12.5 Compounding: OAR 855-183 (June 2026), USP 795/797/800, 503A vs. 503B & Beyond-Use Dates
Key Takeaways
Oregon compounding is governed by OAR 855-183, effective June 17, 2026, which adopts USP 795, 797, 800 and 825 and repealed Division 045.
An Oregon drug outlet must notify the Board within 15 days of starting to compound, and the PIC completes the compounding self-inspection by July 1 and within 15 days of becoming PIC.
In Oregon, adding inert, nonallergenic flavoring of 5% or less of total volume is not compounding (ORS 689.608).
Oregon lets pharmacies compound without a patient-specific prescription only for a veterinarian treating non-food-producing animals, delivered to the vet's office; human office-use stock comes from 503B facilities.
Under USP 795, a nonpreserved aqueous preparation without stability data gets a 14-day refrigerated BUD; preserved aqueous 35 days, nonaqueous 90 days and solids 180 days.
Why this matters
Area 4.5 covers "compounding sterile, nonsterile, hazardous, and non-hazardous preparations." Oregon replaced its old compounding division (OAR 855-045) with OAR 855-183, effective June 17, 2026. The new division adopts the current USP chapters by reference. Federal law sets the boundary between 503A pharmacy compounding and 503B outsourcing facilities.
What is and is not compounding (OAR 855-183-0005; ORS 689.608)
Compounding means combining, admixing, diluting, pooling or reconstituting other than as the manufacturer's labeling provides. It covers preparation for a patient-specific prescription, and preparation in anticipation of prescriptions based on routine, regularly observed prescribing patterns.
It is not compounding to:
- Mix or reconstitute according to FDA-approved labeling.
- Prepare a single-dose sterile product per manufacturer labeling.
- Activate a proprietary bag–vial system per FDA labeling.
- Add flavoring that is inert and nonallergenic, has no effect other than flavor, and is no more than 5% of total volume (ORS 689.608, 2024).
Oregon's Division 183 requirements
| Requirement | Rule |
|---|---|
| Applies to | Sterile and nonsterile compounding for humans and animals, by any outlet in or outside Oregon compounding for Oregon. All must be registered as drug outlets |
| Standards adopted | USP 795 (nonsterile, v. 11/01/2023), USP 797 (sterile, v. 02/01/2026), USP 800 (hazardous drugs, v. 11/01/2023) and USP 825 (radiopharmaceuticals) |
| Notice | A drug outlet must notify the Board within 15 days of starting to compound, using Board forms |
| Self-inspection | The PIC completes the Compounding Self-Inspection Form by July 1 each year and within 15 days of becoming PIC |
| Pharmacist duties | Supervise compounding, restrict access to the compounding area, and verify every compounded preparation and its records |
| Facilities | No animals in compounding areas. Nonsterile compounding areas may not have porous or particle-generating flooring |
| Records | Master formulation and compounding records kept 3 years |
| Labeling | Preparation labels follow USP 795 and 797. Dispensing labels follow OAR 855-041 (pharmacies), 855-043 (practitioner dispensing) or 855-139 (remote dispensing sites) |
| Veterinary office use | A patient-specific prescription is not required when a licensed veterinarian requests compounding for non-food-producing animals. The preparation is delivered only to the veterinarian or the vet's office (OAR 855-183-0030) |
| Non-resident compounders | From November 1, 2027, they must show inspection under current USP standards, or accreditation from PCAB, CCE, NABP, The Joint Commission or another Board-approved body |
| Outsourcing facilities | FDA-registered 503B facilities must register with the Board as manufacturers |
Federal framework: 503A versus 503B
| Feature | Section 503A (traditional pharmacy compounding) | Section 503B (outsourcing facility) |
|---|---|---|
| Oversight | Primarily state boards. Exempt from cGMP, new-drug approval and adequate-directions labeling if conditions are met | FDA registration and inspection; cGMP applies |
| Prescriptions | Patient-specific prescription, or limited anticipatory compounding based on prescribing history | May compound with or without prescriptions, including office-use stock for providers |
| Bulk substances | Must meet a USP/NF monograph, be a component of an approved drug, or be on FDA's 503A bulks list | 503B bulks list or the FDA drug-shortage list |
| Copies | May not compound regularly or in inordinate amounts copies of commercially available drugs | May not compound copies of approved drugs unless they are on the drug-shortage list |
| Reporting | — | Product reports to FDA every six months; adverse-event reporting |
| Labeling | — | "This is a compounded drug," plus facility and other required information |
USP 795: nonsterile beyond-use dates (no stability data)
| Preparation type | Maximum BUD |
|---|---|
| Aqueous, non-preserved | 14 days refrigerated |
| Aqueous, preserved | 35 days (refrigerated or controlled room temperature) |
| Nonaqueous (water activity below 0.6) | 90 days |
| Solid dosage forms | 180 days |
USP 797: sterile categories and beyond-use dates
| Category | Typical setting | BUD (room temperature / refrigerator / freezer) |
|---|---|---|
| Category 1 | ISO 5 primary engineering control in an unclassified segregated compounding area | 12 hours / 24 hours |
| Category 2, aseptic, from sterile starting components, no sterility test | Cleanroom suite (ISO 7 buffer and ante areas) | 4 / 10 / 45 days |
| Category 2, aseptic, with nonsterile components, no sterility test | Cleanroom suite | 1 / 4 / 45 days |
| Category 3 | Cleanroom with added personnel, sterility and environmental requirements | Up to 60 / 90 / 120 days (aseptic) and longer for terminally sterilized, with the required testing |
Cleanroom buffer areas are kept at positive pressure of at least 0.020 inch of water column relative to the ante area for non-hazardous compounding. Hazardous-drug rooms are negative pressure (section 12.4). Compounders complete garbing, hand hygiene, gloved fingertip and media-fill competency testing at the USP-specified intervals.
Warning
A clinic asks an Oregon 503A pharmacy for a stock supply of compounded lidocaine cream "for office use" for human patients. Federal 503A requires patient-specific prescriptions, apart from limited anticipatory compounding, so office-use supplies for human patients come from a 503B outsourcing facility. Oregon's no-prescription exception is limited to veterinarians treating non-food-producing animals.
Exam scenario
An Oregon pharmacy begins compounding a nonpreserved oral suspension, using water, from commercial tablets on September 1. It must notify the Board by September 16 (15 days). Its PIC completes the compounding self-inspection form. Without stability data, the preparation gets a BUD of 14 days refrigerated. Adding a flavoring that is 4% of total volume to a commercial antibiotic reconstituted per its label is not compounding under ORS 689.608. Adding 8% would be compounding.
An Oregon retail pharmacy will begin nonsterile compounding on March 1. When must it notify the Board under OAR 855-183?
Within 15 days of initiating compounding, using the Board-provided form
Before the next annual registration renewal on March 31
Within 30 days, by letter to the PIC's preceptor
No notice is required for nonsterile compounding
Without stability data, what is the maximum USP 795 beyond-use date for a compounded preserved aqueous oral suspension?
14 days refrigerated
90 days
180 days
35 days
Which compounding request may an Oregon 503A pharmacy fill without a patient-specific prescription?
Stock vials of a sterile injection for a dermatology clinic's patients
Office-use compounded creams for a family physician
A compounded preparation requested by a licensed veterinarian for use in dogs and cats, delivered to the vet's office
Bulk capsules shipped to a physician in another state
Sections you finish are checked off in the contents.