The Food and Drug Administration (FDA) said Tuesday night that it is not banning or prohibiting Ivermectin consumption.
In a statement, FDA Deputy Director-General Oscar Gutierrez, Jr. emphasized that the antiparasitic drug is “authorized” by the regulatory body. This means it cannot be considered an illegal drug.
However, he pointed out that “no oral Ivermectin” was registered with the FDA and what is only registered with them is the cream product containing Ivermectin to treat parasitic infestation or infection in human beings.
“Other Ivermectin preparations are for animals or for veterinary use only,” he stated.
He also noted that the FDA issued the Compassionate Special Permit (CSP) to a specialized medical institution to use Ivermectin as an “investigatory drug.”
“This is an authorization to import or bring in a certain quantity of Ivermectin oral preparation to be used by the hospital. It is not a product market authorization,” he stressed.
Only pharmacists who hold licenses granted by the Professional Regulation Commission, he said, can compound Ivermectin and dispense compounded drug preparations “upon a written order” of a doctor for a specific patient.
“Only those FDA-licensed drug outlets with an FDA-approved activity to compound can be prepared and dispense compounded drug preparations,” he added, citing Republic Act no. 10918 or the Pharmacy Law.
Although it is not illegal, FDA also clarified that it does not encourage the off-label use of Ivermectin by physicians, especially without the consent of the patient.
Filipino doctor Dr. Allan Landrito, the most popular Ivermectin proponent in the country, has recently been granted a license to operate (LTO) as a drug trader by the FDA.
An LTO allows Landrito’s group to import, distribute, market, advertise and manufacture its products to the country. Such a permit must be first secured before Landrito can apply for product registration for the 15-mg Ivermectin capsule he compounded himself.
Landrito, a practicing integrative medical doctor, claimed to have treated at least 8,000 Covid-19 patients with his self-made drug despite not having a permit from the FDA.
He claimed that none of his patients developed any side effects after taking the drug and almost 100 percent of them have recovered from Covid-19.