Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Search for FDA Guidance Documents

Search for FDA Guidance Documents

                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents Home
          Regulatory Information
          Search for FDA Guidance Documents
          Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal FoodSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food
					
		
		November 2017


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
	Share
    Post
    Linkedin

    Email
    PrintDocket Number:
		    FDA-2017-D-5996
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine
          Center for Food Safety and Applied Nutrition


This guidance is intended for persons who participate in certain “co-manufacturing” agreements in the production of human or animal food. By “co-manufacturing,” we mean a contractual arrangement whereby one party (the brand owner) arranges for a second party (the co-manufacturer) to manufacture/process human or animal food on behalf of the first party.

FDA has established requirements for a supply-chain program for raw materials and other ingredients for which a receiving facility has identified a hazard requiring a supply-chain-applied control in two regulations. The first regulation, which we established in 21 CFR part 117, is entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (“part 117”). The second regulation, which we established in 21 CFR part 507, is entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (“part 507”). Also, in our regulation entitled “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (FSVP regulation; established in 21 CFR part 1, subpart L) we established that an importer that is a receiving facility is deemed to be in compliance with most of the requirements of the FSVP regulation for a food it imports, as long as the importer is in compliance with the supply-chain program requirements of part 117 or part 507 rule for that food. When an importer that is a receiving facility is in compliance with the supply-chain program requirements, the only requirement of the FSVP regulation that applies is the requirement for importer identification at entry (21 CFR 1.509). Current industry co-manufacturing arrangements may include a supply-chain program established and implemented by the brand owner, the co-manufacturer, or both. This guidance advises such persons of specific circumstances in which FDA does not intend to take enforcement action regarding a co-manufacturer’s compliance with the supply-chain program requirements.

Not all co-manufacturers are required to have supply-chain programs. If there are no hazards requiring supply-chain-applied controls in the raw materials and other ingredients used by a co-manufacturer, then the co-manufacturer does not need a supply-chain program, and this guidance is not applicable. This guidance is applicable when the brand owner approves and specifies to the co-manufacturer which suppliers must be used and there is a hazard that requires a supply-chain-applied control. Note, the brand owner is not considered the supplier of the co-manufacturer under the regulations if the brand owner does not manufacture/process the food, raise the animal, or grow the food that is provided to the co-manufacturer.

We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 CFR 10.115). This guidance is immediately effective because FDA has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word *should*in FDA guidances means that something is suggested or recommended, but not required.

**Download the Guidance**

Related Information

FSMA Rules & Guidance for IndustrySubmit Comments
	   		  			    		Submit Comments Online
					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2017-D-5996.

                                                                                  Content current as of:
      11/06/2017
         
                  
Regulated Product(s)
		 Food & BeveragesLaw(s) & Regulation(s)
			  Food Safety Modernization ActSearch for FDA Guidance Documents

        Search for FDA Guidance Documents

          
                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop