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Showing 1–50 of 108 regulations
Regulation of Combination Products
21 CFR Part 4 establishes current good manufacturing practice (CGMP) requirements for combination products, which are products containing two or more constituent parts (drugs, devices, or biological products). The regulation clarifies how CGMP rules apply to both co-packaged and single-entity combination products, defines key terms, and outlines the regulatory framework for designing and implementing CGMP operating systems at manufacturing facilities.
Protection of Human Subjects
21 CFR Part 50 establishes requirements for the protection of human subjects in clinical investigations regulated by the FDA. It applies to investigations involving drugs, biological products, medical devices, food additives, dietary supplements, and related products submitted for FDA approval. The regulation defines the scope of coverage, applicable regulatory sections, and key definitions for research and marketing permit applications across multiple FDA-regulated product categories.
General Enforcement Regulations
General enforcement regulations under the Federal Food, Drug, and Cosmetic Act establishing that FDA regulations apply to causing prohibited acts, defining key terms like labeling and label, and clarifying the agency's statutory authorities for food, drug, and cosmetic regulation including provisions on package labeling and net quantity declarations.
Enforcement Policy
FDA enforcement policy governing regulatory actions under the Federal Food, Drug, and Cosmetic Act. Establishes procedures for recalls, corrections, and voluntary removals of violative products including foods, drugs, devices, cosmetics, biologics, and tobacco. Defines recall classifications based on health hazard severity and clarifies distinctions between recalls, market withdrawals, and stock recoveries.
Regulatory Hearing Before the Food and Drug Administration
21 CFR Part 16 establishes procedures for regulatory hearings before the FDA when the Commissioner considers regulatory actions affecting drugs, devices, food, cosmetics, and tobacco products. Hearings are available under specific statutory provisions including premarket approval withdrawals, device bans, mandatory recalls, investigational device exemptions, and tobacco product orders. The procedures apply when the Commissioner discretionarily offers a hearing or when statutory provisions mandate one, but exclude informal presentations and certain admission refusals.
Color Additive Petitions
21 CFR Part 71 establishes the petition process for proposing color additives for use in foods, drugs, cosmetics, or human body coloring. Petitioners must submit detailed information including the additive's chemical identity, composition, physical and chemical properties, production methods, and safety data. Petitions require specification of intended uses, proposed conditions of use, and supporting toxicological and analytical data to demonstrate safety and suitability for FDA approval.
Environmental Impact Considerations
21 CFR Part 25 establishes FDA procedures for implementing the National Environmental Policy Act (NEPA), requiring environmental impact assessments for major Federal actions related to FDA-regulated products including drugs, biologics, and medical devices. The regulation defines key NEPA terms and establishes supplemental procedures consistent with FDA's authority under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act.
General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics
21 CFR Part 81 establishes general specifications and restrictions for provisional color additives used in foods, drugs, and cosmetics under the Color Additive Amendments of 1960. The regulation lists provisionally approved color additives, requires progress reports, and prohibits their use in eye-area products. It also documents termination of provisional listings for specific colors due to safety concerns, including Ext. D&C Yellow Nos. 9 and 10 (due to β-naphthylamine contamination) and FD&C Red No. 1 (due to demonstrated toxicity in animal feeding studies).
General Administrative Rulings and Decisions
21 CFR Part 2 establishes FDA administrative procedures for declaring imminent hazards to public health and conducting examination and investigation samples of foods, drugs, and cosmetics. An imminent hazard exists when evidence shows a product poses significant health threat requiring immediate correction. FDA officers collecting official samples must gather at least twice the estimated quantity needed for analysis, with exceptions for limited availability, cost exceeding $150, or samples from importers or labeled manufacturers. The regulation governs sample handling, preservation, and evidentiary retention for enforcement actions under the Federal Food, Drug, and Cosmetic Act.
Electronic Records; Electronic Signatures
21 CFR Part 11 establishes FDA criteria for electronic records and signatures to be considered trustworthy, reliable, and equivalent to paper records. The regulation applies to electronic records created, modified, maintained, or transmitted under FDA regulations and those submitted under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. Electronic signatures meeting these requirements are treated as equivalent to handwritten signatures unless specifically excepted. Electronic records may replace paper records unless paper is required, and computer systems must be subject to FDA inspection.
Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
21 CFR Part 99 establishes requirements for manufacturers disseminating information about unapproved or new uses of FDA-approved drugs, biologics, and devices to healthcare practitioners, pharmacy benefit managers, health insurers, group health plans, and government agencies. The regulation defines key terms including health care practitioners, manufacturers, and new uses, and specifies that unsolicited requests from healthcare providers are exempted from these dissemination requirements.
Financial Disclosure by Clinical Investigators
FDA regulation requiring disclosure of financial interests and compensation arrangements between clinical investigators and study sponsors for drugs and medical devices. Investigators must disclose equity interests, proprietary interests in tested products, and compensation affected by study outcomes to minimize potential bias in clinical data submitted for FDA marketing applications.
Color Additives
21 CFR Part 70 establishes federal regulations governing color additives used in foods, drugs, and cosmetics under the Federal Food, Drug, and Cosmetic Act. The regulation defines color additives as dyes, pigments, or synthetic substances capable of imparting color when added to food, drugs, cosmetics, or the human body, and clarifies exemptions for natural food ingredients and substances where color is incidental to primary function. The FDA's Color Certification Branch administers certification procedures for regulated color additives.
Civil Money Penalties Hearings
21 CFR Part 17 establishes procedures for FDA administrative hearings on civil money penalties for violations of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. Penalties apply to violations involving prescription drug marketing, medical devices, pesticide residues, clinical trials, direct-to-consumer drug advertising, biologics, electronic products, mammography standards, vaccine record falsification, and tobacco products.
Listing of Certified Provisionally Listed Colors and Specifications
21 CFR Part 82 establishes specifications and certification requirements for provisionally listed coal-tar colors used in food, drugs, and cosmetics. The regulation defines key terms including alumina, blanc fixe, and gloss white, and sets permissible limits for impurities such as lead, arsenic, and heavy metals in straight colors and certifiable mixtures. It outlines requirements for batch composition, diluent safety, and certification procedures for color products intended for food, drug, and cosmetic applications.
Product Jurisdiction
21 CFR Part 3 establishes FDA procedures for determining which internal agency component has primary jurisdiction over premarket review of combination products containing any mixture of drugs, devices, and biologics. It implements the Safe Medical Devices Act and modernization amendments to streamline oversight by eliminating the need for multiple FDA component approvals on a single product.
Good Laboratory Practice for Nonclinical Laboratory Studies
21 CFR Part 58 establishes Good Laboratory Practice (GLP) standards for nonclinical laboratory studies supporting FDA applications for regulated products including drugs, medical devices, biologics, food and color additives, and electronic products. The regulation ensures quality and integrity of safety data submitted under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act by defining requirements for test articles, control articles, study scope, and application types covered.
Patent Term Restoration
This regulation establishes FDA procedures for reviewing patent term restoration applications under 35 U.S.C. 156 for patents related to drugs, medical devices, food additives, and color additives. It defines the FDA's role in determining patent eligibility, calculating regulatory review periods, and adjudicating due diligence challenges through informal hearings.
Institutional Review Boards
21 CFR Part 56 establishes standards for Institutional Review Boards (IRBs) that oversee clinical investigations of FDA-regulated products including drugs, medical devices, biological products, foods, dietary supplements, and electronic products. The regulation defines the composition, operation, and responsibilities of IRBs to protect the rights and welfare of human research subjects.
General
21 CFR Part 200 establishes general provisions for FDA and drug manufacturers/distributors regarding communication of drug safety and labeling information. It specifies envelope formatting requirements (color-coded borders and statements) for mailing important drug warnings, prescribing information changes, and corrections to physicians and pharmacists. It also authorizes FDA inspection of contract facilities used by pharmaceutical manufacturers and permits pharmacists to receive dosage and indication data from manufacturers.
Labeling
FDA regulation 21 CFR 201.1 establishes labeling requirements for finished pharmaceutical drug products, mandating that labels conspicuously display the manufacturer's, packer's, or distributor's name and place of business. The rule defines manufacturer status based on performance of specific operations including mixing, tableting, encapsulating, sterilizing, and filling; allows shared manufacturing designations when multiple parties perform different operations; and clarifies that certain contracted operations (soft-gelatin encapsulation, aerosol filling, sterilization by irradiation, lyophilization, and ethylene oxide sterilization) do not disqualify primary manufacturer designation.
Prescription Drug Marketing
21 CFR Part 203 establishes procedures and requirements for the distribution of prescription drugs, including bulk drug substances and finished dosage forms, to protect public health and prevent drug diversion. It covers reimportation and wholesale distribution, sales by hospitals and charitable organizations, and distribution of drug samples, implementing the Prescription Drug Marketing Act of 1987 and related amendments.
Guidelines for State Licensing of Wholesale Prescription Drug Distributors
This regulation establishes minimum standards and conditions for state licensing of wholesale prescription drug distributors operating in interstate commerce, implementing the Prescription Drug Marketing Act of 1987. It defines key terms including prescription drugs, wholesale distribution, wholesale distributors, and health care entities, while specifying exemptions from wholesale distribution requirements such as intracompany sales, emergency transfers, drug samples, and certain inter-entity transactions.
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code
21 CFR Part 207 establishes requirements for registration and listing of domestic and foreign drug establishments manufacturing human drugs (including biologics) and animal drugs. It defines key terms including active pharmaceutical ingredients, bulk drug substances, commercial distribution, and labeling requirements for prescription drugs, OTC drugs, and animal drugs, along with establishment definitions for regulatory compliance and National Drug Code assignment.
Medication Guides for Prescription Drug Products
21 CFR Part 208 establishes FDA requirements for Medication Guides—patient labeling for prescription drug products and biologics that present serious public health concerns. Manufacturers must distribute FDA-approved patient information for drugs where patient awareness of risks, adverse effects, or adherence is critical to safe and effective use, with guidance on content, format, and distribution requirements.
Prescription Drug Advertising
Prescription drug advertising requirements under 21 CFR Part 202 establish rules for how drugs must be advertised. Key provisions include: ingredient information must appear together without intervening matter; ingredient listing order and quantities must match product labels; proprietary names cannot imply unique effectiveness for common substances; inert ingredients cannot be featured to exaggerate value; proprietary names must not create confusion with other drugs; and established names must accompany proprietary names with specified type size and placement requirements throughout advertisements.
Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement
21 CFR Part 209 requires authorized dispensers and pharmacies to distribute a standardized side effects statement with each dispensed prescription drug product approved under FDA section 505. The statement directs consumers to call their doctor about side effects and report adverse events to FDA at 1-800-FDA-1088. Distribution must occur with new and refill prescriptions via sticker, vial cap, separate paper, consumer medication information, or FDA-approved Medication Guide, using clear type no smaller than 6-10 points depending on format.
Imprinting of Solid Oral Dosage Form Drug Products for Human Use
21 CFR Part 206 requires manufacturers to imprint solid oral dosage form drug products (tablets, capsules) with identification codes via embossing, debossing, engraving, or printing. The rule applies to prescription, over-the-counter, biological, and homeopathic drugs unless exempted. Exemptions include clinical investigation drugs, bioequivalence study drugs, extemporaneously compounded drugs, radiopharmaceuticals, and products where imprinting is technologically infeasible due to size or physical characteristics.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.