21 CFR 1270.1 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Regulations Under Certain Other Acts Administered By The Food And Drug Administration (§ 1210.1 To Parts 1272-1299) — Human Tissue Intended For Transplantation (§ 1270.1 To § 1270.43) — General Provisions (§ 1270.1 And § 1270.3) — Scope.

(a) The regulations in this part apply to human tissue and to establishments or persons engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue.

(b) Regulations in this chapter as they apply to drugs, biologics, devices, or other FDA-regulated commodities do not apply to human tissue, except as specified in this part.

(c) Regulations in this chapter do not apply to autologous human tissue.

(d) Regulations in this chapter do not apply to hospitals or other clinical facilities that receive and store human tissue only for transplantation within the same facility.