The Food and Drug Administration has released guidance for supply-chain programs in co-manufacturing agreements for the production of human or animal food.

The guidance applies to raw materials and other ingredients for which a receiving facility has identified a hazard requiring a supply-chain-applied control. The guidance does not apply if there are no hazards requiring supply-chain-applied controls in the raw materials or other ingredients used by a co-manufacturer. The guidance applies when the brand owner specifies which suppliers must be used, and there is a hazard that requires a supply-chain-applied control.

The regulations are established in 21 CFR Part 117 and 21 CFR Part 507. The guidance is immediately effective, because FDA has determined that prior public participation is not feasible or appropriate.