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Pharm Laws

TermDefinition
Food & Drug Act of 1906 correct LABELING of drugs / ingredients / PURITY
Misbranding brand or label misleading or inaccurate
Adulterated does not conform to standards of quality, strength, or purity
Food, Drug, & Cosmetic Act 1938 meds=PURE/SAFE, created FDA/authorizied drug safety testing
Harrison Narcotic Act 1914 limit use of opiates, required IRS registration for manufacturers / distributors
Durham-Humphrey Amendment 1951 created legend drugs (OTC/Rx), allowed refills
Kefauver-Harris Amendment 1962 required proof of purity, safety, and efficacy before approval / clinical trials
Comprehensive Drug Abuse Prevention and Control Act of 1970 classified 5 levels of controlled subs., required DEA #s
Poison Prevention Packaging Act 1970 required childproof caps on most Rx (Nitrostat - exception)
Drug Listing Act of 1972 FDA list of drugs, requires NDC #s
Orphan Drug Act 1983 incentives to create treatments for uncommon conditions
Prescription Drug Marketing Act 1987 restricts distribution of Rx drugs and requires wholesalers to be licensed
Anabolic Steroid Act of 1990 classified anabolic steroids as Schedule III
Omnibus Budget Reconciliation Act 1990 required counseling for new Pts/new Rxs (med reconciliation)
Health Insurance Portability and Accountability Act (HIPAA) 1996 legal standard to protect patient PHI
Drug Addiction Treatment Act of 2000 allows detox / opioid addiction Rx
Medicare Modernization Act 2003 created Medicare part D, Rx coverage / MTM
Combat Methamphetamine Epidemic Act 2005 Placed limits on pseudoephedrine - 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 REMS programs
HITECH (Health Information for Economic and Clinical Health Act) 2009 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; makes it mandatory to report any illegitimate/adultereated products
Created by: user-1965687
Popular Pharmacology sets

 

 



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