Feedback for Seeking Feedback on Proposed Implementation Timeline for NAPRA's Sterile Compounding Standards

Pharmacist  ·  June 29, 2016

I believe 2 years is not sufficient for hospitals to become fully compliant with the NAPRA guidelines. The changes involve the hospital executive level to have funding for all the physical renovations required. Securing funding and planning major renovations take more than two years. We have been trying to modfiy our existing oncology satellite for years and have not made any progress. NAPRA also requires a "third-party evaluator" to assess the competency of the sterile compounding supervisor. There is no structure in place for this entity. Who certifies the third-party in the first place? Until this is resolved it is not possible to move forward. There needs to be a national body to certify these third-party evaluators. NAPRA completely removed the sterility and stability testing allowed in USP797, meaning the BUD limits must be followed. This requires a complete change in workflow and an increase in costs as medications will have a much shorter BUD. For hospitals who cannot meet the standards, the existing Drug Dispensing Premises that are certified by OCP are not willing to manufacture any items that do not generate enough volume/profit. This is especially difficult for pediatrics hospitals that require less common preparations. Hospitals who cannot meet standards are driven to use DDPs which led to why all this began in the first place.

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