[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 713-714]
 
                        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 
 
                      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 
Sec. Sec.  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-eligibility, 
current good tissue practice, 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, 
Sec. Sec.  207.20(f) and

[[Page 714]]

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-eligibility 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.

[66 FR 5466, Jan. 19, 2001, as amended at 69 FR 29829, May 25, 2004]