Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice

Details

• Journal Article:
  Morbidity and Mortality Weekly Report (MMWR)
• Description:
  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) tTesting capability resulting from the anticipated Aplisol shortage (1).
• Subjects:
  Antigens, Bacterial Full Report Humans Practice Guidelines As Topic Public Health Practice Tuberculin Test Tuberculosis
• Source:
  MMWR Morbidity Mortal Weekly Rep. 68(24):552-553
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• DOI:
  http://dx.doi.org/10.15585/mmwr.mm6824a4
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Pubmed ID:
  31220054
• Pubmed Central ID:
  PMC6586373
• Document Type:
  Journal Article
• Place as Subject:
  United States
• Pages in Document:
  2 pdf pages
• Volume:
  68
• Issue:
  24
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:86fb0821612e3fbf2e77026d0fa90e526975858ce7addfe30dfacbd5c19b0ada8f5e56b33777b47bd038748f75824497a4dfce787c517dd90598c75ea8e17b5b
• Download URL:
  https://stacks.cdc.gov/view/cdc/79516/cdc_79516_DS1.pdf
• File Type:
  [PDF - 62.70 KB ]