How to Keep DEA Controlled Substance Records
Meet a recordkeeping regime aimed at diversion, not at product quality.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
Controlled substance recordkeeping sits outside the GMP harmonisation architecture entirely. There is no ICH position and no mutual recognition; the registering authority’s concern is diversion rather than product quality, and its requirements are prescriptive where quality regulations are principle-based. A facility running an excellent quality system can be comprehensively non-compliant here, because the two regimes ask different questions.
- 1
Establish your registration and what it permits
Registration is by activity and by location, and it authorises specified schedules. Handling a substance in a schedule your registration does not cover is a status violation that no recordkeeping quality can remedy.
- 2
Take the initial inventory, then a new one at least every two years
After the initial inventory, take a new inventory of all stocks on hand at least every two years. It may be taken on any date within two years of the previous one, and it is a count of what is physically present rather than a report from a system.
- 3
Separate Schedule I and II records from everything else
Records and inventories for Schedules I and II are maintained separately from all other records. Schedules III to V may be maintained separately or in a form where the required information is readily retrievable from ordinary business records — a distinction easy to get wrong in an integrated system.
- 4
Keep records readily retrievable for at least two years
Every inventory and record required under this part is kept and available for inspection and copying for at least two years. Readily retrievable is a substantive requirement, not a description — records that exist but take days to assemble do not meet it.
- 5
Account for every unit received, dispensed, destroyed and lost
The regime is built on accountability of quantities. Losses and thefts have their own reporting obligations, and an unexplained discrepancy is a diversion signal rather than an inventory variance to be adjusted out.
- 6
Control physical security alongside the records
Storage, access control and the security requirements attached to registration sit beside recordkeeping and are inspected together. Perfect records over an inadequately secured store fail on the point the regime exists to address.
- !Quality-system recordkeeping assumed to satisfy a regime aimed at diversion rather than quality.
- !Schedule I and II records held in the same system as everything else.
- !Readily retrievable treated as a description rather than as a requirement records must actually meet.
- !An inventory discrepancy adjusted out rather than treated as a potential diversion signal.
How to Keep DEA Controlled Substance Records: frequently asked questions
Common questions on keep dea controlled substance records.
How often is a full inventory required?
After the initial inventory, a new inventory of all stocks on hand at least every two years. It may be taken on any date falling within two years of the previous biennial inventory, which gives some scheduling latitude but no relief from the interval itself.
How long do the records have to be kept?
At least two years from the date of the inventory or record, available for inspection and copying, and readily retrievable. Note that other regimes applying to the same facility may require longer retention of overlapping records, and where they do the longer period governs.
Why does this sit outside the usual GxP architecture?
Because the authority is a law enforcement body and its interest is diversion, not product quality. There is no harmonisation position, no mutual recognition, and no reliance on another regulator. A facility with an exemplary quality system can be fully non-compliant here, and frequently is.