COMPLIANCE POLICY GUIDE (CPG)
Chapter 2 - Biologics December 2019
Sub Chapter 200 - 220: General
Sub Chapter 270 - 275: Non-blood Products
Sub Chapter 280: In Vitro Diagnostic Products - Reagents
Sub Chapter 200 - 220: General
- 205.100 CPG 7134.03 Deleted 12/21/98, Obsolete
- CPG Sec. 210.100 Deleted 4/26/1999, Outdated and Obsolete (CPG 7134.05)
- CPG Sec. 210.150 Deleted (CPG 7134.09)
- CPG Chapter 2: 7134.07
- CPG Sec.220-100 (7134.11) IS Shipment Biologicals for Medical Emergency
Sub Chapter 230: Blood
- CPG 7134.12
- CPG Sec. 230.110 - Withdrawn, June 29, 2012, Outdated and Obsolete
- CPG 7134.02
- CPG 7134.17
- FDA CPG 230.140, Evaluation and Processing Post Donation Information Reports
- CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor
Sub Chapter 231: Platelets
- CPG Sec. 231.100- Platelets, Pooled (CPG 7134.13)
- CPG Sec. 231.110- Quality Control Testing of Platelet Concentrate (Human) and Cryoprecipitated Antihemophilic Factor (Human) (CPG 7134.16)
- CPG Sec. 231.120- Time Period for Separation of Platelets from Platelet-Rich Plasma When Preparing Platelets and Fresh Frozen Plasma (CPG 7134.20)
- CPG Sec. 231.130- Storage of Platelet Concentrate for up to Five Days (CPG 7134.21)
Sub Chapter 250 - 257: Plasma
- FDA Compliance Policy Guide 7134.08 Source Plasma
- CPG 7134.22
- CPG 7134.18
- CPG 7134.14
- CPG Sec. 252.110 Volume Limits for Automated Collection of Source Plasma
- CPG Sec. 253.100- Use of Units of Plasma and Fresh Frozen Plasma Which Have Been Thawed (CPG 7134.19)
- CPG 7134.15
- CPG 7134.10
- CPG 7134.23
- CPG Sec. 257.100 DEFERRAL OF SOURCE PLASMA DONORS
Sub Chapter 270 - 275: Non Blood Products
- CPG Sec. 270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting Changes (CPG 7134.06)
- CPG 7134.04
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
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.