• There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Superseded date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

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
Pages
0
PublisherName
Code of Federal Regulations
Status
Superseded
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
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

View more information
$68.75
Including GST where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more