FDA CPG Chapter 2 Biologics Table Contents

Chapter 2 - Biologics - Contents

Sub Chapter 200 - 220: General

205.100 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210.100 CPG 7134.05 Deleted 4/26/1999, Outdated and Obsolete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215.100 CPG 7134.07 Deleted 03/28/2000, Outdated and Obsolete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: Blood

230.100 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: Platelets

231.100 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: Plasma

250.100 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 Products

270.100 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