A collaborative effort to comply with USP chapter 797 for compounding sterile preparations for investigational use.

PURPOSE: A collaborative effort between two pharmacy specialty areas for ensuring compliance with United States Pharmacopeia (USP) chapter 797 for compounded sterile preparations (CSPs) is described.

SUMMARY: In September 2005, an investigational drug service (IDS) satellite was opened at a 1157-bed, level 1 trauma, academic hospital in Minnesota. After construction of the IDS satellite, a collaborative consulting service was established between the two pharmacy areas. Protocol-specific investigational medications requiring extemporaneous compounding were reviewed by both an IDS pharmacist and a hospital compounding pharmacist to provide recommendations to investigators. High-risk compounding was performed by the hospital compounding pharmacy, and patient-specific, medium- and low-risk compounding of CSP doses was performed by IDS pharmacy personnel for research participants. A small subset of investigational medications met high-risk criteria and was referred to the hospital compounding pharmacy. After final clearance from quarantine, the high-risk preparations were transferred to the inpatient IDS satellite for dispensing of patient-specific investigational medication doses. The compounding pharmacy followed standardized quality-assurance procedures to ensure sterility, purity, and endotoxin appropriateness for the investigational medications. Quality control of investigational CSPs was maintained by hand delivery of the investigational medication and documentation and disposition via hard-copy receipt on the nursing units. Based on chapter 797 requirements, the department of pharmacy's education and training changed to reflect the new compounding requirements for CSPs, including 20 hours of didactic training for aseptic manipulation skills and practical assessments of aseptic technique using growth media.

CONCLUSION: A collaborative effort between two specialty areas of pharmacy services ensured compliance with USP chapter 797 requirements for compounded sterile preparations.