NCPA sent out the following articles in their Wednesday, May 6th edition of qAM. Click here if you are interested in subscribing to this valuable resource offered by NCPA.
Pharmacies that are solicited to purchase SARS-CoV-2 (the virus causing COVID-19) antibody tests need to know that while tests may have EUA, they might not be authorized for the CLIA-waived point-of-care setting. Before you perform a test on a patient (molecular, antigen, or antibody) verify that the test is deemed to be authorized for the CLIA-waived setting by checking the list of test kit manufacturers with an FDA emergency use authorization. There must be a "W" in the column titled "authorized settings" for any test to be performed in a CLIA-waived laboratory. This includes test kits that are part of a telehealth bundle. Pharmacies that purchase antibody test kits in anticipation of the product becoming authorized for use in CLIA-waived settings do so at their own risk. For more information or help researching a company, email covid@ncpa.org or visit the NCPA coronavirus testing page.
On May 14, the FDA updated its guidance for pharmacy compounders who experience shortages, due to the COVID-19 public health emergency, of the personal protective equipment they use to compound sterile drugs. FDA clarified that these drugs can be compounded in a segregated compounding area that is not in a cleanroom, when the following beyond-use dates are utilized: up to 12 hours for product stored at room temperature, and up to 24 hours for products stored refrigerated. These BUDs aim to reduce the risk of contamination.
