21 CFR § 4.3 - What current good manufacturing practice requirements apply to my combination product?

---
identifier: "/us/cfr/t21/s4.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 4.3 - What current good manufacturing practice requirements apply to my combination product?"
title_number: 21
title_name: "Food and Drugs"
section_number: "4.3"
section_name: "What current good manufacturing practice requirements apply to my combination product?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "4"
part_name: "REGULATION OF COMBINATION PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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."
regulatory_source: "78 FR 4321, Jan. 22, 2013, unless otherwise noted."
cfr_part: "4"
---


# 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 and 211 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 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 through 680 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 of this chapter apply to a combination product that includes an HCT/P; and

(e) The current good manufacturing practice requirements in part 213 of this chapter apply to a combination product that includes a drug constituent part that is a medical gas.

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