Amid ongoing scrutiny of compounding pharmacies, the Food and Drug Administration has issued new draft guidelines to address a contentious debate: When should compounders use the same raw ingredients that are found in prescription medicines?
Known in industry parlance as bulk substances, these ingredients figure prominently in discussions over the safe use of compounded medicines, as well as rising tensions between drug makers and compounders that are vying for some of the same patients.
And so, the agency is issuing what FDA Commissioner Scott Gottlieb called a “critical policy document” that addresses how bulk substances should be used by certain types of compounders along with an updated list of substances available for compounding.
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It’s hard to sympathize with Par on this one. Vasopressin was available generically and multisource at $100/dose when competition was forced to leave the market. This type of DESI scam, sanctioned by the FDA, is the bigger problem in my humble opinion.
Hi Wes
Thanks for writing in. And yes, I’d noted this in my last post about the litigation:
“It is worth noting that Vasostrict was approved in 2014 as part of an FDA program that encourages drug makers to invest in proving the safety and effectiveness of medicines that were sold without formal approval for decades. This also caused other companies to halt manufacturing of unapproved versions of a drug. After Endo and Par won approval, the Vasostrict list price increased from $4.27 to $138.40 per vial in November 2016, a 3,141 percent increase, according to a recent article in the Journal of the American Medical Association.”
Regards,
ed at pharmalot