the system of precedents established by decisions in cases throughout legal history
are passed by legislative bodies at the federal, state, and local levels.
is the system of rules and regulations establish by the governmentsal bodies such as the FDA
Food and drug act of 1906
government pre-approval of drugs is required.. prohibits the interstate transportation of sale of adulterated and misbranded food and drugs
usually refers to mixing other matter of an inferior and sometimes harmful quality with food or drink intended to be sold. As a result of adulteration, food or drink becomes impure and unfit for human consumption.
1938 Food, drug and cosmetic act
requires new drugs to be shown to be safe before marketing...created the food and drug administration(FDA)
investigation of new drug application (INDA)
is submitted for a new drug entity to start investigational studies
New drug application(NDA)
is submitted for drug approval
The abbreviated New Drug Application(ANDA)
is the form that should be submitted to the FDA to obtain approval to market a generic product
United States Adopted Name (USAN)
the generic name of a drug
1951 Durhan-Humphrey Amendment
Federal law prohibits dispensing without a prescription or "rx only". an amendment to the FDCA(food drug and cosmetic act)
1962 Keffauver- Harris Amendment
Manufactures required to provide proof of safety and effectiveness before marketing
drugs being used in clinical trials
1970 Controlled Substances Act
The CSA classifies five levels of drugs that have potential for abuse and restricts their distribution.
1970 Poison Prevention Packaging Act (PPPA)
Requires child proof packaging on all controlled meds and most rx drugs
schedule I controlled substance, a drug with the highest potential for abuse, which may be used only for research under a special license. No accepted medical use in the US
schedule II controlled substance, a drug with a high potential for abuse, for which dispensing is severely restricted and prescriptions may not be refilled.
schedule III controlled substance, a drug with a moderate potential for abuse, which can be refilled no more than 5 times in a 6 months and only if authorized by the physician for this time period.
schedule IV controlled substane, a drug dispensed under the same restrictions as schedule III, but having less potential for abuse.
schedule V controlled substance, a drug with a slight potential for abuse; some of which may be sold without a prescription depending on state law, but the purchaser must sign for the drug and show identification.
Drug listing of 1972
required the FDA to assign each new drug a unique and permanent code known as the National Drug COde (NDC number) has ten digits, has 3 segments of numbers that indicate the labeler,product,and package code
1976 Medical Device Amendment
Requires premarket approval for safety and effectiveness of life sustaining and life suporting medical devices
Orphan Drug Act of 1983
is a drug that is intended for use by a few patients with rare diseases. Developing these drugs is usually not cost effective. (Ex: (Huntington's, Tourettes, Muscular Dystrophy, etc)
1990 Omnibus Budget REconcilliation Act (OBRA)
Requires pharmacists to offer counseling to Medicaid patients regarding medications.
FDA modernization Act
Federal drug legend ("Federal law prohibits the dispensing of this medication without a prescription") is now represented by the abbreviation "RX" on the container.
Dietary Supplement health and education act (DSHEA)
focused on dietary supplements and is the primary legislation governing the labeling and product information that can be used by nutraceutical companies; give FDA the authority to remove unsafe products from the market
Health Insurance Portability and Accountability act of 1996(HIPPA)
The Portability section of the Act simply guarantees that persons covered by health insurance by one employer can obtain health insurance through the second employer if they change jobs. The Accountability section of the act answers the question of who and what should be accountable for specific healthcare activities.
code of ethics
the standards of acceptable behavior developed by and for members of a profession
Food and Drug Administration (FDA)
a federal agency charged with enforcing regulations against selling and distributing adulterated, misbranded, or hazardous food and drug products
This is the FDA reporting service for adverse effects that occur from use of approved drugs.
The FDA has the authority to obtain an injunction from the court and force the manufacturer to recall the drug product if it is contaminated, is of poor quality, or causes serious adverse reactions
A _____________ drug recall indicates that the product will cause serious adverse health conditions or death.
a ______________ drug recall indicates that the product will cause adverse health events that are temporary or medically reversible
A___ drug recall indicated that the product will probably not cause an adverse health event
Drug enforcement Agency(DEA)
federal agency responsible for enforcing laws and regulations governing narcotics and controlled substances
DEA form 222
Controlled Substance order form issued by the Drug Enforcement Administration for the purpose of distributing Schedules I and II controlled substances
Controlled Substance Act
requires pharmacies to purchase class-II controlled substances with DEA form 222
first copy goes to the DEA, second copy goes to the pharmacy, third copy stays with the physician
United states pharmacopeia (usp)
provides drug info and sets standards for the quality and consistency of drugs, promotes the safe and proper use of meds, and verifies ingredients in dietary supplements.
national association of boards of pharmacy (NABP)
Meets to discusses trends and issued facing pharmacy, but has no regulatory authority
phase I clinical trial
safety - small number of people tested for basic pharmacokinetics of drug (absorption, half-life, Vd, potential toxicities)
phase II clinical trial
a clinical trial on more persons than in phase I, intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase III clinical trial
a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects.after successful conclusion of phase III clinical trials it will receive formal approval from the FDA
Codes of behavior related to business and contractual relationships between groups and individuals.
a civil wrong committed against a person or property,