Chapter 2 - Biologics - ContentsSub Chapter 200 - 220: General205.100 CPG 7134.03 Deleted 12/21/98, Obsolete 210.100 CPG 7134.05 Deleted 4/26/1999, Outdated and Obsolete 210.150 CPG 7134.09 Deleted 215.100 CPG 7134.07 Deleted 03/28/2000, Outdated and Obsolete 220.100 Interstate Shipment of Biological Products for Use in Medical Emergencies CPG 7134.11 Sub Chapter 230: Blood230.100 Blood and Blood Products - Definitions CPG 7134.12 230.110 Registration of Blood Banks and Others Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood Products CPG 7134.01 (Revised 8/17/2000) 230.120 Human Blood and Blood Products as Drugs CPG 7134.02 230.130 Adequate Space for Determination of Donor Suitability CPG 7134.17 230.140 Evaluation and Processing Post Donation Information Reports (07/09/1999 new) 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor (05/07/2002 new) Sub Chapter 231: Platelets231.100 Platelets, Pooled CPG 7134.13 231.110 Quality Control Testing of Platelet Concentrate (Human) and Cryoprecipitated Antihemophilic Factor (Human) CPG 7134.16 231.120 Time Period for Separation of Platelets from Platelet-Rich Plasma When Preparing Platelets and Fresh Frozen Plasma CPG 7134.20 231.130 Storage of Platelet Concentrate for up to Five Days CPG 7134.21 Sub Chapter 250 - 257: Plasma250.100 Source Plasma - Guidelines for Informed Consent Forms CPG 7134.08 250.500 Plasma Brokers - Registration and Compliance with Good Manufacturing Practices CPG 7134.22 251.100 Schedule of Physical Examination for Donors Receiving Immunization Injections CPG 7134.18 252.100 Source Plasma - Regulatory Action Based on Overbleeding CPG 7134.14 252.110 Volume Limits for Automated Collection of Source Plasma (03/06/2000 New) 253.100 Use of Units of Plasma and Fresh Frozen Plasma Which Have Been Thawed CPG 7134.19 254.100 Source Plasma - Use of Units from Donors Subsequently Found to be Reactive to a Serologic Test for Syphilis CPG 7134.15 255.100 Quantitative Testing for Serum Proteins in Plasmapheresis Donors CPG 7134.10 256.100 Plasmapheresis - 48-hour Period Between Plasmapheresis Procedures CPG 7123.23 257.100 Deferral of Source Plasma Donors Due To Red Cell Loss During Collection of Source Plasma by Automated Plasmapheresis (Reissued, 3/22/2000) Sub Chapter 270 - 275: Non-blood Products270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting Changes CPG 7134.06 275.100 Immune Milk CPG 7134.04 Sub Chapter 280: In Vitro Diagnostic Products - Reagents 280.100 Stability Requirements for Licensed In Vitro Diagnostic Products 280.110 Microbiological Control Requirements in Licensed Anti-Human Globulin and Blood Grouping Reagents Revised May 31, 2002 tc |