NCPA Submits Round Two of Comments to USP Regarding Proposed Chapter on Handling of Hazardous Drugs: This week NCPA submitted comments to the U.S. Pharmacopeial Convention (USP) regarding USP's proposed new General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. This was the second opportunity NCPA had to comment to USP on this proposed Chapter. USP 800 has many implications for all community pharmacies who handle any hazardous drugs contained on the National Institute for Occupational Safety and Health (NIOSH) list.

NCPA made clear in our comments that our members do not currently have the physical space to recreate/reformat their labs to comply with these requirements. Doing so would be completely prohibitive for some and cost-prohibitive for most. The unfortunate result is reduced patient access to compounded medications. NCPA is asking USP to place this chapter above <1000>, so our members are afforded the opportunity to perform the appropriate analyses, and integrate best practices where appropriate based on individual practices. In addition, we strongly recommend that USP perform a cost/benefit study to demonstrate that the benefits would outweigh the costs of implementing the proposed Chapter <800>. As well, we recommended that USP host a series of stakeholder meetings to allow all impacted parties the ability to voice their opinions and concerns with Chapter <800> with the ultimate outcome being the identification of practical solutions to meet the ultimate goals of Chapter <800>. The proposed chapter still contains burdensome requirements of questionable significance for workplace safety. NCPA maintains that the proposed Chapter <800> requirements will likely divert our members' time and resources from other activities meant to benefit the workplace safety of employees and patients.

Of note, NCPA was one of eight organizations, including the American Medical Association (AMA), who signed a joint letter to USP related to similar concerns with the proposed Chapter.

NCPA Updates FDA Officials on Independent Pharmacists Readiness to Comply with Track and Trace Requirements: On Monday, June 1, officials from FDA held a "listening session" to gauge dispenser readiness for the Drug Supply Chain Security Act (DSCSA) July 1 deadline to receive, maintain and store transaction information. NCPA joined several pharmacy associations and shared the results of a recent membership survey that revealed that many dispensers still had not heard from primary and secondary wholesalers about available services or software solutions. FDA has not yet indicated whether it will push back the July 1 deadline as it had for manufacturers and wholesalers last year. NCPA will continue to update members as more information becomes available.