Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's regulatory and enforcement priorities regarding compounding certain ibuprofen oral suspension products by outsourcing facilities to provide to hospitals and health systems for administration within the hospital or health-system and 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. This final guidance revises and replaces the guidance of the same name issued on January 25, 2023. Revisions were made to describe the Agency's regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products by outsourcing facilities to provide to 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, pat