What does CFR 21 cover?


What does CFR 21 cover?

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

What is meant by 21 CFR?

Title 21 of the CFR or the Code of Federal Regulations deals with governing of food and drugs in the United States for three of its governing bodies: The FDA (Food and Drug Administration), DEA (Drug Enforcement Agency) and ONDCP (Office of National Drug Control Policy).

What federal regulation requires testing of tissue donors for communicable diseases?

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to screen and test cell and tissue donors for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases.

What is a CFR requirement?

Code of Federal Regulations (CFR) The CFR is a codification of the general and permanent rules that were published in the FR by the Executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation.

What is CFR compliant?

CFR stands for “Code of Federal Regulation.” 21 CFR Part 11, in particular, details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records.

What is HCT P donor?

Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases | FDA. The .gov means it’s official. The site is secure.

How do you test for communicable diseases?

One of the tests for communicable diseases is called a purified protein derivative (PPD) skin test. This test shows whether or not the patient has tuberculosis, an infection that most often affects the lungs and is spread through airborne contact with the breath of an infected individual.

How do you cite far?

Federal Acquisition Regulation (FAR): An example of a Federal Acquisition Regulation citation is: FAR 16.405-2. To cite to a historical FAR section, include the appropriate year in the parenthetical: FAR 17.109 (2008).