Description
FDA (we) is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in Title 21 of the Code of Federal Regulations (CFR) regarding blood and blood components. This notice is being issued under 21 CFR 640.120(b) to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical. Maintaining platelet availability in the face of logistical challenges (e.g., in military, prehospital, or austere settings) or other threats to blood availability (e.g., mass casualty events or public health emergencies) is critical to assure that platelets are available to patients with active bleeding.
Scope & Applicability
Product Classes
5Platelets stored continuously at 1 to 6°C; CSP intended for the treatment of active bleeding; CSP are intended for the treatment of active bleeding
Conventional platelets stored at 20 to 24°C
RTP compared to CSP in clinical studies
establishments already licensed to manufacture apheresis platelets
establishments already licensed to manufacture Whole Blood-derived platelets
Stakeholders
1Entities responsible for manufacture and labeling of CSP; Must follow instructions for use provided by the device manufacturer; Blood establishments that manufacture licensed blood components
Regulatory Context
Attributes
4Should be 6 months from the date of collection.; Expiration or use-by period on container label
Storage temperature for cold-stored platelets
Maximum dating period for CSP under alternative procedures
CSP must be stored continuously at 1-6°C
Identified Hazards
Hazards
1Risk factor in platelet storage; Risk controlled by cold storage; control the risk of bacterial contamination for up to 14 days
Related CFR Sections (11)
- 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 →
- 21CFR640.120§ 640.120 Alternative procedures.
(a) The Director, Center for Biologics Evaluation and Research, may issue an exception or alternative to any requirement in subchapter F of chapter I of title 21 of the Code of Federal Regulations regarding blood, blood components, or blood products. The Director may issue such an exception or alterRead full regulation →
- 21CFR640.20§ 640.20 Platelets.
(a) Proper name and definition. The proper name of this product shall be Platelets. The product is defined as platelets collected from one unit of blood and resuspended in an appropriate volume of original plasma, as prescribed in § 640.24(d) .Read full regulation →
- 21CFR640.24§ 640.24 Processing.
(a) Separation of plasma and platelets and resuspension of the platelets must be in a closed system. Platelets must not be pooled during processing unless the platelets are pooled as specified in the directions for use for the blood collecting, processing, and storage system approved for such use byRead full regulation →
- 21CFR610.53§ 610.53 Dating periods for Whole Blood and blood components.
(a) General. Dating periods for Whole Blood and blood components are specified in the table in paragraph (b) of this section.Read full regulation →
- 21CFR606.65§ 606.65 Supplies and reagents.
All supplies and reagents used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be stored in a safe, sanitary and orderly manner.Read full regulation →
- 21CFR640.25§ 640.25 General requirements.
(a) Storage. Immediately after resuspension, Platelets shall be placed in storage at the selected temperature range. If stored at 20 to 24 °C, a continuous gentle agitation of the platelet concentrate shall be maintained throughout the storage period. Agitation is optional if stored at a temperatureRead full regulation →
- 21CFR606.145§ 606.145 Control of bacterial contamination of platelets.
(a) Blood collection establishments and transfusion services must assure that the risk of bacterial contamination of platelets is adequately controlled using FDA approved or cleared devices or other adequate and appropriate methods found acceptable for this purpose by FDA.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 →
- 21CFR606.122§ 606.122 Circular of information.
A circular of information must be available for distribution if the product is intended for transfusion. The circular of information must provide adequate directions for use, including the following information:Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
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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)