FDA Issues Compliance Policy on Blood Pressure and Pulse Donor Eligibility for Blood Establishments

Biologics manufacturers relying on plasma-derived starting materials face renewed scrutiny of their upstream donor eligibility controls following FDA's Center for Biologics Evaluation and Research (CBER) issuance of a compliance policy guidance addressing blood pressure and pulse requirements for donor eligibility determinations at blood and Source Plasma collection establishments.

The guidance, filed under docket FDA-2022-D-0362, applies to establishments collecting blood and blood components intended for transfusion or further manufacturing use, including Source Plasma. It operates within the regulatory framework established by the donor eligibility final rule published May 22, 2015, which amended donor eligibility and blood component testing requirements across 21 CFR to strengthen blood supply safety and protect donor health. That rule became effective May 23, 2016.

For CMC leads and supply chain directors at plasma-derived biologics manufacturers, the compliance policy clarifies how collection establishments are expected to interpret and apply vital sign thresholds as part of donor eligibility screening. Gaps at the collection level can propagate upstream into starting material qualification, directly implicating 21 CFR Part 211 obligations around raw material controls and, where applicable, biologics license commitments tied to plasma master files.

Source Plasma establishments operating under existing standard operating procedures should assess whether current blood pressure and pulse screening protocols align with the compliance expectations articulated in this guidance. Any deviation between site practice and the policy's parameters carries inspection risk, particularly given CBER's sustained focus on donor suitability as a foundational element of biologics safety assurance.

Comments on the guidance may be submitted at any time under 21 CFR 10.115(g)(5), with written submissions directed to FDA Dockets Management, referencing docket FDA-2022-D-0362; technical questions are routed through CBER's Office of Communication, Outreach and Development.

The measurable checkpoint for affected establishments is a gap assessment of donor vital sign screening SOPs against the compliance policy parameters before the next scheduled CBER inspection cycle.

Source: FDA Center for Biologics Evaluation and Research via FDA Guidance Documents RSS Feed, October 14, 2026. Docket: FDA-2022-D-0362.