CFR 21(PTS200-299) : 0
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date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
Superseded by
Language(s)
English
Publisher
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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
| DocumentType |
Standard
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0
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| PublisherName |
Code of Federal Regulations
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| Status |
Superseded
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| SupersededBy |
| 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 |
| 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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