FDA’s determination of whether to classify a product as a drug will be made based on the statutory definition set forth in sections 201(g) and 201(h) of the Food ,Drug and Cosmetic Act (FD&C Act), as applied to the scientific data concerning the product that are available to FDA at the time the classification determination is made.

FDA defines Drugs as: (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C).

If the classification of a product as a drug, device, biological product or combination product is unclear or in dispute, a Request For Designation (RFD) with the Office of Combination Products (OCP) can be filed to obtain a formal classification determination for the product, as provided for under section 563 of the FD&C. In reviewing an RFD, the Agency considers the information provided in the RFD as well as other information available to the Agency at that time. Generally, the Agency will respond in writing within sixty days of the RFD filing, identifying the classification of the product as a drug, device, biological product, or combination product.

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