عرض 601–648 من أصل 648 لائحة
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.
Premarket Approval of Medical Devices
21 CFR Part 814 establishes the premarket approval (PMA) process for Class III medical devices intended for human use. The regulation defines procedures for FDA review to ensure devices are safe and effective before market introduction, applies to devices not on the market before May 1976 or those required by regulation to obtain PMA approval, and sets conditions for approval and supplemental applications.
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 800 establishes sterility and tamper-resistant packaging requirements for contact lens solutions and ophthalmic medical devices. All contact lens solutions, eye cups, and similar ophthalmic preparations must be sterile at the time of filling and closing, with appropriate labeling and warnings. Multiple-dose containers must contain preservatives or be labeled with duration limits. Products failing to meet these standards are considered adulterated or misbranded.
Clinical Chemistry and Clinical Toxicology Devices
21 CFR Part 862 establishes the FDA classification framework for clinical chemistry and clinical toxicology devices intended for human use. It defines the scope of device regulation, specifies that calibrators used with these devices are classified as Class II regardless of the device's classification due to their critical role in measurement accuracy, and outlines the premarket approval requirements and effective dates for devices classified as Class III.
Voluntary Filing of Cosmetic Product Ingredient Composition Statements
21 CFR Part 720 establishes a voluntary program for manufacturers, packers, and distributors of cosmetic products to file ingredient composition statements with the FDA on Form FDA 2512. Filings must occur within 180 days of the rule's effective date for existing products, or within 60 days of commercial distribution for new products. The filing requires disclosure of product name, manufacturer details, brand name, cosmetic category, and complete ingredient listings, with information made available to poison control centers and licensed physicians for safety and medical purposes.
Substances Generally Recognized as Safe
21 CFR Part 582 establishes the regulatory framework for substances generally recognized as safe (GRAS) for use in food and animal feed. The regulation defines GRAS status, outlines good manufacturing and feeding practices including restrictions on quantities, and authorizes the FDA Commissioner to maintain lists of approved substances such as spices, essential oils, natural seasonings, and flavorings. Substances must be of appropriate grade and prepared as food ingredients, with quantities limited to what is reasonably necessary to accomplish their intended effect.
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.
Labeling and Packaging Requirements for Controlled Substances
21 CFR Part 1302 establishes labeling and packaging requirements for controlled substances distributed in the United States. Manufacturers must print schedule symbols on commercial containers and labeling in a prominent, easily identifiable manner. Specific exemptions apply to containers too small to accommodate labels, clinical research involving blind studies, and exported substances. All containers must be sealed to detect tampering. These requirements apply to imported controlled substances but not to those intended for export.
Implantation or Injectable Dosage Form New Animal Drugs
21 CFR Part 522 establishes specifications, sponsors, and conditions of use for injectable and implantation dosage form new animal drugs including acepromazine (tranquilizer/preanesthetic), alfaxalone (anesthetic), amikacin (antibiotic), and aminopentamide (anti-emetic/anti-diarrheal). Each drug section specifies dosage amounts for target species, indications for use, and limitations including veterinary-only restrictions and controlled substance designations where applicable.
Exemptions from Federal Preemption of State and Local Medical Device Requirements
21 CFR Part 808 establishes procedures for states and localities to seek exemption from federal preemption of medical device requirements under the Federal Food, Drug, and Cosmetic Act. The FDA Commissioner may grant exemptions for state/local requirements that are either more stringent than federal standards or required by compelling local conditions, provided they do not conflict with federal law. General applicability requirements and those identical to federal standards remain non-preempted.
Importation and Exportation of Controlled Substances
21 CFR Part 1312 establishes procedures for importation, exportation, and transshipment of controlled substances. Importers must obtain DEA authorization through registration and permits (for Schedules I-II and certain Schedule III-V substances) or import declarations (for other Schedule III-V substances). Each shipment requires separate authorization, and applicants must submit detailed information including drug names, dosage forms, NDC numbers, and quantities on DEA Form 357 through the DEA Diversion Control Division secure network.
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.
New Animal Drugs for Use in Animal Feeds
21 CFR Part 558 establishes regulatory framework for new animal drugs approved for use in animal feeds. It defines two drug categories based on withdrawal period requirements, and three medicated feed types (A, B, C) with specific manufacturing standards, nutrient composition requirements, and concentration limits. Type A articles are drug-only components; Type B feeds contain ≥25% nutrients for further feed manufacturing; Type C feeds are complete or supplemental feeds for direct animal consumption.
Records and Reports of Listed Chemicals and Certain Machines; Importation and Exportation of Certain Machines
21 CFR Part 1310 establishes record-keeping and reporting requirements for regulated persons who handle DEA-designated listed chemicals and certain machines (tableting and encapsulating equipment). The regulation specifies two lists of chemicals subject to oversight, allows the DEA Administrator to add or remove substances via Federal Register notice, and requires manufacturers and distributors to maintain transaction records and file reports, particularly for ephedrine, pseudoephedrine, phenylpropanolamine, and gamma hydroxybutyric acid when shipped via postal or commercial carriers.
Procedures for Performance Standards Development
21 CFR Part 861 establishes procedures for FDA development of performance standards for Class II and Class III medical devices. Standards address device performance characteristics, design, manufacturing processes, quality control, testing requirements, labeling, and distribution restrictions to ensure safety and effectiveness. The FDA coordinates with other federal agencies and stakeholder organizations in standard-setting.
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.
Certain Other Dosage Form New Animal Drugs
21 CFR Part 529 establishes conditions of use for certain new animal drugs in dosage forms, including amikacin for treating genital infections in mares, chloramine-T for controlling bacterial disease in farmed fish, chlorhexidine for prevention/treatment of metritis and vaginitis in cattle and horses, ciclesonide for managing equine asthma, and detomidine gel. All drugs are restricted to veterinary use and include specific dosing, indications, and usage limitations.
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.
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.
Immunology and Microbiology Devices
21 CFR Part 866 establishes the regulatory classification framework for immunology and microbiology devices intended for human use in commercial distribution. The regulation defines scope, premarket approval requirements, and effective dates for Class III devices, requiring FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercial distribution, with specified grace periods for devices marketed before May 28, 1976.
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.
Food Additive Petitions
21 CFR Part 571 establishes the procedure for submitting food additive petitions to the FDA under the Federal Food, Drug, and Cosmetic Act. Petitioners must submit applications in triplicate with detailed information on the food additive's chemical identity, composition, manufacturing methods, analytical controls, stability data, and proposed uses. The regulation specifies content requirements including physical/chemical/biological properties, specifications, impurities, and manufacturing details for each entity involved in production.
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.
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.
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.
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.
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 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.
Banned Devices
21 CFR Part 895 establishes procedures for the FDA Commissioner to ban medical devices intended for human use that present substantial deception or unreasonable risk of illness or injury. A device becomes adulterated when banned and cannot be relabeled for veterinary use to circumvent the ban. The Commissioner may initiate banning proceedings based on available data when risks cannot be corrected through labeling changes.
Cosmetic Product Warning Statements
21 CFR Part 740 establishes requirements for warning statements on cosmetic product labels. Manufacturers must display warnings whenever necessary to prevent health hazards, with statements appearing prominently in bold type on contrasting backgrounds (minimum 1/16 inch height). Specific warnings are mandated for products with unsubstantiated safety claims and for self-pressurized containers, including precautions against eye contact, puncture, incineration, and high temperature exposure.
Hematology and Pathology Devices
21 CFR Part 864 establishes the regulatory framework for hematology and pathology devices intended for human use in commercial distribution. It outlines classification requirements, premarket approval timelines for Class III devices, and exemptions from premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act. Manufacturers must demonstrate substantial equivalence to existing devices and comply with applicable FDA guidance.
New Animal Drug Applications
21 CFR Part 514 establishes procedures for submitting New Animal Drug Applications (NADAs) to the FDA. Applications must be filed in triplicate and include detailed identification, chemistry data, scientific rationale, clinical and laboratory study summaries, labeling, and other supporting information as appropriate. Applications must be signed by the applicant or authorized U.S. representative and may reference prior FDA submissions if specifically identified and authorized.
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.
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.
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.
Enhancement and Standardization of Climate-Related Disclosures for Investors
Public-company climate disclosure rule covering governance, strategy, risk management, GHG metrics (Scope 1 and 2 for large filers), and financial statement impacts.
Emission Guidelines for Existing Sources in the Oil and Natural Gas Sector (Subpart OOOOc)
Emission guidelines that states must follow when developing plans to limit methane emissions from existing oil & gas sources.
Standards of Performance for New, Reconstructed, and Modified Sources in the Oil and Natural Gas Sector (Subpart OOOOb)
Final rule tightening methane and VOC standards on new, reconstructed, and modified oil & gas facilities, including super-emitter response programme.
Oil and Gas Production Safety Systems on the OCS
Production safety system requirements for offshore facilities including SCSSV, surface safety valves, and emergency shut-down systems.
Exclusions from definition of hazardous waste (RCRA Subpart A)
Defines materials excluded from RCRA Subtitle C hazardous waste regulation, including domestic sewage, certain spent caustics, and recycled materials.
Waste Prevention, Production Subject to Royalties, and Resource Conservation
Updates rules on flaring, venting, and royalty-bearing methane losses from onshore federal and tribal oil & gas leases.
Process Safety Management of Highly Hazardous Chemicals
Process safety management requirements for facilities handling highly hazardous chemicals above threshold quantities, including PHA, MOC, and mechanical integrity.