FDA GUIDANCE DOCUMENT

Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Part 1

FEBRUARY 2023

IMMEDIATELY IN EFFECT

I. INTRODUCTION

This guidance describes the Food and Drug Administration's (FDA or the Agency) regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products by outsourcing facilities to provide to: 1) hospitals and health systems for administration within the hospital or health system and/or 2) State-licensed pharmacies (including those within hospitals and health systems), and applicable Federal facilities, to dispense to patients for use at home after receiving a valid, patient-specific prescription. The United States is currently experiencing a significant number of infections involving three viruses: Coronavirus Disease 2019 (COVID-19), respiratory syncytial virus (RSV), and influenza. Each of these viruses may produce fever in young children. FDA has received reports related to increased demand for pediatric fever-reducing medications, including ibuprofen oral suspension products. Further, FDA has received a number of reports related to hospitals, health systems, and State-licensed pharmacies experiencing challenges with obtaining these medications to use for fever and pain treatment of pediatric patients as well as for adults who are unable to swallow solid oral dosage forms (e.g., persons with feeding tubes) due, for example, to regional disparities in infection rates, distribution of resources, or other regional conditions that may evolve quickly during the winter months when the incidence of respiratory infections is expected to peak. This guidance revises and replaces the guidance for industry called Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act that was issued on January 20, 2023. FDA is continually assessing the needs and circumstances related to the temporary policy set forth in this guidance, and as relevant needs and circumstances evolve, FDA intends to update, modify, or withdraw this policy as appropriate.

This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately to bolster access to ibuprofen oral suspension products compounded by outsourcing facilities and provided to hospitals, health systems, State-licensed pharmacies, and applicable Federal facilities during the current surge in respiratory infections, but it remains subject to comment in accordance with the Agency's good guidance practices.

In general, FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

For the most recent version of the guidance, check the FDA guidance web page at:
https://www.fda.gov/​regulatory-​information/​search-​fda-​guidance-​documents.

Next week's newsletter will cover the "Background" on this topic.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition