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42 U.S.C. 216, 243, 263a, 264, 271.
66 FR 5466, Jan. 19, 2001, unless otherwise noted.
69 FR 68681, Nov. 24, 2004, unless otherwise noted.
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(a) Verification. You must not use supplies and reagents until they have been verified to meet specifications designed to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases. Verification may be accomplished by the establishment that uses the supply or reagent, or by the vendor of the supply or reagent.
(b) Reagents. Reagents used in processing and preservation of HCT/Ps must be sterile, where appropriate.
(c) In-house reagents. You must validate and/or verify the processes used for production of in-house reagents.
(d) Records. You must maintain the following records pertaining to supplies and reagents:
(1) Records of the receipt of each supply or reagent, including the type, quantity, manufacturer, lot number, date of receipt, and expiration date;
(2) Records of the verification of each supply or reagent, including test results or, in the case of vendor verification, a certificate of analysis from the vendor; and
(3) Records of the lot of supply or reagent used in the manufacture of each HCT/P.