Athenex Sues FDA To Get Vasopressin On List Of Drugs That Can Be Compounded
Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.
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Expected flurry of FDA proposals against 503B compounding from bulk drug substances follows vasopressin court ruling.
By siding with the FDA against bulk compounding of vasopressin, is court encouraging more limits to Section 503B outsourcing facilities?
FDA has announced a multifaceted effort to tackle the oversight of drug compounding facilities this year. On the to do list: setting the groundwork for establishing centers for excellence for outsourcing facilities; finalizing a guidance on identifying insanitary conditions at drug compounding facilities, and finalizing a memorandum of understanding targeting traditional compounders that distribute an “inordinate” amount of their compounded drugs across state lines.