[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2006] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR1271] [Page 720-722] 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? Subpart A_General Provisions Sec. 1271.1 What are the purpose and scope of this part? 1271.3 How does FDA define important terms in this part? 1271.10 Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do? 1271.15 Are there any exceptions from the requirements of this part? 1271.20 If my HCT/P's do not meet the criteria in Sec. 1271.10, and I do not qualify for any of the exceptions in Sec. 1271.15, what regulations apply? Subpart B_Procedures for Registration and Listing 1271.21 When do I register, submit an HCT/P list, and submit updates? [[Page 721]] 1271.22 How and where do I register and submit an HCT/P list? 1271.25 What information is required for establishment registration and HCT/P listing? 1271.26 When must I amend my establishment registration? 1271.27 Will FDA assign me a registration number? 1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings? Subpart C_Donor Eligibility 1271.45 What requirements does this subpart contain? 1271.47 What procedures must I establish and maintain? 1271.50 How do I determine whether a donor is eligible? 1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I maintain? 1271.60 What quarantine and other requirements apply before the donor- eligibility determination is complete? 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited? 1271.75 How do I screen a donor? 1271.80 What are the general requirements for donor testing? 1271.85 What donor testing is required for different types of cells and tissues? 1271.90 Are there exceptions from the requirement of determining donor eligibility, and what labeling requirements apply? Subpart D_Current Good Tissue Practice 1271.145 Prevention of the introduction, transmission, or spread of communicable diseases. 1271.150 Current good tissue practice requirements. 1271.155 Exemptions and alternatives. 1271.160 Establishment and maintenance of a quality program. 1271.170 Personnel. 1271.180 Procedures. 1271.190 Facilities. 1271.195 Environmental control and monitoring. 1271.200 Equipment. 1271.210 Supplies and reagents. 1271.215 Recovery. 1271.220 Processing and process controls. 1271.225 Process changes. 1271.230 Process validation. 1271.250 Labeling controls. 1271.260 Storage. 1271.265 Receipt, predistribution shipment, and distribution of an HCT/ P. 1271.270 Records. 1271.290 Tracking. 1271.320 Complaint file. Subpart E_Additional Requirements for Establishments Described in 1271.10 1271.330 Applicability. 1271.350 Reporting. 1271.370 Labeling. Subpart F_Inspection and Enforcement of Establishments Described in 1271.10 1271.390 Applicability. 1271.400 Inspections. 1271.420 HCT/Ps offered for import. 1271.440 Orders of retention, recall, destruction, and cessation of manufacturing. Authority: 42 U.S.C. 216, 243, 263a, 264, 271. Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted. (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 722]] 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]