Laws and Legislation Flashcards
FDA
Researches and approves drugs
job of physician
Prescribe (can dispense samples)
job of pharmacist
dispense
job of allied health professional
liaison between physician and pharmacist, and will get a lot of questions from the patient about their prescription
USP-NF
sets standards for purity, potency, quality, efficacy
DEA
combat drug trafficking and illegal drug use
Pure Food and Drug Act
made USP-NF but had many loopholes
Shirley amendment
prohibited fraudulent claims by the manufacturer
Harrison narcotic act
established the term narcotic and regulated opium and codeine
Food, Drug, and Cosmetic Act
safety testing on all drugs (test for toxicity and report side effects), formed FDA
Durham-Humphrey amendment
- distinguished between otc and rx and labeling as such
- required warning labels
Kefauver-harris amendment
required proof of effectiveness
Controlled substances act
repealed all previous legislation:
- regulated drugs with potential for abuse
- established 5 schedules
- made rehab for drug abuse and dependence
- created BNDD (Bureau of narcotics and dangerous drugs)
- created DEA
Bureau of narcotics and dangerous drugs
register people who manufacture, prescribe, dispense, or administer any controlled substances
Poison prevention packaging act
ensure child-resistant packaging for otc and rx
Drug Listing Act
established national drug code for FDA to identify manufacturer, formulation, size of packaging using a unique code
Drug regulation and reform act
briefer investigation of new drugs, faster consumer access
orphan drug act
established funding for research for the use of drugs in the treatment of rare, chronic illnesses
Drug price competition and patent term restoration act
eased requirements for marketing generic drugs by allowing companies to prove bioequivalence without duplicate trials
Omnibus budget reconciliation act
OTC drugs are an important part of the medical record and should be documented
anabolic steroids control act
put anabolic steroids as a controlled substance
prescription drug amendments of 1992
rapid FDA approval of medications for life-threatening diseases and debilitating conditions
Food and Drug administration modernization act
rapid FDA approval of medications for life-threatening diseases and debilitating conditions
