FDA re­vis­es ac­tion on com­pound­ed ibupro­fen, cit­ing oral ver­sion short­age

The FDA put out guid­ance Thurs­day ex­pand­ing sup­ply of a spe­cif­ic form of ibupro­fen, one of the ma­jor ac­tive in­gre­di­ents in over-the-counter pain re­lief med­i­cine such as Advil.

In its newest re­vised guid­ance, the fed­er­al reg­u­la­to­ry agency is now giv­ing the green light to out­sourc­ing fa­cil­i­ties to pro­vide com­pound­ed, oral­ly sus­pend­ed forms of ibupro­fen to state-li­censed phar­ma­cies that can be giv­en to pa­tients at home, pro­vid­ed that a pa­tient has a valid and pa­tient-spe­cif­ic pre­scrip­tion.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER