If you don't know what a bill does, don't vote for it. This bill fails to deliver upon the goals it promises. Health care is already undergoing innovation and it is innovating everyday. This bill was originally introduced in 2022 and since then, questions asked originally have not been answered and the list of unanswered questions continues to grow. Federal laws ultimately dictate health innovation and this bill does not address those laws. The reality is, that this bill is far more likely to deter genuine health innovation than promote it in the long run. The ambiguity of the bill's goals and vague consumer protections makes it ripe for abuse for vulnerable populations. Will "health consumers" know they are dealing with a "product" that is not necessarily subject to normative VA health regulations? How will "health consumers" that have been adversely affected, know that it is the State Commissioner who they will need to reach out to in order to "provide data"? The bill leaves it up to the company themselves to describe the risks, will the Commonwealth have its own subject matter experts who can review these risks? If you don't know what a bill does, don't vote for it. THERE IS NO NEED FOR A LEGAL PATHWAY FOR HUMAN EXPERIMENTATION IN VIRGINIA. The only thing more ambiguous than the consumer protections in this bill, the beneficiaries. If this bill is heard again next year, it will 5 years since it was originally heard. 5 years is the same time window allotted in this bill, yet not a single VA company has spoken in favor of this bill. In that 5 years, has it been brought to the committee's attention at least 5 Virginia companies that would benefit or 5 Virginia specific health regulations that are overly burdensome to "health innovation" occurring in the Commonwealth? If you don't know what a bill does, don't vote for it.

Prior to my retirement, I was Staff Director of a major subcommittee of the US House of Representatives, and my immediate boss was Congressman Jon Porter, who represented: LAS VEGAS, NEVADA. And Jon used to tell me, "Ron, I never go into those places because I figured out a long time ago how they pay for them." And, of course he was saying casinos are NOT money losers for the house. Every time lawmakers seem to want new laws that govern behavior they send us deeper into the swamp of moral rot and decay, not to mention teaching our children to use drugs and engage in promiscuous behavior, all of which are destructive to our neighborhoods, cities, states, and most important, our Nation. Encouraging "striking it rich" and "I'll beat the odds" activity causes individuals and families to sacrifice limited incomes on the pipe dream that they will be "more lucky, next time." Do NOT impose this new scourge on us--NO CASINO in Fairfax County. Ron Martinson 703 354-3997

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

Now, more than ever, does The Commonwealth have such an urgent task to provide consistent, accessible, and affordable health care services for women. Without well researched programs and streamlined processes women are at risk. Please support these initiatives and vote to strengthen these necessary footholds for all women in Virginia.

Comments Document

See attached for written testimony. Thank you!

Comments Document

Letter of support for HB 1976

The Virginia NAACP strongly supports HB1976, the Maternal Health Monitoring Pilot Program, for the following key reasons: 1. Maternal health disparities are a critical issue for communities of color, particularly Black women, who face significantly higher rates of maternal mortality. According to studies, Black women in Virginia are more than three times as likely to die from pregnancy-related complications. The bill seems to focus on addressing hypertension and diabetes during pregnancy, which are among the leading causes of maternal complications, and disproportionately affect Black and Latina women. By providing remote monitoring, this pilot program aims to help identify and manage these conditions early, reducing the risks for both mothers and babies. 2. Remote patient monitoring is particularly beneficial for rural and low-income communities where access to healthcare services is often limited. This program would make it easier for women to receive consistent care and monitoring without the burden of traveling long distances to appointments. Black and Brown communities often face systemic barriers to accessing timely, quality care. This pilot program would provide an important step toward improving healthcare access and ensuring that all women, regardless of race or income, receive the care they need during pregnancy. 3. The NAACP has long advocated for health equity, and this program directly aligns with that goal. By focusing on hypertension and diabetes, two conditions that can be controlled with appropriate care and early intervention, the program aims to reduce the inequities in maternal health outcomes.

Comments Document

See attached letter

Comments Document

See attached for Philips comment letter. Thanks!

Comments Document

See attached letter.