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 In this section:

                Manual of Compliance Policy Guides

Manual of Compliance Policy Guides: Foreword

                        Chapter 1 - General
          Chapter 2 - Biologics
          Chapter 3 - Devices
          Chapter 4 - Human Drugs
          Chapter 5 - Food, Colors, and Cosmetics
          Chapter 6 -  Veterinary Medicine
          CPG Revision/Update History Home
          Inspections, Compliance, Enforcement, and Criminal Investigations
          Compliance Manuals
          Manual of Compliance Policy Guides
          Chapter 2 - BiologicsManual of Compliance Policy Guides Chapter 2 - Biologics
  
  	
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    PrintSub Chapter 200 - 220: General

Sub Chapter 230: Blood

Sub Chapter 231: Platelets

Sub Chapter 250 - 257: Plasma

Sub Chapter 270 - 275: Non-blood Products

Sub Chapter 280: In Vitro Diagnostic Products - Reagents

Sub Chapter 200 - 220: General

CPG Sec. 205.100 Deleted 12/21/98, Obsolete
	CPG Sec. 210.100 Deleted 4/26/99, Outdated and Obsolete
	CPG Sec. 210.150 Deleted
	CPG Sec. 215.100 IND Filings; Completion of Applicable Portions Prior to Final Action on License Applications or License Supplements, Deleted 03/28/2000, Outdated and Obsolete
	CPG Sec. 220.100 - IS Shipment Biologicals for Medical EmergencySub Chapter 230: Blood

CPG Sec. 230.100 Blood and Blood Products - Definitionsis obsolete and was withdrawn on 1/30/2020.
	CPG Sec. 230.110- Registration of Blood Banks, Other Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood Products  is outdated and obsolete and was withdrawn on 6/29/2012.
	CPG 230.120 Human Blood and Blood Products as Drugsis obsolete and was withdrawn on 1/30/2020.
	CPG 230.130 Adequate Space for Determination of Donor Suitability is obsolete and was withdrawn on 7/16/2018.
	CPG Sec. 230.140 Evaluation and Processing Post Donation Information Reports is obsolete and was withdrawn on 7/16/2018.
	CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donorwas revised on 12/6/2019Sub Chapter 231: Platelets

CPG Sec. 231.100 *Platelets, Pooled* is obsolete and was withdrawn on 7/16/2018.
	CPG Sec. 231.110 Quality Control Testing of *Platelets* [ ] and Cryoprecipitated Antihemophilic Factor (Human)
	CPG Sec. 231.120 Time Period for Separation of Platelets from Platelet-Rich Plasma When Preparing *Platelets* and Fresh Frozen Plasma* is obsolete and was withdrawn on 7/16/2018.
	CPG Sec. 231.130 Storage of *Platelets* [ ] for up to five (5) Days is obsolete and was withdrawn on 7/16/2018.Sub Chapter 250 - 257: Plasma

CPG Sec. 250.100 Source Plasma – Guidelines for Informed Consent Forms (Obsolete, Withdrawn on 11/28/2017)
	CPG Sec. 250.500 Plasma Brokers - Registration and Compliance with Good Manufacturing Practices is obsolete and was withdrawn on 7/16/2018.
	CPG Sec. 251.100 Schedule of Physical Examination for Donors Receiving Immunization Injections (Obsolete, Withdrawn on 11/28/2017)
	CPG Sec. 252.100 Source Plasma - Regulatory Action Based on Overbleeding (Obsolete, Withdrawn on 11/28/2017)
	CPG Sec. 252.110 Volume Limits for Automated Collection of Source Plasma (Obsolete, Withdrawn on 11/28/2017)
	CPG Sec. 253.100 Use of Units of *Plasma and Fresh Frozen Plasma* Which Have Been Thawed
	CPG Sec. 254.100 Source Plasma - Use of Units from Donors Subsequently Found to be Reactive to a Serologic Test for Syphilis (Obsolete, Withdrawn on 11/28/2017)
	CPG Sec. 255.100 Quantitative Testing for Serum Proteins in Plasmapheresis Donors (Obsolete, Withdrawn on 11/28/2017)
	CPG Sec. 256.100 Plasmapheresis - 48-hour Period Between Plasmapheresis Procedures (Obsolete, Withdrawn on 11/28/2017)
	CPG Sec. 257.100 Deferral of Source Plasma Donors Due To Red Cell Loss During Collection of Source Plasma by Automated Plasmapheresis (Obsolete, Withdrawn on 11/28/2017)Sub Chapter 270 - 275: Non Blood Products

CPG Sec. 270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting Changesis obsolete and was withdrawn on 1/30/2020.
	CPG Sec. 275.100 Immune Milkis obsolete and was withdrawn on 1/30/2020.Sub Chapter 280: In Vitro Diagnostic Products - Reagents

CPG Sec. 280.100 Stability Requirements - Licensed In Vitro Diagnostic Products
	CPG Sec. 280.110 Microbiological Control Requirements-Licensed Anti-Human Globulin & Blood Grouping Reagents

                                                                                  Content current as of:
      04/24/2019Manual of Compliance Policy Guides: Foreword

          
                        Chapter 1 - General
          Chapter 2 - Biologics
          Chapter 3 - Devices
          Chapter 4 - Human Drugs
          Chapter 5 - Food, Colors, and Cosmetics
          Chapter 6 -  Veterinary Medicine
          CPG Revision/Update History
 
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