February 10, 2023
FDA amends 503B ibuprofen compounding guidance. Yawn.
Late Thursday we learned that FDA has updated its January 20 GFI on ibuprofen compounding by 503Bs. The update would allow 503Bs to sell the ibuprofen suspension they prepare to 503A pharmacies.
“While we’ve not had time to thoroughly review the revision, I presume it’s meant to try to stimulate an economic model in which 503Bs find it worthwhile to do what the earlier GFI was aimed at doing, which is to alleviate the shortage,” said APC’s Scott Brunner. “My sense is it won’t accomplish that. As we told the agency last month, it can do more to alleviate the shortage by providing 503As more latitude to compound the OTC suspension, the way Canada has done.”