13.2 Inspections, Self-Inspection Forms & Discipline of Drug Outlets

Why this matters

Area 4.7 also covers "requirements for an inspection" and "classifications and processes of disciplinary actions that may be taken against" a practice setting. Oregon inspects every outlet. Its main tools are the annual PIC self-inspection form, compliance officer inspections and outlet discipline, including civil penalties of up to $10,000 per violation.

The inspection framework

• Self-inspection (OAR 855-115-0210(1)(h)): the PIC completes the Board's self-inspection form for the outlet type by July 1 each year and within 15 days of becoming PIC. The form must be signed and dated, reviewed with all pharmacy staff, filed conspicuously (not mailed to the Board), kept three years, and produced immediately when a compliance officer asks. Forms exist for:

  • Retail, institutional and non-resident retail outlets.
  • Compounding, kiosks and remote dispensing sites.
  • Correctional, dispensing practitioner, home dialysis, animal euthanasia, community health clinic, nuclear and wholesale outlets.

• Compliance officer inspections (OAR 855-104-0115): a compliance officer is the Board's authorized representative and must be allowed into any drug outlet at all reasonable hours. Officers may:

  • Inspect conditions, structures, equipment, materials and methods.
  • Inspect all drugs and devices.
  • Take photographs and record video and audio.
  • Review, verify and copy records and documents.

  All licensees and employees must fully cooperate with the officer's questions and requests. Refusing an inspection is grounds for discipline.

• Duty to cooperate (OAR 855-104-0005): licensees and registrants must cooperate with Board investigations.

• Plan of correction: the PIC develops, implements and submits a plan of correction for inspection observations within the time the Board allows (OAR 855-115-0210(1)(g)).

• Record production: records less than 12 months old are produced at the inspection. Older records stored off site are produced within 3 business days (OAR 855-104-0055).

Grounds for disciplining an outlet

ORS 689.405 applies to certificates of registration as well as individual licenses. The Board may refuse, suspend, revoke or restrict an outlet's registration. OAR 855-041-1170 lists outlet-specific grounds:

1. Unprofessional conduct (OAR 855-006-0020).
2. Advertising or soliciting that endangers patients or is false, fraudulent, deceptive or misleading, including unsupported claims about services, products or prices.
3. Failing to provide a working environment that protects patient health and safety (OAR 855-041-1010).
4. Offering inducements to transfer prescriptions from another outlet.
5. Interfering with the pharmacist on duty's professional control.
6. Any ground in ORS 689.405 or 689.490.

Other outlet violations include operating without a certificate (ORS 689.335), failing to register or report changes (ORS 689.325), and refusing inspection.

Sanctions and process

The PIC and the pharmacists on duty are responsible for compliance. Discipline of the outlet does not shield individual licensees from their own discipline, and the reverse is also true. The Board publishes disciplinary actions.

Typical inspection focus areas

From the Board's 2026 retail self-inspection form:

• Posted licenses and hours.
• Policies and procedures.
• Technician training records and written task procedures.
• Counseling documentation.
• Label physical descriptions and expiration dating.
• Controlled-substance inventories and reconciliations (367/93-day).
• Drug-loss reporting.
• Cold storage and vaccine logs.
• Language services and interpreter records.
• Prescribing records (7 years).
• CDTM agreement review (every 2 years).
• Final verification practices.
• Locker, kiosk and RDSP affiliations.

Exam scenario

A compliance officer arrives unannounced at 11 a.m. on a Tuesday and asks to photograph the controlled-substance storage area and copy the last two Schedule II reconciliations. The pharmacist on duty must allow it. The PIC must produce the current self-inspection form immediately and records from the past 12 months at once. The officer finds that the last Schedule II reconciliation was 110 days ago. The PIC submits a plan of correction within the deadline the Board sets. The Board may also impose a civil penalty of up to $10,000 on the outlet, and separately discipline the PIC.