21 CFR PART 1270 HUMAN TISSUE INTENDED FOR TRANSPLANTATION

Authority: Secs. 215, 311, 361, 368 of the Public Health Service Act (42 U.S.C. 216, 243, 264, 271).

Section 1270.1 Scope.

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

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

Section 1270.3 Definitions.

(a) Act for the purpose of this part means the Public Health Service Act, section 361 (42 U.S.C. 264).

(b) Banked human tissue means any tissue derived from a human body, which:

(1) Is intended for administration to another human for the diagnosis, cure, mitigation, treatment, or prevention of any condition or disease;

(2) Is recovered, processed, stored, or distributed by methods not intended to change tissue function or characteristics;

(3) Is not currently regulated as a human drug, biological product, or medical device;

(4) Excludes kidney, liver, heart, lung, pancreas, or any other vascularized human organ; and

(5) Excludes semen or other reproductive tissues, human milk, and bone marrow.

(d) Donor means a human being, living or dead, who is the source of tissue for transplantation.

(e) Recovery means the obtaining from a donor of tissue that is intended for use in human transplantation.

(f) Processing means any activity to prepare, preserve for storage, and/or remove from storage to assure the potency, quality and/or sterility of human tissue for transplantation.

(g) Distribution includes any transfer of human tissue from one establishment or individual to another establishment or individual (including importation), whether or not such transfer is entirely intrastate and whether or not possession of the tissue is taken.

(h) Storage means holding tissue in any facility other than the facility at which the tissue is to be implanted.

(i) Quarantine means the identification of banked human tissue as not suitable for transplantation or the holding of banked human tissue in an area clearly identified as being for quarantine.

Section 1270.5 Donor testing and screening.

(a) Donor blood specimens shall be tested for the following communicable disease serological markers by tests approved for such uses by the Food and Drug Administration:

(1) Human immunodeficiency virus-1 antibody (anti-HIV-1);

(2) Human immunodeficiency virus-2 antibody (anti-HIV-2);

(3) Hepatitis B surface antigen (HBsAg); and

(4) Hepatitis C virus antibody (anti-HCV).

(b) Such infectious disease testing shall be performed by a laboratory appropriately certified under the Clinical Laboratories Improvement Act of 1988 (CLIA).

(c) Banked human tissue shall be quarantined or accompanied by records indicating that the donor's blood has been tested and found negative in approved tests for anti-HIV-1, anti-HIV-2, HBsAg, and anti-HCV.

(d) Banked human tissue shall be quarantined from donors who, within 48 hours prior to taking the blood sample, have been transfused with four or more units of blood, blood components, colloids or crystalloids in adults, or any transfusions within 48 hours in children under 12 years of age, unless:

(1) A pretransfusion blood sample is available for infectious disease testing; or

(2) An adequate algorithm is used to ensure that there is not hemodilution sufficient to alter test results.

(e) Determination that a donor of banked human tissue intended for transplantation is suitable shall include ascertainment of the donor's identity and adequately completed and accurately recorded relevant medical history which assures freedom from risk factors for or clinical evidence of hepatitis B, hepatitis C, or HIV infection. For corneal retrieval which occurs under authorization of a specific State or territorial law the relevant medical history shall include all available medical, coroner, and autopsy records.

(f) Banked human tissue for transplantation shall be quarantined or accompanied by records of the donor's relevant medical history as defined in paragraph (e) of this section which assure freedom from risk factors for or clinical evidence of hepatitis B, hepatitis C, or HIV infection.

Section 1270.7 Written procedures.

(a) There shall be written procedures prepared and followed for all significant steps in the infectious disease testing process under Section 1270.5 which shall conform to manufacturers' instructions for use contained in the package inserts for the required test kits. These procedures shall be readily available to the personnel in the area where the procedures are performed, unless impractical. Any deviation from the written procedures shall be recorded and justified.

(b) There shall be written procedures prepared and followed for all significant steps for determining the medical history of the donor as provided in Section 1270.5. Such procedures shall be readily available to personnel who may perform the procedures.

Any deviation from the written procedures shall be recorded and justified.

(c) In conformity with this section, any facility may use current standard written procedures such as those in a technical manual prepared by another organization, provided the procedures are consistent with and at least as stringent as the requirements of this part.

Section 1270.9 Records, general requirements.

(a) Records shall be maintained concurrently with the performance of each significant step required in this part in the performance of infectious disease screening and testing of donors of human tissue for transplantation. All records shall be accurate and indelible and legible. The records shall identify the person performing the work, the dates of the various entries, and shall be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular tissue involved.

(b) All banked human tissue shall be quarantined until:

(1) All infectious disease testing under Section 1270.5 has been completed, reviewed by a responsible official, and found to be negative;

(2) Donor screening has been completed, reviewed by a responsible official, and determined to assure freedom from risk factors for or clinical evidence of hepatitis B, hepatitis C, or HIV infection; and

(3) Copies of the testing and screening records accompany the tissue.

(c) All records, or true copies of such records, required under this part shall be readily available for authorized inspection at any establishment or from any individual that recovers, processes, stores, or distributes banked human tissue. Records that can be immediately retrieved from another location by electronic means meet the requirements of this paragraph.

(d) Records required under this part may be retained electronically, or as original paper records, or as true copies such as photocopies, microfiche, or microfilm, in which case suitable reader and photocopying equipment shall be readily available.

(e) Records shall be retained for no less than 10 years.

Section 1270.11 Specific records.

Records shall be maintained which include:

(a) Results and interpretation of all required infectious disease tests and retests.

(b) The destruction or other disposition of unsuitable banked human tissue.

(c) Information on the identity and medical history of the donor, as required by Section 1270.5(e) in English or, if in another language, accompanied by a verified translation.

Section 1270.13 Inspections.

(a) An establishment covered by regulations in this part shall permit authorized representatives of the Food and Drug Administration to make at any reasonable time such inspection of the establishment, its facilities, equipment, processes, products, and records as may be necessary in the judgment of such representatives to determine compliance with the provisions of this part. Inspections may be made with or without notice and will ordinarily be made during regular business hours.

(b) Frequency of inspection will be based upon the compliance history of the establishment and at the agency's discretion.

(c) The inspector shall call upon the acting head of the establishment and may question the personnel of the establishment as the inspector deems necessary.

(d) The inspector may review and copy any records required to be kept pursuant to part 1270.

(e) Ordinarily, records containing the name or other positive identification of donors or recipients of human tissue will not be copied unless the identification is suitably expurgated.

However, such information may be copied if necessary, such as to document distribution of potentially infectious tissue.

Section 1270.15 Recall and destruction of banked human tissue.

(a) Upon a finding that banked human tissue may be in violation of the regulations in this part, an authorized Food and Drug Administration (FDA) representative may:

(1) Serve upon the person who distributed the tissue a written order that the tissue be recalled or destroyed, as appropriate, and upon persons in possession of the tissue that the tissue shall be retained until it is recalled by the distributor, destroyed, or disposed of as agreed by FDA, or the safety of the tissue is confirmed; and

(2) Take possession of and/or destroy the violative tissue.

(b) The written order will ordinarily provide that the human tissue be recalled or destroyed with 5 days from the date of receipt of the order and will recite with particularity the facts which justify the order.

(c) After receipt of an order under this part, the person in possession of the human tissue shall not distribute or dispose of the tissue in any manner except to recall and destroy it consistent with the provisions of the order, under the supervision of an authorized official of FDA.

(d) In lieu of paragraphs (b) and (c) of this section, other arrangements for assuring the proper disposition of the tissue may be agreed upon by the person receiving the written order and an authorized official of FDA. Such arrangements may include providing FDA with records or other written information that adequately assure that the tissue has been recovered, processed, stored, and distributed in conformance with this part.

(e) Within 5 days of receipt of a written order for recall or destruction of tissue (or within 5 days of the agency's possession of such tissue), the recipient of the written order or prior possessor of such tissue, may request a hearing on the matter in accordance with part 16 of this chapter.