Dietary Supplement Definition Cfr

12 if space is not adequate to list the required information as shown in the sample labels in paragraph e 11 of this section the list may be split and continued to the right as long as the headings are repeated.

Dietary supplement definition cfr. Ingredient means any substance that is used in the manufacture of a dietary supplement and that is intended to be present in the finished batch of the dietary supplement. A preventing microbial contamination. Subpart n returned dietary supplements. 111 515 when must a returned dietary supplement be destroyed or otherwise suitably disposed of.

A dietary supplement labeling guide chapter iv. 111 510 what requirements apply when a returned dietary supplement is received. The net quantity of contents statement for a dietary supplement is the statement that informs consumers of the amount of dietary supplement that is in the container or package. A food or dietary supplement for which a claim subject to sections 343 r 1 b and 343 r 3 of this title or sections 343 r 1 b and 343 r 5 d of this title is made in accordance with the requirements of section 343 r of this title is not a drug solely because the label or the labeling contains such a claim.

111 510 what requirements apply when a returned dietary supplement is received. An ingredient includes but is not necessarily limited to a dietary ingredient as defined in section 201 ff of the act. Iv dietary supplement containing dietary ingredients with and without rdis and drvs. 111 503 what are the requirements under this subpart n for written procedures.

This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master. You must take measures to exclude from any operations any person who might be a source of microbial contamination due to a health condition where such contamination may occur of any material including components dietary supplements and contact surfaces used in the manufacture packaging labeling or holding of a dietary supplement. Cfr code of federal regulations title 21. 21 cfr part 111 the ds cgmp rule requires persons who manufacture package label or hold a dietary supplement to establish and follow current good manufacturing practice the cgmps.

Subpart n returned dietary supplements 111 503 what are the requirements under this subpart n for written procedures. Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement.