FDA-Registered 503B Outsourcing Facility
STASKA Pharmaceuticals is an FDA-registered 503B compounding outsourcing facility in Bennet, Nebraska. We compound office-use sterile medications for licensed healthcare facilities under current Good Manufacturing Practice (cGMP). For a hospital pharmacy or procurement team, the 503B designation is the line that matters: it is the regulatory framework purpose-built for institutional, office-use supply.
What 503B means for institutional buyers
Unlike a traditional 503A pharmacy that compounds against patient-specific prescriptions, a 503B outsourcing facility is registered with the FDA and produces medications for office use — the kind of stock a facility keeps on hand and administers in the course of care. That distinction carries real procurement weight:
FDA oversight
As a registered outsourcing facility, STASKA operates under FDA inspection and the cGMP standards that govern pharmaceutical manufacturing.
Office-use supply
Facilities can order and stock medications for administration without a patient-specific prescription on file for each unit.
Compounding discipline
Production runs are batched, documented, and tested rather than compounded one prescription at a time.
cGMP Manufacturing
Every product STASKA ships is made under current Good Manufacturing Practice — the same baseline expected of pharmaceutical manufacturing. cGMP is not a single test; it is a system covering qualified materials, validated processes, trained personnel, controlled environments, and complete documentation, all aimed at producing a consistent, quality product batch after batch.
Sterile compounding — USP <797>
Our injectable vials are produced under sterile compounding standards aligned to USP <797>, with the aseptic technique, environmental controls, and process discipline required to compound preparations intended for injection.
In-house analytical testing
Our quality program includes analytical testing and quality assurance review on the medications we produce, so that what leaves the facility meets specification before it ships.
Batch-level traceability
Production is tracked at the batch and lot level with supporting documentation. A Certificate of Analysis is available on request for the lot you receive.
Testing, Quality Assurance & Documentation
In-house analytical testing
Quality is verified, not assumed. STASKA's quality program applies analytical testing and quality assurance oversight across production. Medications are evaluated against established specifications, and release is gated on that review — the product clears QA before it is made available to ship.
Batch traceability and Certificate of Analysis
Every product is compounded in documented batches and tracked at the lot level. That traceability is what lets a receiving pharmacy tie the vials on the shelf back to a specific production record. A Certificate of Analysis (CoA) is available on request for the lot you receive — useful for your own incoming-inspection, formulary, and audit files.
Beyond-use dating
Each product carries a beyond-use / expiration date tied to the lot currently being supplied, so the dating on your order reflects the batch you actually receive.
Environmental Controls & Cleanrooms
Sterile compounding depends on the environment it happens in. STASKA produces in ISO-classified cleanroom space with the engineering controls, monitoring, and procedures appropriate to sterile compounding under USP <797>. Controlling air quality, surfaces, and personnel practices is how a facility protects sterility from the first step of a batch to the last.
A Patient-First Quality Standard
Behind every vial is a patient receiving care at one of the facilities we supply. That is the standard we compound to. The regulatory framework — FDA-registered 503B, cGMP, USP <797> — exists to protect that patient, and our quality program is built around the same goal rather than around the minimum required to ship.
Evaluating STASKA as a supplier
If your pharmacy or procurement team is qualifying STASKA as a vendor, we welcome the diligence. We can provide a Certificate of Analysis for the lots you receive and supporting quality documentation to assist your supplier-qualification and audit process. Reach out to our team and we will route your request to the right people.