Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act February 2023
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
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 in outsourcing facilities for administration in hospitals and health systems. The United States is currently experiencing a surge in 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 and health systems experiencing challenges with obtaining these medications to use in the treatment of pediatric patients with fever 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. 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2023-D-0169.