The Montana Board of Pharmacy published MAR Notice No. 2026-131 on August 3, 2026, opening consultation on a broad rewrite of state pharmacy compounding rules. The amendments to the Administrative Rules of Montana (ARM) Title 24, chapter 174, align sterile and nonsterile compounding with the current United States Pharmacopeia (USP) chapters 795, 797, 800 and 825, introduce binding endorsements for sterile compounding and outsourcing facilities, and tighten hazardous-drug handling. A virtual public hearing is set for August 14, 2026 at 9:00 a.m., and written comments are due by August 21, 2026 at 5:00 p.m. The full notice is on the Board of Pharmacy regulations page.
Any pharmacy facility engaged in compounded sterile preparations (CSP), including out-of-state mail-order pharmacies and 503B outsourcing facilities serving Montana, would have to apply for a sterile compounding endorsement, name a designated person accountable for sterile operations, and rewrite standard operating procedures to USP 797 before the next inspection. The endorsements carry no fee. The proposal also redefines "immediate use" from a one-hour to a four-hour window, caps multi-dose vial use at the beyond-use date or 28 days, and adds formal definitions for hazardous drugs (the current NIOSH list), classified areas, primary engineering controls and segregated compounding areas.
What changes for sterile compounding under the proposed ARM 24.174.841?
The rewritten ARM 24.174.841 makes USP 797 the explicit minimum standard for the safety, identity, strength, quality and purity of every CSP prepared in a Montana-licensed facility. Where the existing rule points to a Class 100 environment and Federal Standard 209E, the proposal reanchors the cleanliness vocabulary on ISO 14644-1 classifications and the USP 797 concept of a classified area. Pharmacies must still compound pursuant to a patient-specific prescription under section 503A of the Federal Food, Drug, and Cosmetic Act.
The designated person must keep written or electronic documentation available for Board inspection across eight areas: personnel training and competency assessments; certification reports; environmental air and surface monitoring; equipment calibration and maintenance; receipt of components; SOPs and compounding records; release testing; and complaints and adverse events. This is a documentation shift: facilities that tracked training informally will need structured, inspection-ready records.
Who must obtain the new endorsements, and what does the designated person do?
Every pharmacy facility engaged in CSP, including out-of-state mail-order pharmacies and outsourcing facilities, must apply for a sterile compounding endorsement and identify a designated person under USP 797. A separate outsourcing facility endorsement is created for 503B-registered facilities. Both are added to the facility license at no cost, and let the Board see at license level which facilities perform sterile compounding and which operate as outsourcing facilities.
The designated person is personally responsible and accountable for the performance and operation of the facility and its personnel as they relate to CSP, and owns the quality program, competency assessments, environmental monitoring and corrective actions. Pharmacist-in-charge roles at hospital, home-infusion and mail-order pharmacies serving Montana should map that assignment now, because the rule makes the role a precondition of the endorsement, not a downstream detail.
How are hazardous drugs and radiopharmaceuticals affected?
Sterile hazardous-drug compounding must meet both USP 797 and USP 800 and be performed in an appropriate negative-pressure environment, with policies covering personal protective equipment, training, hazardous labeling, spill containment and waste disposal under applicable local, state and federal law. The proposal adopts the NIOSH hazardous-drug list as the reference and adds a standalone definition, aligning Montana with the standard most hospital pharmacies already follow operationally.
Sterile radiopharmaceuticals are pulled explicitly under USP 825 for preparation, compounding, dispensing and repackaging, closing a gap where the existing rule named no radiopharmacy standard. Facilities that prepare them should confirm their primary engineering control, shielding and documentation map to USP 825.
What else changes: transfers, alternate delivery and facility moves?
Beyond compounding, the package amends three operational rules. ARM 24.174.835 clarifies prescription transfers: a pharmacy technician may initiate a transfer if the pharmacy's policies allow it, and transfers must be completed in a timeline that meets patient safety needs. ARM 24.174.839 permits secure locker systems for prescriptions already labeled and ready for pickup, at a prescriber office or a Montana-licensed pharmacy or medical practitioner dispenser, subject to prior Board approval of security, access, recordkeeping and counseling. ARM 24.174.803 requires 30 days' notice before a facility changes location, remodels, or changes its scope of practice, and no longer forces a new license for in-building moves, aligning with DEA procedure.
| Deadline | Action |
|---|---|
| August 7, 2026, 5:00 p.m. | Request disability accommodations or alternative formats |
| August 14, 2026, 9:00 a.m. | Virtual public hearing (Zoom only, no in-person option) |
| August 21, 2026, 5:00 p.m. | Written comments due via dli.mt.gov/rules or P.O. Box 1728, Helena, MT 59624 |
Continuous, per-jurisdiction real-time monitoring surfaces this kind of state-board proposal the moment it publishes, not at the next inspection cycle.
Take advantage of this real-time watch
For Montana-licensed pharmacies, hospital and home-infusion compounders, mail-order pharmacies serving the state, and 503B outsourcing facilities, the next steps are concrete: confirm whether your facility performs sterile compounding and needs the endorsement, assign and document the designated person, gap-check your SOPs and training records against the eight documentation areas, and verify your hazardous-drug environment meets USP 800 negative-pressure requirements. File comments by August 21, 2026 if the four-hour immediate-use window or the endorsement scope affects your operations. Obsidian tracks this proposal through adoption so your team acts on the final rule without manual monitoring.
