[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.150]

[Page 731-733]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS--Table of Contents
 
                 Subpart D_Current Good Tissue Practice
 
Sec. 1271.150  Current good tissue practice requirements.

    (a) General. This subpart D and subpart C of this part set forth 
current good tissue practice (CGTP) requirements. You must follow CGTP 
requirements to prevent the introduction, transmission, or spread of 
communicable diseases by HCT/Ps (e.g., by ensuring that the HCT/Ps do 
not contain communicable disease agents, that they are not contaminated, 
and that they do not become contaminated during manufacturing). 
Communicable diseases include, but are not limited to, those transmitted 
by viruses, bacteria, fungi, parasites, and transmissible spongiform 
encephalopathy agents. CGTP requirements govern the methods used in, and 
the facilities and controls used for, the manufacture of HCT/Ps, 
including but not limited to all steps in recovery, donor screening, 
donor testing, processing, storage, labeling, packaging, and 
distribution. The CGTP provisions specifically governing determinations 
of donor eligibility, including donor screening and testing, are set out 
separately in subpart C of this part.
    (b) Core CGTP requirements. The following are core CGTP 
requirements:
    (1) Requirements relating to facilities in Sec. 1271.190(a) and 
(b);
    (2) Requirements relating to environmental control in Sec. 
1271.195(a);
    (3) Requirements relating to equipment in Sec. 1271.200(a);

[[Page 732]]

    (4) Requirements relating to supplies and reagents in Sec. 
1271.210(a) and (b);
    (5) Requirements relating to recovery in Sec. 1271.215;
    (6) Requirements relating to processing and process controls in 
Sec. 1271.220;
    (7) Requirements relating to labeling controls in Sec. 1271.250(a) 
and (b);
    (8) Requirements relating to storage in Sec. 1271.260 (a) through 
(d);
    (9) Requirements relating to receipt, predistribution shipment, and 
distribution of an HCT/P in Sec. 1271.265(a) through (d); and
    (10) Requirements relating to donor eligibility determinations, 
donor screening, and donor testing in Sec. Sec. 1271.50, 1271.75, 
1271.80, and 1271.85.
    (c) Compliance with applicable requirements--(1) Manufacturing 
arrangements (i) If you are an establishment that engages in only some 
operations subject to the regulations in this subpart and subpart C of 
this part, and not others, then you need only comply with those 
requirements applicable to the operations that you perform.
    (ii) If you engage another establishment (e.g., a laboratory to 
perform communicable disease testing, or an irradiation facility to 
perform terminal sterilization), under a contract, agreement, or other 
arrangement, to perform any step in manufacture for you, that 
establishment is responsible for complying with requirements applicable 
to that manufacturing step.
    (iii) Before entering into a contract, agreement, or other 
arrangement with another establishment to perform any step in 
manufacture for you, you must ensure that the establishment complies 
with applicable CGTP requirements. If, during the course of this 
contract, agreement, or other arrangement, you become aware of 
information suggesting that the establishment may no longer be in 
compliance with such requirements, you must take reasonable steps to 
ensure the establishment complies with those requirements. If you 
determine that the establishment is not in compliance with those 
requirements, you must terminate your contract, agreement, or other 
arrangement with the establishment.
    (2) If you are the establishment that determines that an HCT/P meets 
all release criteria and makes the HCT/P available for distribution, 
whether or not you are the actual distributor, you are responsible for 
reviewing manufacturing and tracking records to determine that the HCT/P 
has been manufactured and tracked in compliance with the requirements of 
this subpart and subpart C of this part and any other applicable 
requirements.
    (3) With the exception of Sec. Sec. 1271.150(c) and 1271.155 of 
this subpart, the regulations in this subpart are not being implemented 
for reproductive HCT/Ps described in Sec. 1271.10 and regulated solely 
under section 361 of the Public Health Service Act and the regulations 
in this part, or for the establishments that manufacture them.
    (d) Compliance with parts 210, 211, and 820 of this chapter. With 
respect to HCT/Ps that are drugs (subject to review under an application 
submitted under section 505 of the Federal Food, Drug, and Cosmetic Act 
or under a biological product license application under section 351 of 
the Public Health Service Act) or that are devices (subject to premarket 
review or notification under the device provisions of the act or under a 
biological product license application under section 351 of the Public 
Health Service Act), the procedures contained in this subpart and in 
subpart C of this part and the current good manufacturing practice 
regulations in parts 210 and 211 of this chapter and the quality system 
regulations in part 820 of this chapter supplement, and do not 
supersede, each other unless the regulations explicitly provide 
otherwise. In the event that a regulation in part 1271 of this chapter 
is in conflict with a requirement in parts 210, 211, or 820 of this 
chapter, the regulations more specifically applicable to the product in 
question will supersede the more general.
    (e) Where appropriate. When a requirement is qualified by ``where 
appropriate,'' it is deemed to be ``appropriate'' unless you can 
document justification otherwise. A requirement is ``appropriate'' if 
nonimplementation of the requirement could reasonably be expected to 
result in the HCT/P not meeting its specified requirements related to 
prevention of introduction, transmission, or spread of communicable 
diseases, or in your inability to

[[Page 733]]

carry out any necessary corrective action.