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CFR › Title 21 › Chapter I › Subchapter F › Part 606 › Subpart H › Section 606.140

21 CFR 606.140 - Laboratory controls.

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§ 606.140
Laboratory controls.
Laboratory control procedures shall include:
(a) The establishment of scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective.
(b) Adequate provisions for monitoring the reliability, accuracy, precision and performance of laboratory test procedures and instruments.
(c) Adequate identification and handling of all test samples so that they are accurately related to the specific unit of product being tested, or to its donor, or to the specific recipient, where applicable.

Title 21 published on 2012-04-01

no entries appear in the Federal Register after this date.

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
USC : Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

§ 553 - Rule making

§ 702 - Right of review

§ 703 - Form and venue of proceeding

§ 704 - Actions reviewable

USC : Title 15 - COMMERCE AND TRADE

§ 331 to 374 - Omitted

USC : Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 331 - Prohibited acts

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 355 - New drugs

§ 360 - Registration of producers of drugs or devices

§ 360j - General provisions respecting control of devices intended for human use

§ 360 note - Registration of producers of drugs or devices

§ 371 - Regulations and hearings

§ 374 - Inspection

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 216 - Regulations

§ 262 - Regulation of biological products

§ 263 - Preparation of biological products by Service

§ 263a - Certification of laboratories

§ 264 - Regulations to control communicable diseases