BLOOD Centers Act

The BLOOD Centers Act mandates the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to establish an expedited process for approving certain supplemental applications submitted by blood centers. This process is specifically designed for blood centers that wish to add an apheresis collection device to an existing biologics license application (BLA) at a location not previously licensed for such a device. Under this expedited procedure, the Secretary must approve the supplemental application within 30 days of its submission. Approval can only be withheld if there are specific concerns about the safety, purity, or potency of products at the location, or if the operator has a systemic failure to meet standards. To be eligible, the blood center owner or operator must hold a BLA for at least one site and either have BLA approval at three or more FDA-registered locations or be accredited and in good standing by an approved blood collection organization.