As far as compounding pharmacies are concerned, the FDA is compounding their problems.
After a fungal meningitis outbreak that claimed 64 lives two years ago was traced to a compounding pharmacy, the agency has been cracking down. Dozens of compounders have been inspected, and some were issued warning letters for poor practices. In a few instances, the FDA urged the public to avoid a compounder’s medicines or attempted to shutter an operation (see here and here).
The stepped-up oversight was hastened by a new law that bolstered FDA authority. But compounders say the get-tough approach is a double-edged sword. Hospitals, doctors and patients may eventually have more confidence in compounded’ medicines, but in the meantime costs and red tape have increased. And a new batch of proposed guidelines issued by the FDA last week has set off another round of anguish.
The FDA maintains the guidelines are “critical to protecting public health.” But Scott Karolchyk of QmedRx, a compounder based in Maitland, Florida, argues “the FDA is trying to punish success. If these [guidelines] go into effect, a lot of pharmacies face onerous restrictions. And limiting good compounding pharmacies only hurts patients and their access to medications.”
At issue are two particular stipulations. The first affects only traditional compound pharmacies that cater to individual patients and comprise the majority of compounders. The FDA would cap their interstate shipments at 30% of their overall business. Historically, interstate shipments are a criteria used to differentiate traditional compounders from others operating more like drug makers. The idea now is to dissuade smaller compounders from overreaching by otherwise requiring them to register with the FDA and follow established manufacturing standards.
The cap could actually be a more restrictive 5% if a state fails to sign an agreement – a memorandum of understanding – with the FDA. But traditional compounders believe that even a 30% cap is too restrictive and that some patients may not be able to obtain medicines as easily because not every compounder makes the same medications.
“There are some compounding pharmacies that are highly specialized in what they do, and they get patient referrals from all over the U.S.,” says a spokesman for the International Academy of Compounding Pharmacists, a trade group. “Why should they be limited at all if they are filling one prescription at a time in accordance with the regulations?”
The other stipulation that riles compounders concerns expiration dates for repackaging biologics, which are injected or infused. Often, a compounder divides a vial into smaller vials. The guideline would require a biologic that is mixed, diluted or repackaged by a traditional compounder to be administered to a patient within four hours unless microbial testing is done. In that case, there would be a 24-hour time limit.
Meanwhile, outsourcing facilities, which are typically larger compounders that adhere to strict manufacturing standards, would have up to five days if additional studies are done. “I think that’s going to be very difficult, though,” says Charles Leiter of Leiter’s Compounding in San Jose. “There will be waste, and that benefits brand-name drug makers, which will be able to sell more product.”
The real question, though, is the extent to which compounders can forestall the changes. “The landscape is shifting,” says Gabrielle Cosel, the manager of drug safety at Pew Trusts. “Access is very important, but you don’t want to preserve access at the expense of quality and safety.”