Insights

During the pandemic, many hospitals shifted attention from USP renovations to dealing with COVID surges, staffing shortages and revenue shortfalls. We observed hospitals in three stages of USP preparedness: 1) Hospitals that had completed renovations based upon the proposed USP 797 and 795 updated guidance, 2) hospitals that were amid renovations, and 3) hospitals that were still in planning/budgeting for renovations. Most hospitals in the third category were stopped in their tracks as financial pressures forced organizations to implement rolling furloughs, stop elective surgeries and open pandemic crisis command centers.

Roll forward to 2021 and the country’s health care organizations started to reopen towards a new normal for operations. USP released the new draft guidance for chapters 795 (non-sterile compounding) and 797 (sterile compounding) for public comment. Visante strongly encourages organizations to submit comments now through the deadline of January 31, 2022. USP is also holding several open forums for both Chapter 795 and Chapter 797. Registration for these forums may be accessed through this link USP Virtual Open Forum Series: Proposed Revisions to Compounding General Chapters.

In early October 2021, the FDA released updated DRAFT guidance for hospitals and health systems. The comment period recently closed and hopefully, organizations took the opportunity to submit comments about the change from a “one-mile rule” to a “24-hour rule.” Visante believes the language proposed is still vague and needs further clarification from FDA regarding the intent and at what point in time the “clock starts ticking.” Depending on the final interpretation this language may have significant impact on IDNs with centralized service centers or those planning to centralize sterile compounding services.

Going forward in 2022, Visante encourages organizations to take action and move their cleanrooms into full compliance with USP chapters 797 and 800. Several states have already moved forward with enforcement of USP 800 which will be enforceable by all once USP 797 becomes final. That said, now is the time to get renovations started and completed.

Visante continues to see the 503A and 503B markets remain strong into and beyond 2022. Before the pandemic, the sterile compounding space was estimated at between $1.2 to $1.9 billion. Visante also noted the FDA DRAFT guidance strongly encouraged the outsourcing of sterile compounded products to 503Bs. The market continues to be an attractive target for private equity firms in the health care sector due to continued growth and EBIDTA trading multiples at acquisition. We also see more activity by hospitals and health systems investing in commercial 503B providers to create an equity stake and a larger voice in the compounding and supply decisions.

As compounding standards continue to evolve, documentation and standards compliance requirements also will become more rigorous and challenging for pharmacy in 2022 and beyond. Standards never get lower they only become more robust and we believe that 2022 signals another step closer to cGMP standards for sterile compounding. As healthcare continues to struggle with personnel issues the evolution of innovative documentation systems like Pharmacy Stars Compounding360 will become more critical to help pharmacy programs meet quality documentation requirements more efficiently.

The final story for 2022 compounding and compliance has yet to be written but pharmacy leaders are urged to continue vigilance in the regulatory updates from USP, FDA and State Boards.