Outsourced Compounding

April 2020 : State of Pharmacy Compounding - Vol.17 No. 4 - Page #46
Category: Outsourced Compounding Services (503B)

Outsourced compounding utilization grew by 10% this year as facilities of all sizes are looking to their vendors to increase the efficiency and effectiveness of CSP production. Both 503B and 503A operations remain under significant regulatory scrutiny, making it important for pharmacy to monitor their vendors’ responses to any 483s issued by the FDA.

To assist with your vetting of outsourced compounders, PP&P is pleased to present the following webinar:

Deliver Uninterrupted Care Under COVID-19: Compliance Strategies for Effective Outsourced Compounding

with Lou Diorio, RPh, FAPhA
Friday, May 1, 2020, 1:00-1:30PM

Facilities of all sizes increased their reliance on outsourced compounders this year, with 74% of all hospital pharmacies now utilizing outsourced vendors for CSPs.

While this year saw a small decrease in the number of facilities looking to outsourced vendors to offset shortages, this issue remains a significant driver of outsourced compounding.

Safety and sterility issues with outsourced vendors remain a concern. One-third of hospital pharmacies reduced or curtailed their outsourcing volume over the past year due to these concerns.

Larger facilities are more likely to respond to sterility or safety concerns by bringing some outsourcing back in-house.

This year saw no improvement in the number of facilities utilizing internal guidelines for their vendor selection process, although there is significant interest in developing these tools.

Rarely is pharmacy not involved in the contract review process with outsourced compounding vendors.

While visiting outsourced vendors to review their processes and monitor for compliance is often recommended, this is not a common practice. Just 35% of survey respondents have ever conducted a site visit of their vendor.

While 97% of pharmacy directors are satisfied with their vendors, just 20% rate their outsourced compounder as excellent.

Over the past year, CAPS, Nephron, QuVa, and SCA Pharma have become the leading outsourced compounding vendors. Note that Pharmedium has since ceased operations; as such, additional data will follow as hospital pharmacies readjust their outsourced compounding efforts.

Click here to view a larger version of this chart

Just 55% of pharmacy directors have ascertained whether their outsourced vendor has been inspected by the FDA. It is pharmacy’s responsibility to be aware of their vendor’s inspection status and to review the vendor’s response to any regulatory findings.

Pharmacy directors are even less likely to monitor their vendor’s inspection status with their state board.

Given FDA’s increased scrutiny of both 503B and 503A operations, it is not surprising that many outsourced compounding vendors have received 483s. Those pharmacy directors monitoring their vendor’s responses to a 483 have been universally satisfied by their vendor’s corrective action.


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