FDA dismisses exemption claims in repackager warning letter

By Nick Taylor

The FDA has fired another salvo in its fight for oversight of "pharmacies" by hitting a repackager with a warning letter. The repackager, Stat Rx, claimed that it was working as a pharmacy, but the FDA disagrees, categorizing it as a drug manufacturer subject to cGMPs and regulatory oversight.

When inspectors visited the Georgia site in February, they found multiple violations of cGMPs, such as a failure to keep reserve samples of repackaged products. Stat Rx claimed that as a repackaging pharmacy it is exempt from the regulation. The claim held little sway with the FDA.

"Your firm's routine business operations exceed the traditional practice of pharmacy," the FDA said. As the FDA sees it, Stat Rx is primarily involved in "processing and repacking approved drugs for resale by other entities." And that makes it fair game for the FDA. In the letter, FDA inspectors take Stat Rx to task over its efforts to tackle cross-contamination.

Stat Rx repackaged both beta-lactams and non-beta-lactams at the site. Some people are allergic to beta-lactams, like penicillin, so drug manufacturing plants go to great lengths to avoid cross-contamination. The attempt by Stat Rx to stop contamination--described as an "Antibiotic Room"--fell short of FDA expectations. FDA inspectors raised the problem during the visit and Stat Rx promised to outsource beta-lactams work within weeks. The FDA now wants to see documentation of the move and stressed the need to check whether the contractor is up to scratch.

It's not quite as simple as outsource and move on though. The FDA is asking Stat Rx for details of how it will fix what it views as a contaminated facility. "You have not demonstrated how you plan to decontaminate your facility or the actions you will take to address any distributed products in expiry that may have been impacted by the above cross-contamination risks," the FDA said.

- here's the warning letter