Compounding pharmacies should be aware of recent developments in the law surrounding bioidentical hormone therapy (cBHT). In the field of pharmacy, compounding (performed in compounding pharmacies) is preparation of a custom formulation of a... Read More
Blogs & Articles | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A)

On October 26, 2020, the Food and Drug Administration (FDA) issued its long awaited final MOU which describes the conditions under which certain compounded drugs by a pharmacist in a state-licensed pharmacy, or by a licensed physician, are exempt... Read More
Community Oncology Practices & Other Dispensing Physician Practices | Integrated Delivery Network and Hospital System Pharmacy | Life Sciences | State and National Pharmacy Associations | Traditional Compounding Pharmacies (503A)

A compounding pharmacy based in Kentucky, and its owner, admitted on October 29, 2020 in federal court to unlawful distribution of compounded prescription drugs.  The Pharmacy pleaded guilty to unlawful distribution of substances that the FDA had... Read More
Blogs & Articles | Life Sciences | Pharmacy Law | Traditional Compounding Pharmacies (503A) | White Collar Criminal Defense & Government Investigations

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)