---
kind: "section"
citation: "21 C.F.R. § 4.3"
title: "21"
number: "4.3"
heading: "What current good manufacturing practice requirements apply to my combination product?"
url: "https://uscodex.org/cfr/21/4.3"
---

# §4.3. What current good manufacturing practice requirements apply to my combination product?


If you manufacture a combination product, the requirements listed in this section apply as follows:

- (a) The current good manufacturing practice requirements in parts [210](/cfr/21/part210.md) and [211](/cfr/21/part211.md) of this chapter apply to a combination product that includes a drug constituent part other than a medical gas;
- (b) The current good manufacturing practice requirements in [part 820](/cfr/21/part820.md) of this chapter apply to a combination product that includes a device constituent part;
- (c) The current good manufacturing practice requirements among the requirements (including standards) for biological products in parts [600](/cfr/21/part600.md) through [680](/cfr/21/part680.md) of this chapter apply to a combination product that includes a biological product constituent part to which those requirements would apply if that constituent part were not part of a combination product;
- (d) The current good tissue practice requirements including donor eligibility requirements for HCT/Ps in [part 1271](/cfr/21/part1271.md) of this chapter apply to a combination product that includes an HCT/P; and
- (e) The current good manufacturing practice requirements in [part 213](/cfr/21/part213.md) of this chapter apply to a combination product that includes a drug constituent part that is a medical gas.

## Notes

### Amendments

[78 FR 4321, Jan. 22, 2013, as amended at 89 FR 51766, June 18, 2024]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 360ddd, 360ddd-1, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.

### Source

Source: 78 FR 4321, Jan. 22, 2013, unless otherwise noted.

### Amendments

[78 FR 4321, Jan. 22, 2013, as amended at 89 FR 51766, June 18, 2024]