On February 24, 2024, the Drug Enforcement Administration (“DEA”) released a long-anticipated proposed rule that aims to permanently extend controlled substance prescribing flexibilities beyond the COVID-19 Public Health...more
At the April 13, 2022 Georgia Board of Pharmacy meeting, the Board discussed changes to Chapter 480-36 which governs retail pharmacy remote drug order processing. The discussion was aimed at new verbiage that would require...more
Over the last few months the California Board of Pharmacy has been busy considering several changes to its current rules and how it regulates various entities under its purview....more
Taking effect January 1, Oregon recently approved a temporary rule implementing SB 763, which requires licensure of pharmaceutical sales representatives who visit health care providers in the state of Oregon for 15 or more...more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
The pandemic has spared no industry. As fast-food chains have sought to drive business through chicken sandwich wars, Burger King’s release of its chicken sandwich was delayed in Michigan due to a shortage of pickle jars....more
References to Operation Warp Speed (OWS) have been present throughout our coverage of the ethical questions related to the development and distribution of a COVID-19 vaccine. In fact, OWS is part of a broader public-private...more
On September 16, 2020, the Trump Administration issued, for the first time, a planning framework for allocation and distribution of an eventual COVID-19 vaccine (the Federal Distribution Strategy). After briefly summarizing...more
With the release of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) on Tuesday and only a matter of days to provide comments, our next posts in the Bioethics in a Pandemic...more
At our Virtual Summit, Continuity Beyond Coronavirus, the keynote session starting everything off will feature a Legal Ops leader who’s seen his company skyrocket to national – even global – prominence over the last several...more
The Belgian Federal Agency for Medicines and Health Products (AFMPS) has announced that it has abolished measures introducing quotas for the supply of paracetamol-based medicinal products. ...more
Seyfarth Synopsis: In the latest development in the ultra-high stakes nationwide Prescription Opiate Litigation, the U.S. Court of Appeals for the Sixth Circuit granted the petition for writ of mandamus brought by twelve...more
The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. ...more
The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more
The Connecticut Department of Consumer Protection Drug Control Division (DCP) has issued guidance for health care providers regarding refills and reissuances of controlled substance prescriptions for patients without an...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
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) allowing distribution of two decades-old malaria drugs — Chloroquine Phosphate and Hydroxychloroquine Sulfate — to treat COVID-19. ...more
While several drugs are being studied in Japan to treat COVID-19, none have yet been approved. However, reports indicate remdesivir, a drug developed by as a treatment for Ebola virus disease, has been administered as a...more
The Spanish Ministry of Health placed on manufacturers and marketing authorization holders (MAHs) – or their local representatives – new reporting, supply, and manufacturing obligations with respect to 347 medicinal products...more
On March 24, 2020, the Massachusetts Commissioner of Public Health issued a Pharmacy Practice Order related to pharmacy practice by retail and institutional pharmacies....more
On March 12, 2020, an Appeals Panel of the United States Pharmacopeial Convention (“USP”) granted appeals to revisions of two compounding standards—General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparation...more
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact...more
The Federal Drug Enforcement Agency (DEA) issued guidance permitting DEA-registered practitioners to prescribe controlled substances without an in-person medical exam of the patient for the duration of the COVID-19 public...more
The Ohio Board of Pharmacy (OBOP) is actively working to modify its rules or formulate temporary guidance and procedures to help combat the spread of COVID-19 (coronavirus) and aid in the delivery of pharmacy care to impacted...more
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more