In accordance with its mandate to safeguard the health of the Filipino people, PFDA reminds the Market Authorization Holders (MAH) of COVID-19 test kits of the prohibition of online selling of PFDA-certified COVID-19 antibody test kits.
PFDA reiterates the message of FDA advisory numbers 2020-497 and 2020-498, which addressed the MAH and the public, respectively, on the online distribution, purchase, and administration of COVID-19 antibody test kits including rapid tests, point-of-care, lateral flow, ELISA, GICA and CLIA. The advisories were released last April 1, 2020 which states that these kits are strictly for professional use and not for personal use. The kits covered in these advisories must be purchased from a licensed hospital, drug store or pharmacy under a prescription of a physician. Only trained medical professionals guided by a physician can administer and interpret the test results.
The regional field offices and enforcement units are requested to conduct exhaustive monitoring of online platforms and issue urgent sanctions, as necessary. The public is also enjoined to report such incidences through PFDA’s online reporting portal, eReport.
1. FDA Circular No. 2020-016