Description
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.
Scope & Applicability
Product Classes
3The specific drug product category addressed by the guidance; 100 mg/5 mL concentration product discussed in guidance; The specific compounded drug product covered by this guidance
compounded drug product subject to labeling requirements
Drugs not FDA-approved undergoing lower regulatory standards
Stakeholders
4Facilities registered under section 503B; Entities reporting adverse events under Section 503B.
Facilities registered under section 503B that compound human drug products; entities that compound drugs under section 503B; Entities that compound drug products under section 503B
Entities dispensing compounded medications to patients
Facilities administering compounded products
Regulatory Context
Attributes
2BUD for nonsterile drug products; required date to be inserted on the product label
BUD is restricted to the last time point at which the data remained within specifications
Identified Hazards
Hazards
1Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water
Related CFR Sections (8)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR211.137§ 211.137 Expiration dating.
(a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166 .Read full regulation →
- 21CFR211.166§ 211.166 Stability testing.
(a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include:Read full regulation →
- 21CFR211.84§ 211.84 Testing and approval or rejection of components, drug product containers, and closures.
(a) Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.Read full regulation →
- 21CFR211.100§ 211.100 Written procedures; deviations.
(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, inRead full regulation →
- 21CFR211.167§ 211.167 Special testing requirements.
(a) For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be appropriate laboratory testing to determine conformance to such requirements. The test procedures shall be in writing and shall be followed.Read full regulation →
- 21CFR211.122§ 211.122 Materials examination and usage criteria.
(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials; such written procedures shall be followed. Labeling and packaging materials shall be representatively samplRead full regulation →
- 21CFR211.160§ 211.160 General requirements.
(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
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Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
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Medinatura New Mexico, Inc.
- 2025-12-16
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Sklar Personal Care Inc.
- 2025-12-16
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Microvascular Tissue, Inc.
- 2025-12-11
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Catalent Indiana, LLC
- 2025-12-09
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DeVere Manufacturing Inc.
- 2025-12-09
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CDL Services, Inc. DBA Technichem
- 2025-12-09
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Seaway Pharma Inc.
- 2025-12-02
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PQ Pharmacy, LLC
See Also (8)
- IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations: Guidance for Industry (Status: Final)
- Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry (Status: Draft)
- DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for Industry (Status: Final)
- Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information: Guidance for Industry (Status: Final)
- Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy: Guidance for Industry (Status: Final)
- Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products (Status: Final)
- Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates: Guidance for Industry (Status: Final)
- Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals (Status: Final)