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
Articles | Life Sciences | Pharmacy Law | Traditional Compounding Pharmacies (503A)

Last week, the U.S. Court of Appeals for Second Circuit ruled that the Food and Drug Administration (FDA) cannot prosecute pharmaceutical manufacturers’ representatives for speech promoting the lawful, off-label use of an FDA-approved drug.  The... Read More
Drug and Device Advertising, Marketing & Promotion Legal Review | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)