Blood Products Advisory Committee

1
Blood Products Advisory Committee

• June 20, 2003
• Kay R. Gregory, MS, MT(ASCP)SBB

2
AABB Task Force on Recovered Plasma

• AABB
• ABC
• ARC
• BCA
• ASBPO

3
Background Recovered Plasma

• Outdated terminology
• Outdated system of regulation

4
Proposed Licensing Requirements
5
Product Name

• Plasma for Manufacture

6
Donor Qualification

• Same as allogeneic Whole Blood
• Collected concurrently with cellular products for
  transfusion/by apheresis
• 3/10/95 FDA Memorandum ? Revision of FDA
  Memorandum of August 24, 1982 Requirements for
  Infrequent Plasmapheresis Donors

7
Method of Preparation

1. Separate plasma from Whole Blood
2. Infrequent plasmapheresis w/automated collection
   of cellular products for transfusion/infrequent
   plasmapheresis
3. Convert plasma for transfusion (e.g. FFP) to
   Plasma for Manufacture

8
Method of Preparation, contd

• Plasma for Manufacture by separation from WB ?
  anytime during dating period for WB
• Plasma for transfusion converted to Plasma for
  Manufacture ? anytime during dating period/up to
  1 yr. after outdate as transfusible component

9
Expiration Date

• 2 years from date of collection

10
Testing for Infectious Disease

• Same requirements as Whole Blood
• except
• Negative result for Anti-HBc not required
• Negative result for Anti HTLV I/II not
  required

11
Labeling Product Name

• Plasma for Manufacture

12
Labeling Statement of Freezing Time

• Frozen Within _____ Hours After Phlebotomy

13
Labeling Caution Statement

• Caution For Manufacturing Use Only into
  Injectable Products

14
Labeling Product Code

• From Uniform Labeling Guidelines or ISBT 128

15
Labeling Amount

• Total volume or weight of plasma

16
Labeling For Whole Blood-Derived Plasma for
Manufacture

• Name and volume of source material, e.g., From
  500 mL CPD Whole Blood

17
Labeling For Plasma for Manufacture Collected
by Plasmapheresis

• Total type and volume of anticoagulant used

18
Labeling Storage Temperature

• -18C or colder

19
Labeling Facility Identification

• Name, address, license number of collection
  facility
• Name, address, license number of institution
  where separated (if different than collection
  facility)

20
Labeling Testing Statement

• Negative by FDA required tests

21
Labeling Collection Date

• Month, date and year

22
Component Retrieval

• Same as required by FDA for Source Plasma or
  recovered plasma

23
Records

• Retained for 10 years

24
Freezing

• Not within a specific time frame. Instead
• Specify time on label so fractionator can
  determine suitability for intended use

25
Short Supply Agreements

• No longer necessary when Plasma for Manufacture
  becomes available

26
Collection/Expiration Dates

• Now Collection date on recovered plasma label
• Continue this practice, but
• Acceptable to require expiration date instead of
  collection date when expiration date established
  for Plasma for Manufacture

27
Additional considerations

• Adequate time to obtain license
• Abbreviated application process

28
Plasma for Manufacture

• Working together
• We can make it happen.