FDA Publishes Notice to Remove Substances from its Bulks List I for Section 503B Outsourcing Facilities … and Let’s Watch What Happens Next

By Karla L. Palmer — We posted last year about the dispute over FDA’s determination to include certain nominated substances on its Bulk Substances List 1 for Section 503B outsourcing facilities.  Recall that in 2017, after FDA approved Endo/Par’s Vasostrict® finished drug product, several entities nominated active pharmaceutical ingredient vasopressin for inclusion on FDA’s Section 503B Bulk Substances List 1.  After review of the nominations, FDA added vasopressin to Bulks List 1 in mid-2017.  Next, FDA’s nomination and listing process (already the subject of two Agency revisions and “redos” since 2014, blogged about here) ground to a halt.  The nominations process and the list itself was (and remains) the subject of contentious litigation involving FDA, Endo Pharmaceuticals and its subsidiary Par Sterile Products, and outsourcing facility Athenex Pharma Solutions. After proposing to change the nomination…

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