21 CFR 1271.210 - Supplies and reagents.

§ 1271.210 Supplies and reagents.

(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.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1271 after this date.

  • 2016-12-13; vol. 81 # 239 - Tuesday, December 13, 2016
    1. 81 FR 89848 - Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; correction.
      Effective December 13, 2016.
      21 CFR Parts 20, 201, 207, 314, 514, 515, 601, 607, and 1271
The section you are viewing is cited by the following CFR sections.