ASHP Urges FDA to Make Changes to Compounding Guidances Released in April 2016

On July 18, ASHP submitted comments strongly urging FDA to make revisions to the three draft compounding guidances published in April 2016. Compounding regulation has long been a priority issue for ASHP. “ASHP and our members have been leaders in ensuring that compounded preparations are safe for the patients we serve,” said ASHP Chief Operating Officer and Senior Vice President of the Office of Policy, Planning and Communications Kasey K. Thompson, Pharm.D., M.S., M.B.A. “In a highly regulated environment overseen by CMS, state Boards of Pharmacy, state health departments, various accrediting bodies, and others, we need guidance that is tailored to ensure that hospital and health systems can continue to provide high-quality, effective, and efficient care to the patients they serve.”