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Additional Standards for Human Blood and Blood Products
21 CFR Part 640 establishes manufacturing and quality standards for human whole blood and blood products intended for transfusion. Requirements cover donor examination, blood collection using sterile pyrogen-free containers with approved anticoagulants, storage at 1–6 °C, labeling, tamper-proof sealing, and aseptic processing to prevent contamination. Licensed establishments must supervise all manufacturing steps including donor identification, laboratory testing, and reissue conditions.
Licensing
21 CFR Part 601 establishes procedures for obtaining biologics licenses from the FDA for biological products including therapeutic DNA plasmids, synthetic peptides, monoclonal antibodies, and recombinant DNA-derived products. Applicants must submit comprehensive safety, purity, and potency data from nonclinical and clinical studies, manufacturing information, stability data, labeling specimens, and environmental assessments to the Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research.
Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
21 CFR Part 607 establishes establishment registration and product listing requirements for manufacturers of human blood and blood products, as well as manufacturers of licensed devices and biological products used in device manufacturing. The regulation defines key terms including blood products, establishments, manufacturing processes, and commercial distribution, and applies to blood banks, plasma donor centers, transfusion services, and independent testing laboratories.
Physical Medicine Devices
21 CFR Part 890 establishes the FDA classification framework for physical medicine devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, including class III device approval timelines and substantial equivalence determinations. Manufacturers must demonstrate why their devices are substantially equivalent to existing devices and comply with applicable premarket notification procedures under 21 CFR Part 807.
Dental Devices
21 CFR Part 872 establishes the FDA classification framework for dental devices intended for human use in commercial distribution. It outlines scope, substantially equivalent device determinations, and premarket approval requirements for Class III devices, with grace periods and exemptions specified under the Federal Food, Drug, and Cosmetic Act.
Obstetrical and Gynecological Devices
21 CFR Part 884 establishes the regulatory framework for obstetrical and gynecological devices in commercial distribution. It outlines device classification procedures, premarket approval requirements under FDA section 515, and distinguishes between devices marketed before and after May 28, 1976. Manufacturers must demonstrate substantial equivalence for premarket notifications, and Class III devices require FDA approval before commercial distribution unless exempted.
General
21 CFR Part 1105 establishes FDA's premarket submission requirements for tobacco products. The regulation specifies grounds for refusing to accept applications, including submissions that lack required contact information, English translation, proper FDA forms, product identification details, environmental assessments, or a U.S. agent signature for foreign applicants. Accepted submissions receive a tracking number and processing acknowledgement.
Premarket Tobacco Product Applications
21 CFR Part 1114 establishes procedures and requirements for submitting premarket tobacco product applications (PMTAs) to the FDA, including evaluation procedures and postmarket reporting obligations. The regulation defines key terms such as tobacco product accessories, additives, adverse experiences, brand characteristics, and composition, and specifies the scope of applicability, excluding premium cigars and modified risk tobacco product applications unless they seek dual marketing orders.
General
21 CFR Part 1000 establishes general provisions and definitions for the regulation of electronic products that emit radiation under the Federal Food, Drug, and Cosmetic Act. Key terms include electronic product radiation (ionizing or nonionizing electromagnetic or particulate radiation, or sonic/ultrasonic waves), electronic products (manufactured items containing electronic circuits that emit such radiation), and related industry roles such as manufacturers, distributors, and dealers. The regulation provides foundational definitions for chassis families, component classifications, and model designations used in subsequent radiation safety standards.
Mammography
21 CFR Part 900 implements the Mammography Quality Standards Act (MQSA) by establishing procedures for FDA-approved accreditation bodies to evaluate mammography facilities and setting minimum national quality standards. The regulation defines key terms related to mammography operations, including accreditation bodies, adverse events (poor image quality, delayed reporting, unqualified personnel), air kerma measurement, and continuing education requirements for clinical staff.
Regulations Under the Federal Import Milk Act
21 CFR Part 1210 establishes regulatory requirements for imported milk and cream under the Federal Import Milk Act. It defines milk, cream, and related dairy products; specifies pasteurization standards (minimum 143°F for 30 minutes or 161°F for 15 seconds); and requires dairy farms and processing plants to undergo sanitary inspections scoring at least 50 out of 100 points and be available for examination by authorized agents. The rules apply to all milk and cream offered for import into the continental United States.
Administrative Functions, Practices, and Procedures
21 CFR Part 1316 establishes administrative inspection procedures under the Controlled Substances Act and Controlled Substances Import and Export Act. The regulation authorizes DEA inspectors to enter controlled premises to inspect records, verify inventory, collect samples, and examine equipment and materials related to controlled substances and listed chemicals manufacturing, distribution, and storage.
Medical Device Reporting
21 CFR Part 803 establishes medical device reporting requirements for device user facilities, manufacturers, importers, and distributors. Device user facilities must report deaths and serious injuries caused or contributed to by devices, maintain adverse event files, and submit annual summaries. Manufacturers and importers must report similar events and device malfunctions, while distributors must maintain incident records without reporting obligations. These requirements protect public health by ensuring devices remain safe, effective, and not adulterated or misbranded.
DEA Mailing Addresses
This regulation provides the official mailing addresses for the Drug Enforcement Administration (DEA) to be used when submitting correspondence and documents to the agency.
Mandatory Declassification Review
This regulation establishes procedures for mandatory declassification review of classified information held by the Office of National Drug Control Policy (ONDCP). It outlines how requests are submitted to the Security Officer, how ONDCP reviews and determines whether to declassify information under Executive Order 12356, and provides an appeal process to the ONDCP Director for denied requests. Information classified by other agencies is referred to those agencies for review. No fees are charged for these reviews.
General Hospital and Personal Use Devices
21 CFR Part 880 establishes the regulatory classification and premarket approval requirements for general hospital and personal use devices intended for human use in commercial distribution. The regulation defines the scope of device classification, requires manufacturers to demonstrate substantial equivalence, and specifies that Class III devices require FDA premarket approval before commercial distribution, with grace periods for devices marketed before May 28, 1976.
Intramammary Dosage Form New Animal Drugs
21 CFR Part 526 establishes regulations for intramammary dosage form new animal drugs used in lactating and dry dairy cattle. The regulation specifies approved formulations of amoxicillin, ceftiofur, and cephapirin benzathine for treating bovine mastitis, including dosing amounts, indications, milk and meat withdrawal periods, and restrictions on veterinary-only use and extralabel application.
Human Cells, Tissues, and Cellular and Tissue-Based Products
21 CFR Part 1271 establishes FDA requirements for establishments manufacturing human cells, tissues, and cellular and tissue-based products (HCT/Ps). The regulation creates an electronic registration and listing system and mandates compliance with donor-eligibility procedures, current good tissue practice standards, and communicable disease prevention measures. It applies to HCT/P manufacturers regulated under the Public Health Service Act, whether or not products enter interstate commerce, and requires adherence to manufacturing and quality standards.
Notification of Defects or Failure to Comply
21 CFR Part 1003 establishes notification requirements for manufacturers of electronic products regarding defects or non-compliance with Federal standards, particularly those involving unintended or excessive electronic product radiation emissions that pose injury risk. Manufacturers must immediately notify the Secretary and relevant dealers, distributors, and purchasers upon discovery of defects or compliance failures in products manufactured after October 1968.
Ophthalmic Devices
21 CFR Part 886 establishes the FDA regulatory framework for ophthalmic devices intended for human use in commercial distribution. The regulation sets forth device classifications, premarket notification requirements under part 807, and premarket approval (PMA) procedures for class III devices. Manufacturers must demonstrate substantial equivalence to existing devices or obtain FDA approval before commercial distribution, with specific grace periods and effective dates specified for different device categories introduced before or after May 28, 1976.
Definitions
21 CFR Part 1300 establishes definitions for controlled substances under the Controlled Substances Act and related regulations. Key definitions include anabolic steroids (controlled hormonal substances chemically related to testosterone), automated dispensing systems for medication management, and basic chemical classes of controlled substances. The regulation clarifies DEA authority and distinguishes between controlled substances and dietary ingredients or botanical compounds that are exempt from classification.
General
21 CFR Part 700 establishes general provisions and definitions for cosmetic products under the Federal Food, Drug, and Cosmetic Act. Key definitions include cosmetic product, ingredients, flavors, fragrances, proprietary ingredients, and manufacturing/packaging processes. The regulation defines commercial distribution thresholds (>$1,000 annual gross sales), establishes requirements for ingredient chemical descriptions, and outlines procedures for reporting allergic reactions and bodily injuries associated with cosmetic use.
Importation and Production Quotas for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
21 CFR Part 1315 establishes procedures for setting annual importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine. The regulation applies to DEA-registered manufacturers and importers of these bulk chemicals and drug products, defines quota types including assessment of annual needs, individual manufacturing quotas, procurement quotas, and import quotas, and exempts personal imports not exceeding 7.5 grams per substance in any 30-day period.
Current Good Manufacturing Practice for Blood and Blood Components
21 CFR Part 606 establishes current good manufacturing practice (cGMP) standards for blood and blood components collection, processing, compatibility testing, storage and distribution. The regulation defines key terms including blood, blood components, plasmapheresis, plateletpheresis, and leukapheresis procedures. It requires facilities and personnel to maintain adequate safety, purity, potency and effectiveness, with personnel having appropriate education, training and experience. Facilities must be clean, orderly, suitably constructed and properly maintained to ensure compliance with cGMP requirements.
Exemption Requests and Substantial Equivalence Reports
21 CFR Part 1107 establishes the FDA's process for granting exemptions from substantial equivalence reporting requirements for minor modifications to legally marketed tobacco products involving changes to tobacco additives. Manufacturers must submit detailed requests to the Center for Tobacco Products demonstrating that the modification is minor, does not require a substantial equivalence report to protect public health, and does not increase appeal to minors, toxicity, addictiveness, or abuse liability.
Cosmetic Labeling
21 CFR Part 701 establishes labeling requirements for cosmetic products, including prohibitions on misbranding, specifications for ingredient declaration in descending order of predominance, and standards for label prominence and conspicuousness. Requirements address language, visibility, and accurate ingredient representation to prevent consumer deception.
General
21 CFR Part 1100 establishes FDA authority over tobacco products, defining the scope of regulations under the Federal Food, Drug, and Cosmetic Act. It covers cigarettes, smokeless tobacco, roll-your-own tobacco, and nicotine-containing products, while clarifying definitions of accessories, components, and packaging. Products intended for drug purposes (smoking cessation, disease treatment) are excluded from tobacco regulation.
Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
21 CFR Part 1301 establishes registration procedures for manufacturers, distributors, dispensers, importers, and exporters of controlled substances under the Controlled Substances Act. Every person engaged in these activities must obtain DEA registration unless exempt. Online pharmacies must obtain a modified registration to dispense controlled substances via the Internet. Separate registrations are required for each principal place of business where such activities occur.
Records and Reports
21 CFR Part 1002 establishes record-keeping and reporting requirements for manufacturers, dealers, and distributors of electronic products, particularly radiation-emitting devices. Manufacturers must submit performance data, technical safety information, and test data to the FDA's Center for Devices and Radiological Health. Exemptions apply to products solely for export, components sold to other manufacturers, U.S. Government products with national security restrictions, and certain diagnostic x-ray equipment assemblers. Trade secret information is kept confidential.
General and Plastic Surgery Devices
21 CFR Part 878 establishes the FDA classification framework for general and plastic surgery devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, particularly for Class III devices, which must obtain FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercial distribution unless exempt or reclassified. Manufacturers must demonstrate substantial equivalence and comply with applicable regulatory submission procedures.
Voluntary Registration of Cosmetic Product Establishments
21 CFR Part 710 establishes a voluntary registration program for cosmetic product establishments in the US. Manufacturers and packagers of cosmetic products must register with the FDA within 30 days of beginning operations using Form FD-2511, providing establishment name, address, business trading names, and business type. Registration is not required for beauty shops, retailers, physicians, hospitals, research facilities, or other exempt entities. No registration fee applies, and registration does not indicate FDA approval.
Investigational Device Exemptions
21 CFR Part 812 establishes procedures for Investigational Device Exemptions (IDEs), permitting unapproved medical devices to be shipped and investigated in clinical trials while exempting them from certain FDA requirements including premarket approval, performance standards, and misbranding rules. The regulation defines IDE applicability, abbreviated requirements for non-significant-risk devices, and exemptions for certain device categories.
Additional Standards for Diagnostic Substances for Laboratory Tests
21 CFR Part 660 establishes additional standards for diagnostic substances used in laboratory tests, specifically covering antibody to hepatitis B surface antigen. The regulation defines proper sourcing from immunized animal plasma/blood or hepatitis B surface antigen-positive human donors, specifies processing methods to ensure specificity and potency, and mandates labeling requirements including source indication, test method recommendations, and hepatitis transmission warnings. Ancillary reagents must meet purity standards and be manufactured to prevent contamination.
Food Additives Permitted in Feed and Drinking Water of Animals
21 CFR Part 573 establishes permitted food additives for animal feed and drinking water. Regulations cover acrylamide-acrylic acid resin as a thickener/suspending agent in aqueous feed suspensions, aminoglycoside 3'-phosphotransferase II enzyme for genetic modification of crops, ammoniated cottonseed meal as a protein source in ruminant feed (max 20% of ration), and ammoniated rice hulls as fiber and nonprotein nitrogen source in beef cattle feed (max 20% of ration). Each additive includes specifications, approved uses, and labeling requirements for safe application.
Performance Standards for Electronic Products: General
Performance standards for electronic products under 21 CFR Part 1010 establish certification and labeling requirements to control electronic product radiation. Manufacturers must certify conformance to applicable standards via permanently affixed labels or tags, with certification based on individual product testing or qualified manufacturing programs. The regulation covers general provisions for radiation control and includes specific provisions for laser products incorporating certified laser systems.
Oral Dosage Form New Animal Drugs
21 CFR Part 520 establishes specifications and conditions of use for oral dosage form new animal drugs, including acepromazine (tranquilizer for dogs and cats), acetazolamide (for heart failure and intraocular pressure in dogs), afoxolaner/moxidectin/pyrantel combination (for heartworm prevention and parasite control in dogs), and albendazole suspension (for livestock). All drugs require veterinary oversight and specify dosage amounts, indications for use, and applicable limitations.
General Biological Products Standards
21 CFR Part 610 establishes general standards for licensed biological products in the US, requiring manufacturers to complete conformity tests on each product lot before release and permitting FDA oversight of lot samples and protocols. The regulation specifies testing requirements for potency, sterility, and safety, allows equivalent methods with FDA approval, and governs release procedures through the Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research.
Medical Devices; Reports of Corrections and Removals
21 CFR Part 806 establishes requirements for medical device manufacturers and importers to report corrections and removals to the FDA. Device manufacturers must promptly report actions that reduce health risks or remedy violations of the Federal Food, Drug, and Cosmetic Act, while maintaining records of all corrections and removals. Exempt actions include performance improvements that do not reduce health risk, market withdrawals, routine servicing, and stock recovery.
Medical Device Classification Procedures
21 CFR Part 860 establishes the procedures and criteria for classifying and reclassifying medical devices intended for human use into one of three regulatory control classes (I, II, or III) based on safety and effectiveness. The regulation defines classification criteria, describes the roles of advisory committees and the FDA Commissioner, and prescribes the data required to support device classification determinations. It also governs public participation and information disclosure in classification proceedings.
Gastroenterology-Urology Devices
21 CFR Part 876 establishes the classification and regulatory framework for gastroenterology-urology devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, including that Class III devices require FDA approval via premarket approval application (PMA) or product development protocol (PDP) before commercial distribution, with specified grace periods for devices marketed before May 28, 1976, and mandatory approval for new devices introduced after that date.
Regulations Under the Federal Caustic Poison Act
21 CFR Part 1230 establishes labeling and packaging requirements for caustic and corrosive substances shipped in interstate or foreign commerce. Containers must bear clear labels with the common name of the dangerous substance, prominent "Poison" warnings in 24-point Gothic capitals, and directions for medical treatment in case of internal or external injury. Labeling must be firmly affixed and readily visible. Manufacturers, wholesalers, and distributors are responsible for compliance, with limited exemptions for non-household containers at shipment.
Repurchase, Repairs, or Replacement of Electronic Products
CFR Part 1004 establishes manufacturer obligations for electronic products that fail to comply with federal standards or have defects. Manufacturers must repair and bring products into conformity, replace them with equivalent compliant products, or refund the purchase price at no cost to consumers, including reimbursement for transportation. Manufacturers must submit detailed plans to the Secretary for approval before executing repairs or replacements.
Public Availability of Information
21 CFR Part 1401 establishes procedures for the Office of National Drug Control Policy (ONDCP) to implement the Freedom of Information Act (FOIA). It defines ONDCP's mission to coordinate federal anti-drug efforts and outlines rules for public information requests, fee categories, and dispute resolution mechanisms.
Cigarettes, Smokeless Tobacco, and Covered Tobacco Products
21 CFR Part 1140 establishes federal restrictions on the sale, distribution, and use of cigarettes, smokeless tobacco, and covered tobacco products under the Federal Food, Drug, and Cosmetic Act. The regulation defines key terms including cigarettes, smokeless tobacco, covered tobacco products, accessories, components, manufacturers, distributors, and importers. The primary purpose is to reduce youth access and use of tobacco products and mitigate health consequences from tobacco consumption.
Requirements for Electronic Orders and Prescriptions
21 CFR Part 1311 establishes requirements for electronic orders and prescriptions of controlled substances, particularly Schedule I and II drugs. It mandates that electronic transmission systems meet authentication, nonrepudiation, and message integrity standards, with digital signatures using Public Key Infrastructure (PKI) technology identified as compliant. The regulation incorporates by reference cryptographic security standards from NIST, including FIPS publications 140-2, 180-2, and 180-3.
Minimum Required Warning Statements
21 CFR Part 1143 establishes definitions and minimum required warning statements for tobacco products subject to federal regulation. It defines key terms including cigars, cigarettes, roll-your-own tobacco, accessories, and components, and specifies packaging and point-of-sale requirements. The regulation mandates warning statements on packaging and advertisements for cigarette tobacco, roll-your-own tobacco, cigars, and other covered tobacco products, including warnings regarding nicotine addictiveness.
Biological Products: General
21 CFR Part 600 establishes FDA submission procedures and mailing addresses for licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). The regulation specifies separate submission channels for biologics license applications, deviation reports, samples, and promotional materials, with distinct addresses for each center and submission type, including special handling for radioactive biological products.
Performance Standard for Electrode Lead Wires and Patient Cables
This regulation establishes a performance standard for electrode lead wires and patient cables used with medical devices, requiring connectors with conductive patient connections to comply with IEC 601-1 subclause 56.3(c). Manufacturers must demonstrate compliance through inspection and testing by May 1998 for specified devices and May 2000 for others, with provisions for exemptions or variances upon petition.
Interstate Conveyance Sanitation
21 CFR Part 1250 establishes sanitation standards for interstate conveyances (land, air, and water carriers) to prevent transmission of communicable diseases. It defines key terms including contamination, potable water, food service utensils, and shellfish, and references CDC quarantine requirements. The regulation covers bactericidal treatment, waste management, and sanitation practices for vessels and conveyances engaged in interstate traffic.
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
21 CFR Part 807 establishes registration and device listing requirements for manufacturers and initial importers of medical devices. The regulation defines key terms including commercial distribution, establishment, manufacture, official correspondent, and initial importer. It outlines exemptions from commercial distribution requirements, including internal transfers within affiliated companies, investigational use devices, and certain pre-1976 Class III devices. Device manufacturers and importers must register establishments annually and maintain current officer/director information with the FDA.