The Honorable Rodney Willett, The majority of patients that enter a healthcare facility receive sterile intravenous medications. Most of those medications are mixed by pharmacy staff in an area of high regulatory and operational scrutiny. If the medication is not compounded correctly, the impact to patient safety can be detrimental, and there are recent examples across the country that highlight that potential. The sterility, stability, and ultimate safety of sterile compounded medications is of top priority for healthcare organizations. Support of HB1905 will improve the safety of compounded sterile products across the Commonwealth. It will also allow health systems the flexibility to strategically make financial and operational compounding decisions to ensure patients have access to the medications needed for their treatment. These decisions will be in accordance with all applicable regulatory and practice standards to ensure the safety of all compounded sterile drug products. The improvement in the safety of compounded sterile products is by allowing centralizing of compounding services to facilities and personnel within the health system that specialize and utilize advanced technology to improve the safety of compounded sterile drug products. In the current state, compliance to regulatory standards is dispersed to multiple facilities, and to a significant amount of compounding personnel. This may increase the risk of noncompliance and potential safety concerns to patients through sterile compounding by personnel who are not experienced or dedicated to compounding, or in facilities with limited capital resources. We believe that when USP-compliant practices are followed, the safety of these products remains consistent, whether used within the originating facility or shared with a sister site. Conversations with national organizations also suggest that the actions proposed in this bill do not violate any enforceable FDA policy. In fact, the FDA has modified its Industry Guidance with respect to the prescription requirement in section 503A of the FD&C, to allow distribution of a compounded drug products to patients within a health system. Organizations must take into consideration the FDA Industry Guidance, but currently our legislation is more restrictive than the federal agency that oversees 503B Outsourcing Facilities. The legislative proposal will align with the recent FDA Industry Guidance document. In addition, utilization of available 503B Outsourcing facilities does not necessarily lead to improved safety of compounded sterile drug products. Concerns about 503B oversight persist, as 33 of the 88 registered facilities have never been inspected, and inspection intervals can span years. There has been a dramatic shift over the past 3 years away from contracting with one or two outsourced vendors, to now 24% of facilities use 5 or more outsourced vendors that may be licensed before an initial inspection. Across the nation, the trend over the last 3 years has been a curtailing of outsourcing amounts due to member sterility or safety concerns from utilizing 503B Outsourcing Facilities. HB1905 will have a significant impact to our patients. It will also make available opportunities to improve care, and ensure availability of products, through legislation that many other states have already in place. Thank you for your support of this critical legislation! Jamin Engel Sentara Health

SUPPORT I am writing in support of this bill as a Virginia-based hospital pharmacist with 14 years of experience. I have seen many instances where giving hospitals the ability to support each other within a health system would prove beneficial to patient care. (1) Richmond water outage - Caused severe disruptions in pharmacy operations at three hospitals within my community (St Marys, Richmond Community, Memorial Regional Medical Center). (2) Norovirus outbreak - Outbreaks unpredictably impact departments and leads to staffing shortages with 48-72 hour quarantine periods per VDH rules. It would have been immensely helpful if hospitals a few miles away within the same health system could have jumped in and helped make sterile compounding products ahead of time to reduce workload at the impacted hospital and reduce delays in delivering patient care. (3) Medication shortages - Shortages continue to significantly impact the pharmaceutical supply chain. There are many instances where drug is available due to higher inventory at one hospital while another may be out of stock. This issue recently impacted hospitals across the nation due to the damage Hurricane Helene caused on Baxter's North Carolina manufacturing plant. (4) Clean room air handler malfunctions - Unfortunately hospital clean rooms are not immune from HVAC issues. We have had air handlers break or not function (despite being brand new) at multiple Virginia hospitals over the past couple years. This took 2-3 months to rectify during which time those hospitals could not make medications ahead of time as per usual workflow. The changes in this bill would allow other hospitals within our health system with fully functioning clean rooms to help prepare products while repairs were underway. All hospitals work under the same laws and regulations so a sterile compounded product made at one hospital in preparation of patient care is equally safe as one made at another hospital within the same health system. They would use the same drugs coming from the same distributer and everything would be tracked within the same electronic health record at the medical center. These hospitals also fall under the same regulatory guidance as each other (The Joint Commission on hospital accreditation, Board of Pharmacy, Drug Enforcement Agency, Food and Drug Agency, Department of Environmental Quality, and Centers for Medicare and Medicaid Services).

Good afternoon. I represent 14 hospital pharmacy departments across the Commonwealth of VA and would like to express my support for this bill. Over the last several years, Virginia hospital pharmacy departments have been inundated with drug and supply chain shortages that have challenged our abilities to provide safe and timely compounding of medications to our patients. In addition, under current law and regulation, it is required that compounding activities must occur on the campus where drug administration occurs, which requires each campus to create duplicate services. Also, as with the most recent water outage in Richmond, during a major natural disaster/utility outage the inability to provide medication compounding from another hospital campus under same ownership is far more of a risk to patient care than shuttling safely prepared drug from another owned hospital campus. I do believe that allowing central health system compounding of medications does mitigate many of the concerns above. Central compounding allows for one facility to share resources efficiently across one or many sister hospitals thus cutting down on compounding burden, drug and supply expense, and the need for large capital outlay to build and maintain a hospital clean room at each hospital. There would also be less expired/wasted drug as there would be less need to compound at each facility. In addition, with drug shortages being as common as they are, i could see significant benefit in our rationing strategies by sharing from a single (or fewer compounding sites) across the state. In addition, during COVID and most recently during the boil water advisory in Richmond and surrounding counties, it has become obvious that there needs to be a solution that allows one hospital to compound on behalf of another hospital when facility operations are actually or potentially jeopardized. Allowing compounding from a sister facility would also help during construction projects where a clean room must be shut down. This would prevent a specific hospital from having to figure out how to build a temporary IV room on site while that construction occurs. Overall, i think VA BOP inspected clean rooms that are in compliance with 797 and under a single health system's umbrella can safely and more efficiently compound medications including sterile products for one another and at less cost to the health system. Thank you for considering this legislation that has been used already on an emergent basis in the Commonwealth.

Please support our ability to share resources and care for patients in a timely manner! Lauren McDaniel, PharmD, BCIDP

Comments Document

Delegates, This bill's request is simple: It modernizes the Virginia Code to allow hospitals to compound drugs for each other within their systems when a healthcare provider safely administers them. The language here keeps patient care and safety in mind in that the originating hospital pharmacy maintains responsibility for the product to the patient. This allowance enhances the ability to ensure timely access to medications, and flexibility during emergencies, and supports the financial stewardship of healthcare dollars. Sourcing medications takes a variety of partners including those outsourcing pharmacies that are able to do things in greater supply with better expiration dating and those companies will always be valuable partners. Brad McDaniel, PharmD, MBA, BCCCP Roanoke, VA