At a court hearing on November 24, 2020, a bankruptcy judge approved a settlement entered in late October between Purdue Pharma L.P. (“Purdue”) and the Department of Justice (“DOJ”), under which Purdue Pharma L.P. plead guilty in New Jersey... Read More
On Sept. 7, 2017, Allergan filed two lawsuits in the US District Court for the Central District of California against Imprimis Pharmaceuticals and Sincerus Florida, two US FDA-registered 503B outsourcing facilities, and Prescriber's Choice, a... Read More
The FDA has recently provided limited additional information in an informal email on whether a pharmacy may use certain bulk drug substances in compounding. Specifically, the FDA has indicated that drug products containing Estriol may be compounded... Read More
A New Jersey-based sterile compounding pharmacy recently entered into a Consent Decree with the Food and Drug Administration (FDA) following an investigation by the Agency in which the pharmacy was cited for unsanitary conditions and violations of... Read More
On May 15, 2013, bi-partisan legislation was introduced to establish a new framework for compounding regulation. The Pharmaceutical Compounding Quality and Accountability Act (“PCQAA”) was introduced by Senators Tom Harkin (D-Iowa), Lamar... Read More
