Express Scripts, Inc. (“ESI”), following a period of stay in its April 7, 2020 recoupment action, has resumed its efforts to recover funds from certain pharmacies who submitted claims to TRICARE in 2015, this time, with no indication of slowing... Read More
Blogs & Articles | Community, Retail Pharmacies | Life Sciences | Traditional Compounding Pharmacies (503A)

The Food and Drug Administration (FDA) has now issued three Guidance’s pertaining to processes and formulas for compounding of alcohol-based hand sanitizers during the COVID-19 public health emergency: Temporary Policy for Preparation of... Read More
Blogs & Articles | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)

Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the current consumer difficulties accessing alcohol-based hand sanitizers, and in response to the many queries concerning compounding these products, the Food and Drug Administration (FDA) has... Read More
COVID-19 Resources | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)

While the Drug Quality and Security Act (DQSA), which created significant implications for compounders by effectively reinstating Section 503A the Federal Food Drug and Cosmetic Act (FD&C Act), was signed in November 2013, its full effect has... Read More
Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)

The FDA recently issued an Interim Policy on compounding using bulk drug substances under Section 503A and 503B of the Food Drug and Cosmetic Act (FD&C Act) offering important guidance for compounding pharmacies. 503A Section 503A sets forth... Read More
Blogs & Articles | Life Sciences | Outsourcing Facilities (503B) | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)

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
Blogs & 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)