CFR - Code of Federal Regulations Title 21 (2024)

FAQs

What is Title 21 of the Code of Federal Regulations CFR? ›

The Code of Federal Regulations Title 21 contains the codified Federal laws and regulations that are in effect as of the date of the publication pertaining to food and drugs, both legal pharmaceuticals and illegal drugs. Sign up for email alerts on CFR Title 21, Food & Drugs products, news, and offers.

What is 21 CFR Part 11? Title 21 CFR Part 11 establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures. It is a portion of Title 21 of the Code of Federal Regulations.

Compliance with the 21 CFR guidelines for pharma requires efficient management of disparate GMP functions to ensure drug products meet the requirements for safety, quality, strength, and purity.

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.

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).

At the heart of the issue is law enforcement agencies' Title 21 authority -- which allows the federal government to investigate drug crimes. As it currently stands, Homeland Security Investigations has to ask the Justice Department first before investigating drug crimes.

The Dietary Supplement (DS) CGMP rule in 21 CFR part 111 (“the DS CGMP rule”) requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged ...

(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

21 CFR Part 11 ensures that any data stored or exchanged electronically is secure, accurate, and reliable. It also requires companies to adhere to certain standards of data security.

The 21 CFR Part 11 compliance checklist is a tool that can be used to evaluate the level of compliance with the requirements outlined in 21 CFR Part 11. It provides a comprehensive list of questions to consider when assessing the compliance of electronic records and electronic signature systems.

What is 21 CFR indication for use? ›

(i) Indications for use. A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.

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

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration.

The 21 CFR Part 11 requirements outline criteria for electronic records, electronic signatures, and handwritten signatures on electronic records to be considered trustworthy, reliable, and comparable to paper records and signatures on paper.

FDA 21 Code of Federal Regulations (CFR) Part 11 refers to the FDA's regulations on electronic records and electronic signatures for clinical trials. Since most sponsors and research sites now use electronic documents, Part 11 has become more important than ever.

21 CFR Part 210 - PART 210—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL. § 210.1 Status of current good manufacturing practice regulations. § 210.2 Applicability of current good manufacturing practice regulations. § 210.3 Definitions.

21 CFR Part 820 is a set of regulations from FDA that outlines the current good manufacturing practice (CGMP) requirements that medical device manufacturers in the United States must follow with regards to their quality system.

Difference between 21 CFR Part 210 and 211

Where Part 210 covers manufacturing, facilities and controls, Part 211 covers additional areas for finished drug products, such as labeling, production processes, equipment management and personnel.

Sec. 861.30 Development of standards.