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
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
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
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
With the imminent need for information on government action in regards to medical issues and potential lifesaving treatments during the Covid-19 pandemic, various state and federal agencies have seemingly dismissed the public’s right to... Read More
The rising cost of healthcare and the renewed focus on personal hygiene related to the COVID-19 pandemic has brought a marked increase in the use of over-the-counter (OTC) medications such as cold remedies, antihistamines, pain relievers and hand... Read More
The Food and Drug Administration (FDA) continues to make drug compounding a high priority and will enforce the requirements of the Drug Quality and Security Act (DQSA). On May 13, 2020, the FDA issued two letters, one denying a Citizen’s... Read More
As rising medication costs continue to burden patients and our healthcare system, the Food and Drug Administration (FDA) has undertaken a Drug Competition Action Plan to streamline the Abbreviated New Drug Application (ANDA) process and encourage... Read More
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
On April 30, 2020, the Food and Drug Administration (FDA) issued new guidance relaxing certain requirements under the Drug Supply Chain Security Act (DSCSA) for COVID-19 related drug products. In the guidance, FDA explained that under the DSCSA... Read More
