USP <800> - A Challenge and Opportunity
While a deadline nearly two years away may seem distant, Gates Healthcare Associates believes that taking action now on USP <800> will allow our clients to not only meet the challenges posed by these new hazardous drug handling requirements, but to continue to grow their compounding business.
Based on Gates Healthcare's experience, most pharmacies will need to significantly update their facilities to maintain compliance. This process involves hiring consultants, engineers, designers and builders and then making it through final regulatory approvals. Pharmacies also must integrate USP <800> requirements into their existing operating procedures and practices, as well as provide training for employees.
Non-compliance will not only leave workers unprotected, but could also potentially harm your pharmacy's fiscal health. Penalties, fines, potential legal actions and, ultimately, suspension or termination of license are all potential outcomes of non-compliance.
On the other hand, Gates Healthcare believes compliant pharmacies will see their business grow, simply because their non-compliant competitors will be forced out of the hazardous drug market. The need for such compounded preparations is not going to decrease, but the number of pharmacies able to provide these medications will. Prescribers and patients will simply move their business to compliant facilities.
On July 1, 2018, USP <800> becomes enforceable by state boards of pharmacy and other regulatory agencies. In light of this, pharmacy operators must have a plan of implementation so that they are not on the outside looking in to a room that is out of compliance with hazardous drug handling standards.
Ideally, this process should begin with a gap analysis, a thorough study of the compliance goal and how best to reach it. Engaging the assistance of experts with years of compliance expertise, well-honed insights into compounding pharmacy practice, and intimate knowledge of the regulatory landscape is an important next step.
The Gates Healthcare team stays on top of regulatory changes. For example, the compounding experts at the U.S. Pharmacopeial Convention recently added proposed revisions to USP <800> regarding external venting in areas used for hazardous drug compounding.
Our team can work with healthcare facilities in a cost-effective manner to assure they are compliant. We offers our clients a complete gap analysis and help implementing their USP<800> compliance plan including assistance with facility design, personnel training and standard operating procedures.
