Regulations last checked for updates: Feb 07, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 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]
authority: 21 U.S.C. 321,331,351,352,353,355,360,360b-360f,360h-360j,360l,360hh-360ss,360aaa-360bbb,360ddd,360ddd-1,371,372,379e,381,383,394; 42 U.S.C. 216,262,263a,264,271
source: 78 FR 4321, Jan. 22, 2013, unless otherwise noted.
cite as: 21 CFR 4.3