if they aren't signed with the manage care plan
Americans With Disabilities Act prohibits discrimination against individuals with physical, mental, and emotional disabilities
FDA responsible for reviewing and approving all investigational new drug apps
Created by: tconway33



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