Inspections, Compliance, Enforcement, and Criminal Investigations
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Chapter 2 - Biologics
Sub Chapter 200 - 220: General
Sub Chapter 270 - 275: Non-blood Products
Sub Chapter 280: In Vitro Diagnostic Products - Reagents
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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CPG Sec. 205.100 Deleted 12/21/98, Obsolete CPG Sec. 210.100 Deleted 4/26/99, Outdated and Obsolete CPG Sec. 210.150 Deleted CPG Sec. 215.100 IND Filings; Completion of Applicable Portions Prior to Final Action on License Applications or License Supplements, Deleted 03/28/2000, Outdated and Obsolete CPG Sec. 220.100 - IS Shipment Biologicals for Medical Emergency
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Sub Chapter 230: Blood
CPG Sec. 230.100 Blood and Blood Products - Definitions CPG Sec. 230.110- Registration of Blood Banks, Other Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood Products CPG 230.120- Human Blood and Blood Products as Drugs CPG 230.130- Adequate Space for Determination of Donor Suitability CPG Sec. 230.140 Evaluation and Processing Post Donation Information Reports CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor
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Sub Chapter 231: Platelets
CPG Sec. 231.100- *Platelets, Pooled* CPG Sec. 231.110- Quality Control Testing of *Platelets* [ ] and Cryoprecipitated Antihemophilic Factor [ ] CPG Sec. 231.120- Time Period for Separation of Platelets from Platelet-Rich Plasma When Preparing *Platelets* and Fresh Frozen Plasma* CPG Sec. 231.130- Storage of *Platelets* [ ] for up to five (5) Days
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Sub Chapter 250 - 257: Plasma
CPG Sec. 250.100- Source Plasma - Guidelines for Informed Consent Forms CPG Sec. 250.500- Plasma Brokers - Registration and Compliance with Good Manufacturing Practices CPG Sec. 251.100- Schedule of Physical Examination for Donors Receiving Immunization Injections CPG Sec. 252.100- Source Plasma - Regulatory Action Based on Overbleeding CPG Sec. 252.110 Volume Limits for Automated Collection of Source Plasma (03/06/2000 New) 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 CPG Sec. 255.100- Quantitative Testing for Serum Proteins in Plasmapheresis Donors CPG Sec. 256.100- Plasmapheresis - 48-hour Period Between Plasmapheresis Procedures CPG Sec. 257.100 DEFERRAL OF SOURCE PLASMA DONORS
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