Global regulations corpus
Browse 15,090 regulations from 36 regulators
2,998 updated in the last 30 days. Public corpus — no signup required to read.
Showing 151–200 of 263 regulations
Tolerances for Residues of New Animal Drugs in Food
21 CFR Part 556 establishes tolerances for residues of new animal drugs in food. The regulation requires applicants to submit proposed tolerances when seeking approval of new animal drugs for food-producing animals. Tolerances are set based on acceptable daily intake (ADI) and acute reference dose (ARfD) to ensure consumer safety, with residue limits codified for approved and conditionally approved drugs.
Miscellaneous
21 CFR Part 1307 establishes miscellaneous provisions for controlled substance regulation under DEA authority. It clarifies that state and federal law requirements remain in effect, allows practitioners to request regulatory exceptions, permits registered dispensers to distribute controlled substances to other practitioners up to 5% of their annual dispensed volume without separate distributor registration, and exempts incidental controlled substance manufacturing by registered manufacturers from additional registration requirements.
Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
21 CFR Part 630 establishes minimum criteria for blood and blood component donations intended for transfusion or further manufacturing. Blood establishments must determine donor eligibility, assess donation suitability, and notify deferred donors. The regulation defines key terms including blood, blood components, donors, and relevant transfusion-transmitted infections (HIV, HBV, HCV, HTLV, syphilis, West Nile virus, Chagas disease, CJD, vCJD, and malaria). Requirements apply to establishments manufacturing blood and blood components.
Intentional Genomic Alterations in Animals
21 CFR Part 528 establishes regulatory pathways for intentional genomic alterations in animals, including rabbits producing recombinant human Factor VII in milk for hemophilia treatment, genetically modified Atlantic salmon with enhanced growth rates in contained freshwater facilities, pigs with CD163 gene deletion conferring PRRSV resistance, pigs with modified GGTA1 gene for use as food or therapeutic sources, and chickens producing human lysosomal acid lipase for medical treatment. Food and feed restrictions apply to certain lineages.
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.
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.
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.
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.
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.
Quotas
This regulation establishes procedures for DEA quotas on Schedule I and II controlled substances. It defines three quota types—aggregate production, individual manufacturing, and procurement—and five subcategories covering commercial sale, transfers, product development, and replacement of disposed material. Quotas limit the total and per-manufacturer quantities of controlled substance APIs that may be produced or procured annually for pharmaceutical manufacturing.
Records and Reports of Registrants
21 CFR Part 1304 establishes recordkeeping and reporting requirements for registrants under the Controlled Substances Act, including manufacturers, distributors, importers, researchers, and practitioners. Registrants must maintain inventories and file reports as required by the Act; individual practitioners have limited recordkeeping obligations except for maintenance or detoxification treatments. Records may be consolidated into one system covering all controlled substance activities conducted under a single registration.
Prescriptions
21 CFR Part 1306 establishes procedures for prescribing and dispensing controlled substances to patients. It defines who may issue prescriptions (authorized individual practitioners), requires prescriptions be issued for legitimate medical purposes in the usual course of professional practice, and sets forth prescription format requirements including patient/practitioner information and drug details. Special provisions apply to Schedule III-V narcotic drugs used for maintenance or detoxification treatment.
Controls to Satisfy the Requirements of the Act Applicable to the Manufacturing of Marihuana
21 CFR Part 1318 establishes regulatory controls for the registration and manufacturing of marihuana, including cultivation, growth, and harvest procedures. Registered manufacturers must deliver their total cannabis crops to the Administration within four months of harvest, with the Administration taking physical possession and controlling access. Applicants must demonstrate compliance with statutory requirements and public interest considerations under the Controlled Substances Act and international Single Convention obligations.
Medicated Feed Mill License
21 CFR Part 515 establishes the licensing requirements for medicated feed mills manufacturing animal feeds containing new animal drugs. Applicants must submit Form FDA 3448 with facility details, FDA registration number, responsible personnel information, and certifications confirming compliance with good manufacturing practices, applicable drug regulations, and record-keeping requirements. The FDA Center for Veterinary Medicine reviews applications within 90 days, and supplemental applications are required for ownership or address changes.
Unique Device Identification
21 CFR Part 830 establishes requirements for unique device identification (UDI) of medical devices. The regulation defines key terms including UDI, device identifier, production identifier, labeler, and automatic identification and data capture (AIDC) technology. UDIs must adequately identify devices through distribution and use, comprising a fixed device identifier and conditional production identifier elements such as lot/batch number, serial number, expiration date, or manufacturing date. The Global Unique Device Identification Database (GUDID) serves as the repository for device identification information.
New Animal Drugs for Investigational Use
This regulation establishes exemptions from FDA approval requirements for new animal drugs intended solely for investigational use, including in vitro laboratory tests and clinical trials in animals. Distributors must ensure proper labeling, maintain records of shipments for two years, and verify that recipients are conducting legitimate research. Edible products from investigational animals cannot enter the food supply without FDA or USDA authorization.
Postmarket Surveillance
21 CFR Part 822 establishes postmarket surveillance requirements for class II and III medical devices under the Federal Food, Drug, and Cosmetic Act. Manufacturers must implement surveillance plans for devices where failure poses serious health risks, are implanted long-term, support life outside healthcare facilities, or have significant pediatric use. The regulation defines key terms, responsibilities of designated persons and investigators, and procedures for collecting, analyzing, and reporting safety data to protect public health.
New Animal Drugs for Minor Use and Minor Species
This regulation (21 CFR Part 516) establishes procedures for designating and approving new animal drugs for minor uses and minor species, implementing section 573 of the Federal Food, Drug, and Cosmetic Act. It defines key terms including minor use, minor species, major species, MUMS drugs, and requirements for demonstrating functional superiority. The rule governs various dosage forms including oral, injectable, ophthalmic, topical, and feed-based formulations for animals other than humans or major livestock species.
Cardiovascular Devices
21 CFR Part 870 establishes FDA classification and regulatory requirements for cardiovascular devices intended for human use. The regulation outlines premarket approval (PMA) requirements for Class III devices, substantially equivalent device determinations under 510(k) submissions, and effective dates for compliance. Manufacturers must demonstrate substantial equivalence to existing devices or obtain FDA premarket approval before commercial distribution, with grace periods specified for devices classified before May 28, 1976.
Orthopedic Devices
21 CFR Part 888 establishes FDA classification and regulatory requirements for orthopedic devices intended for human use in commercial distribution. Devices classified as Class III require premarket approval (PMA) or completed product development protocol (PDP) before marketing, with specific effective dates and grace periods outlined. Manufacturers must demonstrate substantial equivalence to existing devices via premarket notification submissions.
Medical Device Recall Authority
21 CFR Part 810 establishes FDA procedures for exercising medical device recall authority under the Federal Food, Drug, and Cosmetic Act. It defines key terms including recall, correction, removal, serious adverse health consequences, and unique device identifiers, and outlines requirements for cease distribution orders and mandatory recall strategies applicable to device manufacturers, distributors, and user facilities.
Labeling
FDA regulation 21 CFR Part 801 establishes labeling requirements for medical devices in package form. Manufacturers, packers, and distributors must conspicuously display their name and place of business (including street address, city, state, and ZIP code) on device labels. Labels must clarify the relationship between the labeled entity and the device (e.g., "Manufactured for", "Distributed by"). The regulation defines key terms including implantable devices, finished devices, expiration dates, and automatic identification and data capture (AIDC) technology for unique device identification.
Radiology Devices
21 CFR Part 892 establishes the regulatory framework for radiology devices intended for human use in commercial distribution. The regulation sets out device classification requirements, premarket approval procedures, and exemption limitations. Manufacturers must demonstrate substantial equivalence to existing devices and comply with FDA approval requirements based on device class, with specific grace periods and effective dates governing commercial distribution of new or substantially altered radiology devices.
Anesthesiology Devices
21 CFR Part 868 establishes the FDA classification framework for anesthesiology devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements for Class III devices, defines substantial equivalence standards for premarket notification submissions, and specifies effective dates for FDA approval orders. Manufacturers must demonstrate substantial equivalence to existing devices or obtain premarket approval (PMA) or product development protocol (PDP) clearance before commercial distribution.
Medical Device Tracking Requirements
21 CFR Part 821 establishes mandatory tracking requirements for class II and III medical devices that meet FDA criteria, including those likely to cause serious adverse health consequences, implanted for over one year, or used as life-sustaining/supporting devices outside facilities. Manufacturers must trace devices from production through distributors to patients; failure to comply constitutes misbranding and a prohibited act. Manufacturers bear primary responsibility and must notify FDA if discontinuing business, with tracking records transferred or responsibility reassigned in writing.
Extralabel Drug Use in Animals
21 CFR Part 530 establishes conditions for extralabel use of FDA-approved drugs in animals by licensed veterinarians. Extralabel use—employing approved drugs in species, indications, dosages, or routes not on the label—is permitted only when animal health is threatened and within a valid veterinary-client-patient relationship. The rule prohibits advertising extralabel uses and requires veterinary records for FDA oversight and public health protection.
Food Additives
21 CFR Part 570 establishes regulatory definitions and provisions governing food additives under the Federal Food, Drug, and Cosmetic Act. It defines food additives as substances not exempted that become food components or affect food characteristics, including packaging materials with migration potential. The regulation outlines safety standards, requiring reasonable certainty of harmlessness based on scientific procedures, and addresses general recognition of safety, cumulative dietary effects, and prior sanctions.
Schedules of Controlled Substances
21 CFR Part 1308 establishes the schedules of controlled substances under the Controlled Substances Act, assigning DEA code numbers to opiates, opium derivatives, hallucinogenic substances, depressants, and other controlled drugs for identification and registration purposes. Applicants for procurement quotas, import/export permits, and registrants handling controlled substances must reference the appropriate code numbers on applications and declarations.
Required Warnings for Cigarette Packages and Advertisements
This regulation establishes requirements for warning labels on cigarette packages and advertisements sold in the United States. It defines key terms including cigarette, manufacturer, distributor, and retailer, and clarifies that retailers are not liable for compliant packaging supplied by licensed manufacturers, though they remain responsible for advertisements they display or alter.
Performance Standards for Microwave and Radio Frequency Emitting Products
This regulation establishes performance standards for microwave ovens manufactured after October 6, 1971, setting limits on microwave radiation emission and requiring safety interlocks. Microwave ovens must not exceed 1 milliwatt per square centimeter power density at 5+ centimeters from the external surface before purchase, and 5 milliwatts per square centimeter thereafter. Devices must have at least two operative safety interlocks designed to prevent microwave generation when cavity access is possible, with at least one interlock resistant to human body contact and magnetic manipulation.
User Fees
21 CFR Part 1150 establishes user fee requirements for tobacco product manufacturers and importers under the Federal Food, Drug, and Cosmetic Act. Domestic manufacturers and importers must pay their proportional share of annual FDA user fees based on product removals. Monthly reporting to FDA is required by the 20th of each month, including identification information, units of product removed by class (cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, roll-your-own tobacco), and Federal excise taxes paid.
Importation and Exportation of List I and List II Chemicals
21 CFR Part 1313 establishes procedures for importing, exporting, transshipping and in-transit shipment of List I and List II chemicals under the Chemical Diversion and Trafficking Act. Importers and exporters must notify the DEA at least 15 days before importing chemicals meeting threshold quantities, file declarations on DEA Form 486/486A, establish documented business relationships with customers, and maintain required records including supplier information and transaction frequency.
Retail Sale of Scheduled Listed Chemical Products
This regulation establishes requirements for retail sales of scheduled listed chemical products (ephedrine, pseudoephedrine, phenylpropanolamine) for personal use. It sets daily purchase limits (3.6 grams per substance per day), packaging requirements for nonliquid forms (blister packs or unit dose packets), and mandates loss reporting to the DEA within 15 days. Requirements apply to face-to-face retail sales and mail-order sales through regulated sellers and distributors.
Importation of Electronic Products
CFR Part 1005 establishes importation requirements for electronic products subject to federal radiation control standards. Imported electronic products must bear compliance certification labels or tags; non-complying products are refused entry unless brought into compliance through a petition process. The regulation provides procedures for sample testing, inspection, notification, and hearing rights for importers.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Performance Standards for Ionizing Radiation Emitting Products
21 CFR Part 1020 establishes performance standards for ionizing radiation emitted by television receivers with cathode ray tubes manufactured after January 15, 1970. The regulation limits radiation exposure rates to 0.5 milliroentgens per hour at 5 centimeters from the external surface, with measurement requirements and testing conditions specified for user controls, service controls, and component failure scenarios. Manufacturers must affix warning labels on receivers exceeding exposure limits.
In Vitro Diagnostic Products for Human Use
21 CFR Part 809 establishes regulatory requirements for in vitro diagnostic (IVD) products intended for human use, including reagents, instruments, and systems used to diagnose disease or determine health status. The regulation defines IVD products as medical devices under the Federal Food, Drug, and Cosmetic Act, specifies labeling requirements including proprietary name, intended use, ingredient declarations, warnings, and storage instructions, and addresses confidentiality of submitted data. Requirements vary by product class and may include prescription restrictions and hazard-specific precautions.
Neurological Devices
21 CFR Part 882 establishes the FDA regulatory framework for neurological devices intended for human use in commercial distribution. The regulation sets forth device classification requirements and premarket approval procedures, specifying that class III neurological devices require FDA premarket approval (PMA) or completed product development protocol (PDP) before commercial distribution, with grace periods for devices marketed before May 28, 1976, but not for new devices introduced after that date.
Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food
21 CFR Part 579 establishes safety standards for using ionizing radiation in animal feed and pet food production. Facilities may use gamma rays (cobalt-60, cesium-137) or electrons (up to 10 MeV) to treat complete animal diets and ingredients. For poultry feed, additional X-ray sources are permitted. Minimum effective dose for salmonella control is 2.0 kGy; maximum is 25 kGy. Facilities must comply with Part 507 and incorporate applicable Part 179 food irradiation regulations.
Ear, Nose, and Throat Devices
21 CFR Part 874 establishes FDA classification and regulatory requirements for ear, nose, and throat (ENT) medical devices intended for human use in commercial distribution. The regulation outlines premarket approval procedures, including requirements for Class III devices to obtain FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercialization, with specified grace periods for devices marketed before May 28, 1976, and mandatory immediate approval for new or substantially altered devices.
Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of Animals
This regulation affirms certain food substances as generally recognized as safe (GRAS) for use in animal feed and drinking water. Specific substances listed include ethyl alcohol with ethyl acetate as an energy source in ruminant supplements, hydrophobic silicas as anticaking agents in vitamin preparations (limited to 5%), and 25-hydroxyvitamin D3 as a vitamin D3 source in broiler chicken feed and water (not exceeding 69 ppb in feed or 34.5 ppb in water), each with defined purity and usage specifications.
Substances Prohibited from Use in Animal Food or Feed
21 CFR Part 589 establishes prohibitions on substances in animal food and feed that present potential health risks or lack adequate safety data. The regulation prohibits gentian violet in all animal feed and propylene glycol in cat food, and restricts mammalian proteins in ruminant feed to prevent disease transmission. Violations render animal feed adulterated under the Federal Food, Drug, and Cosmetic Act.