21 CFR 117.5 - Exemptions

What it says

Section 117.5 lists facilities and activities that are exempt from some or all of 21 CFR Part 117. Examples include facilities that are not required to register with FDA, certain activities carried out by farms, food covered by the seafood, juice and low-acid canned food regulations for the hazards those rules address, and dietary supplements covered by their own cGMP rule. Other facilities are not exempt but have modified requirements, for example qualified facilities.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• An exemption usually applies to specific parts of the rule rather than to everything. A facility can be exempt from the preventive controls requirements and still have to follow the current good manufacturing practice requirements.
• Exemptions depend on the facts, such as the type of food, the activities performed and the hazards covered by another regulation, so they have to be reassessed when the product mix or operations change.
• Where an exemption covers only certain hazards, for example those addressed by a seafood or juice HACCP rule, the facility is still responsible for the other hazards.

What FDA inspectors look for

• Whether the basis for each exemption claimed is documented and still accurate for the current products and activities.
• Whether activities that fall outside an exemption are covered by the full requirements.
• Whether mixed-type facilities apply the right requirements to each of their activities.

Related regulations