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Drugs; Official Names and Established Names
21 CFR Part 299 establishes procedures for designating official and established names for drugs under the Federal Food, Drug, and Cosmetic Act. The regulation defines official names as those designated by the FDA Commissioner under section 508, and established names as official names, compendial names, or common/usual names. The FDA recognizes the U.S. Adopted Names Council for deriving nonproprietary drug names and generally relies on compendial or common names rather than routinely designating new official names.
Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol
FDA regulation establishing maximum allowable alcohol concentrations in over-the-counter oral drug products by age group: 10% for adults and children 12+, 5% for children 6-11, and 0.5% for children under 6. Requires prominent labeling of alcohol percentage on principal display panels and allows exemptions with FDA approval.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act
21 CFR Part 329 establishes postmarketing adverse event reporting requirements for nonprescription human drugs under FD&C Act Section 760. Manufacturers must submit Individual Case Safety Reports (ICSRs) electronically to FDA containing patient information, adverse event details, suspect product data, reporter information, and responsible person contact details. Reports must include outcomes, dates, medical narratives, test results, product identifiers (NDC, lot number), dosing information, and concomitant medications. Patient names should be replaced with unique identification codes to protect privacy.
Antiperspirant Drug Products for Over-the-Counter Human Use
FDA regulation 21 CFR Part 350 establishes safety, efficacy, and labeling standards for over-the-counter antiperspirant drug products. The regulation specifies permitted active ingredients (aluminum and aluminum-zirconium compounds) at defined concentration limits, requires proper product identification and indications labeling, and references compliance with general OTC drug provisions under 21 CFR Part 330.
Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]
This regulation establishes standards for over-the-counter sunscreen drug products, including definitions of sun protection factor (SPF) categories, permitted active ingredients with concentration limits (such as titanium dioxide, zinc oxide, avobenzone, and oxybenzone), and testing procedures to ensure safety and efficacy for topical use.
Current Good Manufacturing Practice for Medicated Feeds
21 CFR Part 225 establishes current good manufacturing practice (CGMP) standards for medicated feeds to ensure drug safety, identity, strength, quality, and purity. The regulation applies to all facilities and equipment used in medicated feed production, requires qualified personnel with adequate training and supervision, and mandates proper building construction, maintenance, and sanitation to prevent contamination and pest infestation.
Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 211 establishes minimum current good manufacturing practice (cGMP) standards for finished pharmaceutical drug products for human and animal use. The regulation requires establishment of a quality control unit with authority to approve/reject components, containers, in-process materials, and finished products; mandates adequate laboratory facilities for testing; and requires personnel to have appropriate education, training, and experience in manufacturing operations and cGMP requirements.
Common or Usual Names for Nonstandardized Animal Foods
21 CFR Part 502 establishes requirements for common or usual names of nonstandardized animal foods. Manufacturers must use simple, accurate names that identify the food's basic nature and characterizing properties. Percentage declarations of key ingredients and statements about ingredient presence or absence are required when they materially affect price, consumer acceptance, or could otherwise mislead consumers. Font size and placement requirements apply to percentage and presence/absence declarations on product labels.
Current Good Manufacturing Practice for Medical Gases
21 CFR Part 213 establishes current good manufacturing practice (cGMP) requirements for the preparation of designated medical gases for human and animal administration. The regulation defines key terms including batches, lots, components, acceptance criteria, and lot numbering requirements. It applies to manufacturers and processors involved in liquefied, nonliquefied, or cryogenic medical gas production, packaging, labeling, testing, and quality control operations.
Section 804 Importation Program
Section 804 Importation Program establishes FDA procedures for time-limited programs permitting importation of eligible prescription drugs from Canada. The rule defines eligible drugs as FDA-approved medications available in the U.S. that also meet Canadian regulatory requirements, excluding controlled substances, biologics, and certain high-risk formulations like injectables and inhaled drugs. Importers must follow specified compliance, labeling, and adverse event reporting requirements.
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.
Special Requirements for Specific Human Drugs
This regulation establishes special requirements for specific human drugs under 21 CFR Part 250. It designates thyroid-containing drug preparations combined with central nervous system stimulants as misbranded when marketed for obesity treatment unrelated to hypothyroidism, finding no medical rationale for such use in patients with normal thyroid function. Additionally, stramonium preparations are regarded as misbranded if labeled for self-medication due to documented abuse potential and serious toxic effects including delirium and coma from oral ingestion.
Investigational New Drug Application
This regulation establishes procedures and requirements for Investigational New Drug (IND) applications submitted to the FDA. It defines the scope of clinical investigations subject to IND requirements, specifies exemptions (including lawfully marketed drugs, in vitro diagnostics, laboratory research-only drugs, and certain placebo studies), and references institutional review and informed consent standards. The regulation governs which drug products must obtain FDA approval before conducting clinical trials.
Applications for FDA Approval to Market a New Drug
21 CFR Part 314 establishes procedures for submitting new drug applications (NDAs) and abbreviated new drug applications (ANDAs) to the FDA for approval to market new drugs under the Federal Food, Drug, and Cosmetic Act. The regulation outlines the agency's drug review process, defines key terms including active ingredients and exclusivity periods, and sets requirements for amendments, supplements, and postmarketing reports, while excluding designated medical gases and certain biologics subject to separate licensing provisions.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
This regulation establishes current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls for animal food facilities in the US. It defines applicability criteria, prohibits operation of non-compliant animal food manufacturing facilities, and establishes requirements for hazard analysis and preventive controls. Facilities manufacturing both human and animal food may comply with human food standards instead if requirements are met.
Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use
This regulation establishes standards for over-the-counter nighttime sleep-aid drug products containing diphenhydramine hydrochloride or diphenhydramine citrate. It specifies approved active ingredients, dosage limits (50 mg and 76 mg respectively), labeling requirements including indications and warnings, and defines nighttime sleep-aids as drugs for relief of occasional sleeplessness. Products meeting these conditions are recognized as safe and effective.
Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research
Part 361 establishes conditions under which radioactive drugs are considered safe and effective for basic research use in human subjects. Research must be approved by a Radioactive Drug Research Committee and meet strict limits on pharmacological dose, radiation dose, and cumulative exposure. Studies must demonstrate qualified investigators, proper licensure, informed consent, institutional review, and adverse event reporting.
Human Drug Compounding
This regulation establishes FDA rules for human drug compounding under 21 CFR Part 216. It lists bulk drug substances approved for compounding (including Brilliant Blue G and several topical agents), identifies substances excluded from compounding (Oxitriptan, Piracetam, Silver Protein Mild, Tranilast), and sets FDA evaluation criteria based on physical/chemical characterization, safety, efficacy evidence, and historical use. Compounders cannot claim FDA approval for products made with listed substances.
Animal Food Labeling
This regulation establishes labeling requirements for packaged animal food, defining the principal display panel as the most visible label area and specifying its measurement for different container shapes. It requires all mandatory label information to appear prominently on either the principal display panel or information panel (positioned to its right), with minimum type size of 1/16 inch for legibility and conspicuousness.
Topical Otic Drug Products for Over-the-Counter Human Use
FDA regulation establishing over-the-counter topical otic drug products for human use. Defines earwax removal aids containing 6.5% carbamide peroxide in anhydrous glycerin, and ear drying aids containing 95% isopropyl alcohol in 5% anhydrous glycerin. Specifies labeling requirements, indications, warnings, and usage directions for both product types, with age restrictions and duration limits.
Anticaries Drug Products for Over-the-Counter Human Use
FDA regulation 21 CFR Part 355 establishes standards for over-the-counter anticaries drug products for topical use on teeth. The regulation defines allowable active ingredients (primarily sodium fluoride), dosage forms (dentifrices, treatment rinses, preventive gels), and fluoride concentrations to prevent dental cavities. Products meeting these requirements are recognized as safe and effective.
Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
21 CFR Part 330 establishes requirements for over-the-counter human drugs to be recognized as safe, effective, and not misbranded. OTC drugs must comply with current good manufacturing practices, be manufactured at registered establishments, meet labeling requirements under the Federal Food, Drug, and Cosmetic Act, contain only safe inactive ingredients, and include required warnings such as keeping products out of reach of children and overdose instructions.
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
21 CFR Part 341 establishes safety and efficacy standards for over-the-counter cold, cough, allergy, bronchodilator, and antiasthmatic drug products in oral, inhalant, or topical forms. It defines product categories, lists approved active ingredients (including antihistamines, antitussives, and bronchodilators), and sets conditions for marketing these products without misbranding.
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.
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.
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.