§ 640.22 Collection of source material

(a) Whole blood used as the source of Platelets shall be collected as prescribed in § 640.4 .

(b) [Reserved]

(c) If plateletpheresis is used, the procedure for collection must be as prescribed in §§ 640.21 , 640.64 (except paragraph (c)), and 640.65, or as described in an approved biologics license application (BLA) or an approved supplement to a BLA.

(d) The phlebotomy shall be performed by a single uninterrupted venipuncture with minimal damage to, and minimal manipulation of, the donor's tissue.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

FDA guidance that cites § 640.22

• Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff 1 Dec 2007

Amendment history

Federal Register documents that created or amended this section.

• 40 FR 4304 29 Jan 1975
• 45 FR 27927 25 Apr 1980
• 49 FR 23834 8 Jun 1984
• 50 FR 4139 29 Jan 1985
• 55 FR 11013 26 Mar 1990
• 59 FR 49351 28 Sept 1994
• 64 FR 45372 19 Aug 1999
• 64 FR 56453 20 Oct 1999
• 72 FR 45887 16 Aug 2007
• 80 FR 29904 22 May 2015