Following issues on the use or prohibition of use of Ivermectin, the Food and Drug Administration (FDA) clarifies that there is no ban on the purchase and use of the drug product Ivermectin as long as such product is registered with the FDA.
For human use, Ivermectin is currently registered as a prescription drug in topical formulation for the treatment of external parasites such as head lice and skin conditions such as rosacea.
For veterinary use, Ivermectin is approved as an oral and intravenous preparation for the prevention of heartworm disease and treatment of internal and external parasites in certain animal species. The product should be administered according to its approved indication, or as prescribed by a duly licensed veterinarian.
The FDA imposes no ban on the purchase and use of Ivermectin, and further recommends that the use of Ivermectin should strictly follow the approved indications as described above. “Currently, there is no registered Ivermectin oral formulation for human use and the FDA has not received any application for such use”, Director General Eric Domingo said.
However, the presence of an unregistered Ivermectin 15mg capsule has been recently detected in the market by the FDA. Also, contrary to the approved indication, information is also being circulated that Ivermectin is a cure for COVID-19. Thus, the FDA issued FDA Advisory Nos. 2021-0526 and 2021-0625-A, warning the public against the purchase of the unregistered Ivermectin and the use of the product for treatment of COVID-19.
The public is informed that under the Republic Act No. 9711, or the “Food and Drug Administration Act of 2009,” the sale of any unregistered health product is prohibited. The prohibition extends to any online sale of unregistered products. “There are legal ways to use Ivermectin in the country but they have to go through the process and all applications for authorization will be processed quickly,” DG Domingo added.
The FDA is committed in ensuring the public’s access to drug products with proven safety, quality and efficacy. “All applications for drug authorization and those related to the COVID-19 mitigation are evaluated with utmost diligence and priority,” DG Domingo ended.