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  • CFR 21(PTS200-299) : 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 200-299

    Available format(s):  Hardcopy

    Superseded date:  20-11-2019

    Language(s):  English

    Published date: 

    Publisher:  Code of Federal Regulations

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

    Part 200 - General
    Part 201 - Labeling
    Part 202 - Prescription drug advertising
    Part 203 - Prescription drug marketing
    Part 205 - Guidelines for State licensing of wholesale
               prescription drug distributors
    Part 206 - Imprinting of solid oral dosage form drug products
               for human use
    Part 207 - Registration of producers of drugs and listing of
               drugs in commercial distribution
    Part 208 - Medication Guides for prescription drug products
    Part 210 - Current good manufacturing practice in manufacturing,
               processing, packing, or holding of drugs; general
    Part 211 - Current good manufacturing practice for finished
               pharmaceuticals
    Part 216 - Pharmacy compounding
    Part 225 - Current good manufacturing practice for medicated
               feeds
    Part 226 - Current good manufacturing practice for Type A
               medicated articles
    Part 250 - Special requirements for specific human drugs
    Part 290 - Controlled drugs
    Part 299 - Drugs; official names and established names

    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    Status Superseded
    Superseded By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
    DI-TCSP-82040 Base Document:2016 RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)
    DD ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
    DIN EN ISO 12417-1:2016-02 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    ANSI/AAMI/ISO 13408-3:2006(R2015) ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    AAMI TIR15 : 2016 PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
    ASTM F 2038 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    AAMI ISO 13408-3:2006 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    ASTM E 3106 : 2017 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
    ASTM D 6398 : 2008 : R2014 Standard Practice to Enhance Identification of Drug Names on Labels (Withdrawn 2022)
    ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
    I.S. EN 16679:2014 PACKAGING - TAMPER VERIFICATION FEATURES FOR MEDICINAL PRODUCT PACKAGING
    ASTM F 2900 : 2011 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
    NFPA 400 : 2016 HAZARDOUS MATERIALS CODE
    ASME BPE : 2016 BIOPROCESSING EQUIPMENT
    17/30355946 DC : 0 BS ISO 21976 - PACKAGING - TAMPER VERIFICATION FEATURES FOR MEDICINAL PRODUCT PACKAGING
    14/30251609 DC : 0 BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    BS EN 16679:2014 Packaging. Tamper verification features for medicinal product packaging
    AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    ASTM F 2042 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    ASTM F 2042 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    I.S. EN ISO 12417-1:2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    ASTM F 2383 : 2011 : REDLINE Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
    ASTM F 3089 : 2014 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    NFPA 1 : 2021 FIRE CODE
    ASTM F 2038 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
    BS EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
    ASTM F 2312 : 2011 : REDLINE Standard Terminology Relating to Tissue Engineered Medical Products
    UNE-EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
    AAMI TIR48 : 2015 QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS
    I.S. EN ISO 13408-3:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    UNI EN ISO 13408-3 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    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)
    ASTM F 2042 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
    NFPA 55 : 2016 COMPRESSED GASES AND CRYOGENIC FLUIDS CODE
    DIN EN ISO 12417-1 E : 2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    BS EN ISO 13408-3:2011 Aseptic processing of health care products Lyophilization
    ASTM F 2038 : 2000 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    PREN 16679 : DRAFT 2013 PACKAGING - TAMPER VERIFICATION FEATURES FOR MEDICINAL PRODUCT PACKAGING
    ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
    UNE-EN ISO 12417-1:2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
    ASTM E 1705 : 2015 : REDLINE Standard Terminology Relating to Biotechnology
    ASTM F 2038 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    ASTM F 2042 : 2000 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    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 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
    ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
    EN 16679:2014 Packaging - Tamper verification features for medicinal product packaging
    EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
    EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
    AAMI ISO TIR 12417 : 2011 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
    14/30288557 DC : 0 BS EN 16679 - PACKAGING - TAMPER VERIFICATION FEATURES FOR MEDICINAL PRODUCT PACKAGING
    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
    DIN EN ISO 13408-3:2011-09 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
    ASTM E 2363 : 2014 : REDLINE Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
    ASTM F 2211 : 2013 Standard Classification for Tissue Engineered Medical Products (TEMPs)
    NFPA 1 : 2018 FIRE CODE
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