September 18, 2003

1
Revisions to Labeling and Storage Requirements
for Blood and Blood Components, Including Source
Plasma

• September 18, 2003
• Elizabeth Callaghan
• Division of Blood Applications

2
Revisions to Labeling and Storage

• Proposed rule published July 30, 2003
• Main objectives
• Consolidate, simplify, and update container
  labels and instruction circular regulations
• Remove inconsistencies with ISBT 128
• Modify shipping and storage temperatures for
  frozen noncellular products

3
Revisions to Labeling and Storage

• Combined both WB and SP labeling requirements
  into one section of the CFR
• shall to must
• Registration/license number to unique facility
  identifier
• Anticoagulant no longer has to precede proper name

4
Revisions to Labeling and Storage

• SP storage temp changed from 20 C to 30 C
• SP shipping temp changed to 15C
• FFP/Cryo
• Storage temp
• -18 to -25 3 month expiration
• -25 or colder 2 year expiration
• Shipping temp
• Same as storage

5
Revisions to Labeling and Storage

• Comments due by 10/28/03
• Sent to
• Division of Dockets Management (HFA-305)
• FDA
• 5630 Fishers Lane, Rm 1061
• Rockville, MD 20852
• Or
• www.fda.gov/dockets/ecomments
• Docket No. 2003N-0211

6
Revisions to Labeling and Storage

• Changed testing statement to include all required
  testing not just HIV, HBV and Syphilis
• Testing statement on recovered plasma
• Du to weak D