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30 Cards in this Set
- Front
- Back
Pure Food and Drug Act of 1906
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Prohibits the interstate transportation or sale of adulterated and misbranded food or drugs.
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Food, Drug, and Cosmetic Act of 1938 (FDCA)
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Defined adulteration and misbranding of drugs and food products. Required all drug applications to be filed with the FDA.
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Durham-Humphrey Act of 1951
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Amendment of FDCA requiring all products to have adequate directions unless they contain Caution label. Separated drugs into legend (prescription) and non-legend (over the counter).
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Kefauver-Harris Amendment of 1962
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Requires all medication in the U.S. to be pure, safe, and effective.
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Comprehensive Drug Abuse Prevention and Control Act of 1970
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Created the DEA, under Department of Justice supervision. Defined 5 Schedules for drugs based on potential for abuse.
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Schedule I
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No accepted medical use in U.S. and extreme potential for abuse.
Examples: Cocaine, Marijuana, Opium, Rohypnol |
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Schedule II
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Medical use with high abuse potential with severe psychological or physical dependency. Examples: Adderall, Codeine, Morphine sulfate, OxyContin, Ritalin
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Schedule III
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Medical use with abuse potential.
Examples: Testosterone, Hydrodone + Acetaminophen |
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Schedule IV
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Less abuse potential which may lead to limited physical or psychological dependence.
Examples: Ambien, Lorazepam |
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Schedule V
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Less abuse potential. Includes exempt narcotics.
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DEA Form 224
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New Pharmacy Registration Form
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DEA Form 41
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Surrender of Controlled Substance to DEA or other Law Enforcement for Disposal
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DEA Form 222 |
Transfer of Controlled Substance to another registrant. Records must be kept 2 years |
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DEA Form 106 |
Report Theft of Significant Loss of Controlled Substance. Must notify within 1 business day of discovery. |
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Controlled Substances Records must be kept: |
at least 2 years |
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All CII records and inventories must be |
kept separate from all other records
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Paper prescription records for Controlled Substances III, IV and V can be filed together if they have a |
Red "C" stamp not less than one inch high. |
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Controlled Substance inventory must be done every 2 years. There must be an actual physical count of ________ drugs. |
CII |
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DEA Form 222a |
used for ordering additional forms to order Controlled Substances |
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Narcotic Addiction Treatment Act 1974
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AddictionTreatment Programs that use CS agents in treatment must register with DEA
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Drug Addiction Treatment Act 2000 (DATA)
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Allows individual physicians to treat drug dependence without having to register as a Narcotics Treatment Program.
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Combat Methamphetimine Epidemic Act (CMEA)
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limits sale of Ephedrine, phenylpropanolamine (PPA), and pseudoephedrine (PSE) to
3.6gm/day or 9 gm/month. |
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Stark I and Stark II |
"anti-kickback" legislation which prohibits physicians with a financial interest from making referrals of Medicare/Medicaid patients to each other. |
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MAC |
established Maximum Allowable Costs for drugs |
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MTM |
Medication Therapy Management |
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DUR |
Drug Utilization Review |
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Medicare Part B |
covers Outpatient services, including DME |
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Medicare Part D |
Covers Rx drugs and medical supplies for insulin administration
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Medicare part C |
Combinationof A&B in a managed care plan
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Medicare Part A |
covers Inpatient services |