Regulation .04 Incorporation by Reference.
Regulation .04 Incorporation by Reference.LinkCopy Citation
A.
In this chapter, the following documents are incorporated by reference.
B.
Documents Incorporated.
(1)
Standards for Tissue Banking (American Association of Tissue Banks, 14th Edition), Sections C, D, E, F, G, H, J, K, L, and M1-8 only;
(2)
Standards for Blood Banks and Transfusion Services [(American Association of Blood Banks, 29th Edition);] (Association for the Advancement of Blood & Biotherapies), 34th Edition;
(3)
International Quality Plasma Program (IQPP) (Plasma Protein Therapeutics Association):
(a)
Community-based Donor Standard V5 (2020);
(b)
Cross Donation Management Standard V3 (2014);
(c)
Recording Donor Adverse Events V2 (2018);
(d)
Donor Education Standard V3 (2014);
(e)
Donor Fluid Administration Standard V1 (2014);
(f)
Use of National Donor Deferral Registry Standard V3 (2008);
(g)
Qualified Donor Standard V5 (2020);
(h)
Viral Marker Standard V5 (2022);
(i)
Personnel Education and Training Standard V5 (2019);
(j)
Plasma Collection Facility Standard V4 (2019);
(k)
Quality Assurance Standard V5 (2020); and
(4)
42 U.S.C. §§1320d et seq., as amended;
(5)
42 U.S.C. §§17921 et seq., as amended; and
(6)
45 CFR Parts 160, 162, and 164, as amended.