It was with great interest that I read the article “A Financial Evaluation of the Centralized Repackaging of Intracameral Moxifloxacin for Cataract Surgery and Its Impact on Cost Reduction” in the October 2018 issue of Hospital Pharmacy. There are points which I do not understand and would ask for guidance to achieve clarification.
In the article, it is stated that “The Aurora Pharmacy Packaging Center (APPC) is a 503a compounding pharmacy within Aurora Health Care that repackages bulk pharmaceuticals into unit doses for distribution within the health care system.” Such a statement disclaims status as a hospital pharmacy, rendering production at the facility subject to regulations defined by the Drug Quality and Security Act (DQSA).
A hospital pharmacy may compound and repackage for its affiliates, if said affiliates are within a 1-mile radius of the repackaging site. If the affiliate is outside of this range, it must observe regulations defined by the DQSA. However, APPC is a self-defined 503a pharmacy.
A 503a pharmacy requires an advance individual patient-specific prescription before dispensing. A review of your text and process documentation (Figures 1-3) is absent process or documentation for the inclusion of a patient name. Indeed, the text states that, like a manufacturer, production is based on projected patient volume, not patient specific need.
With this in mind, how is the APPC able to claim status as a 503a compounding pharmacy, yet produce in a manner akin to that of a manufacturer or a 503b outsourcing facility? Is it receiving individual patient-specific prescriptions prior to dispensing to its affiliates?
Footnotes
Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.