Compounding Academy: FDA Sends Warning Letter to PCCA

Brooks Rogers, Pharm.D. Compounding Academy President

FDA Sends Warning Letter to PCCA

While Covid-19 vaccines are currently dominating your pharmacy landscape, it may have been easy to miss the warning letter that the FDA sent to Professional Compounding Centers of America (PCCA) this January which stemmed from a visit to PCCA’s Houston facility in October 2019.

PCCA is one of the largest Active Pharmaceutical Ingredient (API) wholesalers in the compounding space and has been a pillar in compounding education for decades. Findings from the FDA are nothing to take lightly. The letter from the FDA had three main discoveries:

1. PCCA received drug ingredients from at least one API supplier whose drugs had been placed on “import alert” at the time they were imported by PCCA. 2. PCCA failed to ensure that the glycerin API it repackages corresponds to appropriate quality standards. This failure causes the glycerin API to be impure and misbranded. 3. FDA requested that PCCA publicly disclosure their manufacturers.

PCCA’s initial response to each of these findings are as follows:

1. None of our current API manufacturers are on FDA Import

Alert. When a manufacturer is issued an Import Alert, PCCA immediately disqualifies and eliminates that manufacturer. 2. PCCA has complete confidence in the quality of the glycerin we provide and our glycerin manufacturer. Our glycerin is of the highest quality and PCCA has thoroughly validated this U.S.-based manufacturer. This manufacturer is also an FDA-registered facility. The FDA has asked for additional testing, in which PCCA is reviewing. 3. PCCA product labeling has been revised to ensure products are not “misbranded.” FDA wants to make sure that PCCA’s customers understand that PCCA is not the original manufacturer of the chemicals and bulk substances we sell. They want this clearly “branded” on product labeling. PCCA has revised our product labeling to clearly state that PCCA is a repacker or repackager.

This change became effective as of January 25, 2021.

PCCA upholds that there are no quality issues with any of their products, all of their products are from FDA-registered facilities and this will not affect your pharmacy operations or patients. PCCA has yet to provide a more detailed response on this matter, but in the meantime, back to your regularly scheduled programming: Covid-19 vaccines. § It may have been easy to miss the warning letter that the FDA sent to Professional Compounding Centers of America (PCCA) this January which stemmed from a visit to PCCA’s Houston facility... Findings from the FDA are nothing to take lightly.