On June 14, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act No. 18-166 “An Act Concerning the Prevention and Treatment of Opioid Dependency and Opioid Overdoses in the State” (PA 18-166).

This legislation seeks to address the ongoing opioid crisis in Connecticut in part by: (i) implementing a new opioid overdose reporting requirement for hospitals and emergency medical services (EMS) personnel, (ii) establishing a statutory framework under which health care practitioners and pharmacists may partner with law enforcement or other government agencies, EMS providers, or community health organizations to expand distribution and availability of naloxone and similar drugs, (iii) enacting statutory limitations on the circumstances in which providers may prescribe controlled substances for family members or themselves, and (iv) commissioning a study of the feasibility of opioid intervention courts. This legislation has varying effective dates, which are noted below.
Continue Reading Connecticut Legislature Again Addresses Opioid Crisis

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