FSMA Supply Chain Programs for the Dietary Supplement Industry
Dietary supplement manufacturers and raw material suppliers are not exempt from all the requirements of 21 CFR 117 and may be required to have a written supply chain plan. This course focuses on the key obligations under 21 CFR 117 subpart G that are on products with a Nutrition Facts label.
Although dietary supplement manufacturers may be exempt from the preventative controls and supply chain program requirements of 21 CFR 117, raw material suppliers are not and many dietary supplement companies also manufacture products, such as meal replacements that are foods. These companies are not exempt and are required to have a written supply chain program as part of their food safety plan.
In this short training, we highlight the key requirements of 21 CFR 117 subpart G that are required for all raw material suppliers and any dietary supplement manufacturer that makes a product with a Nutrition Facts label.
Learning Outcomes
At the end of this course, you will know and understand:
- The components of a supply chain program
- Similarities and differences between FSMA-based supply chain programs and the supplier qualification requirements of 21 CFR 111
- What manufacturers and raw material suppliers need to do to be compliant with this part of the regulation.
- Where to find the new regulations under 21 CFR
- The complex requirements for supplier audits
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