January 23, 2023
FDA’s guidance on compounding ibuprofen isn’t just for 503Bs
Last Friday, FDA issued guidance on compounding certain ibuprofen oral suspension products that allows 503Bs to compound ibuprofen suspension under certain conditions. But buried in the FAQs FDA published regarding the GFI is some guidance for 503As, too.
The agency said the action was in response to increased demand due to the early start and severity of this year’s cold and flu season. It said the guidance was intended to provide temporary flexibility to hospitals and health systems in helping ensure treatment options are available when those facilities are unable to obtain oral suspension drug products for the treatment of pediatric patients with fever, and for adults who are unable to swallow solid oral ibuprofen products.
“This guidance comes not a moment too soon and provides a path by which 503Bs can help meet the urgent need for ibuprofen suspension that hospitals are experiencing,” said APC’s Scott Brunner. “But included in the Frequently Asked Questions FDA published on its website is a tiny reminder to 503As, too.”
That FAQ clarifies whether 503A compounders can make ibuprofen and acetaminophen oral suspensions if a shortage has not been declared:
In other FDA guidance, the term “regularly or in inordinate amounts” has been defined as no more than four units.
“It’s not new, and it may not amount to much—and it’s entirely possible the costs of preparing a compounded version of ibuprofen and acetaminophen oral suspensions may be more than consumers would expect to pay—but in emergency situations, that permission might make a difference,” added Brunner.
The guidance—which was immediately effective on Jan. 20—specifies circumstances under which 503Bs can compound ibuprofen suspension. Read details here.