Laws Flashcards
Omnibus budget reconciliation act (OBRA 90)
Pharmacist must offer counseling to Medicaid patients regarding medications.
Pure Food and Drug 1906
Food & drug act 1906
Drug labels cannot contain false information. Government preapproval of drugs is required.
Harrison Tax Act 1914
Licenses are required for prescribers of narcotics and they are required to pay a tax.
Durham - Humphrey 1951
Distinguished between legend and OTC drugs.
Food Drug Cosmetic Act 1938
Drugs must be safe for human consumption before marketing - Sulfa.
Poison prevention packaging act 1970
Child resistant containers. Can be opened by 90% of adults, and by 20% of children.
Controlled substances act 1970
Classifies five levels of controlled substances that have potential for abuse; establishes the drug enforcement administration (DEA) as a division of the Justice Department.
Drug listing act 1972
10 character national drug code.
Hatch – Waxman act 1984
Allows substitution of generics.
Prescription drug marketing act 1987
Prohibit sale of sample drugs. Requires drug wholesalers to be licensed by the state.
Kefauver - Harris amendment 1962
Requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug.
MedWatch
Reporting program maintained by the FDA. Encourages healthcare professionals to report adverse affects that occur from approved drugs or other medical products.
Injunction
Court order that prevents the manufacture from distributing the drug.
Class 1 Recall
Where there’s a strong likelihood that the product will cause serious adverse effects or death.
Class 2 Recall
Where product may cause temporary but reversible adverse affects, or in which there is little likelihood of serious adverse effects.
