---
kind: "section"
citation: "21 C.F.R. § 210.2"
title: "21"
number: "210.2"
heading: "Applicability of current good manufacturing practice regulations."
url: "https://uscodex.org/cfr/21/210.2"
---

# §210.2. Applicability of current good manufacturing practice regulations.

- (a) The regulations in this part and in parts [211](/cfr/21/part211.md), [213](/cfr/21/part213.md), 225, and 226 of this chapter as they may pertain to a drug; in parts [600](/cfr/21/part600.md) through [680](/cfr/21/part680.md) of this chapter as they may pertain to a biological product for human use; and in [part 1271](/cfr/21/part1271.md) of this chapter as they are applicable to a human cell, tissue, or cellular or tissue-based product (HCT/P) that is regulated as a drug (subject to premarket review under an application submitted under [section 505](/cfr/21/505.md) of the act or under a biologics license application under section 351 of the Public Health Service Act); shall be considered to supplement, not supersede, each other, unless the regulations explicitly provide otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general.
- (b) If a person engages in only some operations subject to the regulations in this part and in parts [211](/cfr/21/part211.md), [213](/cfr/21/part213.md), 225, 226, 600 through 680, and 1271 of this chapter, and not in others, that person need only comply with those regulations applicable to the operations in which the person is engaged.
- (c) An investigational drug for use in a phase 1 study, as described in [§ 312.21(a)](/cfr/21/312.21.md?p=a) of this chapter, is subject to the statutory requirements set forth in [21 U.S.C. 351(a)(2)(B)](/usc/21/351.md?p=a-2-B). The production of such drug is exempt from compliance with the regulations in [part 211](/cfr/21/part211.md) of this chapter. However, this exemption does not apply to an investigational drug for use in a phase 1 study once the investigational drug has been made available for use by or for the sponsor in a phase 2 or phase 3 study, as described in § [312.21(b)](/cfr/21/312.21.md?p=b) and [(c)](/cfr/21/312.21.md?p=c) of this chapter, or the drug has been lawfully marketed. If the investigational drug has been made available in a phase 2 or phase 3 study or the drug has been lawfully marketed, the drug for use in the phase 1 study must comply with [part 211](/cfr/21/part211.md).

## Notes

### Amendments

[69 FR 29828, May 25, 2004, as amended at 73 FR 40462, July 15, 2008; 74 FR 65431, Dec. 10, 2009; 89 FR 51769, June 18, 2024]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 360ddd, 360ddd-1, 371, 374; 42 U.S.C. 216, 262, 263a, 264.

### Source

Source: 43 FR 45076, Sept. 29, 1978, unless otherwise noted.

### Amendments

[69 FR 29828, May 25, 2004, as amended at 73 FR 40462, July 15, 2008; 74 FR 65431, Dec. 10, 2009; 89 FR 51769, June 18, 2024]