part_subject: "REGULATION OF COMBINATION PRODUCTS"
subpart_code: "A"
subpart_subject: "Current Good Manufacturing Practice Requirements for Combination Products"
section_number: "4.3"
section_subject: "What current good manufacturing practice requirements apply to my combination product?"
cfr_reference: "21 CFR 4.3"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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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;
(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.