2022-11120: Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry." The draft guidance document addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. Specifically, the draft guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment's failure to comply with certain requirements in the biologics regulations regarding donation suitability, donor eligibility, and quarantine hold for Source Plasma. FDA expects that the compliance policy described in the draft guidance will increase the availability of blood and blood components, including Source Plasma, while maintaining the health of blood donors and the safety of blood and blood components.
The agency’s own summary, as published.
What this changes
Amends 2 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
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