September 04, 2013, 13:00 ET (1:00 PM ET)

CDCHAN-00355

In HAN 345 (http://emergency.cdc.gov/HAN/han00345.asp), April 2013, CDC reported that TUBERSOL®, a product of Sanofi Pasteur Limited, was in shortage nationwide. Although supplies were restored in early June 2013, TUBERSOL® is in shortage again until at least the middle o f October 2013. A t the current time, the 5 tuberculin units/0.1 mL, 5 mL (50 tests), multiple dose vials are unavailable. The 5 tuberculin units/0.1 mL, 1 mL (10 tests), multiple dose vials are in limited supply. This notice updates and supersedes the advice in HAN 345 and advises public health officials, clinicians, and workers in occupational health and infection control about how to adapt testing protocols to the recurrent shortage.

TUBERSOL® is one o f two purified-protein derivative (PPD) tuberculin antigen solutions that are licensed by the United States Food and Drug Administration (FDA). JHP Pharmaceuticals, LLC, manufactures APLISOL®, the other PPD tuberculin product that is licensed by FDA. JHP Pharmaceuticals, LLC, has notified FDA that APLISOL® is on allocation, meaning that historical customers have precedence for buying the product, and APLISOL® is available in restricted quantity. Regional shortages o f APLISOL® have been reported since healthcare providers switched from TUBERSOL® to APLISOL®.

Health Alert Network (HAN)

United States