On December 7, 2020, Connecticut Governor Ned Lamont signed Executive Order No. 9Q (the “Order”) in anticipation of the approval of COVID-19 vaccines. The Order addresses and expands COVID-19 vaccine administration, establishes flu vaccine reporting requirements for pharmacists, and limits out-of-network charges for administration of authorized COVID-19 vaccines. Specifically, the Order:
Continue Reading In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting

Massachusetts continues to issue directives and guidance for health care providers in response to COVID-19. In this post we highlight Orders and Guidance issued by Massachusetts Governor Baker and the Massachusetts Department of Public Health (DPH). The guidance addresses topics including collection of COVID-19 demographic information, use of alternative space for provision of health care treatment, health professional licensing, EMS transport of patients, hospital policies for returning exposed health care personnel to work, use of PPE and equipment, and updates for pharmacies.
Continue Reading Massachusetts Issues COVID-19 Orders and Guidance for Providers

On March 24, 2020, the Massachusetts Commissioner of Public Health issued a Pharmacy Practice Order related to pharmacy practice by retail and institutional pharmacies. The Order as well as supplemental guidance issued by the Board of Registration in Pharmacy (Board) is effective as of March 24.
Continue Reading Massachusetts Issues COVID-19 Orders and Related Guidance for Pharmacies and Pharmacy Professionals

In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). As emphasized in a recent U.S. Department of Justice policy memorandum, FDA noted that its guidance documents do not establish legally enforceable responsibilities and, instead should be viewed only as agency recommendations, unless specific regulatory or statutory requirements are cited.


Continue Reading FDA Issues New Compounding Guidance