Description
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled “Temporary Policies for Compounding Certain Parenteral Drug Products.” As of October 10, 2024, pursuant to section 319(a) of the Public Health Service Act (PHS Act), Department of Health and Human Services (HHS) Secretary Becerra has determined that public health emergencies (PHEs) exist as a result of the consequences of Hurricane Helene in the States of North Carolina, Florida, Georgia, Tennessee, and South Carolina, and as a result of the consequences of Hurricane Milton in the State of Florida. In late September 2024, Hurricane Helene had a devastating impact on one of the largest manufacturers of certain intravenous and peritoneal dialysis solutions in the United States. This guidance describes the FDA’s regulatory and enforcement priorities regarding the compounding of certain parenteral drug products by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities.
Scope & Applicability
Product Classes
3The subject of the temporary compounding policies.; Injectable drugs subject to temporary compounding policies
Testing requirements for sterile compounded drug products
Essential parenteral drug products such as intravenous and peritoneal dialysis solutions.
Stakeholders
4Facilities registered with FDA that compound drug products.
State-licensed pharmacies and Federal facilities not registered as outsourcing facilities.; Compounders not registered as outsourcing facilities
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 compounding drug products under section 503A; Entity compounding drug products
Regulatory Context
Attributes
5Dating for drug products compounded by pharmacy compounders.
BUD is restricted to the last time point at which the data remained within specifications
Required label element for outsourcing facilities
Dating requirements for drug products compounded by outsourcing facilities.
Default BUD assigned to compounded products; Assigned date for compounded drug products
Identified Hazards
Hazards
1Emergencies resulting from Hurricane Helene and Hurricane Milton causing supply disruptions.
Related CFR Sections (6)
- 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 →
- 21CFR211.166§ 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 →
- 21CFR211.137§ 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 →
- 21CFR211.167§ 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 →
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SV Labs Corporation
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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)