When industry veterans gathered in Boston for the 2025 Compounding Pharmacy Compliance (CPC) Conference, all eyes were on one of the most anticipated sessions of the year — a presentation by Dr. Ross Caputo, President & CEO of Eagle.
Former IVT Speaker of the Year (2021), Dr. Caputo returned to the CPC stage not just with insight, but with experience. His presentation, titled “Lessons Learned in Interpreting and Operationalizing USP 795 and 797,” was less about theory — and more about what actually works.
What’s Changed — and Why It Matters
The recent updates to USP <795> and <797> have challenged the compounding world to raise the bar. It’s no longer enough to “follow SOPs.” Now, compliance requires deep integration of training, documentation, facility control, and evidence-based testing.
From beyond-use dating (BUD) to aseptic simulation, pharmacies are expected to not just know the standards — but to prove them operationally.
“There’s a difference between reading a regulation and living it,” Dr. Caputo told the room.
The Designated Person: Not a Title, a Responsibility
One of the most misunderstood shifts? The role of the Designated Person (DP). Many assume it’s just the pharmacist-in-charge. Not quite.
According to USP, the DP is anyone — or a team — formally accountable for compounding operations, environmental control, and regulatory adherence. Dr. Caputo urged attendees to define DP roles functionally, not by job titles. And most importantly? Document everything.
Hazardous Drugs, Higher Stakes
With USP <800> now fully applicable, hazardous drug (HD) compounding must meet a higher standard. Negative pressure rooms, proper venting, and rigorous wipe sampling aren’t optional — they’re expected.
Dr. Caputo shared a common pitfall: facilities that think passing a certification once means they’re in the clear. The truth? “If you’re not monitoring airflow or exposure routinely, you’re just hoping for compliance.”
Potency ≠ Stability
Here’s where it gets technical — and where many pharmacies fall short.
A drug holding potency over time does not automatically meet stability requirements under the new standards. Category 3 compounded sterile preparations (CSPs) now demand:
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Stability-indicating test methods
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Container-closure integrity
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Particulate testing
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AME (antimicrobial effectiveness) for aqueous formulas
And those tests? They must be run on the exact formulation, container, and components you’re actually using. No substitutions.
Categories 1, 2, 3 — Not Just New Labels
Gone are the days of “low-, medium-, high-risk” compounding. The USP revisions now classify CSPs as Categories 1, 2, or 3, with levels based on environmental control, garbing, testing, and procedural rigor — not just how complex the product is.
This change impacts beyond-use dating, monitoring schedules, and garbing protocols. And yes — it’s a heavy lift.
“If you’re treating a Category 3 CSP like a Category 1, you’re gambling with compliance,” Dr. Caputo cautioned.
Media-Fill and Smoke Studies: Simulation Is the Standard
Off-the-shelf media-fill kits? Often inadequate.
Media-fill testing must fully simulate your facility’s aseptic process — duration, personnel, manipulations, interruptions, the whole picture. Dr. Caputo emphasized that your media-fill should tell your story, not just meet a checklist.
And as for smoke studies — video recording is now standard. Each compounding process (vials, IV bags, syringes) should be assessed individually.
The Bottom Line: Compliance Is a Living System
Throughout the presentation, one theme came through loud and clear: data without action is meaningless.
Environmental results, personnel requalifications, SOP updates, deviations — these aren’t just records to keep. They’re opportunities to identify trends, anticipate risks, and continuously improve.
“You don’t fail an audit because you had an excursion,” Dr. Caputo said.
“You fail it because you didn’t know why it happened.”
What Comes Next?
As states stagger in how they adopt USP standards, pharmacies must prepare for the most stringent interpretation. Some will audit for <795> compliance; others may enforce <800> with zero grace. Dr. Caputo encouraged facilities to stay ahead by creating internal standards that exceed the baseline — not just meet it.
At Eagle Analytical, our mission remains unchanged: to help compounding pharmacies not just survive regulation changes, but lead through them.
Whether it’s stability studies, media-fill testing, facility qualification, or SOP development, our team is here to support your compliance — every step of the way.
📞 Need help navigating the new USP standards?
Visit eagleanalytical.com or call us at 800.745.8916
Relevant Services
✓ Stability Testing for BUD Validation
✓ Smoke Studies & Video Documentation
✓ USP <800> Containment Planning
✓ Custom SOPs & QA Consulting
