Logging of the receipt, dispensing and disposal of controlled substances is a crucial requirement. Complete and accurate records, in keeping with the regulations, have to be maintained at all times.
Controlled substances are subject to the control and supervision of the Drug Enforcement Administration (DEA). These drugs are classified into Schedules I to V based on their potential for abuse. They are used in both medical care and for research purposes. In either case, having a DEA license is a must for prescribing, administering or otherwise handling the controlled substances.
The federal agency is very circumspect when issuing DEA controlled substance licenses and subjects the licensees to a string of rules and regulations. These are enforced in a stringent manner with regular audits and even unannounced inspections. Even the slightest hint of a contravention can invite the DEA to the doorstep.
While DEA license holders do exercise caution and vigilance when it comes to storage and security of the controlled substances, they are often stumped by the recordkeeping requirements.
Indeed, the log requirements are not only challenging, but also tend to vary between the classes of drugs. This is because while the DEA requires that the licensee should maintain a record of all controlled substances received and dispensed, it also prescribes different conditions based on the schedule of the drugs.
Schedule II substances require the most detailed record keeping as it comprises of the most potent narcotics. They must also be maintained and stored separately from records for other controlled substances. Actually, drugs in Schedule I are the most dangerous and are considered as having the highest potential for abuse to the extent of severe psychological or physical dependence(think marijuana, LSD and heroin). However, as they have no currently accepted medical use, they cannot be prescribed even by regular DEA-licensed healthcare professionals. They are only available to individual researchers for specific projects which entails a special application for license.
Coming to Schedule II to V, not only do the regulations vary from one class to another, but the substances can change classes too. Therefore, it is crucial to monitor and stay updated with the controlled substance regulations at all times.
The fallout can be severe. Inaccurate, incomplete, or missing records can lead to imposition of penalties and even suspension of the license.
As a general principle, all the records should be maintained for a period of two years. They must be easily retrievable for inspection by the DEA agents. Theft and losses have to be reported to the DEA in a timely manner. Inventory has to be maintained separately and is subject to another set of rules and regulations.
Given the level of regulations and compliance, having a skilled professional on the job becomes mandatory. Compliance experts – like Titan Group (https://titangroupdea.com/) - can be engaged for this task. They will take care of all aspects from the controlled substance license registration to the record keeping to the preparation for audits and inspections.
The federal agency is very circumspect when issuing DEA controlled substance licenses and subjects the licensees to a string of rules and regulations. These are enforced in a stringent manner with regular audits and even unannounced inspections. Even the slightest hint of a contravention can invite the DEA to the doorstep.
The Recordkeeping
While DEA license holders do exercise caution and vigilance when it comes to storage and security of the controlled substances, they are often stumped by the recordkeeping requirements.
Indeed, the log requirements are not only challenging, but also tend to vary between the classes of drugs. This is because while the DEA requires that the licensee should maintain a record of all controlled substances received and dispensed, it also prescribes different conditions based on the schedule of the drugs.
Schedule II substances require the most detailed record keeping as it comprises of the most potent narcotics. They must also be maintained and stored separately from records for other controlled substances. Actually, drugs in Schedule I are the most dangerous and are considered as having the highest potential for abuse to the extent of severe psychological or physical dependence(think marijuana, LSD and heroin). However, as they have no currently accepted medical use, they cannot be prescribed even by regular DEA-licensed healthcare professionals. They are only available to individual researchers for specific projects which entails a special application for license.
Coming to Schedule II to V, not only do the regulations vary from one class to another, but the substances can change classes too. Therefore, it is crucial to monitor and stay updated with the controlled substance regulations at all times.
The fallout can be severe. Inaccurate, incomplete, or missing records can lead to imposition of penalties and even suspension of the license.
As a general principle, all the records should be maintained for a period of two years. They must be easily retrievable for inspection by the DEA agents. Theft and losses have to be reported to the DEA in a timely manner. Inventory has to be maintained separately and is subject to another set of rules and regulations.
Given the level of regulations and compliance, having a skilled professional on the job becomes mandatory. Compliance experts – like Titan Group (https://titangroupdea.com/) - can be engaged for this task. They will take care of all aspects from the controlled substance license registration to the record keeping to the preparation for audits and inspections.
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