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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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FDA Registration and Exemptions

Title 21 Part 607 discusses establishment registration. Facilities that manufacture blood components must register with the FDA and provide a listing of all blood products that are manufactured. Registration is required annually between November 15 and December 31 and the product listing information must be updated every June and December.
An exemption is made for transfusion services that perform compatibility testing and transfusion of blood and blood components, but do not routinely collect or process blood and blood components. The exempt transfusion service must be part of a facility certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) or must meet equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS). Note that the collection and processing of blood and blood components in an emergency situation (determined by a responsible person and documented in writing), therapeutic collection of blood or plasma, the preparation of recovered human plasma for further manufacturing use, or preparation of red blood cells for transfusion are not acts requiring establishment registration.