FDA Strengthens Compounding Safety with Cesium Ban And Research Collaboration
FDA has taken additional steps to make drug compounding safer for patients, including a ban on cesium chloride because of “significant safety risks” it poses and a pair of university research collaborations to help further develop a list of bulk drug ingredients that can be safely compounded.
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The ingredient, cesium chloride, also was the subject of a citizen petition by consumer advocacy group Public Citizen asking the FDA to prohibit its use in supplements. The FDA has warned five firms marketing products labeled as supplements and containing cesium chloride.
Petition was consumer advocacy group's first request for halt to approval of an entire drug class; Public Citizen has gotten full and partial approval of other recent petitions.
Par says FDA shouldn't have authorized a compounded version of Vasostrict, but parties have asked court to wait until March, when a guidance is expected that may resolve the company's concerns.