GRASE, or Generally Recognized As Safe and Effective, is a status that the Food and Drug Administration (FDA) can give to certain over-the-counter (OTC) drugs. This status means that the FDA has determined that the drug is safe and effective for its intended use, based on the available scientific evidence and the historical use of the drug. The GRASE status is typically given to drugs that have been in use for a long time, and for which there is a long history of safe use, that has been recognized by experts in the field.
When the FDA determines that a drug is GRASE, it is placed into one of two categories: Category I or Category II. Category I drugs are considered safe and effective for their intended use when used as directed, and no warning statement is required. Category II drugs are considered safe and effective for their intended use, but the labeling for these products must contain a disclaimer stating that the safety and effectiveness of the product for this use have not been established.
In order for a drug to be considered GRASE, the FDA must evaluate the available scientific evidence, including data from clinical studies, and determine that the benefits of the drug outweigh any potential risks, that the drug has been in use for a long time and that there is a long history of safe use recognized by experts in the field. The FDA also considers other factors, such as the drug's history of use and any adverse effects reported to the FDA.
The GRASE determination is significant, as it allows manufacturers to sell OTC drugs without first obtaining FDA approval. This can save time and costs for the manufacturer, and provide a more rapid access to certain products for the consumers. However, this doesn't mean that all OTC drug products are GRASE, manufacturers must still submit a New Drug Application (NDA) for new drug products that are not yet GRASE and have no therapeutic equivalence to a GRASE product.
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