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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2020]
[CITE: 21CFR630.40]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F - BIOLOGICS

PART 630 -- REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE

Subpart C - Donor Notification

Sec. 630.40 Requirements for notifying deferred donors.

(a) Notification of donors. You, an establishment that collects blood or blood components, must make reasonable attempts to notify any donor, including an autologous donor, who has been deferred based on the results of tests for evidence of infection with a relevant transfusion-transmitted infection(s) as required by § 610.41(a) of this chapter; any donor who has been deferred as required under § 630.30(b)(3) because their donated platelets have been determined under § 606.145(d) of this chapter to be contaminated with an organism that is identified as likely to be associated with a bacterial infection that is endogenous to the bloodstream of the donor; and any donor who has been determined not to be eligible as a donor based on eligibility criteria under §§ 630.10 and 630.15. You must attempt to obtain the results of further testing required under § 610.40(e) of this chapter prior to notifying a donor of the deferral. If notification occurs prior to receipt of such results, you must also notify a deferred donor of the results of the further testing. You must notify a donor as described in paragraph (b) of this section.

(b) Content of notification. You must provide the following information to a donor deferred or determined not to be eligible as a donor as described in paragraph (a) of this section:

(1) That the donor is deferred or determined not to be eligible for donation and the reason for that decision;

(2) Where appropriate, the types of donation of blood or blood components that the donor should not donate in the future;

(3) Where applicable, the results of tests for evidence of infection due to relevant transfusion-transmitted infection(s) that were a basis for deferral under § 610.41 of this chapter, including results of further testing as required in § 610.40(e) of this chapter; and,

(4) Where appropriate, information concerning medical followup and counseling.

(c) Time period for notification. You must make reasonable attempts to notify the donor within 8 weeks after determining that the donor is deferred or determined not to be eligible for donation as described in paragraph (a) of this section. You must document that you have successfully notified the donor or when you are unsuccessful that you have made reasonable attempts to notify the donor.

(d) Autologous donors. (1) You also must provide the following information to the referring physician of an autologous donor who is deferred based on the results of tests for evidence of infection with a relevant transfusion-transmitted infection(s) or whose platelets indicate evidence of a bacterial infection that is endogenous to the bloodstream of the donor as described in paragraph (a) of this section:

(i) Information that the autologous donor is deferred based on the results of tests for evidence of infection due to relevant transfusion-transmitted infection(s), as required under § 610.41 of this chapter, and the reason for that decision;

(ii) Where appropriate, the types of donation of blood or blood components that the autologous donor should not donate in the future; and

(iii) The results of tests for evidence of infection due to relevant transfusion-transmitted infection(s), that were a basis for deferral under § 610.41 of this chapter, including results of further testing as required in § 610.40(e) of this chapter.

(2) You must make reasonable attempts to notify the autologous donor's referring physician within 8 weeks after determining that the autologous donor is deferred as described in paragraph (a) of this section. You must document that you have successfully notified the autologous donor's referring physician or when you are unsuccessful that you have made reasonable attempts to notify the physician.

[66 FR 31176, June 11, 2001. Redesignated and amended at 80 FR 29898, May 22, 2015]

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