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The only requirement is the drug is used in the practice of medicine.“Off-Label” and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices – Information Sheet If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects. Use of a marketed product in this manner does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight. Here are some of the most popular off-label treatments for rosacea Isotretinoin was shown to be effective in patients with treatment-resistant rosacea by Nikolowski and Plewig in 1980 for the first time. The PCDS would like to thank Dermatoweb, Derm Quest (Galderma), and others who have contributed images. All named individuals and organisations maintain copyright for the relevant images. This website is non-profit and holds the images for educational purposes only. Any image downloaded must only be used for teaching purposes and not for commercial use. Notice and credit must be given to the PCDS or other named contributor. Please follow this link if you have any high-quality images that you can contribute to the website. 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