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Recordkeeping Requirements for Controlled Substances

All DEA registrants are subject to a host of regulations which include maintaining a clear and complete record of the inventory of controlled substances. The form and period is also prescribed by the Act.


The Drug Enforcement Administration (DEA) maintains a strict vigil over the manufacturing, prescribing, administering, dispensing and usage of the controlled substance drugs in tune with the stipulations of the Controlled Substances Act.

The prescribed protocols for controlled substances require clear recordkeeping in the stipulated manner. This is applicable to veterinary controlled substances too with specific inventories and records in the form of a veterinary controlled drug log. Moreover, the inventory requirements also extend to the samples of controlled substances provided to healthcare practitioners by the pharmaceutical companies.

That’s not all either. Records of controlled substances listed in Schedule I and II have to be maintained separately from all other records of controlled substances. In a similar vein, records of Schedule III, IV and V substances must be maintained separately from the regular business records of the DEA-registered healthcare practitioner.



What does it entail?


Recordkeeping is nothing but maintaining a complete and accurate record of the controlled substances on hand along with the date that the inventory was conducted. It can be handwritten, typewritten or in printed form; what is important is that it should be readily retrievable for inspection or audit purposes from the ordinary business records of the DEA-registered practitioners.

An initial inventory has to be taken at the start of business or when the healthcare practitioner obtains the DEA license to prescribe, administer or dispense the controlled substances. This has to be followed by an inventory of all controlled substances on hand at least once in every two years. Moreover, all records related to controlled substances have to be maintained for a minimum period of two years from the date of the last transaction.

In practice, it is advisable to conduct the inventory at more frequent intervals to avoid any chance of discrepancy, loss, theft, etc. This ensures internal accountability and can bring any inconsistency to light immediately as two years is quite a long time to keep track of what might have gone wrong and when. Any diversion or loss can be tracked and reported quickly.

While the DEA does not mandate any specific format for the logbook or recordkeeping, it should include the names and descriptions of the controlled substances, number of dosage units and commercial containers – be it tablets, bottles, etc. It should also indicate the date the controlled substance was received, name of supplier, amount received and authorized person handling the substances. It should be signed or initialled with the authorized person’s name.

How to do it?


Neither does the recordkeeping sound easy nor is it simple to practice. And given all that is riding on maintaining full and proper DEA compliance, it is always better to engage the services of a DEA compliance professional – like Titan Group (https://titangroupdea.com/). They will train, guide and handhold the team to ensure that the recordkeeping and other protocols are in order at all times!
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