FDA: Online selling of COVID-19 test kits is prohibited

Published March 5, 2021, 1:25 PM

by Analou de Vera

Online selling of coronavirus disease (COVID-19) test kits is prohibited, the Food and Drug Administration (FDA) reminded the public.

covid test
A Manila Healthek Inc. staff shows the COVID-19 test kit developed by experts from the Philippine Genome Center and the National institute of Health of the University of the Philippines-Manila at press conference at the University of the Philippines Diliman. (ALVIN KASIBAN / MANILA BULLETIN FILE PHOTO)

“These COVID-19 test kits with FDA special certification are strictly for medical professional use and not intended for personal use,” the agency said in its advisory no. 2021-0434.

The FDA said that this included all types of FDA certified COVID-19 test kits: reverse transcription polymerase chain reaction (RT-PCR), antibody, and antigen based.

“The FDA is mandated to protect the health and safety of the Filipino people by regulating the manufacture, importation, distribution, sale, offering for sale, advertisement, and promotion of health products including in-vitro diagnostic medical devices in the country,” the agency said, citing the Republic Act No. 9711 or the Food and Drug Administration Act of 2009.

FDA Director General Rolando Enrique Domingo directed all of the agency’s regional field offices and regulatory enforcement units to “conduct exhaustive monitoring of online platforms.” He also instructed the FDA regional offices and units to “pursue and implement immediate regulatory and enforcement actions as warranted.”