11.4 Theft & Loss Reporting, Disposal, Reverse Distribution & Take-Back Receptacles
Key Takeaways
An Oregon pharmacy must report a confirmed significant drug loss, or any controlled substance loss related to suspected theft, to the Board within 1 business day by email.
DEA must be notified in writing within 1 business day of discovering a theft or significant loss, and DEA Form 106 must be filed within 45 days.
Schedule II stock goes to a reverse distributor on a DEA Form 222 issued by the reverse distributor; Schedule III–V transfers use invoices.
Oregon take-back receptacles must be in view of but not behind the pharmacy counter, and the pharmacy must notify the Board within 30 days of starting or ending a program.
Two employees must handle collection-receptacle liners, and deposited drugs may never be counted, sorted or accepted by hand from patients.
Why this matters
Area 4.2 covers "reporting" and the "disposal of hazardous drugs" alongside controlled substances. Theft and loss reporting has two simultaneous clocks, Board and DEA. Disposal and take-back have strict handling rules. Oregon adds a one-business-day Board report and specific take-back placement and notice rules.
Reporting theft or significant loss
| To whom | Deadline and content | Source |
|---|---|---|
| Oregon Board of Pharmacy | Without undue delay, but within 1 business day of a confirmed significant drug loss, or any loss related to suspected theft of a controlled substance. Email pharmacy.druglossreporting@bop.oregon.gov with "Controlled Substance Loss Notification" in the subject line | OAR 855-115-0115; OAR 855-104-0010; OAR 855-041-1030 |
| DEA Field Division | In writing within 1 business day of discovering a theft or significant loss of any controlled substance | 21 CFR 1301.76(b) |
| DEA Form 106 | File a complete and accurate DEA Form 106 electronically within 45 days after discovery | 21 CFR 1301.76(b) |
Oregon's rule also covers confirmed significant losses of drugs generally, not only controlled substances. Its suspected-theft trigger covers any controlled-substance loss related to suspected theft, even a small one.
Is a loss "significant"? (21 CFR 1301.76(b))
DEA lists factors to consider:
- The actual quantity lost in relation to the type of business.
- The specific substances lost.
- Whether the loss can be tied to access by particular people or to unique activities.
- A pattern of losses over time, and the results of efforts to resolve them.
- Whether the drugs are likely candidates for diversion.
- Local trends and other signs of diversion potential.
In-transit losses are generally reported by the supplier that shipped the drugs, unless the purchaser has signed for the delivery. Breakage or spillage is not treated as theft. Witnessed, non-recoverable breakage is documented on DEA Form 41 with two witnesses, and any recoverable product is quarantined and destroyed through proper channels.
Disposing of pharmacy stock
- Reverse distributors: the usual route for outdated, damaged or recalled controlled-substance stock. Schedule II transfers need a Form 222 (or CSOS order) issued by the reverse distributor to the pharmacy. Schedule III–V transfers are documented by invoice. The reverse distributor handles destruction and files the required DEA records. The pharmacy keeps its transfer records (3 years in Oregon).
- DEA Form 41 documents the destruction of controlled substances by a registrant, for example destruction of inventory on site where permitted, with witnesses.
- Oregon: drugs must be disposed of under state and federal law (OAR 855-041-1025). Hazardous and pharmaceutical waste disposal must be covered in written policies (OAR 855-041-1040). Quarantined controlled substances awaiting disposal must remain secured and are counted in the inventory.
- Damaged inventory after a disaster may be treated as adulterated. Controlled-substance losses are reported to DEA on Forms 41, 106 or 107 as appropriate (OAR 855-007-0120).
Patient take-back: collection receptacles
Pharmacies may register with DEA as authorized collectors (21 CFR 1317.40) and install collection receptacles for ultimate users' Schedule II–V controlled substances and non-controlled drugs, which may be commingled.
| Federal requirement (21 CFR 1317.75) | Oregon add-on (OAR 855-041-1046) |
|---|---|
| Inside the registered location, in immediate proximity of the area where controlled substances are stored and an employee is present (visible from the pharmacy counter) | Inside the retail drug outlet, accessible to the public and in view of, but not behind, the pharmacy counter |
| Securely fastened to a permanent structure; locked outer container; removable inner liner; slot that admits but doesn't allow removal | Adequate security, installation, maintenance and liner tracking, with double signatures where required |
| Opening locked when no employee is present (for example, after pharmacy hours) | Documented personnel training and accountability |
| Two employees install and remove inner liners. Deposited drugs are never counted, sorted, inventoried or handled | Notify the Board within 30 days of starting or ending a collection program |
| Only ultimate users (or other authorized non-registrants) deposit their own drugs; staff may not take drugs from patients | Pharmacies may get a free take-back box through Oregon's DEQ-overseen drug take-back program |
Warning
A patient hands a bag of leftover opioids across the counter to a technician "for disposal." Under federal collection rules and OAR 855-041-1045(1), staff may not accept it. The patient must deposit it personally in the collection receptacle, or use a mail-back envelope or take-back event.
Exam scenario
During a 93-day Schedule II reconciliation on a Monday, an Oregon PIC finds 120 oxycodone 30 mg tablets missing, with a pattern pointing to one shift. The PIC must notify the Board by email within one business day (by Tuesday) and DEA in writing within one business day, then file DEA Form 106 within 45 days. The PIC documents the discrepancy and investigation. If a licensee is terminated as a result, the outlet reports the termination within 10 working days. Separately, the pharmacy's expired hydromorphone goes to a reverse distributor, which issues a Form 222 for the Schedule II transfer.
An Oregon pharmacist confirms on Wednesday that a significant quantity of oxycodone was stolen. What are the reporting deadlines?
Notify the Board and DEA within 10 days
Notify only DEA, using Form 106 within 45 days
Notify the Board within 30 days and DEA within 7 days
Notify the Board within 1 business day and DEA in writing within 1 business day, then file DEA Form 106 within 45 days
Where must an Oregon retail pharmacy place a DEA-authorized collection receptacle?
Inside the outlet, accessible to the public and in view of, but not behind, the pharmacy counter
In the parking lot for 24-hour access
Behind the pharmacy counter so only staff can reach it
In the restroom for privacy
An Oregon pharmacy wants to send expired fentanyl patches (CII) to a reverse distributor. Which document authorizes the transfer?
An invoice prepared by the pharmacy
DEA Form 106
A DEA Form 222 (or CSOS order) issued by the reverse distributor
A Board of Pharmacy destruction permit
Sections you finish are checked off in the contents.