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Pt. 111 21 CFR Ch. I (4111 Editions) (HFS565), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. 51 FR 24475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996; 66
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What is 21 cfr part 111?
21 CFR Part 111 is a regulation issued by the Food and Drug Administration (FDA) that establishes the current good manufacturing practice (cGMP) requirements for dietary supplements.
Who is required to file 21 cfr part 111?
Manufacturers, distributors, and holders of dietary supplement products are required to comply with 21 CFR Part 111.
How to fill out 21 cfr part 111?
To fill out 21 CFR Part 111, companies must follow the specific requirements outlined in the regulation, which include maintaining proper documentation, implementing quality control measures, and conducting testing of ingredients and finished products.
What is the purpose of 21 cfr part 111?
The purpose of 21 CFR Part 111 is to ensure the quality, purity, and labeling accuracy of dietary supplements to protect the public health.
What information must be reported on 21 cfr part 111?
Information that must be reported on 21 CFR Part 111 includes the name and address of the manufacturer, a description of the product, a list of ingredients, and the documentation of testing and quality control measures.
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