Please thoughtfully consider the addition of regionalization of hospital packaging within Part XI regulating Pharmacy Services to Hospitals.

ASHP Pharmacy Forecast for 2015-2019 indicates that the pharmacy departments in at least 50% of hospitals will be responsible for preparing nearly all compounding sterile products needed for the hospital’s patients.  An increasing amount of facilities are moving away from outsourcing facilities due to unresolved FDA 483’s and subsequent warning letters. 

The increasing demand on internal sterile compounding operations is exponentiated by changes in USP guidelines and CETA regulations that continue to increase demands on facility controls and compounding competencies.  As health systems continue to merge and acquire additional facilities to mitigate changing financial and quality measures, there is an opportunity to utilize and capitalize sterile compounding skilled labor internally and centrally for these systems. 

Insourcing through regionalization allows centralized compounding to ensure quality standards are met and consistency is established throughout the continuum of care within the system.  In comparison to a manufacturing facility, consistency is established through ISO standardization that improves the quality of the end-product.  As facilities and individual sites increase, the risk for inconsistency increases, thus putting our patients at risk.  In addition, sterile compounding continues to involved technological resources, advances in engineering, and specific competency that is better established and implemented at a centralized location for better controls.

California board of Pharmacy 2015 Lawbook for Pharmacy Article 7.6:4128 allows “a centralized hospital packaging pharmacy may prepare medications, by performing the following specialized functions, for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership” 

Wisconsin Chapter Phar 7.01 (2) does not “prohibit institutional pharmacists or community pharmacists serving institutions from receiving prescription orders, dispensing and returning prescription medications consistent with accepted inpatient institutional drug distribution systems”

New Jersey also allows health system regionalization of sterile compounding under section 503A.

Please consider addition to the Virginia Board of Pharmacy regulations the allowance for regionalization of compounded products under a common ownership entity.  The prescription data may be collected by the site of requisition, and can be recalled by the site of distribution allowing for receipt of a valid order prior to dispensing and administration to the end-user to comply with 503A Traditional Compounding.

Recommended addition for consideration:

E. Centralized Hospital Packaging

A centralized hospital packaging pharmacy may prepare medications, unit dose packaging and compounded medications, for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and share a common medical information system.

Thank you for your thoughtful consideration!