OSRX, Inc.
FDA 503B outsourcing facility
Missoula, Montana
Key Takeaways
- FDA-registered 503B outsourcing facility since 2023
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: November 14, 2025
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- October 28, 2023
- Most recent registration
- December 29, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- November 14, 2025
The FDA last inspected OSRX, Inc. on November 14, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. The FDA has not yet determined whether further action will be taken.
What this facility compounds
OSRX, Inc. reports compounding 16 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
- Atropine Sulfate
- Bimatoprost; Timolol Maleate
- Bimatoprost; Timolol Maleate; Dorzolamide Hydrochloride
- Bimatoprost; Timolol Maleate; Dorzolamide Hydrochloride; Brimonidine Tartrate
- Dorzolamide Hydrochloride; Brimonidine Tartrate
- Dorzolamide Hydrochloride; Brimonidine Tartrate; Bimatoprost
- Moxifloxacin Hydrochloride
- Moxifloxacin Hydrochloride; Bromfenac Sodium
- Moxifloxacin Hydrochloride; Dexamethasone Sodium Phosphate
- Moxifloxacin Hydrochloride; Ketorolac Tromethamine; Prednisolone Sodium Phosphate
- Moxifloxacin Hydrochloride; Prednisolone Sodium Phosphate; Bromfenac Sodium
- Phenylephrine Hydrochloride; Tropicamide
- Phenylephrine Hydrochloride; Tropicamide; Cyclopentolate Hydrochloride
- Prednisolone Sodium Phosphate; Bromfenac Sodium
- Prednisolone Sodium Phosphate; Moxifloxacin Hydrochloride
- Timolol Maleate; Brimonidine Tartrate; Dorzolamide Hydrochloride
Location
1120 Kensington Ave, Missoula, MT 59801
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Contact
FDA-registered contact: Amy Frost, 406-541-6121. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of OSRX, Inc. with the Montana Board of Pharmacy.
503B facilities in Montana
Frequently asked questions
Is OSRX, Inc. registered with the FDA?
Yes. OSRX, Inc. is a registered 503B outsourcing facility, first registered with the FDA on October 28, 2023 and most recently registered on December 29, 2025.
Has OSRX, Inc. been inspected by the FDA?
The FDA last inspected OSRX, Inc. on November 14, 2025. A Form FDA 483 was issued.
Has OSRX, Inc. had any FDA drug recalls?
No FDA drug recalls are matched to OSRX, Inc. in the openFDA enforcement database.
What does OSRX, Inc. compound?
OSRX, Inc. reports compounding 16 active ingredients to the FDA.
Where is OSRX, Inc. located?
OSRX, Inc. is located in Missoula, Montana (1120 Kensington Ave).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by OSRX, Inc.. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.