Published: Monday, May 24, 2021
This form is for use in conjunction with Section 10 Recommendations for Dietary Ingredient Processors, AHPA Good agricultural collection practices and good manufacturing practices for botanical materials. Supporting information for specific elements can be attached to this form.
Section 10 consists of recommendations to be considered; they are not legal or regulatory requirements except as noted. Facilities that manufacture , pack, or hold dietary supplements are subject to the regulations in 21 CFR Part 111, while those that manufacture, pack, or hold dietary ingredients are technically subject only to the requirements of Part 117. However, in order to ensure their own compliance with the requirements of Part 111, dietary supplement manufacturers often expect their ingredient suppliers to go above and beyond the basic requirements set forth in Part 117, particularly with respect to raw material controls, process controls, recordkeeping, and general quality systems management. Therefore, dietary ingredient processors that do not follow the full requirements of Part 117 may want to consider implementing the additional recommendations set forth below.
Dietary ingredient processors may be required to comply with the provisions of 21 CFR Part 111 under two circumstances.
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