We had to use a secondary source for our injections after our regular one switched ownership. When that happens the FDA has to re-certify the new owners. We were told in May they'd gain approval and be up and running by mid August. When that didn't happen we were forced to use a secondary supplier. The compounding industry (which manufacturers these injections) was turned on it's head after 2012's fiasco with New England Compounding Pharmacy and that created a whole new series of regulations—a major one being they divided the compounders into 503A Compounders (retail pharmacies) and 503B Compounders (manufacturing pharmacies).
Because we use a large amount of injections, we’ve been using a 503B facility since 2018.
Axia--our 503B--which is a huge manufacturing facility, recently was sold to a new ownership group. Following the new regulations, it ceased operating in May 2021 for re-certification of its new owners by the FDA.
The FDA is taking up to 6-12 months to re-issue their seal of approval to the new ownership. Meanwhile, thousands of pharmacies and clinics like us across the country have been caught short and had to use emergency sources for things like their customized injections.
We’ve had to move to a smaller, 503A facility to manufacture our shots and it’s taking them longer than normal to ramp up production and testing since they are a much smaller pharmacy.
The good news is our original 503B should be back up next week and we’ve also developed a new 503B facility that can handle our orders so, hopefully, this supply problem does not happen again.
We appreciate your patience!
If you have any questions or need to schedule an appointment, feel free to contact us by phone at 304.720.9073, by email at firstname.lastname@example.org, or on Facebook Messenger by clicking here.