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Companies are positioning themselves as approved high-volume compounders
At a January 9 update to its website, FDA noted that 14 pharmacy locations, representing 11 companies, have already registered as high-volume compounders (officially, “outsourcing facilities”) under the newly established Drug Quality and Security Act (DQSA). While thousands of individual pharmacies perform compounding (the practice of formulating a drug for a specific patient need), a smaller number do this in volume, and a smaller number yet do this as a business service nationally to hospital systems and other healthcare providers). One of those had been the now-defunct New England Compounding Center, which allegedly produced the contaminated steroid that has caused over 750 serious injuries—including deaths—since mid-2012, and which led in part to passage of DQSA in November. Interestingly, half of these registered facilities have had Form 483 letters issued by FDA that are in the process of being resolved. FDA's website also posted the list of over 80 compounding facilities that had 483s in 2013.
A Reuters report, noting the registrations posting, says that at least some of these companies are looking to gain a marketing edge with clients—meaning that the normal functioning of market demand and quality assurances is starting to take effect. “Registration” with FDA simply means that the necessary paperwork has been filed; fees, inspections and certifications will come later. FDA issued draft guidance in December, but the mechanics of the process are still being worked out.
When—and if—the outsourcing facility status becomes entrenched in US drug distribution, there might be also an expansion of the friction between manufacturers (who choose certain formulations for their branded products—and not others) and these facilities, such as what has been occurring when Roche’s Genentech unit introduced Lucentis, an alternative form of Avastin (bevacizumab) for macular degeneration, at a higher price. In the meantime, though, healthcare-provider customers will be getting a more reliable source of compounded products for their patients.