Compounding exec Cabaliero on shortages, CMOs and biotech

Joe Cabaleiro is executive director at the Pharmacy Compounding Accreditation Board, a nonprofit dedicated to standards and principles for pharmacy compounding. We asked in a phone interview about the role of compounding pharmacies during drug shortages.

Has the drumbeat of drug shortages brought compounding pharmacies into the limelight?

Joe Cabaleiro: Yes, for multiple reasons. First, a lot of shortages involve the basics--electrolytes, for example. They're in regular demand and are relatively straightforward to produce. Second is timing: the level of quality in the compounding industry has improved; the business has evolved; we've become a more viable source. Third, compounding pharmacies are becoming more capable. Some can even step in for shortages of sterile compounds made from non-sterile API.

Are compounding pharmacies becoming the go-to source for those seeking drugs in short supply?

JC: Compounding pharmacies are not licensed manufacturers; they are a pharmacy niche, not a manufacturing niche. They make versions of drugs suitable for patients who have difficulty taking more traditional medications available commercially--those with allergies or requiring a dosage form different from what's commercially available, and formulations for kids of adult drugs, for example.

Some compounding pharmacies are good at making drugs in various formulations: solutions, suspensions, injectables. But the more complex formulations--those involving slow-release matrices, for example--are still problematic. I don't think compounding pharmacies look at themselves as an alternative to drug manufacturers.

Can you envision a compounding-pharmacy/CMO hybrid created solely to avert or resolve drug shortages?

JC: I could imagine that, assuming it could get past the regulatory and intellectual property issues. The FDA doesn't treat pharmacies in the same way it treats manufacturers. 

Bioprocessing is inherently more complex than small-molecule drug manufacturing. What role can compounding pharmacies play in biotech drug shortages?

JC: We haven't seen compounding of biopharma drugs to the same level as small molecules. There has been a role, however. Compounding pharmacies would split vials of Genentech's cancer drug Avastin into individual doses that eye doctors used to treat macular degeneration at a fraction of the cost of the big biotech's eye treatment, Lucentis.

Is there a future for compounding pharmacies in biotech?

JC: I can see a future in which compounding pharmacies partner with biotechs as drugs become more specific to the individuals taking them. Collaboration would involve a biotech's intellectual property and a pharmacy's compounding expertise. The more complex the drug, the more compounding pharmacies need to get the training and accreditation for their quality systems and processes to match the risk level of the treatments they're making. 

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