We are excited to be closing out the year by making another key addition to our team of experts, one who brings a wealth of experience in pharmacy practice and who can assist our clients on many fronts including preparing for regulatory inspections.
Preparation is always a common theme at this time of year, as organizations wrap up projects and look forward to starting new ones in the coming year. We are doing the same as we continue to provide services tailored to our clients' challenges and opportunities.
Best wishes for a happy holiday season and a prosperous new year.
Ernest P. Gates Jr., RPh, FASCP, FIACP, FACAPresident, Gates Healthcare Associates
FDA Compliance Expert Joins Gates Team
Manella has consulted to domestic and international pharma and device companies on quality assurance, manufacturing, FDA remediation, marketing, finance and personnel issues. He also has supported compounding pharmacy operations in Ohio and New Jersey in preparing for state board of pharmacy inspections and remediation activities related to FDA Form 483 observations, warning letters and consent decrees.
He is the former CEO of Coldstream Laboratories, a sterile drug contract manufacturing business for which he raised $21 million for construction, startup and operations. His varied experience allows an understanding of all business disciplines, which truly complements his background as a trained scientist with a degree in chemistry.
Countdown to USP <800> Compliance Has Begun
More than two years ago, we started working with some of our pharmacy clients to help them prepare for an inevitability: the USP <800> deadline on hazardous drug handling. Ensuring compliance with the new standards would be time-consuming and require additional resources to raise the bar in such key areas as environmental monitoring, training and equipment.
Now, the clock is really ticking. The deadline is December 1, 2019 -- less than a year away.
If preparing for USP <800> is not yet a priority, it should be. Compounders, in particular, will be impacted given that USP <800> will go into effect simultaneously with the publication of a major revision to USP <797>, with updated guidelines for compounding and sterile preparations.
If your organization is already compliant or approaching compliance, then you are well-positioned to take advantage of the new regulatory environment. If not, then it would be wise to take action on this issue sooner rather than later, including by connecting with a consultant with the expertise to meet this challenge head on and position your organization for success.
The Gates Healthcare team stands ready to work with healthcare facilities in a cost-effective manner to assure they are compliant with all USP standards. Don't get caught unprepared for this sea change in pharmacy regulation.