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Recall and DEA
drug recall classes; NDC numbers; DEA forms; DEA number
| Term | Definition |
|---|---|
| Drug Recall Class I | an attempt must be made to notify the patient that the drug may cause serious harm or death |
| Drug Recall Class II | the probability of serious harm is not likely and the effects may be associated with consistency or potency |
| Drug Recall Class III | not likely to cause any serious harmful effects and does not go to the patient level |
| NDC Number | a number assigned to every drug, RX or OTC, composed of three numbers which identify the manufacturer, drug, and package size |
| First five numbers of NDC number | identifies the manufacturer |
| Second four numbers of the NDC number | identifies the drug |
| Last two digits of the NDC number | identifies the package size |
| DEA 222 | used for purchasing and returning of outdated CII drugs. It is comprised of 3 copies |
| DEA 222 Blue Copy | the pharmacy keeps on file for at least 2 years |
| DEA 222 Green Copy | the seller sends to the local DEA |
| DEA 222 Brown Copy | the seller or manufacturer keeps |
| DEA 106 | used to report lost or stolen controlled drugs (used when 5% of the yearly product sold is missing) |
| DEA 41 | used to document the destruction of controlled drugs |
| DEA 224 | needed for a pharmacy to dispense controlled drugs |
| DEA 363 | is needed to operate a controlled substance treatment program or compound controlled substances |
| DEA 225 | needed to manufacture or distribute controlled drugs |
| DEA number | number given to anyone who prescribes controlled medications |