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Pharm CH 2

The Drug Approval Process

American Hospital Formulary Service Drug Information
controlled substances is generally a drug or chemical whose manufacture, possession, or use is regulated by a government
Drug Enforcement Administration
malfeasance Giving the correct drug but by the wrong route that results in the patient's death
misfeasance Negligence; giving the wrong drug or drug dose that results in the patient's death
nonfeasance Omission; omitting a drug dose that results in the patient's death
United States Pharmacopeia—Drug Information the current three-volume authoritative source for drug standards
United States Pharmacopeia National Formulary
U.S. Food and Drug Administration approves new drugs
chemical name of a drug The chemical name describes the drug's chemical structure.
Generic name of a drug The generic name is the official, nonproprietary name for the drug. This name is not owned by any drug company and is universally accepted. Most drugs are ordered by generic name.
2007: Food and Drug Administration Amendments Act This act allows the FDA to mandate postmarketing safety studies and to affect the distribution of drugs that are found to be not as safe as premarket studies indicated.
2009: Family Smoking Prevention and Tobacco Control Act This act allows the FDA to regulate cigarettes by various measures such as requiring prominent warning labels and complete ingredient lists and prohibiting youth marketing.
2010: Patient Protection and Affordable Care Act quality, affordable health care for all Americans, improved quality and efficiency of health care, prevention of chronic disease and improved public health,improved access to innovative medical therapies, community living services and supports.
Brand name of a drug The brand (trade) name, also known as the proprietary name, is chosen by the drug company and is usually a registered trademark owned by that specific company. Drug companies market a compound using its brand name.
Kefauver-Harris Amendment to the 1938 Act came from infants being born with limb deformities in the 1950's after taking thalidomide in the 1st trimester--tightened controls on drug safety, and required that adverse reactions and contraindications must be labeled and included in the literature.
Durham-Humphrey Amendment to the 1938 Act Amendment to the Food, Drug, and Cosmetic Act of 1938-- distinguished between drugs that can be sold with or without prescription and those that should not be refilled without a new prescription.
Schedule F Prescription Drugs. All prescription drugs, except narcotics and controlled substances, are available only by prescription (written or verbal)
1938: Food, Drug, and Cosmetic Act empowered the FDA to ensure drug safety by monitoring and regulating the manufacture and marketing of drugs.
Schedule one drug High potential for drug abuse. No accepted medical use. Labeled C-I.
Schedule two drug High potential for drug abuse. Accepted medical use. Can lead to strong physical and psychological dependency. Labeled C-II.
Schedule three drug Medically accepted drugs. Potential abuse is less than that for schedules I and II. May cause dependence. Labeled C-III.
Schedule Four Drug Medically accepted drugs. May cause dependence. Labeled C-IV.
Schedule Five Drug Medically accepted drugs. May cause dependence. Labeled C-IV.
Kefauver-Harris Amendment Tightened controls on drug safety and testing
Food, Drug, and Cosmetic Act Empowered the FDA to monitor and regulate the manufacturing and the marketing of drugs.
Durham-Humphrey Amendment determines which drugs will be OVC
Created by: MBO



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