Nationwide shortage of tuberculin skin test antigens : CDC recommendations for patient care and public health practice

Details

• Corporate Authors:
  Centers for Disease Control and Prevention (U.S.)
• 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.
  
  
• Subjects:
  Equipment And Supplies Tuberculin Tuberculin Test Tuberculosis/diagnosis
• Source:
  HAN ; 420
• Series:
  Health Alert Network
• Document Type:
  HAN Health Advisory
• Name as Subject:
  United States ; United States
• Pages in Document:
  3 unnumbered pages
• Issue:
  420
• Collection(s):
  Health Alert Network (HAN)
• Main Document Checksum:
  urn:sha-512:4be98d0b9c3a22f511a1ef851bd5de4de11c820a0552262870b435c83bbb71b874a317e4083cee2002a436c9e0a3dcfbef8f9c453b2c4c931313a8334e82414c
• Download URL:
  https://stacks.cdc.gov/view/cdc/78871/cdc_78871_DS1.pdf
• File Type:
  [PDF - 310.59 KB ]