---
kind: "section"
citation: "21 C.F.R. § 1271.1"
title: "21"
number: "1271.1"
heading: "What are the purpose and scope of this part?"
url: "https://uscodex.org/cfr/21/1271.1"
---

# §1271.1. What are the purpose and scope of this part?

- (a) **Purpose.** The purpose of this part, in conjunction with §§ [207.9(a)(5)](/cfr/21/207.9.md?p=a-5), [210.1(c)](/cfr/21/210.1.md?p=c), [210.2](/cfr/21/210.2.md), [807.20(d)](/cfr/21/807.20.md?p=d), and [820.1(a)](/cfr/21/820.1.md?p=a) of this chapter, is to create an electronic 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 [§ 1271.10](/cfr/21/1271.10.md).
  - (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, §§ [207.9(a)(5)](/cfr/21/207.9.md?p=a-5) and [807.20(d)](/cfr/21/807.20.md?p=d) of this chapter require you to register and list your HCT/P's following the procedures in [part 207](/cfr/21/part207.md) (if a drug and/or biological product) of this chapter or [part 807](/cfr/21/part807.md) (if a device) of this chapter. Sections [210.1(c)](/cfr/21/210.1.md?p=c), [210.2](/cfr/21/210.2.md), [211.1(b)](/cfr/21/211.1.md?p=b), and [820.1(a)](/cfr/21/820.1.md?p=a) of this chapter require you to comply with the donor-eligibility procedures in [subpart C](/cfr/21/subpartC.md) of this part and the current good tissue practice procedures in [subpart D](/cfr/21/subpartD.md) of this part, in addition to all other applicable regulations.

## Notes

### Amendments

[66 FR 5466, Jan. 19, 2001, as amended at 69 FR 29829, May 25, 2004; 81 FR 60223, Aug. 31, 2016]

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.

### Amendments

[66 FR 5466, Jan. 19, 2001, as amended at 69 FR 29829, May 25, 2004; 81 FR 60223, Aug. 31, 2016]