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27 Cards in this Set
- Front
- Back
DEA Form 363
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compound or conduct a narcotic treatment program
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DEA Form 41
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disposal or destruction
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DEA Form 224
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dispense (pharmacies)
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DEA Form 106
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theft
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DEA Form 222
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to order CII substances
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DEA Form 225
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manufacturer or distribute
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Pure Food and Drug Act
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First pharmacy law; prohibits manufacture, sale, or transport of poisonous patent medicines
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Harrison Narcotic Act
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requires prescriptions for opium- based products (narcotics)
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Food, Drug, and Cosmetic Act (FDCA)
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all drugs are required to have directions for use and warnings
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Labeling requirement for prescription labels
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pharmacy name, address, phone number
serial number (Rx number) date of fill expiration date patient's name prescriber's name directions for use warnings (if needed) auxiliary labels (if needed) |
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Durham- Humphrey Amendment
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made the distinction between legend drugs and OTC drugs; later replaced legend with "Rx only"
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Kefauver- Harris Amendment
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required drugs to be safe and effective
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Comprehensive Drug Abuse Prevention and Control Act
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established the DEA; created the five schedules of controlled substances
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Poison Prevention Packaging Act
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all prescription drugs must be dispensed in childproof containers
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Drug Listing Act
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National Drug Code (NDC) xxxxx-xxxx-xx
1st set- manufacturer 2nd set- drug name, strength, dosage form 3rd set- package size |
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Medical Device Amendment
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Requires the safety and effectiveness of life- sustaining and life- supporting devices
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Orphan Drug Act
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created to stimulate the development of drugs for rare diseases (200,000 people or less)
Incentives: seven- year market exclusivity tax credit of 50% cost of conducting human trials federal research grants for testing treatments waiver of new drug application FDA fees |
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Drug Price Competition and Patent Term Restoration Act
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aka Hatch- Waxman Act
allows patent extension on trade name once patent expires, allows faster approval process for generic version |
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Prescription Drug Marketing Act
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created to address diversion of large quantities of drugs into a secondary "gray" market
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Anabolic Steroids Control Act
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placed anabolic steroids on schedule CIII
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OBRA '90
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Omnibus Budget Reconciliation Act
mandates the pharmacists to perform a drug utilization review (DUR) and off counseling to patients |
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PDUFA
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Prescription Drug User Fee Act
authorizes FDA to collect fees from companies that produce certain human drug and biological products |
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Dietary Supplement Healthy and Education Act
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greater regulation on dietary supplements
label: "These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." |
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HIPAA
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Health Insurance Portability and Accountability Act
protects health information |
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Medicare Prescription Drug, Improvement, and Modernization
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created prescription drug plan for Medicare patients called Medicare Part D
Medicare patients include elderly, disabled, renal (kidney) failure patients requires pharmacist to off medication therapy management (MTM) which is in depth counseling on all of the patient's medications |
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Food and Drug Administration Modernization Act
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legend drugs must read "Rx only"
adjustment to Durham- Humphrey Amendment |
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Combat Methamphetamine Epidemic Act
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regulates sale of ephedrine, pseudoephedrine, phenylpropanolamine products
daily sale limit to 3.6 grams a day monthly sale limit to 9 grams a month |