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Nationwide shortage of tuberculin skin test antigens : CDC recommendations for patient care and public health practice
  • Published Date:
    06/06/2019
  • Series:
    HAN ; 420
  • Language:
    English
Filetype[PDF-310.59 KB]


Details:
  • Description:
    Distributed via the CDC Health Alert Network

    June 6, 2019, 1130 ET (11:30 AM ET)

    CDCHAN-00420

    The Centers for Disease Control and Prevention (CDC) is expecting a 3 to 10 month nationwide shortage of APLISOL®, a product of Par Pharmaceuticals. APLISOL® is one of two purified-protein derivative (PPD) tuberculin antigens that are licensed by the United States Food and Drug Administration (FDA) for use in performing tuberculin skin tests. The manufacturer notified CDC that they anticipate a supply interruption of APLISOL® 5 mL (50 tests) beginning in June 2019, followed by a supply interruption of APLISOL® 1 mL (10 tests) in November 2019. The expected shortage of APLISOL® 1 mL (10 tests) could occur before November 2019, if demand increases before then. The 3-10 month timeframe for the nationwide shortage is the manufacturer’s current estimate and is subject to change.

    To monitor the status of this supply interruption, visit FDA’s “Center for Biologics Evaluation and Research (CBER)-Regulated Products: Current Shortages” webpage: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-current-shortages.

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