On July 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for sample pooling of specimens when using the SARS-CoV-2 rRT-PCR diagnostic test from Quest Diagnostics....more
This second McGuireWoods alert discussing regulation of hand sanitizer manufacture and distribution addresses new considerations from the Food and Drug Administration (FDA) published in a June 2020 update to its March 2020...more
During the COVID-19 pandemic and national emergency, the U.S. Food and Drug Administration (FDA) has taken a relatively relaxed approach to some of the more concrete regulations governing the nation’s food supply. This month,...more
On April 28, 2020, President Trump invoked powers under the Defense Production Act of 1950 (50 U.S.C. 4501 et seq.), finding that COVID-19 has significantly disrupted the food supply chain with regard to the meat and poultry...more
COVID-19 has forced the healthcare system to adapt to a unique set of circumstances. As reported in prior McGuireWoods updates, a number of state and federal developments have affected the practice of pharmacy during the...more
Amid a sea of regulatory changes occurring in response to the novel coronavirus (COVID-19) pandemic, several states have temporarily suspended cannabis regulation to enhance consumer access to cannabis products during the...more
To provide relief during the coronavirus (COVID-19) pandemic, the U.S. Food and Drug Administration (FDA) announced on March 24, 2020, that it will not enforce certain veterinarian-client patient relationship (VCPR)...more
A complete overhaul to the over-the-counter (OTC) drug system quietly rode its way into law with the Coronavirus Aid, Relief, and Economic Security Act or the CARES Act (H.R. 748), along with several other significant reform...more
As states brace themselves for an increasing number of novel coronavirus (COVID-19) cases, some pharmacy boards have relaxed regulations to ease burdens on pharmacy practitioners. Several states have declared a state of...more
The unprecedented public health emergency created by the novel coronavirus disease (COVID-19) has sparked action by state and federal regulators to ensure greater access to care, while simultaneously limiting the spread of...more
With the COVID-19 pandemic, the demand for hand sanitizer is extremely high, and the supply chain has not kept pace with that demand. In an effort to meet public need, several federal agencies, including the Food and Drug...more
Pharmacies nationwide are struggling to keep up with the demand for new prescriptions of hydroxychloroquine, chloroquine and mefloquine, the decades-old immunosuppressant and/or anti-inflammatory agents used for treating...more
As the nation battles shortages of novel coronavirus (COVID-19) testing kits, the U.S. Food and Drug Administration (FDA) has engaged its emergency use authorizations (EUA) process for unapproved products and uses to...more
In light of the urgent need for medical intervention during the coronavirus pandemic, the Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control...more
The COVID-19 pandemic has brought a cascade of statements from the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). Below are summaries of some of the more pertinent statements...more
Under the Public Readiness and Emergency Preparedness Act, the secretary of the U.S. Department of Health and Human Services can issue a declaration to provide immunity for individuals and entities from any liability arising...more
During the COVID-19 (coronavirus) national emergency, the Food and Drug Administration and U.S. Department of Agriculture continue to emphasize measures intended to keep the food supply safe....more