Nationwide Shortage of TB Skin Test Antigens

The Centers for Disease Control and Prevention (CDC) has issued an alert concerning a shortage of Aplisol®, one of two purified-protein derivative (PPD) tuberculin antigens that are licensed by the FDA for use in performing tuberculin skin tests. Par Pharmaceuticals notified CDC that they expect a 3 to 10-month nationwide shortage of the product, but this is only an estimate and is subject to change.

The CDC advises:

In settings with a low likelihood of TB exposure, the deferment of routine serial testing should be considered in consultation with public health and occupational health authorities. Annual TB testing of healthcare personnel is not recommended unless there is known exposure or ongoing transmission.

To accomplish baseline TB testing, or if testing becomes necessary in response to a known exposure to TB disease, Tubersol® may be substituted for Aplisol®, or an interferon-gamma release assay (IGRA) blood test may be used instead. Allocation of TSTs should be prioritized in consultation with state and local public health authorities. 

To monitor the status of this supply interruption, you may 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