What current good manufacturing practice requirements apply to my combination product?
21 C.F.R. § 4.3
in effectEffective: 2024-07-01If 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;
(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; and
(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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026