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
Blasting off into summer, the U.S. Food and Drug Administration (FDA) is soliciting feedback from the industry about what they would want to see added to the Orange Book. FDA’s Orange Book (also known by its less-used formal...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
The COVID-19 emergency has impacted all aspects of the food and beverage industry, and restaurants are no exception. Realizing the essential economic and food service roles restaurants play — and that restaurants’ needs have...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
With COVID-19 dominating headlines and food manufacturers struggling to ensure that grocery store shelves remain stocked during this pandemic, manufacturers may have missed an important update from the U.S. Department of...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
The next in our series of posts sharing key takeaways from panels at the Healthcare & Life Sciences Private Equity and Lending Conference is authored by our colleagues Brian King and Royce DuBiner, and Kathy Contratto of RSM...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
On Feb. 27, 2020, the U.S. Department of Agriculture (USDA) sent a flash update to the hemp industry announcing changes to some of the more complex aspects of the interim final rule for the establishment of a U.S. Domestic...more
Consumers may not think of salmon as a drug, but according to a recent opinion out of the Northern District of California, certain genetically modified (GMO) salmon qualify as drugs under the Food, Drug, and Cosmetic Act...more
On Jan. 15, the Subcommittee on Health of the Committee on Energy and Commerce held a legislative hearing to discuss cannabis policy. The focal point of most of the hearing was about research into marijuana, its extracts and...more
At last month’s MJBizCon, the premier gathering for cannabis and hemp industry experts, investors and industry professionals addressed cutting-edge issues in this rapidly expanding market....more
On Dec. 12, 2019, the U.S. House of Representatives passed HR 3, the Elijah Cummings Lower Drug Costs Now Act, which would allow the government to negotiate drug prices, among other reforms. Prior to HR 3 being considered on...more