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Warning: Stability Studies for extending BUDs will be enforced

Warning: Stability Studies for extending BUDs will be enforced
June 15, 2018 Seth DePasquale
In BUDs, FDA, QA, QC, Stability

Not a new standard

I’ve written about this in the past: when extending beyond use dates we need to do stability studies (click). For those who’ve been extending your BUDs without stability studies; you’re not alone. However, since my pharmacy is licensed in just about every jurisdiction I can tell you first hand that this will be enforced going forward; Texas being the first to make it a contingency for renewal of your license (I think California is also in this category).

If you’re of the mindset that this is a hassle and is going to cost you a fortune, I caution you with a real case that is being investigated by the FDA (CLICK HERE). A pharmacy in Texas had made an intraocular injection that has caused various adverse reactions “including vision impairment, poor night vision, loss of color perception and reductions in best corrected visual acuity and visual fields.”

To summarize the FDA’s findings: an antibiotic/steroid injection was being compounded with pluronic F127 (poloxamer 407 – a thermo-reversible polymer that gels at body temperature). It seems upon sonication and sterilization (using an autoclave) the compound degraded into acetone (from triamcinolone), formaldehyde, acetaldehyde and formate (from poloxamer). The FDA concludes that given the concentration of poloxamer and the degradation products the adverse reactions were a result of the poloxamer itself and its by-products from the sterilization and storage processes.

RISK RISK RISK (not the game)

The FDA has one common theme that is throughout their inspection manuals and their investigations: RISK. The higher the risk a compound presents to the person it’s being administered to, the more safety checks should be put in place to prevent any issues. I have to say this seems like a very logical and wise way to think about compounding. In this case since we’re talking about an injection that would be going into someone’s eye, this would be one of the most risky compounds that can be made.

Like I said at the beginning, this case highlights the need for compounders to start stability testing their compounds. The enforcement of this isn’t going to get any “lighter” going forward, rather it will be more and more strict. At my pharmacy we make intramuscular injections for horses. Not the riskiest of routes of administration and obviously not being injected into humans. Nonetheless we have targeted our first few compounds that we’ve already begun stability studies on based on sales (not on risk only because all of our compounds hold the same risk). I’d suggest we start this sooner rather than later as these can take up to a year to complete. Check out one of my earlier posts about what goes into a stability study and how to get it done (HERE).

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About the author:

Seth DePasquale is a pharmacist and co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon.

 

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