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Pharm Laws
| Term | Definition |
|---|---|
| Food & Drug Act of 1906 | known as Pure Food & Drug Act - one of the first laws passed to control drugs in the US - concerned w/drug PURITY and correct labeling of drugs & ingredients - required labeling to identify the ingredients in a medication |
| Misbranding | means to brand or label misleadingly or inaccurate |
| Adulterated | does not conform to standards of quality, strength, or purity |
| Food, Drug, & Cosmetic Act 1938 | - focused on meds being pure AND SAFE - FDA was created as a result of the FDCA - gave FDA authority to require adequate testing of new drugs for safety |
| Harrison Narcotic Act 1914 | tried to limit the recreational use of Opium and control the rising addiction problem - required prescriptions and record keeping |
| Durham-Humphrey Amendment 1951 | - created distinction between OTC Rx - required legend (Rx) drugs to carry the statement "Caution: Federal Law prohibits dispensing w/out a prescription" or "Rx" - permitted refills |
| Kefauver-Harris Amendment 1962 | also known as "Drug Efficacy Amendment" - required manufacturers to provide proof of purity safety and EFFECTIVENESS of their drugs before approval - set stage for clinical trails |
| Comprehensive Drug Abuse Prevention and Control Act of 1970 | also known as Controlled Substance Act (CSA) - classified the 5 levels for controlled substances - required DEA numbers and is enforced by the DEA under the Dept of Justice - required warning "May be habit forming" |
| Poison Prevention Packaging Act 1970 | also known as PPPA - designed to reduce the risk of children injjesting dangerous substances - required childproof caps on most prescriptions unless requested otherwise - NitroStat (nitroglycerin) is the biggest exception |
| Drug Listing Act of 1972 | requires FDA to keep a list of drugs; which must have a NDC # - first 4/5 digits = manufacturer - next 4 = product - last 2 = package size |
| Orphan Drug Act 1983 | required the government provides incentives for manufacturers to develop and market drugs for rare diseases/conditions |
| Prescription Drug Marketing Act 1987 | restricting the resale of previously purchased medications - Act that restricts distribution of prescription drugs to legitimate commercial channels and requires drug wholesalers to be licensed by the states |
| Anabolic Steroid Act of 1990 | A law passed w/the intent of minimizing or eliminating the use of anabolic steroids for non-medical purposes - classified anabolic steroids as Schedule III |
| Omnibus Budget Reconciliation Act 1990 | unline most federal laws, OBRA placed expectations on the pharmacist on how to interact w/the patient - primary goal was to find interactions between Medicaid patient's medications/counsel all patients |
| Health Insurance Portability and Accountability Act (HIPAA) 1996 | legal standard to protect patient privacy rights including medical information and communication - safeguard patients PHI PHI = protected health information |
| Drug Addiction Treatment Act of 2000 | allows physicians to prescribe CIII-CV meds for purposes of detox or opioid addiction |
| Medicare Modernization Act 2003 | produced the largest overhaul of medicare in 38 years established MEDICARE PART D - a voluntary plan for Medicare patients, providing coverage for Rx drugs and Med Therapy Managment (MTM) |
| Combat Methamphetamine Epidemic Act 2005 | goal = limit the use of pseudoephedrine in making illegal methamphetamines - limited daily/monthly amounts of pseudo -3.6 GRAMS A DAY/9 GRAMS A MONTH - BTC (behind counter) -sales logbook - customer verification - must be 18 y/o |
| The Food and Drug Administration Amendments Act of 2007 | authorizes FDA to require risk evaluation and mitigation strategies (REMS) or meds if necessary; reduces risk associated w/some drugs - REMS may contain the MEDICATION GUIDE or COMMUNICATION PLAN |
| HITECH (Health Information for Economic and Clinical Health Act) 2009 | an update to HIPAA that strengthened requirements for privacy and security laws related to PHI, especially ePHI - increased penalties for noncompliance of security/privacy laws - provided additional privacy provisions and penalties to HIPAA |
| Drug Supply Chain Security Act (DSCSA) 2015 | aka TRACK AND TRACE - purpose of new law is to aid the FDA in ensuring patient safety by preventing counterfeit, stolen, contaminated, or recalled drug products from entering market makes it mandatory to report any illegitimate/adultereated products |
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