Plasma for fractionation, Australian Red Cross Lifeblood, CON-1111
Product name
Plasma for fractionation
Sponsor name
Australian Red Cross Lifeblood
ARTG
Consent start
Consent no.
CON-1111
Standard
Therapeutic Goods (Standard for Human Cell and Tissue Products'”Donor Screening Requirements) (TGO 108) Order 2021; Part 2 Section 10 (9) , particularly Item 12 in Schedule 1 of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The product will be collected from donors which do not comply with these
requirements for donor deferral but will be able to be collected from anyone
reporting the following activities in the past 3-months: ' for male donors:
male-to-male sex ' for female donors: sex with a man who has ever had sex with a
man ' for transgender donors: sexual contact with a male ' sex work ' sexual
contact with a sex worker (male or female) ' overseas sexual contact with a
resident of a HIV high prevalence country ' sexual contact with a new partner
from a HIV high prevalence country ' sexual contact with an injecting drug user
(current or past) but does not include the current deferral for sexual contact
with a partner known to be infected with a blood-borne virus (HIV, HBV, HCV or
HTLV) i.e. this deferral with be maintained.
Conditions imposed
1. That Lifeblood continues to monitor the literature and informs the
Therapeutics Goods Administration of any new evidence that substantively alters
the estimated risks, such that they become unacceptable.
2. That Lifeblood does not implement the change for plasma for fractionation
until CSL Behring (CSLB) have submitted a variation to Therapeutics Goods
Administration for the change and subsequently received approval from
Therapeutics Goods Administration for the change.
Therapeutic product type
Blood, tissues, and biologicals