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47 Cards in this Set
- Front
- Back
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DEA 224 |
registration for dispensing |
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DEA 225 |
registration for manufacturing, distributing, reverse distributing, importing, exporting, chemical analysis or research
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DEA 363 |
registration for narcotic treatment
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DEA 106 |
theft/loss
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DEA 41 |
Disposal/ destruction
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FDA 2632 |
application for approved narcotic treatment program |
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FDA 2633 |
medical responsibility statement for use in a narc treatment program
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FDA 2635 |
consent to treatment with approved narcotic drug
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FDA 2636 |
hospital request for methadone detoxification treatment program
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FDA 482 |
notice of inspection
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FDA 2438b |
routine notice to observe patient identifying info
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FDA 483 |
inspectional observations
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IND |
investigational new drug -needs to be submitted before any tests on humans FDA has 30 days to decided |
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AND |
-abbreviated new drug -submitted for generic drug approval
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SNDA |
supplemental new drug application -made to change an approved drug, new dosage form, strength, manufacturing process, new indication
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FDA approval type I |
new molecular structure
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FDA approval type II |
new derivative of an approved drug (new salt)
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FDA approval type III |
new formulation
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FDA approval type IV |
new product that is a combination of existing products |
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FDA approval type V |
new manufacture |
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FDA approval type VI |
new indication for approved drug
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DEA 222 forms expire in |
60 days
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drugs that can be used in narcotic treatment plan |
suboxone, subutex methadone LAAM |
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how long to report loss theft to DEA field office |
1 days |
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USAN |
United States Adopted Names --- give generic names to drugs
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Kiefer Harris amendment
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safe and effective -also also allow FDA to regulate drug ads
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Durham - Humphrey amendment |
started OTC class -called in RXs -federal law prohibits dispensing without an RX
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Waxman Hatch
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abbreviated process for generic drugs -increased the length of patents
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CSOC theft must be reported in |
24 hours |
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OTC max quantities per 48 hour |
opium containing: 240 ml or 48 dosage units codeine containing: 120ml or 24 dosage units |
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if you discontinue controlled business you must notify the field office with in |
14 days |
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how long to you have to notify the board when administering an emergency kit |
7 days for providing an emergency kit repeat notification within 30 days if change of ownership of kit change of consulting/designated pharmacist
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after computer failure how long do you have to enter all your downtime |
7 days |
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after unautherourize access how long do you have to report to the board |
10 days |
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after controlled substance loss how long do you have to report to the board and law enforcement |
30 days |
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SPDO |
-- Specialized prescription drug outlet an outlet in an LTCF with is owned and operated by managing prescription drug outlet. doesn’t need a pharmacist |
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MPDO |
Managing prescription drug outlet compounds / dispensing drugs provides pharmaceutical care to residents of LTCF owns all of the drugs |
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pharmacist can compound up to what strength of controlled substance |
20% |
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individuals can apply to reregestration |
60days before expires |
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bulk manufactures can re apply to DEA regestration |
120 days before it expires |
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Dingell bill act |
prohibits shipping between states without regestration |
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NADDI |
National Association of Drug Diversion Investigators (NADDI administers the National Precursor Log exchange (NPLES) at no cost to retailers |
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What DEA 222 forms need to be stored seperately |
DEA forms for carfentanil , diprenorphine, and etorphine must be kept separate for other DEA 222 forms |
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ARCOS |
automation of Reports and consolidated orders system) manufacturers and distributors only report for controlled substances manufactures must report inventories, acquisitions, dispositions of all CI and CII and Gamma-hydroxybutyric acid substance(CIII) |
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Exceptions for tamper resistant packaging |
dermalogica, dentifine, insulin, lozenges |
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Bioequivalence must be |
ADME * Absorption, distribution, metabolism, elimination |
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CSOS transactions must be submitted with in |
2 business days of when the order was filled
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