§4.3. What current good manufacturing practice requirements apply to my combination product?
21 C.F.R. § 4.3
If you manufacture a combination product, the requirements listed in this section apply as follows:
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;
The current good manufacturing practice requirements in part 820 of this chapter apply to a combination product that includes a device constituent part;
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;
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
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.
Notes, amendments, and revision history
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]