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)

HHS Permits Out-of-State Telehealth Providers to Render Certain Services Nationwide     On December 3, 2020, the Department of Health and Human Services (“HHS”) announced a fourth amendment to its declaration under the Public Readiness and... Read More
Blogs & Articles | COVID-19 Resources | Healthcare | Telehealth and Telemedicine

The FDA has delayed the verification of salable returns requirement under the Drug Supply Chain Security Act (DSCSA) until November 27, 2023. On October 22, 2020, FDA released a Guidance delaying enforcement of the provision that requires wholesale... Read More
Blogs & Articles | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

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

In a continuing effort by various federal and state agencies to stop COVID-19 related frauds, the FDA has implemented “Operation Quack Hack.” As such, the FDA has issued close to 50 warning letters, and estimates that it will issue hundreds more... Read More
COVID-19 Resources | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA | Service | White Collar Criminal Defense & Government Investigations