Description
This guidance document provides the current recommendations of the Food and Drug Administration (FDA) for assessment of donor suitability and quarantine and retrieval of blood and blood products in cases of donors exposed to vaccinia virus, which is the virus used in smallpox vaccines. The presence of vaccinia virus in transfused blood or plasma could be harmful to some recipients. Although the presence of vaccinia virus in blood (viremia) has rarely been documented, this possibility has not been assessed using modern laboratory techniques. Therefore, the risk of transmission of vaccinia virus by blood and blood products is uncertain.
Scope & Applicability
Product Classes
5Blood component subject to the recommendations in this guidance
Specific blood component with distinct testing recommendations; Recommendations for testing Source Plasma differ from whole blood.
Blood component intended for further manufacture
Subject of donor eligibility recommendations
Products for further fractionation that need not be quarantined
Stakeholders
4Entities that collect blood and blood components; Entities responsible for testing donations and complying with regulations.
The data for a minimum of six donors should be used
Potential HCT/P donor screening
Responsible for considering record tracing and notification
Regulatory Context
Attributes
1Revised to 3 months following treatment
Identified Hazards
Hazards
2The risk of transmission by blood and blood products is uncertain.
Risk of contamination of blood and plasma
Related CFR Sections (2)
- 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 →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
See Also (8)
- Validation of Procedures for Processing of Human Tissues Intended for Transplantation: Guidance for Industry (Status: Final)
- Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS (Status: Final)
- IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations: Guidance for Industry (Status: Final)
- Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information: Guidance for Industry (Status: Final)
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (Status: Final)
- Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization (Status: Final)
- Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment : Guidance for Industry (Status: Final)
- Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (Status: Final)