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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 310, 350, and 369 Docket No. 78N0064 IN 0910AA01 Antiperspirant Drug Products For OvertheCounter Human Use; Final
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What is 21 cfr parts 310?
21 CFR Part 310 is a set of regulations issued by the Food and Drug Administration (FDA) under the Code of Federal Regulations. It pertains to the regulations regarding the requirements for over-the-counter (OTC) drug products.
Who is required to file 21 cfr parts 310?
Manufacturers, distributors, and packagers of over-the-counter (OTC) drug products are required to comply with the regulations outlined in 21 CFR Part 310.
How to fill out 21 cfr parts 310?
To fill out 21 CFR Part 310, manufacturers, distributors, and packagers of over-the-counter (OTC) drug products need to follow the specific requirements and guidelines outlined in the regulation. This includes ensuring proper labeling, packaging, and manufacturing practices.
What is the purpose of 21 cfr parts 310?
The purpose of 21 CFR Part 310 is to establish the requirements and regulations for over-the-counter (OTC) drug products to ensure their safety, efficacy, and proper labeling. It aims to protect public health by setting standards for OTC drugs.
What information must be reported on 21 cfr parts 310?
The specific information that must be reported on 21 CFR Part 310 depends on the nature of the over-the-counter (OTC) drug product being manufactured, distributed, or packaged. This may include ingredients, labeling information, manufacturing processes, and any adverse events associated with the product.
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