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August 20, 2021: FDA and HHS ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, bamlanivimab, which is at present authorized (PDF, 347 KB) for emergency use only when administered together with etesevimab. Because of this extension, unopened vials of bamlanivimab, injection, seven hundred mg/20 mL, must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and may be saved for a further 6 months from the labeled date of expiry (See Table 1 here). This extension applies to all refrigerated vials of Johnson & Johnson COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage situations. Stockpiling medication, vaccines, and medical merchandise is vital to ensure public health emergency preparedness for both the U.S. Yes, but you will need to write the efficient date in the “Execution” section. Another manner FDA can strategy expiration dating challenges is thru FDA’s expiration dating extension authority under part 564A(b) of the FD&C Act, which was established by PAHPRA in 2013. Before PAHPRA, the distribution, dispensing, or use of merchandise with prolonged expiry, and any related labeling adjustments, had been attainable by way of an EUA or FDA enforcement discretion.

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