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Showing 201–250 of 256 regulations
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Disposal
21 CFR Part 1317 establishes procedures for safe disposal of controlled substances by registered practitioners and other registrants. Authorized methods include on-site destruction, delivery to reverse distributors, return to manufacturers, or DEA assistance. Records and periodic reports to the DEA are required for regular disposals, with conditions set by the Special Agent in Charge to prevent diversion.
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.
Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals
This regulation establishes registration requirements for manufacturers, distributors, importers, and exporters of List I chemicals under DEA jurisdiction. Registration is mandatory for entities handling ephedrine, pseudoephedrine, phenylpropanolamine, and other designated List I chemicals. Annual fees apply: $3,699 for manufacturers and $1,850 for distributors, importers, and exporters. Registration must be submitted online via the DEA's secure portal with payment by ACH transfer or credit card. Separate registrations are required for independent activities (manufacturing, distributing, importing, exporting).
Orders for Schedule I and II Controlled Substances
This regulation establishes procedures for ordering Schedule I and II controlled substances under the Controlled Substances Act. It specifies who may obtain DEA Form 222 or issue electronic orders (registered persons only), exemptions from ordering requirements, and authorization procedures including power of attorney provisions for agents to execute orders on behalf of registrants.
Shredding waste upholstered domestic seating containing POPs: RPS 264
UK Environment Agency regulatory position on shredding waste upholstered domestic seating (WUDS) containing persistent organic pollutants (POPs). Addresses environmental controls and compliance requirements for waste management facilities handling upholstered furniture with POPs contamination.
Assessing and scoring environmental permit and licence compliance
UK guidance on how the Environment Agency assesses and scores compliance with environmental permits, abstraction licences and impounding licences, establishing the criteria and methodology for evaluating permit holder adherence to regulatory requirements.
Renewables obligation: certificates and generation - February 2026
Monthly statistical announcement on certificates issued for renewable energy generation under the UK's Renewables Obligation scheme, tracking renewable generation compliance metrics.
Road fuel prices: 8 June 2026
UK government statistical announcement of weekly prices for unleaded petrol and diesel fuel, providing regular market pricing data for road fuels.
The Environment Agency (NPS/WR/045812): application made to abstract water
The Environment Agency has applied to the Secretary of State for Environment, Food and Rural Affairs for a licence to abstract (remove) water from a source.
Applying for quota to produce or import F gas
UK guidance on applying for fluorinated gas (F gas) production and import quota in Great Britain, covering application procedures and timing requirements for regulatory compliance.
South West Water pleads guilty to six years of pollutions
South West Water pleads guilty to 18 charges of water pollution affecting Devon and Cornwall over a six-year period. Sentencing is scheduled for 30 July 2026. The case addresses environmental compliance failures in water supply operations.
Get voluntary remediation advice for contaminated land and groundwater
UK guidance enabling voluntary remediation advice for contaminated land and groundwater sites. The service provides detailed site-specific regulatory guidance where land contamination has affected controlled waters, supporting compliance and environmental protection.
UKAEA Group Policy Manual
The UKAEA Group Policy Manual consolidates all UK Atomic Energy Authority policies that establish the governance framework supporting the organisation's nuclear energy mission and operations.