11.3 Controlled Substance Inventories: Oregon's 367-Day, 93-Day, 31-Day & 15-Day Rules
Key Takeaways
Oregon requires a written, reconciled inventory of all controlled substances within 367 days of the last one, while federal law requires one only every two years.
In Oregon, Schedule II drugs must be inventoried and reconciled at least every 93 days in retail outlets and every 31 days in institutional outlets.
When the PIC changes, an Oregon pharmacy must complete a full controlled substance inventory with discrepancy reconciliation within 15 days.
Under federal rules, Schedule I–II drugs and Schedule III–V containers holding more than 1,000 units are counted exactly; other opened Schedule III–V containers may be estimated.
The Oregon Board says an on-hand count is not a reconciliation; every discrepancy must be documented and explained, including will-call, e-kit, compounding and expired stock.
Why this matters
Inventory questions are among the most Oregon-specific on the exam. Federal law requires a controlled-substance inventory only every two years. Oregon requires a reconciled inventory of all controlled substances within 367 days of the last one, a Schedule II reconciliation every 93 days in retail (31 days in institutional) pharmacies, and a full inventory within 15 days of a PIC change.
Federal baseline (21 CFR 1304.11)
| Event | Federal requirement |
|---|---|
| Initial inventory | On the date the registrant first engages in dispensing. Record zero if there is no stock |
| Biennial inventory | At least every two years, on any date within two years of the previous one |
| Newly controlled substance | Inventory of that substance on the effective date it is scheduled |
| Timing notation | Taken at the opening or close of business, and the record says which |
| Counting | Schedule I–II: exact count. Schedule III–V: estimated count of opened containers, unless the container holds more than 1,000 tablets or capsules, which requires an exact count |
| "On hand" | Includes drugs returned by customers and awaiting disposal, drugs ordered but not yet invoiced, and drugs stored for the registrant elsewhere |
Oregon requirements
| Oregon rule | Requirement |
|---|---|
| OAR 855-080-0070 | A written inventory of all controlled substances annually, within 367 days of the last written inventory. Records kept 3 years |
| OAR 855-115-0210(1)(i) | The PIC ensures a controlled-substance inventory with discrepancy reconciliation for all controlled drugs, taken before opening or after closing on the inventory date, within 15 days of a change in PIC and at least every 367 days |
| OAR 855-115-0210(1)(i) | Schedule II inventory with reconciliation at least every 93 days in a retail drug outlet and at least every 31 days in an institutional drug outlet |
| OAR 855-139 | Remote dispensing site pharmacies with controlled substances keep a perpetual inventory reconciled every 28 days |
What "reconciliation" means to the Board
The Board's 2026 self-inspection form explains:
- A reconciliation is "an accurate accounting of the outlet's true inventory." A bare on-hand count is not enough.
- The pharmacy compares the count with what should be there: the last inventory plus receipts, minus dispensing, transfers, returns and destruction. Every discrepancy must be documented and clearly explained.
- Even when there are no discrepancies, keep documentation showing the reconciliation was done, such as investigative notes or a screenshot.
- The inventory must include will-call prescriptions awaiting pickup, drugs in long-term care emergency kits, drugs used for compounding, refrigerated items, stock in automated dispensing machines and outdated controlled substances awaiting disposal.
- A pharmacy that is not open 24 hours notes whether the count was taken before opening or after closing.
What the inventory record contains (21 CFR 1304.11)
For each controlled substance in finished form, the inventory lists:
- The name of the substance.
- Each finished form, for example a 10 mg tablet.
- The number of units or volume per commercial container, for example a 100-tablet bottle.
- The number of commercial containers.
Opened containers are counted exactly or estimated under the rule above. The record is dated, says whether it was taken at the opening or close of business, and is kept at the registered location. Schedule II inventories are filed separately from other records. Oregon requires retention for three years (OAR 855-080-0070).
Triggered inventories
- Change of PIC: a full Schedule II–V inventory with reconciliation within 15 days, alongside the new PIC's self-inspection.
- Newly scheduled drug: an inventory on the date the scheduling takes effect (federal), after which it joins the regular cycle.
- Permanent closure: a controlled-substance inventory on the closing date or within 24 hours, plus DEA notification of transfers (OAR 855-041-1092; 21 CFR 1301.52).
- Theft or significant loss: an inventory is the practical first step in determining the loss for the 1-business-day report (section 11.4).
Building a compliant calendar
A retail pharmacy that does its full inventory on January 15 must:
- Reconcile Schedule II no later than April 18 (93 days).
- Reconcile Schedule II again within 93 days of each prior reconciliation.
- Complete the next full inventory by January 17 of the following year (367 days, in a non-leap year).
A biennial federal inventory alone would leave the pharmacy out of compliance with Oregon law.
Warning
The 367-day, 93-day and 31-day periods are maximums between events, not calendar-quarter deadlines. Counting a Schedule II reconciliation in February and then in July violates the 93-day rule, even though each falls in a different quarter.
Exam scenario
A hospital pharmacy's last Schedule II reconciliation was March 1. On April 5, a compliance officer finds that no reconciliation has occurred since. As an institutional drug outlet, the hospital needed a Schedule II reconciliation within 31 days, by April 1, so it is out of compliance. A retail pharmacy with the same dates would have had until June 2. In either case, a count without a documented reconciliation of discrepancies would not satisfy the rule.
An Oregon retail pharmacy completed its last annual controlled substance inventory on February 10. What is the latest date for the next one under OAR 855-080-0070, in a non-leap year?
February 10, two years later
February 12 of the following year (within 367 days)
December 31 of the same year
August 10 of the same year
How often must an Oregon institutional drug outlet complete a Schedule II inventory with discrepancy reconciliation?
At least every 93 days
At least every 367 days
At least every 31 days
Only when the PIC changes
During an Oregon annual inventory, how should an opened stock bottle of 1,000 alprazolam 1 mg tablets (CIV) that is about half full be counted under the federal rule Oregon adopts?
Exact count, because all controlled substances require exact counts in Oregon
It may be omitted because it is opened
Exact count only if the PIC requests it
Estimated count is permitted for an opened Schedule III–V container of 1,000 or fewer units; an exact count is required only if it holds more than 1,000
Sections you finish are checked off in the contents.