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Drugs & pharmaceuticals
Toutes les réglementations du corpus Vantage taguées avec drugs. Les éléments sont tagués par le cron d'enrichissement dès leur arrivée, plus toute attribution thématique pré-renseignée par le connecteur.
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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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Ministry of Health launches probe, questions 2 doctors over promotion of exosome injections
Saudi Arabia's Ministry of Health is investigating two doctors for promoting exosome injections in violation of regulations. The ministry clarified that cosmetic products intended for external use cannot be approved or promoted as medical treatments or administered intravenously without proper regulatory approvals. Healthcare practitioners must comply with licensing requirements and adhere to approved scientific standards, with patient safety as the top priority.
Sports Center Regulations criminalize marketing or use of performance-enhancing drugs
Saudi Arabia's proposed amendments to Sports Center Regulations criminalize marketing and use of performance-enhancing drugs in sports facilities. The regulations strengthen protections for minors and people with disabilities, require parental consent for members under 18, mandate surveillance cameras, and grant Ministry of Sports inspectors broad inspection authority. Non-compliant centers face partial or complete closure, and members may terminate contracts and receive refunds for unmet obligations or injuries.
Certain Other Dosage Form New Animal Drugs
21 CFR Part 529 establishes conditions of use for certain new animal drugs in dosage forms, including amikacin for treating genital infections in mares, chloramine-T for controlling bacterial disease in farmed fish, chlorhexidine for prevention/treatment of metritis and vaginitis in cattle and horses, ciclesonide for managing equine asthma, and detomidine gel. All drugs are restricted to veterinary use and include specific dosing, indications, and usage limitations.
Extralabel Drug Use in Animals
21 CFR Part 530 establishes conditions for extralabel use of FDA-approved drugs in animals by licensed veterinarians. Extralabel use—employing approved drugs in species, indications, dosages, or routes not on the label—is permitted only when animal health is threatened and within a valid veterinary-client-patient relationship. The rule prohibits advertising extralabel uses and requires veterinary records for FDA oversight and public health protection.
New Animal Drugs for Minor Use and Minor Species
This regulation (21 CFR Part 516) establishes procedures for designating and approving new animal drugs for minor uses and minor species, implementing section 573 of the Federal Food, Drug, and Cosmetic Act. It defines key terms including minor use, minor species, major species, MUMS drugs, and requirements for demonstrating functional superiority. The rule governs various dosage forms including oral, injectable, ophthalmic, topical, and feed-based formulations for animals other than humans or major livestock species.
In Vitro Diagnostic Products for Human Use
21 CFR Part 809 establishes regulatory requirements for in vitro diagnostic (IVD) products intended for human use, including reagents, instruments, and systems used to diagnose disease or determine health status. The regulation defines IVD products as medical devices under the Federal Food, Drug, and Cosmetic Act, specifies labeling requirements including proprietary name, intended use, ingredient declarations, warnings, and storage instructions, and addresses confidentiality of submitted data. Requirements vary by product class and may include prescription restrictions and hazard-specific precautions.
General Biological Products Standards
21 CFR Part 610 establishes general standards for licensed biological products in the US, requiring manufacturers to complete conformity tests on each product lot before release and permitting FDA oversight of lot samples and protocols. The regulation specifies testing requirements for potency, sterility, and safety, allows equivalent methods with FDA approval, and governs release procedures through the Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research.
Biological Products: General
21 CFR Part 600 establishes FDA submission procedures and mailing addresses for licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). The regulation specifies separate submission channels for biologics license applications, deviation reports, samples, and promotional materials, with distinct addresses for each center and submission type, including special handling for radioactive biological products.
Ophthalmic and Topical Dosage Form New Animal Drugs
This CFR regulation establishes specifications, sponsor information, and conditions of use for ophthalmic and topical dosage form new animal drugs, including amitraz, bacitracin-neomycin-polymyxin B combinations, buprenorphine, chloramphenicol, and chlorhexidine for veterinary use in dogs and cats. All drugs are restricted to use by or on the order of a licensed veterinarian.
Additional Standards for Miscellaneous Products
21 CFR Part 680 establishes standards for allergenic products used in diagnosis, prevention, or treatment of allergies. Requirements cover source material purity (max 1% foreign material), mold culture processing with approved standard operating procedures, and animal sourcing with veterinary oversight. Manufacturers must document mold identity, processing steps, contamination limits, and report specified animal diseases to the Center for Biologics Evaluation and Research.
Additional Standards for Human Blood and Blood Products
21 CFR Part 640 establishes manufacturing and quality standards for human whole blood and blood products intended for transfusion. Requirements cover donor examination, blood collection using sterile pyrogen-free containers with approved anticoagulants, storage at 1–6 °C, labeling, tamper-proof sealing, and aseptic processing to prevent contamination. Licensed establishments must supervise all manufacturing steps including donor identification, laboratory testing, and reissue conditions.
Licensing
21 CFR Part 601 establishes procedures for obtaining biologics licenses from the FDA for biological products including therapeutic DNA plasmids, synthetic peptides, monoclonal antibodies, and recombinant DNA-derived products. Applicants must submit comprehensive safety, purity, and potency data from nonclinical and clinical studies, manufacturing information, stability data, labeling specimens, and environmental assessments to the Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research.
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.
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.
Intentional Genomic Alterations in Animals
21 CFR Part 528 establishes regulatory pathways for intentional genomic alterations in animals, including rabbits producing recombinant human Factor VII in milk for hemophilia treatment, genetically modified Atlantic salmon with enhanced growth rates in contained freshwater facilities, pigs with CD163 gene deletion conferring PRRSV resistance, pigs with modified GGTA1 gene for use as food or therapeutic sources, and chickens producing human lysosomal acid lipase for medical treatment. Food and feed restrictions apply to certain lineages.
Intramammary Dosage Form New Animal Drugs
21 CFR Part 526 establishes regulations for intramammary dosage form new animal drugs used in lactating and dry dairy cattle. The regulation specifies approved formulations of amoxicillin, ceftiofur, and cephapirin benzathine for treating bovine mastitis, including dosing amounts, indications, milk and meat withdrawal periods, and restrictions on veterinary-only use and extralabel application.
Human Cells, Tissues, and Cellular and Tissue-Based Products
21 CFR Part 1271 establishes FDA requirements for establishments manufacturing human cells, tissues, and cellular and tissue-based products (HCT/Ps). The regulation creates an electronic registration and listing system and mandates compliance with donor-eligibility procedures, current good tissue practice standards, and communicable disease prevention measures. It applies to HCT/P manufacturers regulated under the Public Health Service Act, whether or not products enter interstate commerce, and requires adherence to manufacturing and quality standards.
Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
21 CFR Part 630 establishes minimum criteria for blood and blood component donations intended for transfusion or further manufacturing. Blood establishments must determine donor eligibility, assess donation suitability, and notify deferred donors. The regulation defines key terms including blood, blood components, donors, and relevant transfusion-transmitted infections (HIV, HBV, HCV, HTLV, syphilis, West Nile virus, Chagas disease, CJD, vCJD, and malaria). Requirements apply to establishments manufacturing blood and blood components.
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.
Medicated Feed Mill License
21 CFR Part 515 establishes the licensing requirements for medicated feed mills manufacturing animal feeds containing new animal drugs. Applicants must submit Form FDA 3448 with facility details, FDA registration number, responsible personnel information, and certifications confirming compliance with good manufacturing practices, applicable drug regulations, and record-keeping requirements. The FDA Center for Veterinary Medicine reviews applications within 90 days, and supplemental applications are required for ownership or address changes.
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.
Miscellaneous
21 CFR Part 1307 establishes miscellaneous provisions for controlled substance regulation under DEA authority. It clarifies that state and federal law requirements remain in effect, allows practitioners to request regulatory exceptions, permits registered dispensers to distribute controlled substances to other practitioners up to 5% of their annual dispensed volume without separate distributor registration, and exempts incidental controlled substance manufacturing by registered manufacturers from additional registration requirements.
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.
Current Good Manufacturing Practice for Blood and Blood Components
21 CFR Part 606 establishes current good manufacturing practice (cGMP) standards for blood and blood components collection, processing, compatibility testing, storage and distribution. The regulation defines key terms including blood, blood components, plasmapheresis, plateletpheresis, and leukapheresis procedures. It requires facilities and personnel to maintain adequate safety, purity, potency and effectiveness, with personnel having appropriate education, training and experience. Facilities must be clean, orderly, suitably constructed and properly maintained to ensure compliance with cGMP requirements.
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.
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.
Implantation or Injectable Dosage Form New Animal Drugs
21 CFR Part 522 establishes specifications, sponsors, and conditions of use for injectable and implantation dosage form new animal drugs including acepromazine (tranquilizer/preanesthetic), alfaxalone (anesthetic), amikacin (antibiotic), and aminopentamide (anti-emetic/anti-diarrheal). Each drug section specifies dosage amounts for target species, indications for use, and limitations including veterinary-only restrictions and controlled substance designations where applicable.