Code of Federal Regulations Title 21 - Food and Drugs
Title 21 of the Code of Federal Regulations (CFR) is a comprehensive set of regulations in the United States that governs Food and Drugs. It is the primary legal framework that the federal government uses to ensure the safety, efficacy, and security of a vast range of products that are consumed, applied to, or used on humans and animals.
Agencies that oversee Title 21 CFR:
The regulations in Title 21 are primarily enforced by three federal agencies, each with their specific purview:
Chapter I: Food and Drug Administration (FDA), Department of Health and Human Services
This is by far the largest and most extensive chapter, covering the vast majority of products regulated by the FDA.
Chapter II: Drug Enforcement Administration (DEA), Department of Justice
This chapter focuses on controlled substances, their scheduling, handling, and regulations related to their manufacture, distribution, and dispensing to prevent diversion and abuse.
Chapter III: Office of National Drug Control Policy (ONDCP)
This chapter deals with policies and strategies for drug control, often in a broader, national context.
Key Areas and Products Regulated by Title 21 CFR:
Title 21 is incredibly detailed and covers almost every aspect of the lifecycle of regulated products, from research and development to manufacturing, labeling, marketing, and post-market surveillance. Some of the major categories include:
I. Food for Human Consumption (Subchapter B, Parts 100-199):
General Food Labeling: Requirements for nutritional information (e.g., Nutrition Facts label), ingredient lists, and claims.
Food Additives: Regulations for the use of direct and indirect food additives, generally recognized as safe (GRAS) substances, and prior-sanctioned substances.
Good Manufacturing Practices (GMPs) for Food: Standards for manufacturing, packing, or holding human food to ensure its safety and purity. This includes regulations for specific foods like seafood (HACCP), acidified foods, and low-acid canned foods.
Dietary Supplements: Specific GMPs and labeling requirements for dietary supplements.
Produce Safety: Standards for the growing, harvesting, packing, and holding of produce for human consumption (FSMA Produce Safety Rule).
Preventive Controls for Human Food: Requirements for hazard analysis and risk-based preventive controls (FSMA Preventive Controls Rule).
Imports and Exports: Regulations for imported food and food facilities registration.
II. Drugs for Human Use (Subchapters C & D, Parts 200-499):
Current Good Manufacturing Practices (cGMPs) for Drugs: Detailed regulations for the manufacturing, processing, packing, or holding of drugs to ensure quality, identity, strength, and purity.
Investigational New Drug (IND) Applications: Requirements for clinical trials and the submission of data for new drugs under investigation.
New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs): The full process for seeking FDA approval to market a new drug or a generic drug.
Over-the-Counter (OTC) Drugs: Specific requirements for OTC drug monographs and marketing.
Drug Labeling and Advertising: Regulations for prescription and OTC drug labeling, promotional materials, and advertising.
Human Subject Protection and Institutional Review Boards (IRBs): Rules for the protection of human subjects in clinical trials (21 CFR Part 50) and the responsibilities of IRBs (21 CFR Part 56).
Good Laboratory Practices (GLP): Regulations for nonclinical laboratory studies that support drug safety (21 CFR Part 58).
III. Animal Drugs, Feeds, and Related Products (Subchapter E, Parts 500-599):
Regulations similar to human drugs but tailored for veterinary use, including new animal drug applications and cGMPs for medicated feeds.
IV. Biologics (Subchapter F, Parts 600-680):
Regulations for biological products such as vaccines, blood and blood components, and allergenic products, including licensing, cGMPs, and labeling.
V. Cosmetics (Subchapter G, Parts 700-799):
Regulations concerning cosmetic labeling, ingredient safety, and good manufacturing practices (though less extensive than for drugs or food).
VI. Medical Devices (Subchapter H, Parts 800-898):
Premarket Notification (510(k)) and Premarket Approval (PMA): The two primary pathways for marketing medical devices in the U.S.
Quality System Regulation (QSR): Analogous to cGMPs for drugs, this sets the standards for quality management systems for medical device manufacturers (21 CFR Part 820).
Medical Device Reporting (MDR): Requirements for manufacturers and device users to report adverse events related to medical devices.
Device Classification and Listing: Rules for classifying medical devices based on risk and for registering and listing devices.
VII. Radiological Health (Subchapter J, Parts 1000-1040):
Regulations for electronic products that emit radiation (e.g., X-ray equipment, microwave ovens).
VIII. Tobacco Products (Subchapter K, Parts 1100-1150):
Regulations for the manufacture, marketing, and distribution of tobacco products, including e-cigarettes, cigars, and hookah tobacco.
IX. Controlled Substances (Chapter II, Parts 1300-1322):
Schedules of Controlled Substances: Lists and criteria for classifying drugs into Schedules I through V based on their potential for abuse and accepted medical use (21 CFR Part 1308).
Registration Requirements: For manufacturers, distributors, and dispensers of controlled substances.
Recordkeeping and Reporting: Detailed requirements for maintaining records related to controlled substances.
X. Cross-Cutting Regulations:
21 CFR Part 11: Electronic Records; Electronic Signatures: This is a highly significant regulation that applies across many regulated industries within Title 21. It sets forth the criteria under which the FDA considers electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. This is crucial for digital systems used in manufacturing, testing, and managing data for regulated products.
Title 21 CFR is a dynamic body of law, constantly updated as science, technology, and public health needs evolve. Compliance with these regulations is mandatory for any entity involved in the production, distribution, or research of food, drugs, medical devices, cosmetics, biologics, and tobacco products intended for the U.S. market.
RELATED Blog
0 comments