# Presentation: 001475

## Blood Products Advisory Committee

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

## AABB Task Force on Recovered Plasma

**AABB**
**ABC**
**ARC**
**BCA**
**ASBPO**

## Background – Recovered Plasma

**Outdated terminology**
**Outdated system of regulation**

## Proposed Licensing Requirements

## Product Name

**Plasma for Manufacture**

## 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”**

## Method of Preparation

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

## Method of Preparation, cont’d

**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**

## Expiration Date

**	****	****  ****2 years from date of collection**

## 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**

## Labeling: Product Name

**“****Plasma for Manufacture”**

## Labeling: Statement of Freezing Time

**“****Frozen Within _____ Hours After Phlebotomy”**

## Labeling: Caution Statement

**“****Caution: For Manufacturing Use Only into Injectable Products”**

## Labeling: Product Code

**From Uniform Labeling Guidelines or ISBT 128**

## Labeling: Amount

**	****	**
**	****	****Total volume or weight of plasma**

## Labeling: For Whole Blood-Derived Plasma for Manufacture

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

## Labeling: For Plasma for Manufacture Collected by Plasmapheresis

**Total type and volume of anticoagulant used**

## Labeling: Storage Temperature

**-18C or colder**

## Labeling: Facility Identification

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

## Labeling: Testing Statement

**“****Negative by FDA required tests”**

## Labeling: Collection Date

**Month, date and year**

## Component Retrieval

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

## Records

**	****	****	****Retained for 10 years**

## Freezing

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

## Short Supply Agreements

**No longer necessary when Plasma for Manufacture becomes available**

## 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**

## Additional considerations

**Adequate time to obtain license**
**Abbreviated application process**

## Plasma for Manufacture

**Working together...**
**We can make it happen.**