- pure food and drug act of 1906 prohibit interstate transportation or sale of adulterated and misbranded food/drugs
- food, drug, and cosmetic act of 1938 (fdca 1938) defined adulteration and misbranding of food/drugs + requires that all new drug applications be filed with fda
- durham-humphrey act of 1951 (amendment) requires all products to have adequate directions for use unless they say "caution: federal law prohibits dispensing without a prescription"
- separated drugs into legend and nonlegend (otc)
- allows verbal prescriptions over telephone
- allows refills to be called in from a physician's office
- durham-humphrey act of 1951 (amendment) requires all products to have adequate directions for use unless they say "caution: federal law prohibits dispensing without a prescription"
- kefauver-harris amendment of 1962 medications must be pure, safe, effective
- comprehensive drug abuse prevention and control act of 1970 dea created
- dea 222 (triplicate) ordering medication
- copy 1 - brown, supplier. copy 2 - green, dea office. copy 3 - blue, purchaser
- supplier has 60 days to fill form
- purchaser keeps copy for two years
- dea form 41 (for c2 substances) destroy outdated/unused substances
- dea form 106 report theft
- dea 222 (triplicate) ordering medication
- poison prevention packaging act of 1970 reduce accidental poisoning in children; can't be opened by 80% kids 5 and under but can by 90% of adults (exceptions being meds not requiring child-resistant containers)
- occupational safety and health act of 1970 created osha; reduces hazards in workplace, requires reporting system for illnesses and injuries, ensures safe workplace
- drug listing act of 1972 drug assigned ndc number; five - manufacturer, four - product, two - package size/packaging
- federal privacy act of 1974 regulates what info the government can collect about individuals and how info can be used
- orphan drug act of 1983 medicines for treatments of diseases/conditions for which there are < 200,000 cases in the world + provides incentives for manufacturers to develop and market orphan medications
- hatch-waxman act of 1984 (drug price competition and patent term restoration) encouraged creation of medications by streamlining process for generic drug approval and extending patent licenses
- prescription drug marketing act of 1987 prohibits re-importation of drug into u.s. by anyone except manufacturer; "caution: federal law restricts this drug to use by or on an order of a licensed veterinarian"
- omnibus budget reconciliation act of 1987 revisions to medicare/medicaid conditions of participation regarding long-term care facilities and pharmacy
- anabolic steroid control act of 1990 harsher penalties for abuse of steroids by athletes
- anabolic steroid control act of 2004 increased to 59 substances, new definition
- omnibus budget reconciliation act of 1990 three components of drug review programs
- prospective drug use review
- retrospective drug use review
- educational programs
- food and drug administration safe medical devices act of 1990 all med devices to be tracked and records maintained for durable med equipment
- resource conservation and recovery act general guidelines for waste management program envisioned by congress
- dietary supplement health and education act of 1994 herbal products must be labeled as dietary supplement and be clear about ingredient comp
- health insurance portability and accountability act of 1996 improve health coverage in markets; combat waste, fraud, and abuse in health field; simplify administration of health insurance
- title i insurance reform. protects coverage for people when change or lose jobs
- title ii administrative simplification. health info privacy + electronic transactions
- medicare prescription drug improvement and modernization act of 2003 provides a bunch of benefits in regards to medicare
- isotretinoin safety and risk management act of 2004 mandatory registry due to effects, monthly education, 30-day prescriptions
- combat methamphetamine epidemic act of 2005 3.6 g/day, 9 g/30 day, mail-order restrictions
- medicaid tamper-resistant prescription act just makes sure the prescription pad can't be tampered with through a bunch of federal guidelines
feb 26 2017 ∞
feb 26 2017 +
feb 26 2017 +