In general, a foreign or domestic facility that manufactures, processes, packs, or holds human food for consumption in the United States and that has to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic Act is subject to the requirements related to preventive controls (primarily located in subpart C and subpart G) of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR part 117; 80 Fed. Reg. 55908) (CGMP & PC rule), unless subject to an exemption (see 21 CFR § 117.5 for exemptions). Note that an establishment may also be subject to the Current Good Manufacturing Practice (CGMP) requirements in subpart B; those requirements are not dependent on whether a facility is required to register.
If a research and development (R&D)/pilot plant or test kitchen is a facility required to register (see 21 CFR § 1.225 , it will be subject to the requirements of the CGMP & PC rule, unless an exemption applies (see 21 CFR § 117.5 for exemptions).
Food used in R&D or as product samples is “food” for purposes of the food facility registration requirements of section 415 of the FD&C Act (see 21 CFR Part 1, subpart H). Accordingly, a facility that manufactures/processes, packs, or holds food used in R&D or as product samples is required to register with FDA. However, if the food is not for consumption in the United States by humans or animals, the facility is not required to register (see FDA’s Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) – Revised, Answer to Question C.2.11: “Are facilities that manufacture/process, pack, or hold food used in research and development or as food samples required to register with FDA?”).
If an R&D/pilot plant is not required to register with FDA, it not subject to the requirements of subpart C (Hazard Analysis and Risk-Based Preventive Controls) and subpart G (Supply-Chain Program) of the CGMP & PC rule. However, the R&D/pilot plant could still be subject to the requirements of subpart B (Current Good Manufacturing Practice (CGMP)) of the CGMP & PC rule.
