عرض 401–450 من أصل 648 لائحة
Processing and Bottling of Bottled Drinking Water
21 CFR Part 129 establishes current good manufacturing practice requirements for processing and bottling of bottled drinking water. The regulation mandates that facilities use approved water sources, maintain sanitary conditions throughout processing, bottling, holding, and shipping, and implement controls ensuring product safety. Key requirements include plant construction standards with separated bottling rooms, proper ventilation, enclosed container washing areas, and use of nontoxic materials for water-contact surfaces.
Tree Nut and Peanut Products
21 CFR Part 164 establishes standardized definitions and labeling requirements for mixed nuts products. Mixed nuts must contain at least three to four shelled tree nut and/or peanut ingredients in specified varieties, with each ingredient comprising 2-80% by weight. The regulation prescribes labeling requirements, including disclosure of predominant nut ingredients exceeding 50% by weight, and testing procedures to verify compliance with composition and fill standards.
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.
Canned Fruit Juices
21 CFR Part 146 establishes federal standards for canned fruit juices, including definitions of ingredients (corn syrup, dextrose, glucose syrup, invert sugar, refined sugar) and compliance procedures. It specifies sampling and acceptance criteria for quality and container fill, with detailed lot definitions and defective unit classifications. The regulation includes specific identity standards for lemon juice requiring mechanical extraction from mature lemons with minimum soluble solids content.
Indirect Food Additives: General
21 CFR Part 174 establishes general regulatory provisions for indirect food additives—substances used in food-contact articles such as packaging and processing equipment. It defines good manufacturing practice requirements, including limits on additive migration into food and purity standards for components. The regulation permits use of substances generally recognized as safe, those with prior approval, and those meeting negligible migration thresholds, provided they comply with all applicable Federal Food, Drug, and Cosmetic Act provisions.
Canned Fruits
21 CFR Part 145 establishes federal standards of identity and quality for canned fruits. It defines key ingredients and processing terms including corn sirup, glucose sirup, invert sugar sirup, fruit juice, and packing media. The regulation specifies compositional requirements, density measurement procedures, and labeling standards to ensure safety and consistency in canned fruit products.
Substances Prohibited from Use in Human Food
21 CFR Part 189 prohibits specified substances from use in human food due to public health risks or insufficient safety data. It establishes rules for prohibited cattle materials, including specified risk materials (brain, spinal cord, eyes), small intestine, material from nonambulatory disabled cattle, and mechanically separated beef. Certain tallow and derivatives are permitted if they meet purity standards. The FDA may modify the prohibited list based on new scientific evidence.
Macaroni and Noodle Products
21 CFR Part 139 establishes standards of identity and labeling requirements for macaroni and noodle products. It defines macaroni, spaghetti, and vermicelli based on shape and diameter, specifies permitted optional ingredients including egg white, disodium phosphate, seasonings, salt, gum gluten, and glyceryl monostearate with quantitative limits, and requires labeling statements disclosing optional ingredients used in the finished product.
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.
Secondary Direct Food Additives Permitted in Food for Human Consumption
21 CFR Part 173 establishes permitted secondary direct food additives for human consumption, including polymer substances and adjuvants. The regulation specifies acrylate-acrylamide resins, modified polyacrylamide resins, and ion-exchange membranes as safe food processing additives with defined usage limits and residual monomer restrictions. Acrylamide-based resins are approved as flocculents in sugar juice clarification and scale control, while ion-exchange membranes are permitted for juice processing and pH adjustment.
Cereal Flours and Related Products
21 CFR Part 137 establishes standardized requirements for cereal flours and related products. The regulation defines wheat flour specifications including granulation standards (≥98% passing 212 µm sieve), ash and protein limits, moisture content (≤15%), and permitted optional ingredients such as dough conditioners (ascorbic acid up to 200 ppm) and bleaching agents (chlorine, benzoyl peroxide, azodicarbonamide, etc.). All ingredients must be labeled per FDA requirements, with specific declarations required for bleached flour and enzyme additions.
Food Additives
21 CFR Part 170 establishes regulatory definitions and general provisions governing food additives under the Federal Food, Drug, and Cosmetic Act. A food additive is any substance not exempted by law whose intended use may result in it becoming a component of food or affecting food characteristics, including substances in food contact articles and packaging materials. The regulation defines key terms including food contact substances, common use in food, and safety standards requiring reasonable certainty of harmlessness under conditions of intended use, determined through scientific procedures or general recognition of safety.
Prior-Sanctioned Food Ingredients
21 CFR Part 181 establishes regulatory procedures for food ingredients with prior FDA or USDA approval before September 6, 1958. These prior-sanctioned ingredients are exempt from food additive classification but remain subject to safety review. The FDA may impose limitations, conditions, or prohibitions on use if scientific evidence shows potential health risks, and may issue emergency action levels pending final regulations.
Fish and Fishery Products
21 CFR Part 123 establishes food safety regulations for fish and fishery products, defining key terms and concepts including critical control points, critical limits, food safety hazards, and preventive measures. The regulation applies to processors engaged in commercial handling, preparation, manufacturing, and preservation of fish and molluscan shellfish intended for human consumption, but exempts harvesting, on-vessel preparation, and retail establishments.
Fish and Shellfish
21 CFR Part 161 establishes standards of identity and labeling requirements for fish and shellfish products, particularly oysters. The regulation specifies that canned oysters must be labeled with accurate total weight declarations and sets detailed processing standards for raw, shucked oysters, including water contact time limits (max 30 minutes), draining procedures, and packing requirements to ensure product quality and consumer safety.
Direct Food Substances Affirmed as Generally Recognized as Safe
21 CFR Part 184 establishes the regulatory framework for direct food substances affirmed as generally recognized as safe (GRAS) by the FDA. Ingredients listed must be used in accordance with current good manufacturing practice, appropriate food grade standards, and prescribed conditions of use. The regulation specifies that GRAS affirmation may be limited by food category, functional use, or usage level, and any use outside these limitations requires separate food additive authorization.
Food Additive Petitions
21 CFR Part 171 establishes procedural requirements for petitions requesting approval of food additives under section 409(b) of the Federal Food, Drug, and Cosmetic Act. Petitioners must submit detailed information on the additive's chemical identity, composition, manufacturing process, analytical controls, stability data, and safety assessments to the FDA's Office of Food Additive Safety. Submissions must be in triplicate (or quadruplicate for meat/poultry uses) with English translations of foreign materials and supporting documentation.
Cheeses and Related Cheese Products
21 CFR Part 133 establishes federal standards of identity and compositional requirements for cheeses and related cheese products, including definitions of milk, cream, and pasteurization standards. It specifies analytical methods for measuring moisture, milkfat, and phosphatase levels in cheeses and requires proper labeling of pasteurized process cheese products with equal prominence of all name components.
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.
Food Dressings and Flavorings
21 CFR Part 169 establishes food safety standards for dressings and flavorings. It defines vanilla beans, unit weights, and vanilla constituents for flavoring use. Mayonnaise standards require minimum 65% vegetable oil, specified acidifying ingredients (vinegar or citrus juice at ≥2.5% acidity), egg-derived ingredients, and permitted optional additives including salt, sweeteners, and spices, with all ingredients required to be safe and suitable.
Beverages
21 CFR Part 165 establishes standards for beverages, particularly bottled water. It defines key terms such as lot, sample, and analytical unit for quality testing purposes. Bottled water is defined as water sealed in containers with no added ingredients except optional safe antimicrobial agents and fluoride. The regulation specifies nomenclature for different water types including artesian, ground, mineral, and purified water, with specific chemical and source requirements for each category.
Fruit Butters, Jellies, Preserves, and Related Products
21 CFR Part 150 establishes standards of identity for fruit butters, jellies, preserves, and related products. Fruit butters must be smooth, semisolid foods made from specified fruit ingredients with optional additions such as sweeteners, spices, flavorings, salt, acidifying agents, juice, preservatives, antifoaming agents, and pectin. The mixture must contain at least five parts fruit ingredient to two parts sweetener by weight, with a minimum soluble solids content of 43 percent as determined by refractometer analysis.
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.
Irradiation in the Production, Processing and Handling of Food
21 CFR Part 179 establishes safety standards for using ionizing radiation sources in food production, processing, and inspection. Approved sources include X-ray tubes (≤500 kVp), sealed isotope units (americium-241, cesium-137, cobalt-60, iodine-125, krypton-85, radium-226, strontium-90), californium-252 for moisture measurement, and machine sources up to 10 MeV. Facilities must comply with current good manufacturing practices, apply minimum effective doses not exceeding specified limits (10 grays for standard sources, 2 milligrays for californium-252), use scheduled processes, and ensure packaging compliance.
Milk and Cream
21 CFR Part 131 establishes standards of identity and labeling requirements for milk and cream products in the US. The regulation defines milk as lacteal secretion from healthy cows with minimum 8.25% milk solids not fat and 3.25% milkfat, requiring pasteurization or ultra-pasteurization for beverage use. Cream must contain at least 18% milkfat. The standards specify optional vitamin A and D fortification, permitted ingredients including fruit flavoring and stabilizers, and analytical methods for verifying composition, with detailed nomenclature and labeling requirements.
Indirect Food Additives: Adhesives and Components of Coatings
21 CFR Part 175 establishes safety standards for indirect food additives used in adhesives and coatings that contact food through packaging. Adhesives may be safely used in food packaging if they contain approved substances, remain separated from food by a functional barrier or meet contact limits, and are properly labeled. Pressure-sensitive adhesives for labels and tapes on poultry, dry foods, and processed fruits/vegetables must be formulated from safe substances or prior-approved components, with specified limits on antioxidants, optical brighteners, and photoinitiators.
Canned Vegetables
21 CFR Part 155 establishes standards for canned vegetables, including procedures for determining drained weight, quality compliance, fill of container, and sampling/acceptance criteria. The regulation defines lot compliance based on defect limits, establishes sampling plans and acceptance numbers, and specifies color measurement standards using Munsell color discs for products like tomato concentrates.
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.
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.
Special Requirements for Specific Human Drugs
This regulation establishes special requirements for specific human drugs under 21 CFR Part 250. It designates thyroid-containing drug preparations combined with central nervous system stimulants as misbranded when marketed for obesity treatment unrelated to hypothyroidism, finding no medical rationale for such use in patients with normal thyroid function. Additionally, stramonium preparations are regarded as misbranded if labeled for self-medication due to documented abuse potential and serious toxic effects including delirium and coma from oral ingestion.
Investigational New Drug Application
This regulation establishes procedures and requirements for Investigational New Drug (IND) applications submitted to the FDA. It defines the scope of clinical investigations subject to IND requirements, specifies exemptions (including lawfully marketed drugs, in vitro diagnostics, laboratory research-only drugs, and certain placebo studies), and references institutional review and informed consent standards. The regulation governs which drug products must obtain FDA approval before conducting clinical trials.
Applications for FDA Approval to Market a New Drug
21 CFR Part 314 establishes procedures for submitting new drug applications (NDAs) and abbreviated new drug applications (ANDAs) to the FDA for approval to market new drugs under the Federal Food, Drug, and Cosmetic Act. The regulation outlines the agency's drug review process, defines key terms including active ingredients and exclusivity periods, and sets requirements for amendments, supplements, and postmarketing reports, while excluding designated medical gases and certain biologics subject to separate licensing provisions.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
This regulation establishes current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls for animal food facilities in the US. It defines applicability criteria, prohibits operation of non-compliant animal food manufacturing facilities, and establishes requirements for hazard analysis and preventive controls. Facilities manufacturing both human and animal food may comply with human food standards instead if requirements are met.
Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use
This regulation establishes standards for over-the-counter nighttime sleep-aid drug products containing diphenhydramine hydrochloride or diphenhydramine citrate. It specifies approved active ingredients, dosage limits (50 mg and 76 mg respectively), labeling requirements including indications and warnings, and defines nighttime sleep-aids as drugs for relief of occasional sleeplessness. Products meeting these conditions are recognized as safe and effective.
Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research
Part 361 establishes conditions under which radioactive drugs are considered safe and effective for basic research use in human subjects. Research must be approved by a Radioactive Drug Research Committee and meet strict limits on pharmacological dose, radiation dose, and cumulative exposure. Studies must demonstrate qualified investigators, proper licensure, informed consent, institutional review, and adverse event reporting.
Human Drug Compounding
This regulation establishes FDA rules for human drug compounding under 21 CFR Part 216. It lists bulk drug substances approved for compounding (including Brilliant Blue G and several topical agents), identifies substances excluded from compounding (Oxitriptan, Piracetam, Silver Protein Mild, Tranilast), and sets FDA evaluation criteria based on physical/chemical characterization, safety, efficacy evidence, and historical use. Compounders cannot claim FDA approval for products made with listed substances.
Animal Food Labeling
This regulation establishes labeling requirements for packaged animal food, defining the principal display panel as the most visible label area and specifying its measurement for different container shapes. It requires all mandatory label information to appear prominently on either the principal display panel or information panel (positioned to its right), with minimum type size of 1/16 inch for legibility and conspicuousness.
Topical Otic Drug Products for Over-the-Counter Human Use
FDA regulation establishing over-the-counter topical otic drug products for human use. Defines earwax removal aids containing 6.5% carbamide peroxide in anhydrous glycerin, and ear drying aids containing 95% isopropyl alcohol in 5% anhydrous glycerin. Specifies labeling requirements, indications, warnings, and usage directions for both product types, with age restrictions and duration limits.
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.
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.
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.
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.
Common or Usual Names for Nonstandardized Animal Foods
21 CFR Part 502 establishes requirements for common or usual names of nonstandardized animal foods. Manufacturers must use simple, accurate names that identify the food's basic nature and characterizing properties. Percentage declarations of key ingredients and statements about ingredient presence or absence are required when they materially affect price, consumer acceptance, or could otherwise mislead consumers. Font size and placement requirements apply to percentage and presence/absence declarations on product labels.
Current Good Manufacturing Practice for 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 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.
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.
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.
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.