Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
The FDA regulation governing who may donate blood and how donations are collected: general donor eligibility (§630.10), component-specific eligibility and donation frequency (§630.15), the medical supervision and donor-education framework, and donor notification duties. Established in its current form by the donor eligibility final rule of 22 May 2015, it pairs with the blood CGMP requirements of Part 606 and the donation testing rules of Part 610 Subpart E.
What this does not cover
stated in the document's own scope- Governs donor eligibility and collection; manufacturing CGMP for blood establishments is Part 606, and donation testing is Part 610 Subpart E.
- Covers blood and blood components including Source Plasma; cells and tissues follow the HCT/P donor-eligibility rules of Part 1271, a separate framework.
- A US regime: EU blood collection is governed by the Blood Directive's national implementations until the SoHO Regulation applies from August 2027.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 630 governs the human beginning of the blood supply: who may donate, and under what conditions blood and blood components — including Source Plasma — are collected. Established in its current form by the donor eligibility final rule of 22 May 2015, it requires an eligibility determination before collection built on donor education, a health assessment, and donor questioning against deferral criteria (§630.10); adds component-specific eligibility and donation-frequency rules, including for apheresis collections (§630.15); places collection under medical supervision with defined responsibilities for the responsible physician; and requires notification of donors who are deferred. It works as one system with the blood CGMP of Part 606, the donation-testing rules of Part 610 Subpart E, and the component standards of Part 640.
Scope & applicability
Blood establishments collecting blood and blood components for transfusion or further manufacturing (including Source Plasma) in the US. Manufacturing CGMP sits in Part 606; component-specific standards in Part 640; donation testing in Part 610.
Legal basis & how it acquires force
A regulation under the Public Health Service Act and FD&C Act authorities for blood and blood components, put in place by the final rule of 22 May 2015 — "Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use" — which amended Parts 606, 610, 630, and 640 in a single action and took effect in 2016. Donor-screening practice under the rule is steered by FDA guidance, including the 2023 individual donor assessment policy for HIV risk.
Document structure
| Part | Covers |
|---|---|
| General provisions and definitions | Scope, definitions, and the relationship of Part 630 to Parts 606, 610, and 640 |
| Subpart B — Donor eligibility requirements | The pre-collection eligibility determination: education, health assessment, and questioning (§630.10), plus component-specific rules and donation frequency (§630.15) |
| Medical supervision and exceptions | The responsible physician's duties and the permitted exceptions and alternatives |
| Subpart C — Donor notification | Notifying donors who are deferred or found ineligible, including the basis for deferral |
Key requirements
- Donor eligibility determined before collection: health assessment, donor questioning, and deferral screening (§630.10)
- Component-specific eligibility and donation-frequency limits, including apheresis collections (§630.15)
- Collection under medical supervision with defined responsibilities of the responsible physician
- Donor education, consent-adjacent information, and notification of deferred donors
Implementation tips
- Run eligibility per current FDA guidance layered on the rule — the individual donor assessment policy for HIV risk (2023) changed questionnaire practice without changing the regulation's framework
Revision notes
The 22 May 2015 final rule (effective 2016) consolidated donor eligibility and collection requirements into Part 630, amending Parts 606, 610, and 640 in the same action.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 630 is the donor-facing layer of the US blood framework: Part 606 supplies the CGMP for blood establishments, Part 610 Subpart E the donation testing for relevant transfusion-transmitted infections, and Part 640 the component-by-component standards. Internationally, the EU's SoHO Regulation (2024/1938) — succeeding the Blood Directive — covers the same ground of donor eligibility, protection, and collection standards, and WHO blood-safety guidance carries the model into other jurisdictions.
21 CFR Part 630: frequently asked questions
Quick answers to common questions about 21 CFR Part 630.
What must happen before a blood donation is collected?
The establishment must determine the donor is eligible: provide donor education, assess the donor's health that day, and question the donor against the deferral criteria — covering medical history, risk factors, medications, and travel — with collection only proceeding on a satisfactory determination under §630.10.
What did the 2015 donor eligibility rule change?
It consolidated and modernised donor-eligibility and collection requirements into Part 630, restructured donation testing in Part 610 Subpart E around "relevant transfusion-transmitted infections", and conformed Parts 606 and 640 — one rule, effective 2016, spanning the blood framework.
How is donation frequency controlled?
Section 630.15 sets component-specific rules: intervals between whole-blood donations, limits for apheresis collections including plasma and platelets, and the conditions under which more frequent collection is permissible under medical oversight.
Does Part 630 apply to Source Plasma?
Yes. Part 630's donor-eligibility and medical-supervision framework covers collections for further manufacturing, including Source Plasma, with component-specific provisions in §630.15 and Part 640 supplying the product standards.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.