pharmacy federal law and regulations
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1906 federal food and drugs act
enacted to stop the sale of inaccurately labeled drugs.
1914 harrison narcotics act
enacted because of excessive opium addiction across the U.S.. couldnt purchase opiums without a prescription.
1938 food, drug, and cosmetic act
- -all controlled substances were required to be labeled "Warning: May be habit forming."
- -required drug companies to include package inserts and directions to the consumer regarding safe use.
1951 durham-humphrey amendment
made the initial distinction between a legend drug and OTC drugs; required legend drugs to carry the label "Caution: Federal law prohibits dispensing without a prescription"
1962 kefauver-harris amendments
attempts to ensure the safety and effectiveness of all new drugs on the U.S. market.
1970 comprehensive drug abuse prevention and control act
DEA regulate distribution of scheduled drugs. Schedule I(most restrictive) through IV(least restrictive)
1970 the poison prevention packaging act
required manufacturers and pharmacies to place all medications in containers with childproof caps or packaging.
1987 prescription drug marketing act (PDMA)
addressed issues related to the distribution and wholesale pedigree of human prescription drugs.
1990 omnibus budget reconciliation act (OBRA '90)
states that a pharmacist must counsel at the time of purchase all Medicaid patients who receive new prescriptions.
OBRA requires use of?...
- drug utilization evaluation (DUE):
- a process used to ensure that prescribed drugs are utilized appropriately.
1996 health insurance portability and accountability act (HIPAA)
protected health information. and provides certain rights to a patient.
2000 drug addiction treatment act (DATA 2000)
permits physicians to prescribe controlled substances in schedules C-III, C-IV, or C-V to persons suffering from opioid addiction, for the purpose of maintenance or detoxification treatments.
2003 medicare modernization act (MMA)
this allows Medicare participants to offset high drug costs, which should also reduce preventable hospitalizations resulting from lack of medication treatment.
2005 combat methamphetamine epidemic act
addresses all areas related to manufacture of, enforcement of laws pertaining to, and sale of pseudoephedrine, which can be used to create methamphetamines.
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