[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.1]

[Page 682-683]
 
                        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 A--General Provisions
 
Sec. 1271.1  What are the purpose and scope of this part?


    (a) Purpose. The purpose of this part, in conjunction with 
Secs. 207.20(f), 210.1(c), 210.2, 807.20(d), and 820.1(a) of this 
chapter, is to create a unified registration and listing system for 
establishments that manufacture human cells, tissues, and cellular and 
tissue-based products (HCT/P's) and to establish donor-suitability, 
current good tissue practice,

[[Page 683]]

and other procedures to prevent the introduction, transmission, and 
spread of communicable diseases by HCT/P's.
    (b) Scope. (1) If you are an establishment that manufactures HCT/P's 
that are regulated solely under the authority of section 361 of the 
Public Health Service Act (the PHS Act), this part requires you to 
register and list your HCT/P's with the Food and Drug Administration's 
(FDA's) Center for Biologics Evaluation and Research and to comply with 
the other requirements contained in this part, whether or not the HCT/P 
enters into interstate commerce. Those HCT/P's that are regulated solely 
under the authority of section 361 of the PHS Act are described in 
Sec. 1271.10.
    (2) If you are an establishment that manufactures HCT/P's that are 
regulated as drugs, devices and/or biological products under section 351 
of the PHS Act and/or the Federal Food, Drug, and Cosmetic Act, 
Secs. 207.20(f) and 807.20(d) of this chapter require you to register 
and list your HCT/P's following the procedures in subpart B of this 
part. Sections 210.1(c), 210.2, 211.1(b), and 820.1(a) of this chapter 
require you to comply with the donor-suitability procedures in subpart C 
of this part and the current good tissue practice procedures in subpart 
D of this part, in addition to all other applicable regulations.