Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more
Food - FDA Released Retail Food Employee Health Handbook – The FDA published the Employee Health and Personal Hygiene Handbook to help food employees avoid spreading viruses and bacteria to food....more
On September 25, 2020, the U.S. Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)....more
CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted. The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related...more
The coronavirus (COVID-19) outbreak has led to a dramatic increase in the demand for, and a shortage of, hand sanitizer in the US. In response, the US Food and Drug Administration (FDA) and the US Treasury Department’s...more
The Food and Drug Administration and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have both recently issued guidance documents to allow for the increased production of alcohol-based hand sanitizer during the COVID-19...more
After a whirlwind final week of the lame duck session, where the Legislature passed various, often times emotion-evoking measures (including gun rights, abortion, unemployment compensation fund changes, municipal minimum wage...more