On May 3, 2012 the FDA issued its final rule on sterility testing, amending the requirements for most licensed biological products effective June 4, 2012.  The rule is intended to promote improvement and innovation in the development of sterility test methods by allowing manufacturers the flexibility needed for sterility testing of novel products that may be introduced to the market, enhancing sterility testing of currently approved products, and encouraging manufacturers to utilize scientific and technological advances in sterility test methods as they become available.