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pharmacy laws
pharmacy laws and their definitions
| law | definition |
|---|---|
| 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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