Code of Federal Regulations Title 21. Food and Drugs § 21.1270.35 Specific records

(a) Documentation of results and interpretation of all required infectious disease tests;

(b) Information on the identity and relevant medical records of the donor, as required by § 1270.21(e) in English or, if in another language translated to English and accompanied by a statement of authenticity by the translator which specifically identifies the translated document;

(c) Documentation of the receipt and/or distribution of human tissue;  and

(d) Documentation of the destruction or other disposition of human tissue.