When sourcing OTC COVID-19 tests, pharmacy owners should evaluate new distributors carefully. High demand for a product in short supply is an opportunity for fraud and bad actors. Case in point is a Type I consumer-level recall of unapproved/non-EUA tests. Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed January-November 2021 with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved for distribution or use in the United States by the FDA. Prior to signing a purchase agreement, ask the distributor for a copy of the FDA’s EUA letter, or better yet, look for the test on FDA’s list of COVID-19 diagnostics.
NCPA
