United States
Hong KongRecordkeeping
Records and inventories of controlled substances must be maintained and kept available for at least two years, under 21 CFR 1304.04.
Fixed figures in published regulation, which makes this among the cheapest marks in the domain.
The retention period
At least two years. That is 21 CFR 1304.04, and it applies to records and inventories.
Note that state requirements are frequently longer, and where they are, the longer period governs your practice while the federal figure is what the exam asks about.
Separation
Schedule II records are kept separately from all other records. Schedules III to V may be kept separately or in a form readily retrievable from other records.
It means a record can be separated out from the rest without unreasonable effort - for example by a visible marker that identifies controlled substance entries. Filing Schedule III entries indistinguishably among ordinary dispensing records does not satisfy it, even though the records exist.
What records
- Receipt: what came in, from whom, when
- Dispensing: what went out, to whom, under whose prescription
- Inventory: what is held, at the required intervals
- Destruction and loss, where they occur
Why two years
Because the records exist to allow reconstruction. A DEA inspection compares what came in, what went out and what remains, and any of the three missing makes the account impossible to close.
The biennial inventory sits alongside
A biennial inventory may be taken on any date within two years of the previous biennial inventory date, under 21 CFR 1304.11.
Biennial means every two years. It is a routinely mistaken word and the regulation is explicit about the interval.
What to hold
Two years, 1304.04. Biennial inventory within two years, 1304.11. Schedule II separate, III to V separate or readily retrievable.
Common questions
How long must controlled substance records be kept?
At least two years, under 21 CFR 1304.04.
How are Schedule II records stored?
Separately from all other records.
What does readily retrievable mean?
Separable from other records without unreasonable effort, for example by a visible marker.
What does biennial mean?
Every two years, not twice a year.
Do state rules differ?
Often, and usually longer. The longer period governs practice; the federal figure is examined.