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Chap 3 notes

Chapter 3 Notes

Legend drug any drug that requires a prescription and either of these legends on the label: Rx only or Caution: federal law prohibits dispensing without a prescription
Food and Drug act of 1906 Prohibited interstate commerce in adulterated or misbranded food, drinks and drugs. Government requires pre approval of drugs
1914 Harrison Tax Act Established manufacturers, pharmacists, importers and physicians prescribing narcotics should be licensed and required to pay a tax
1938 Food, Drug and cosmetic act (FDC) Requires new drugs to be shown safe before markting
1927 Food, Drug and Insecticide Administration The law enforcement agency is formed that would be renamed in 1930 as the Food and drug administration
1950 Alberty Food Products vs. US US court of appeals rules that the purpose for which a drug is to be used must be included on the label
1951 Durham-Humphrey Amendment Defines which drugs require a prescription by a licensed practitioner and require them to include this legend on the label: Caution federal law prohibits dispensing without a prescription or Rx only
1962 Kefauver-Harris amendment Requires drug manufacturers to provide proof of safety and effectiveness before marketing
1966 fair packaging and labeling act requires all products to be honestly and informatively labeled
1970 poison prevention act requires child proof packaging on all controlled substance and most prescription drugs
1970 Controlled Substances act (CSA) Classifies 5 levels of drugs that have potential for abuse and restricts heir distribution. the DEA was established by this act
1976 Medical device amendment Requires pre market approval for safety and effectiveness of life sustaining and life supporting medical devices
1983 Orphan drug act provides incentives to promote research, approval and marketing of drugs needed for the treatment of rare diseases
1984 Hatch Waxman / Drug price and patent term restoration act this act allowed for both the extension of drug patent terms and quicker introduction of lower cost generic drugs
1987 prescription drug marketing act restricts distribution of prescription drugs to legitimate commercial channels and requies drug wholesalers to be licensed by the state.
1990 Anabolic steroid control act this act was passed to address abuse of steroids by athletes, and especially teenagers and youngsters
CDER Center for drug evaluation and research
what are the 3 stages of trials? Chemical, Animal and Clinical
Placebo an inactive substance given in place of medicine
Pediatric having to do with the treatment of children
Phase 1 of clinical testing 20-100 people, several months, purpose: mainly safety
Phase 2 of clinical testing up to several hundred people, lasts several months to 2 yrs, purpose: short term safety and effectiveness
Phase 3 of clinical testing several hundred to several thousand, lasts one to four years, purpose: safety, dosage and effectiveness
IND Investigational new drug, only used in trial groups unless granted special treament
CDRH Center for devices and radiological heath
CBER Center for biologics evaluation and research
Schedule 1 Each drug has a high potential for abuse and no accepted medical use in the US. It may not be prescribed. ie. Heroin, various opium derivatives , and hallucinogenic substances
Schedule 2 Each drug has a high potential for abuse and may lead to physical or psychological dependence, but also has a currently accepted medical use in the US. ie. Amphetamines, opium, cocaine, methadone, and various opiates
schedule 3 Each drugs potential for abuse is less than class 1 or 2 and there is urgently medical use in the US, but abuse may lead to mild or moderate dependence. ie. Anabolic steroids, various compounds containing quantities of narcotic substances, codeine
schedule 4 each drug has a low potential for abuse relative to schedule 3 drugs, and there is current accepted medical use in the US
schedule 5 Each drug hs low potential or buse relative to schedule 4 drugs and there is current accepted medical use in the US. Abuse may lead to physical or psychological dependence
DEA number All prescribers of controlled substances must be an authorizd DEA dealer and are assigned a number to put on all prescriptions
DEA form 222 Used to order C-I and C-II substances. must be filled out in pen, typewriter or indelible pencil and be signed by n authorized person in triplicate
DEA form 224 Application for new registration
DEA form 224-a Renewal application for registration
DEA form 224-b retail pharmacy registration affidavit for chain renewal
DEA form 41 registrants inventory of drugs surendered
DEA form 106 Report of theft or loss of controlled substances
DEA form 363 New application registration- narcotic treatment program
DEA form 363-a Application for DEA registration- NTP renewal registration
DEA 510 Application for registration- for chemical registration
Medwatch a program run by the FDA to catch adverse side effects or problems in Prescription drug
Class 1 recall Where there is a strong likelihood that the product will cause serious averse effects or death
Class 2 recall Where a product may cause temporary but eversable adverse reactions or in which there is little likelihood of serious adverse effects
Class 3 recall Where a product is not likely to cause any adverse reaction or effect
FDA Enforcement Report Where recalls are listed publicly weekly
3 steps of recalls Report of adverse effects, Manufacturer agrees to recall, Consumers contacted and meds recalled
USP United States Pharmacopeia- a voluntary, not for profit organization that sets standards for the manufacturer and distribution of drugs and related products in the US
JCAHO Joint Commission on Accreditation of Health Care Organizations
Created by: megancarter



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