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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.
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 Animal Drugs for Use in Animal Feeds
21 CFR Part 558 establishes regulatory framework for new animal drugs approved for use in animal feeds. It defines two drug categories based on withdrawal period requirements, and three medicated feed types (A, B, C) with specific manufacturing standards, nutrient composition requirements, and concentration limits. Type A articles are drug-only components; Type B feeds contain ≥25% nutrients for further feed manufacturing; Type C feeds are complete or supplemental feeds for direct animal consumption.
Procedures for Performance Standards Development
21 CFR Part 861 establishes procedures for FDA development of performance standards for Class II and Class III medical devices. Standards address device performance characteristics, design, manufacturing processes, quality control, testing requirements, labeling, and distribution restrictions to ensure safety and effectiveness. The FDA coordinates with other federal agencies and stakeholder organizations in standard-setting.
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.
Oral Dosage Form New Animal Drugs
21 CFR Part 520 establishes specifications and conditions of use for oral dosage form new animal drugs, including acepromazine (tranquilizer for dogs and cats), acetazolamide (for heart failure and intraocular pressure in dogs), afoxolaner/moxidectin/pyrantel combination (for heartworm prevention and parasite control in dogs), and albendazole suspension (for livestock). All drugs require veterinary oversight and specify dosage amounts, indications for use, and applicable limitations.
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 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.
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.
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.
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.
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.
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.
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.
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.