Preventive Control Rule – 21 Code of Federal Regulations Part 117
The Preventive Control Rule forHuman food establishes requirements for facilities that manufacture,process, pack, or hold food for consumption.
The primary assessment forcompanies as to whether they are subject to the Preventive Control Rule is therequirement to register with FDA as a food facility, known as Registration ofFood Facilities (http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/default.htm).
If your facility is required toregister, the facility is subject to the Preventive Control Rules, unless thefacility qualifies for an exemption listed within the actual rule.
DSHS Foods Group has put togethera flow diagram to assist companies in determining whether the facility may besubject to the rule.
FDA’s New Preventive Control Rule(21 CFR Part 117) Who is Subject??? Who is Exempt???
FDA has an excellent PreventiveControl website with resources for industry.
Texas Department of State Health Services (DSHS) will be hosting a FSPCA Preventive Controls for Human Food course April 23-25, 2019 in Denton, Texas at the University of North Texas campus University Gateway Center, 801 N Texas Blvd, Denton, TX 76201.
The course begins at 8:30 AM on Tuesday April 23rd and ends at 5:00 PM Thursday April 25th.
The cost of the course is $50. To register and pay certificate fee for the course click the link below:
You can purchase the course book here: http://bookstorefspca.ifpti.org/index.php/course-materials.html
For more information, please email Davonna.Koebrick@dshs.texas.gov.
Food Safety Plan Builder - New!
Guidance for Industry: SeafoodHACCP and the FDA Food Safety Modernization Act - New!
Guidance for Industry: JuiceHACCP and the FDA Food Safety Modernization Act - New!
Guidance for Industry: Low-AcidFoods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDAFood Safety Modernization Act - New!
Guidance for Industry: Application of the Foreign Supplier Verification ProgramRegulation to the Importation of Live Animals - New!
Draft Guidance for Industry: Determining the Number of Employees for Purposes of the“Small Business” Definition in Parts 117 and 507 - New!
Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers ofFood for Humans and Animals - New!
Guidance for Industry: Application of the Foreign Supplier Verification ProgramRegulation to Importers of Grain Raw Agricultural Commodities - New!
Draft Guidance for Industry: Considerations for Determining Whether a Measure Providesthe Same Level of Public Health Protection as the Corresponding Requirement in21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 - New!
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls forHuman Food; Chapter 15: Supply-Chain Program for Human Food Products - New!
Guidance for Industry: #245 - Hazard Analysis and Risk-Based Preventive Controlsfor Food for Animals - New!
Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment orForeign Government - New!
Guidance for Industry: Supply-Chain Program Requirements and Co-ManufacturerSupplier Approval and Verification for Human Food and Animal Food - New!
Guidance for Industry: Current Good Manufacturing Practice Requirements for Foodfor Animals - New!
Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts117 and 507 - New!