When responsibility shifts to the contracted facility, qualifying the pharmacy for USP <797> is of the utmost importance

By Fran McAteer, MRA

In today’s modern hospital pharmacy, a strategy for effective USP <797> compliance is to outsource high-risk medications. High-risk compounded sterile preparations (CSPs) are prepared using non-sterile components. The non-sterile aspect of these admixtures requires the use of a sterile filtration process. Media fill proficiency testing of personnel is at a more complex and more frequent level. Environmental monitoring is weekly as opposed to monthly. With these additional precautions, some modern hospital pharmacies are implementing an outsourcing strategy to established contract compounding pharmacies. In this way, the high-risk application becomes the responsibility of the outsourcing agent.

Why do many hospital pharmacies outsource CSPs?

• Quality–the hospital may not have the facility, space, or equipment to effectively produce the medication.
• Capacity–a hospital pharmacy may need additional capacity depending on various factors such as staffing shortfall, patient needs, facility construction, etc.
• Cost–it may be a simple matter of cost allocation where the outsourcer offers a lower cost of compounding.

In this strategic decision-making process, it is important to qualify the outsourcing pharmacy for USP <797> compliance. It is imperative that the hospital pharmacy research the third-party compounding operation for quality of CSPs. The hospital pharmacy is ultimately responsible for all medications that it supplies to its patients. Senior pharmacy management should perform a non-biased assessment of USP <797> programs at a potential outsourcing candidate. Outsourcing agents should furnish a list of services, including existing quality checks for ensuring the integrity of IVs, syringes, and other products that they consistently supply to their customers. This should incorporate information on compounding procedures, cleanroom applications, trained personnel, expiration dating, and stability programs. A hospital pharmacy can request a list of <797> procedures or may even provide the outsourcer with a quality-oriented questionnaire to better formalize responses. This at least provides baseline information in regard to overall quality. The best way to ascertain this information is to visit the compounding operation. Following is a description of an approved vendor program at a large urban hospital. It involves an on-site audit of the compounder’s facility to assess its commitment to <797>. This audit involves inspecting the physical cleanroom areas, observing personnel aseptic technique, reviewing compounding batch records, and checking labeling and final product storage.

When discussing a potential contract with an outsourcer, request a visit to the site where the medications will be prepared. It is a good idea to send an audit agenda to the appropriate quality representatives of the contracting organization a few weeks before the actual visit date, giving the contractor some time to prepare the information that is requested. The agenda should request a facility tour, a review of specific CSP admixture documentation (preferably a CSP that is already being produced for the hospital), a check of personnel training records, and an audit of sterility, pyrogenicity, and stability test data.

Once on site, check out appropriate licenses such as FDA, BOP, and DEA. A facility tour will help establish a sense of the organization, segregation, material, and personnel flow. Observe the cleanroom facility, look for certification to ISO standards, and observe a CSP being prepared while watching for appropriate cleanroom personnel garbing and aseptic technique. Look for dirt, clutter, and cardboard in the cleanroom; these increase potential contamination. Ask about the frequency of cleaning and sanitization programs. In touring the facility, inspect how material enters and exits the cleanroom. Pay close attention to segregated quarantine, raw materials, and final storage areas as a source of product mix-ups (especially if multiple products are being supplied to multiple hospitals).

After the physical assessment, initiate documentation review. Review environmental monitoring programs, with concentration on data that is above action levels. Is there a corrective action program? Follow a batch record for tracer information; this traceability from the batch record should include appropriate test data such as final pH, sterility, and endotoxins. Personnel training records for the indicated compounding personnel should be inspected for appropriate media proficiency and gowning certification. Equipment maintenance and calibration records should be reviewed and labeling inspected for appropriate information including medication, lot numbers, expiration dating, and NDC numbers.

At the completion of the visit, provide the contractor with a summary of the findings regarding <797> compliance. This meeting is not for discussion, but a list of findings should be presented. The close-out meeting signals the formal end to the facility tour.

Upon returning to the hospital after the visit, provide senior management with a formal report candidly discussing the overall finding. Findings should be categorized as major observations, minor observations, and recommendations. Major observations include critical issues regarding <797> compliance such as failure to do sterility tests, no environmental monitoring program, or insufficient cleanroom facilities. These are issues that impact the overall CSP quality and may eliminate the outsourcer as a supplier for that CSP. Minor observations lack the immediate impact on CSPs and can easily be corrected–lack of appropriate procedures for ancillary tasks, failure to change out tacky mats on a regular basis, etc. Recommendations are minor points that the hospital pharmacy may desire to occur during the preparation of their CSPs–points of discussion that enhance quality systems or a particular method of operation that encompasses unique measures that may be employed by the hospital pharmacy. Once the report is produced and reviewed by senior management, it should be conveyed to the outsourcer. The report may request a follow-up response to the findings within 30 days. Upon receipt of the contractor’s responses, a review with final status should be prepared as Approved, Approved upon Impending Action, or Non-Approved.

This type of approved vendor program provides hospital pharmacy with the due diligence needed to assess the quality levels of a potentially new outsourcing partner, effectively managing multiple outsourcing partners for overall quality and <797> compliance. It also gives the outsourcer the ability to showcase its quality program, which should demonstrate its ability to attract future business.

Fran McAteer is vice president at MRA, an FDA registered laboratory. The author has experience in implementing USP <797> for many hospital pharmacies.