A Texas-based compounder specializing in hormone therapies for men and women was warned by the FDA for extensive cGMP violations as well as producing drugs for which there was no valid prescription. Read More

The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures. Read More

Pharmakon Pharmaceuticals executives routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results showed the strength was often nearly double what it should have been, covered up the error and lied to FDA investigators rather than notifying the FDA or customers, according to a 10-count federal indictment. Read More

The FDA has broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. Only Ipca’s anti-malarial API remains exempted and can be imported into the U.S. Read More