REGULATORY UPDATE: FDA Issues Technical Amendment

September 07, 2021

In a recent Technical Amendment, the Food and Drug Administration (FDA) took action to amend an incorrect regulatory citation in the May 2015 final rule, Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use. The correction applies to 21 CFR 610.40(h)(2)(vii), which provides an exception to “use source plasma from a donor who tests reactive by a screening test for syphilis” as specified in the regulation.

The agency stated that, “In section 610.40(h)(2)(vii), as amended by the May 2015 final rule, FDA inadvertently cited section 640.65(a)(2)(ii). The reference to section 640.65(a)(2)(ii) is an incorrect citation. Accordingly, FDA is removing the reference to section 640.65(a)(2)(ii).”

In addition, to improve the clarity of the regulation, the agency amended 610.40(h)(2)(vii) to replace the reference to section 640.65(b)(2)(i) through (iv) with a reference to § 640.65(b)(2)(ii) through (iv). This clarification aligns the regulation with the preamble of the May 2015 final rule.

The agency noted that donor protein component assessment is required for plasmapheresis procedures regardless of whether or not the syphilis screening requirements are applicable.

Please contact regulatory@aabb.org with questions.