VSHP is in overall support of regulation to regulate brown bagging of drugs requiring reconstitution or compounding prior to administration and the establishment of specific requirements for specialty pharmacies participating in white bagging, with the overall intent of public protection.

VSHP supports the use of definitions of brown bagging and white bagging as established by NABP.

In addition to the regulations under consideration as defined in the NOIRA, VSHP suggests expansion of regulations under consideration to include:

1. Not allowing brown bagging of medications that require special storage, reconstitution or compounding prior to administration due to the risk to the patient and the organization providing administration of the medication.

2. Leverage  current “Any Willing Provider” legislation to allow health systems that have specialty pharmacy/retail pharmacy capability to provide the needed medications for patients receiving care at health system owned locations. Alternatively, include provisions that would allow health systems to provide medications through normal procurement process versus through external specialty pharmacy providers. This would allow more robust coordination, reduce the risk of medication errors and patient harm, limit risk of improper storage of medications, and minimize delays in patient care.

3. Inclusion of requirement for coordination of shipment and arrival date to include physician-based practices and other locations of care since often the transfer is not pharmacy to pharmacy.

In addition, VSHP members have inquired about whether proposed regulations will impact the following scenarios, and we look forward to providing further comment:

• Patient Assistance Programs and Manufacturer Consignment Programs

• Patient request of provider administration of non-reconstituted, non-compounded medications (such as ready to inject syringes) brown bag medications due to concerns with self-administration at home

• Exclusions for emergent situations. Example: Patients with hemophilia admitted to emergency departments requiring emergent blood factor treatment that requires reconstitution that is not carried by pharmacy. These patients usually bring their own blood factor products to the Emergency Department as a result.