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Drug Regulation

Pharmacy Technician

QuestionAnswer
Food and Drug Act Prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Government pre-approval of drugs is required.
Harrison Tax Act In response to growing addiction to opiates and cocaine-containing medicines, the Harrison Tax Act established that manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax.
Food, Drug and Insecticide Administration The law enforcement agency is formed that would be renamed in 1930 as the Food and Drug Administration.
Food, Drug and Cosmetic (FDC) Act In response to the fatal poisoning of 107 peoplee, primarily children, by an untested sulfanilamide concoction, this comprehensive law requires new drugs be shown to be safe before marketing.
Alberty Food Products v. U.S. The United States Court of Appeals rules that the purpose for which a drug is to be used must be included on the label.
Durham-Humphrey Amendment This law defines what drugs require a prescription by a licensed practitioner and requires them to include this legend on the label: "Caution: Federal Law prohibits dispensing without a prescription: or the more recent "Rx Only".
Kefauver-Harris Amendment Requires drug manufactures to provide proof of both safety and effectiveness before marketing the drug.
Fair Packaging and Labeling Act This requires all consumer products in interstate commerce to be honestly and informatively labeled.
Poison Prevention Packaging Act Requires child-proof packaging on all controlled and mosst prescription drugs dispensed by pharmacies. Non-child proof containers may only be used if the prescriber or patient requests one.
Controlled Substances Act (CSA) The CSA classifies five levels of drugs (controlled substances) that have potential for abuse and therefore restricts their distrution.
Medical Device Amendment Requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices.
Orphan Drug Act Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases.
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) This act allowed for both the extension of drug patent terms and quicker introduction of lower cost generic drugs.
Prescription Drug Marketing Act Restricts distribution of prescription drugs to legitimate commercial channels and requires drug wholesalers to be licensed by the states.
Omnibus Budget Reconciliation Act (OBRA) This act requires pharmacists to offer counseling to Medicaid patients regarding medications.
Anabolic Steroid Control Act This act was passed to "address the abuse of steroids by athletes, and especially, youngsters and teenagers."
Health Insurance Portability and Accountability Act This act defined the scope of 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 right to privacy.
Created by: taniamayes
 

 



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