Abstract
CDC is expecting a 3-10 month nationwide shortage of Aplisol, a product of Par Pharmaceuticals, and one of two purified-protein derivative (PPD) tuberculin antigens licensed by the Food and Drug Administration (FDA) for use in performing tuberculin skin tests. This time frame is the manufacturer's current estimate and is subject to change. The manufacturer notified CDC that they anticipate an interruption of supply of Aplisol 5 mL (50 multidose vials) beginning in June 2019, followed by an interruption of the supply of Aplisol 1 mL (10 multidose vials) in November 2019. The expected shortage of Aplisol 1 mL could occur before November 2019 if demand increases before then. Information on the status of this supply interruption will be updated at FDA's Center for Biologics Evaluation and Research-Regulated Products: Current Shortages website (https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-current-shortages). This report includes CDC recommendations for mitigating a reduction in tuberculosis (TB) testing capability resulting from the anticipated Aplisol shortage (1).
Highlights
CDC recommends the following three general approaches to mitigate a reduction in TB testing capability resulting from the expected shortage of Aplisol:
Clinicians who use the IGRA blood tests should be aware that the criteria for test interpretation are different from the criteria for interpreting TSTs [3]
Groups at high risk for TB infection include 1) persons who are recent contacts exposed to persons with TB disease; 2) those born in or who frequently travel to countries where TB disease is common; 3) those who currently or previously lived in large group settings; 4) persons with compromised immune systems, including those with health conditions or taking medications that might alter immunity; and 5) children, especially those aged
Summary
CDC recommends the following three general approaches to mitigate a reduction in TB testing capability resulting from the expected shortage of Aplisol:. Substitute IGRA blood tests for TSTs. Clinicians who use the IGRA blood tests should be aware that the criteria for test interpretation are different from the criteria for interpreting TSTs [3]. Substitute Tubersol for Aplisol for skin testing.
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