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
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
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
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
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
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
In keeping in line with its 2018 Compounding Policy Priorities Plan, the Federal Food and Drug Administration (FDA) released four compounding updates on Monday, July 23rd, including: Compounding risk alert regarding the bulk drug substance,... Read More
For the first time, proposed revisions to USP General Chapter <795> will go through a public comment process. Comments can be submitted through a form on USP’s website no later than July 31, 2018. USP General Chapter <795> governs... Read More
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
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
