Shared Flashcard Set

Details

Laws
Established laws for regulating medicines
17
Medical
Professional
05/13/2009

Additional Medical Flashcards

 


 

Cards

Term
Food and Drug Act of 1906
Definition
Prohibited interstate commerce in adulterated or mis-branded food, drinks, and drugs. Gov't pre-approval of drugs is required.
Term
Harrison Tax Act of 1914
Definition
In response to the growing addiction to opiates, manufacturers, pharmacists, importers, and physicians must be licensed and taxed to perscribe narcotics.
Term
Food, Drug, and Insecticide Administration of 1927
Definition
FDA is formed.
Term
Food, Drug, and Cosmetic Act of 1938
Definition
Law requires that all new drugs must show that they are safe for consumption before marketing.
Term
Alberty Food Products v. US of 1950
Definition
The purpose of the drug must be indicated on the label
Term
Durham-Humphrey Amendment of 1951
Definition
Law defines what drugs require a prescription by a licensed practitioner and requires medicines to include the Legend "Federal Gov't prohibits dispension without a prescription"
Term
Kefauver-Harris Amendment of 1962
Definition
Requires drug manufacturers to provide proof of both drug safety and effectiveness before marketing.
Term
Fair Packaging and Labeling Act of 1966
Definition
Requires all consumer products in interstate commerce to be honestly and informatively labeled
Term
Poison Prevention Packaging Act of 1970
Definition
Requires child-proof packaging on all controlled and most prescription drugs dispensed in pharmacies. Non-Child-Proof caps can only be used if requested by the patient.
Term
Controlled Substance Act of 1970
Definition
The CSA classifies 5 levels of drugs that have potential for abuse and therefore restricts their distribution. The DEA was established for this enforcement.
Term
Medical Device Amendment of 1976
Definition
Requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices.
Term
Orphan Drug Act of 1983
Definition
Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases.
Term
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) of 1984
Definition
Allows for both the extension of drug patent terms and quicker introduction of lower-cost generic drugs.
Term
Prescription Drug Marketing Act of 1987
Definition
Restricts distribution of prescription drugs to legitimate commercial channels and requires drug wholesalers to be licensed by the states.
Term
Omnibus Budget Reconciliation Act(OBRA) of 1990
Definition
Among other things, this act requires pharmacists to offer counseling to Medicaid patients regarding medications.
Term
Anabolic Steroid Control Act of 1990
Definition
This act was passed to address the abuse of steroids by athletes and youngsters.
Term
Health Insurance Portability and Accountability Act (HIPAA) of 1996
Definition
Defined the scope if health information that may and may not be shared among health care providers without patient consent and provided for broad and stringent regulations to protect patients' rights to privacy.
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