I am in overall support of the NOIRA related to brown bagging and white bagging of medications.  I support the use of the NABP definitions as presented.  I am in overall support of the proposed regulations, but would like to submit some additional comments for considerations:

1.  The brown bagging of drugs requiring special storage, reconstituion or compounding prior to administration should not be allowed from a patient safety and administering organization liability perspective.  There is no method to ensure that the medication has been maintained at appropriate temperature and conditions prior to administration.  Even if kept in a refrigerator at the patient home, the is no confirmation that the medication was maintained between 36-46 as required by standard.  For RT medications, there is no confirmation that the medication was maintained at controlled room temperature. This not only puts the patient at risk, but puts the organization administering the medication at risk.  For the most part, this practice is being driven soley for the financial benefit of insurance vendors, not for the benefit Ior safety) of the patient or healthcare provider. 

2.  There are similar concerns related to storage for white bag medications.  There is not the same assurance of integrity as if the organization had provided the medication and stored the medication as required by board of pharmacy regulation and requirements of other accrediting organizations (The Joint Commission, DNV, etc).  Even with special packaging, there is not assurance of maintenance of temperature, putting the patient and administering organization at risk.  Again, this practice is being driven soley for the financial benefit of insurance vendors. 

3.  Coordination of care with medications provided through a "white bag" process is challenging for both the healthcare provider and the patient, resulting in delays in care in many cases.  The burden is put back on the patient and administering organization, while the financial benefit resides with the insurance vendor and out-of-state dispensing pharmacy.  At a minimum, the burden should be placed back on the dispensing pharmacy to take ownership of coordination of shipping and receiving of medication.  Ideally, regulations that pertain to any willing provider and other limitations of provision of services by payers (e.g. site of service limitations) could be strengthened to allow health systems to provide medications through normal procurement and distribution systmes.

Thank you in advance for your intent to draft regulation to control a process that lacks control and oversight today, and to improve the care and safety for our patients.