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  • CFR 21(PTS300-499) : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 300-499

    Available format(s): 

    Superseded date:  20-11-2019

    Language(s): 

    Published date: 

    Publisher:  Code of Federal Regulations

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    Table of Contents - (Show below) - (Hide below)

    Part 300 - General
    Part 310 - New drugs
    Part 312 - Investigational new drug application
    Part 314 - Applications for FDA approval to market a new drug
    Part 315 - Diagnostic radiopharmaceuticals
    Part 316 - Orphan drugs
    Part 320 - Bioavailability and bioequivalence requirements
    Part 328 - Over-the-counter drug products intended for oral
               ingestion that contain alcohol
    Part 330 - Over-the-counter (OTC) human drugs which are generally
               recognized as safe and effective and not misbranded
    Part 331 - Antacid products for over-the-counter (OTC) human use
    Part 332 - Antiflatulent products for over-the-counter human use
    Part 333 - Topical antimicrobial drug products for over-the-counter
               human use
    Part 336 - Antiemetic drug products for over-the-counter human use
    Part 338 - Nighttime sleep-aid drug products for over-the-counter
               human use
    Part 340 - Stimulant drug products for over-the-counter human use
    Part 341 - Cold, cough, allergy, bronchodilator, and antiasthmatic drug
               products for over-the-counter human use
    Part 343 - Internal analgesic, antipyretic, and antirheumatic drug
               products for over-the-counter human use
    Part 344 - Topical OTIC drug products for over-the-counter human use
    Part 346 - Anorectal drug products for over-the-counter human use
    Part 347 - Skin protectant drug products for over-the-counter human
               use
    Part 348 - External analgesic drug products for over-the-counter
               human use
    Part 349 - Ophthalmic drug products for over-the-counter human use
    Part 352 - Sunscreen drug products for over-the-counter human use
               [stayed indefinitely]
    Part 355 - Anticaries drug products for over-the-counter human use
    Part 357 - Miscellaneous internal drug products for over-the-counter
               human use
    Part 358 - Miscellaneous external drug products for over-the-counter
               human use
    Part 361 - Prescription drugs for human use generally recognized as
               safe and effective and not misbranded: Drugs used in
               research
    Part 369 - Interpretative statements re warnings on drugs and devices
               for over-the-counter sale
    Part 370-499 - [Reserved]

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher Code of Federal Regulations
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM D 6398 : 2008 Standard Practice to Enhance Identification of Drug Names on Labels
    UNE-EN ISO 11616:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2012)
    ASTM F 1453 : 1992 : R2012 Standard Guide for Training and Evaluation of First Responders Who Provide Emergency Medical Care
    ASTM D 6398 : 2008 : R2014 Standard Practice to Enhance Identification of Drug Names on Labels (Withdrawn 2022)
    ASTM F 3089 : 2014 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
    ASTM F 1453 : 1992 : R2008 Standard Guide for Training and Evaluation of First Responders Who Provide Emergency Medical Care
    ISEA Z308.1 : 2015 MINIMUM REQUIREMENTS FOR WORKPLACE FIRST AID KITS AND SUPPLIES
    ANSI/AAMI/IEC 60601-1-2:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
    ASTM F 2347 : 2015 : REDLINE Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
    UNE-EN ISO 24442:2012 Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2011)
    I.S. EN ISO 24442:2011 COSMETICS - SUN PROTECTION TEST METHODS - IN VIVO DETERMINATION OF SUNSCREEN UVA PROTECTION (ISO 24442:2011)
    I.S. EN ISO 11616:2017 HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION (ISO 11616:2017)
    ASTM F 1453 : 1992 : R1996 Standard Guide for Training and Evaluation of First Responders Who Provide Emergency Medical Care
    I.S. EN ISO 11609:2017 DENTISTRY - DENTIFRICES - REQUIREMENTS, TEST METHODS AND MARKING (ISO 11609:2017)
    BS EN ISO 24442:2011 Cosmetics. Sun protection test methods. In vivo determination of sunscreen UVA protection
    MSS SP 98 : 2015 PROTECTIVE COATINGS FOR THE INTERIOR OF VALVES, HYDRANTS, AND FITTINGS
    BS EN ISO 11616:2017 Health informatics. Identification of medicinal products. Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
    ASTM F 2212 : 2011 : REDLINE Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
    UNI EN ISO 24442 : 2012 COSMETICS - SUN PROTECTION TEST METHODS - IN VIVO DETERMINATION OF SUNSCREEN UVA PROTECTION
    ISO 11609:2017 Dentistry — Dentifrices — Requirements, test methods and marking
    DD ISO/TS 22224:2009 Health informatics. Electronic reporting of adverse drug reactions
    DI-TCSP-82040 Base Document:2016 RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)
    DIN EN ISO 24442:2012-03 Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2011)
    ISO/TS 22224:2009 Health informatics Electronic reporting of adverse drug reactions
    EN ISO 11616:2017 Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)
    IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
    ISO 24442:2011 Cosmetics Sun protection test methods In vivo determination of sunscreen UVA protection
    EN ISO 24442:2011 Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2011)
    EN ISO 11609:2017 Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2017)
    NSF 51 : 2014 FOOD EQUIPMENT MATERIALS
    ASTM F 1453 : 1992 : R2003 Standard Guide for Training and Evaluation of First Responders Who Provide Emergency Medical Care
    ASTM E 2363 : 2014 : REDLINE Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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