United States
13 régulateurs · 1,865 réglementations · 492 mises à jour dans les 30 derniers jours
Affichage de 451–500 sur 648 réglementations
Antiflatulent Products for Over-the-Counter Human Use
This regulation establishes standards for over-the-counter antiflatulent products, designating simethicone as the active ingredient with a maximum daily dose of 500 mg. It specifies labeling requirements including product identification, indications for use (gas relief, bloating, pressure, fullness), and exemptions from certain overdose warnings. Antiflatulents may be combined with antacid ingredients for concurrent symptoms of gas with heartburn or acid indigestion.
Anorectal Drug Products for Over-the-Counter Human Use
This FDA regulation (21 CFR Part 346) establishes standards for over-the-counter anorectal drug products for external or rectal use. It defines permitted active ingredients including local anesthetics (benzocaine, lidocaine, tetracaine), vasoconstrictors (ephedrine, epinephrine, phenylephrine), and protectants (petrolatum, mineral oil, lanolin, cocoa butter), with specified concentration ranges for safety and efficacy in treating symptoms of anorectal disorders.
Topical Antimicrobial Drug Products for Over-the-Counter Human Use
This regulation establishes standards for over-the-counter topical antimicrobial first aid antibiotic drug products, specifying approved active ingredients (bacitracin, neomycin sulfate, chlortetracycline hydrochloride, tetracycline hydrochloride, polymyxin B sulfate) and their permitted concentrations in ointment, cream, aerosol, and powder forms, as well as allowed combinations of these ingredients for treating minor cuts, scrapes, and burns.
Stimulant Drug Products for Over-the-Counter Human Use
FDA regulation establishing standards for over-the-counter stimulant drug products containing caffeine for oral use. Sets caffeine as the active ingredient, limits dosage to 100-200 mg every 3-4 hours for adults and children 12+, requires warnings about caffeine limits and sleep substitution, and specifies labeling as an alertness aid or stimulant.
Bioavailability and Bioequivalence Requirements
21 CFR Part 320 establishes FDA requirements for demonstrating bioavailability and bioequivalence of drug products in new drug applications, abbreviated new drug applications, and supplemental applications. Applicants must submit evidence of in vivo bioavailability for full NDAs or demonstrate bioequivalence to a reference listed drug for abbreviated NDAs, with FDA authority to waive certain requirements or require additional study reports when concerns arise.
Antiemetic Drug Products for Over-the-Counter Human Use
21 CFR Part 336 establishes standards for over-the-counter antiemetic drug products in oral form. Approved active ingredients are cyclizine hydrochloride, dimenhydrinate, diphenhydramine hydrochloride, and meclizine hydrochloride, each with specific dosage limits and age restrictions. Products must be labeled as antiemetics for motion sickness prevention and treatment, with warnings regarding breathing problems, glaucoma, urinary difficulties, age restrictions, and drowsiness risks.
General
21 CFR Part 500 establishes administrative rulings on food and animal drug manufacturing. It requires thermally processed low-acid foods in hermetically sealed containers to comply with processing and emergency permit regulations. Anthelmintic drugs for animals must include labeling directing users to consult veterinarians for parasitism diagnosis and treatment. Timed-release animal drugs are classified as new animal drugs requiring FDA approval or index listing to ensure safe and effective ingredient release rates.
External Analgesic Drug Products for Over-the-Counter Human Use
This FDA regulation establishes safety, efficacy, and labeling standards for over-the-counter external analgesic drug products for topical use, specifically male genital desensitizers containing benzocaine (3-7.5%) or lidocaine (metered spray ~10mg). Products must include required labeling for indications, warnings about potential rashes or irritation, and specific application directions, with mandatory disclosure that premature ejaculation may require medical supervision.
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use
21 CFR Part 343 establishes standards for over-the-counter analgesic, antipyretic, and antirheumatic drug products for oral use in humans. The regulation identifies aspirin and buffered aspirin as permitted active ingredients for cardiovascular and rheumatologic use, specifies requirements for product combinations with antacids, mandates dissolution testing standards, and prescribes detailed professional labeling requirements including comprehensive prescribing information with standardized section headings and content.
Skin Protectant Drug Products for Over-the-Counter Human Use
21 CFR Part 347 establishes standards for over-the-counter skin protectant drug products, including lip balms and products for poison ivy/oak/sumac dermatitis. The regulation defines permitted active ingredients (such as allantoin, calamine, cocoa butter, dimethicone, glycerin, lanolin, mineral oil, petrolatum, zinc oxide) with specified concentration ranges, and astringent active ingredients (aluminum acetate, aluminum sulfate, witch hazel). Manufacturers must comply with labeling and combination requirements to be deemed safe and effective.
Current Good Manufacturing Practice for Type a Medicated Articles
21 CFR Part 226 establishes current good manufacturing practice (CGMP) requirements for Type A medicated articles used in animal feeds. The regulation mandates that manufacturers maintain adequate personnel qualifications, facility construction and maintenance standards, and equipment controls to ensure products meet safety, identity, strength, quality, and purity specifications. Requirements include proper building design with adequate space for segregated operations, appropriate environmental controls, and facility maintenance protocols to prevent contamination and cross-mixing of products.
Interpretative Statements Re Warnings on Drugs and Devices for Over-the-Counter Sale
21 CFR Part 369 provides interpretative guidance on warning and caution statements for over-the-counter drugs and devices subject to the Federal Food, Drug, and Cosmetic Act. It establishes definitions, clarifies labeling requirements, and suggests warning language to help manufacturers ensure adequate user protection. The regulation emphasizes manufacturer responsibility for compliance and notes that suggested warnings are illustrative, not exhaustive.
Qualifying Pathogens
21 CFR Part 317 defines 'qualifying pathogens' under the Federal Food, Drug, and Cosmetic Act—microorganisms posing serious public health threats for which expedited drug development pathways apply. The regulation lists 21 qualifying pathogens including Mycobacterium tuberculosis, Staphylococcus aureus, and Streptococcus pneumoniae.
Certification and Postmarketing Reporting for Designated Medical Gases
21 CFR Part 230 establishes FDA procedures for certification and postmarketing surveillance of designated medical gases. It requires applicants to submit certifications under the Federal Food, Drug, and Cosmetic Act and defines requirements for adverse event reporting, including serious adverse events. The regulation sets minimum data standards for individual case safety reports and establishes postmarketing safety monitoring systems.
Current Good Manufacturing Practice for Positron Emission Tomography Drugs
Current Good Manufacturing Practice (CGMP) regulations for positron emission tomography (PET) drugs under 21 CFR Part 212. Establishes definitions and requirements for manufacturing PET drugs, including specifications for active pharmaceutical ingredients, batch production and control records, master production procedures, quality acceptance criteria, and final release authorizations by responsible persons in PET production facilities.
Antidiarrheal Drug Products for Over-the-Counter Human Use
This regulation establishes standards for over-the-counter antidiarrheal drug products for oral use. It defines antidiarrheal drugs as those treating diarrhea symptoms and identifies bismuth subsalicylate and kaolin as approved active ingredients. The regulation mandates specific labeling requirements including use statements, warnings about contraindications (bloody/black stool, fever, mucus in stool, ulcers, bleeding disorders), and special warnings for bismuth subsalicylate products including Reye's syndrome caution and salicylate allergy alerts.
New Drugs
21 CFR Part 310 establishes regulatory definitions and interpretations for new drugs under the Federal Food, Drug, and Cosmetic Act. It defines key terms including new drug substances, sponsors, related drugs, special packaging requirements, and radioactive drugs. Newness may arise from new substances, new combinations, new proportions, new uses, or new dosages/administration methods.
Diagnostic Radiopharmaceuticals
This regulation establishes FDA standards for diagnostic radiopharmaceuticals used in vivo for diagnostic and monitoring purposes. It defines diagnostic radiopharmaceuticals, outlines safety and effectiveness evaluation criteria including pharmacological/toxicological activity and absorbed radiation dose, categorizes proposed indications (structure delineation, functional assessment, disease detection, patient management), and specifies methods for demonstrating effectiveness through clinical evaluation against reliable diagnostic standards.
Orphan Drugs
21 CFR Part 316 establishes FDA procedures for orphan drug development and approval. It covers designation requests, investigational drug recommendations, exclusive marketing rights (7-year period), and treatment protocols for rare diseases. The regulation defines key terms including active moiety, clinical superiority, and marketing applications for drugs and biological products intended to treat rare conditions.
Miscellaneous External Drug Products for Over-the-Counter Human Use
FDA regulation 21 CFR Part 358 establishes requirements for over-the-counter wart remover drug products. Approved active ingredients are salicylic acid at specified concentrations in plaster or collodion-like vehicles. The regulation mandates labeling requirements including indications for common and plantar warts, warnings against use on irritated skin, diabetics, and certain wart types, and storage/application directions. Products must comply with general OTC drug standards and misbranding prohibitions.
Ophthalmic Drug Products for Over-the-Counter Human Use
This regulation (21 CFR Part 349) establishes standards for over-the-counter ophthalmic drug products for topical use on eyes and eyelids. It defines product categories including astringents, demulcents, emollients, and irrigating solutions, specifying approved active ingredients with their required concentrations. Products meeting these criteria are recognized as safe and effective and not misbranded.
General
This regulation establishes FDA policies for fixed-combination prescription drugs, prohibits chlorofluorocarbon propellants in human drugs, and requires annual reporting by manufacturers and sponsors of eligible investigational drugs supplied to eligible patients under the Right to Try Act.
Antacid Products for Over-the-Counter (OTC) Human Use
21 CFR Part 331 establishes standards for over-the-counter antacid products suitable for oral administration. It specifies permitted active ingredients (aluminum, magnesium, calcium, bismuth, bicarbonate, citrate, phosphate, and potassium compounds), minimum acid-neutralizing capacity requirements (5 meq), dosage limits by age group where applicable, and ingredient contribution thresholds (minimum 25% of total capacity). Products must comply with general OTC drug conditions under 21 CFR 330.1.
Miscellaneous Internal Drug Products for Over-the-Counter Human Use
21 CFR Part 357 establishes regulatory standards for over-the-counter anthelmintic drug products for oral administration. The regulation specifies that pyrantel pamoate is the approved active ingredient for treating pinworm infections. It defines labeling requirements including product identity, indications, warnings about potential side effects and contraindications (pregnancy, liver disease), dosage instructions based on body weight, and mandatory consumer package insert information covering pinworm identification, symptoms, life cycle, and transmission prevention.
Controlled Drugs
21 CFR Part 290 establishes requirements for dispensing controlled substances scheduled II–V under the Federal Controlled Substances Act. Drugs in these schedules require prescription-only dispensing unless exempted (e.g., codeine preparations ≤200 mg per 100 mL/g with non-narcotic active ingredients). Labels must carry a federal warning prohibiting unauthorized transfer. Emergency oral prescriptions of Schedule II drugs are permitted when immediate administration is medically necessary and written prescription is impractical.
New Animal Drugs
21 CFR Part 510 establishes regulatory definitions and general provisions for new animal drugs under the Federal Food, Drug, and Cosmetic Act. A new animal drug is defined as any drug intended for animals other than humans that is not generally recognized as safe and effective by qualified experts, or has been investigated for safety and effectiveness but not materially used. Newness can arise from new active substances, new combinations, new proportions, new animal species, new therapeutic uses, or new dosages and administration methods.
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR Part 210 establishes minimum current good manufacturing practice (cGMP) standards for the manufacture, processing, packing, and holding of drugs to ensure safety, identity, strength, quality, and purity. Non-compliance renders drugs adulterated and subjects responsible persons to regulatory action. Requirements apply to drug manufacturers, human cell/tissue product handlers, and biological product producers, with exemptions for certain phase 1 investigational drugs.
Unavoidable Contaminants in Animal Food and Food-Packaging Material
21 CFR Part 509 establishes the regulatory framework for managing unavoidable contaminants in animal food and food-packaging materials. It defines naturally occurring versus added poisonous or deleterious substances, and authorizes the FDA to establish tolerances, regulatory limits, and action levels for contaminants. The regulation specifies procedures for setting contamination thresholds at which food is deemed adulterated and requires public notice and comment for action level changes.
Materials Allocation and Priority Performance Under Contracts or Orders to Maximize Domestic Energy Supplies
10 CFR Part 216 establishes procedures for the Department of Energy to allocate materials, equipment, services, and facilities or grant priority performance under contracts to maximize domestic energy supplies under the Defense Production Act. DOE determines whether programs maximize domestic energy supplies and whether supplies are critical and essential for exploration, production, refining, transportation, conservation, or facility construction/maintenance, then communicates findings to the Department of Commerce for final determination on scarcity and necessity before granting Defense Priorities and Allocations System (DPAS) priority ratings.
Energy Code for New Federal Commercial and Multi-Family High Rise Residential Buildings
10 CFR Part 434 establishes minimum energy efficiency standards for design of new Federal commercial and multi-family high-rise residential buildings where design began before January 3, 2007. Based on ASHRAE/IESNA Standard 90.1-1989, it mandates efficiency requirements for building envelopes, electrical distribution, lighting, HVAC, water heating, and energy management systems, excluding buildings under 100 sq ft or those with minimal conditioning loads.
Mandatory Petroleum Price Regulations
This regulation establishes mandatory reporting requirements for crude oil producers conducting enhanced oil recovery projects. Operators must file annual prepaid expenses reports with the Department of Energy by January 31 each year, documenting the nature, timing, and allocation of prepaid expenses for injectants, fuels, and other items used in tertiary recovery operations after September 30, 1981. Reporting continues until all prepaid expenses and their actual use are fully documented.
Alternative Fuel Transportation Program
10 CFR Part 490 implements the Alternative Fuel Transportation Program under the Energy Policy Act of 1992, establishing requirements and definitions for State government and alternative fuel provider fleets. The regulation defines alternative fuels (methanol, ethanol, natural gas, biodiesel, hydrogen, electricity, etc.), alternative-fueled vehicles, and operational requirements for centrally-fueled vehicle fleets, setting the framework for federal fleet compliance with alternative fuel acquisition mandates.
The Office of Science Financial Assistance Program
10 CFR Part 605 establishes policies and procedures for the Department of Energy's Office of Science Financial Assistance Program, governing grants and cooperative agreements for basic and applied research, educational and training activities, and conferences. The program supports multiple scientific areas including basic energy sciences, fusion energy, high energy physics, and university science education, and is available to universities, non-profit organizations, and eligible individuals.
Collection of Foreign Oil Supply Agreement Information
This regulation requires persons with equity interests or contractual rights to extract crude oil from foreign countries to report detailed information about their supply agreements to the Department of Energy, including parties, production volumes, pricing terms, payment obligations, and contract terms. Reports must be submitted within 60 days of forms issuance, 14 days of agreement execution, or upon material changes, with joint operators able to designate a single participant to report on behalf of the operation.
Energy Efficiency Standards for the Design and Construction of New Federal Low-Rise Residential Buildings
10 CFR Part 435 establishes mandatory energy efficiency performance standards for new Federal low-rise residential buildings and major renovations, including maximum allowable fossil fuel-generated energy consumption limits for projects with design-for-construction dates on or after May 1, 2025, and green building certification requirements for projects beginning on or after October 14, 2015. Standards apply to EISA-subject buildings exceeding $2.5 million (adjusted annually).
Loan Guarantees for Clean Energy Projects
10 CFR Part 609 establishes DOE policies and procedures for receiving, evaluating, and approving loan guarantee applications under Title XVII of the Energy Policy Act of 2005. The regulation defines key terms and conditions for supporting Eligible Projects through loan guarantees, including definitions of applicants, borrowers, eligible lenders, and administrative costs incurred during application evaluation, negotiation, and ongoing monitoring of loan guarantee agreements.
Automotive Propulsion Research and Development
Part 473 establishes procedures for reviewing and certifying grants, cooperative agreements, contracts, and projects funded under the Federal Energy Administration Act of 1978 for automotive propulsion research and development. The regulations define applicants, projects, and solicitation requirements for advancing technology in automobile propulsion systems, excluding subcontractors and pre-existing agreements.
Advanced Technology Vehicles Manufacturer Assistance Program
The Advanced Technology Vehicles Manufacturer Assistance Program (10 CFR Part 611) establishes DOE loan assistance for manufacturing facilities producing advanced technology vehicles and qualifying components. Eligible projects include reequipping or establishing U.S. manufacturing facilities, engineering integration work, and critical minerals processing for vehicle supply chains. The program, authorized under the Energy Independence and Security Act of 2007 and expanded by the Inflation Reduction Act of 2022, provides federal loans through the Federal Financing Bank to support domestic production of fuel-efficient and advanced technology vehicles.
Definitions
This regulation establishes definitions for terms used in the Powerplant and Industrial Fuel Use Act of 1978 and related DOE regulations. Key definitions include 'alternate fuel' (electricity or fuels other than natural gas or petroleum, including coal, biomass, solar, geothermal, and waste-derived fuels), 'applicable environmental requirements' (federal and state standards for emissions and waste disposal), and administrative terms such as 'action,' 'affiliate,' and 'aggrieved person' for purposes of DOE proceedings.
Renewable Energy Production Incentives
10 CFR Part 451 establishes Department of Energy incentive payment procedures for qualified renewable energy facilities owned by states, political subdivisions, not-for-profit cooperatives, public utilities, Indian tribes, or Native corporations. Eligible renewable sources include solar, wind, ocean, geothermal, and biomass energy. Payments are based on net electric energy generated and sold, with facility eligibility determined by date of first use and permit receipt.
Security Policies and Practices Relating to Labor-Management Relations
This DOE regulation establishes security policies and practices governing labor-management relations at Department of Energy installations. It sets forth procedures for National Labor Relations Board proceedings at DOE facilities, emphasizing balance between security requirements and traditional labor rights. Key provisions include encouragement of consent elections, maintenance of cleared administrative law judges, counsel clearance procedures, and DOE oversight of contested proceedings to protect classified information while ensuring material evidence is included in unclassified records.
Contractual Provisions
This regulation establishes contractual dispute resolution provisions for DOE contracts involving the sale of personal property to non-federal organizations. Contracts must include a disputes clause providing binding decisions by the Contracting Officer with appeal rights under the Contract Disputes Act of 1978, and require contractor performance continuation pending resolution. Exceptions apply to Power Marketing Administrations' electric power sales contracts and cases where the Secretary determines inclusion would not serve the public interest for foreign governments or international organizations.
Contract Clauses
Establishes standard contract dispute resolution procedures under the Contract Disputes Act of 1978. Contractors may submit written claims to the Contracting Officer for payment, contract adjustments, or other relief. Claims exceeding $50,000 require good-faith certification. The Government and contractors pay interest on disputed amounts at rates set by Treasury or the Department of Energy respectively. The Contracting Officer's decision is final unless appealed within timeframes specified by the Act.
Administrative Procedures and Sanctions
10 CFR Part 205 establishes administrative procedures and available sanctions for proceedings before the Department of Energy and State Offices under the Federal Energy Administration Act and Emergency Petroleum Allocation Act. The regulation defines key terms including actions, adjustments, assignments, consent orders, exemptions, and interpretations relevant to energy allocation and compliance enforcement.
General Allocation and Price Rules
10 CFR Part 210 establishes recordkeeping requirements for firms subject to DOE allocation and price rules. Records must be maintained for transactions and expenses prior to specified dates, with ongoing obligations for firms involved in DOE litigation, those making restitutionary payments under orders, and firms undergoing audits. Record retention periods vary by firm category and may be extended or terminated by DOE notification.
New Restrictions on Lobbying
This regulation establishes restrictions on the use of appropriated Federal funds to pay for lobbying activities in connection with Federal contracts, grants, loans, and cooperative agreements. Recipients of such Federal financial instruments must certify they have not engaged in prohibited lobbying and disclose any non-appropriated fund payments used for lobbying influence.
Procedures for Acquisition of Petroleum for the Strategic Petroleum Reserve
This regulation establishes procedures for the Department of Energy to acquire petroleum products for the Strategic Petroleum Reserve, including purchase, exchange, and deferral mechanisms. It defines key terms such as backwardation, contango, deferral, and exchange, and outlines the roles of contracting officers and relevant DOE offices in managing SPR petroleum acquisitions under federal acquisition regulations.
Standby Mandatory International Oil Allocation
This regulation implements U.S. obligations under the International Energy Program (IEP) to enable mandatory international oil allocation during energy supply emergencies. It applies to firms engaged in producing, transporting, refining, distributing or storing oil under U.S. jurisdiction. The rule remains on standby status and activates only when the President determines allocation is necessary to fulfill IEP obligations and notifies Congress; it reverts to standby within 60 days of emergency deactivation.
Certification, Compliance, and Enforcement for Consumer Products and Commercial and Industrial Equipment
10 CFR Part 429 establishes procedures for certification, compliance determination, and enforcement of energy conservation standards for consumer products and commercial/industrial equipment including HVAC systems, boilers, refrigeration equipment, and electric motors. Manufacturers must comply with applicable energy conservation standards from 10 CFR Parts 430 and 431, with certification conducted by independent, nationally recognized programs following ISO/IEC 17025 and NIST standards.
Trespassing on Commission Property
10 CFR Part 160 prohibits unauthorized entry and the introduction of weapons, explosives, or dangerous materials onto Nuclear Regulatory Commission facilities, installations, and real property. Violations carry civil penalties up to $1,000, with enhanced penalties up to $5,000 or one year imprisonment for breach of enclosed facilities. The regulations expire January 8, 2027, unless extended by the NRC following public comment.