Source: https://www.foodlawfirm.com/blog/guidance-for-industry-determination-of-status-as-a-qualified-facility/
Timestamp: 2020-04-09 20:38:38
Document Index: 489148450

Matched Legal Cases: ['art 117', 'art 507', 'art 117', 'art 117', 'art 117', 'art 117', 'art 507', 'art 507', 'art 507', 'art 507', 'art 117', 'art 507', 'art 117', 'art 507']

Guidance for Industry: Determination of Status as a Qualified Facility - Jason Foscolo PLLC Legal Counsel for Food and Farm Businesses, The Food Law Firm
Determination of Status as a Qualified Facility under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
The first regulation is established in 21 CFR part 117 and is entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (published in the Federal Register on September 17, 2015, 80 FR 55907). In the remainder of this guidance we refer to this regulation as “part 117.” Subparts A, B, and F of part 117 include current good manufacturing practice (CGMP) requirements for domestic and foreign facilities that manufacture, process, pack, or hold human food. Subparts A, C, D, E, F, and G of part 117 include requirements for domestic and foreign facilities that are required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d) to conduct a hazard analysis and implement risk-based preventive controls for human food (the human food preventive controls requirements).
The second regulation is established in 21 CFR part 507 and is entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (published in the Federal Register on September 17, 2015, 80 FR 56170). In the remainder of this guidance we refer to this regulation as “part 507.” For domestic and foreign facilities that are required to register under the FD&C Act, subparts A, B, and F of part 507 include CGMP requirements and subparts A, C, D, E, and F of part 507 include requirements to conduct a hazard analysis and implement risk-based preventive controls for animal food (the animal food preventive controls requirements).
A facility that meets the definition of a “qualified facility” in part 117 or part 507 is subject to CGMP requirements as well as the modified requirements described in 21 CFR 117.201 or in 21 CFR 507.7, respectively. These modified requirements include the requirement that the facility submit a form to FDA, attesting to its status as a qualified facility. Section II of this guidance explains how to determine whether your facility meets the definition of “qualified facility” under part 117 and how to submit Form FDA 3942a attesting to your status as a qualified facility that is subject to the modified requirements in 21 CFR 117.201. Section III of this guidance explains how to determine whether your facility meets the definition of “qualified facility” under part 507 and how to submit Form FDA 3942b attesting to your status as a qualified facility that is subject to the modified requirements in 21 CFR 507.7. The modified requirements also include a requirement that the facility attest to certain food safety practices. See 21 CFR 117.201(a)(2); 507.7(a)(2).
(taken from the FDA website)