As discussed in the last two Board meetings, investigators have started to use a more detailed checklist guide when inspecting sterile compounding pharmacies. It is advised that according to Tennessee Board of Pharmacy Rule 1140-07-.03(f), “ . . . Prefilters in laminar flow hoods shall be changed at least quarterly and a written record of such change shall be maintained. . .” Pharmacists may believe that they are in compliance if the semi-annual certification has been satisfied. However, the certifying technician may only be changing the prefilter every six months as opposed to the required three-month period.
Moreover, pharmacists are expected to give examples of compliance with regard to the physical requirements of sterile compounding as stated in Rule 1140-07-.03, labeling as stated in Rule 1140-07-.05, hazardous products as stated in Rule 1140-07-.06, attire as stated in 1140-07-.07, and quality assurance as stated in Rule 1140-07-.08.
As described, pharmacists shall document proper sterile compounding training and annual continuing education of all compounding personnel. Updated sterile compounding policies and procedures are expected to be readily available for investigator review, and should address each item on the list located in Tennessee Board of Pharmacy Rule 1140-07-.04. The Board expects for policies and procedures to be complete. Pharmacists are expected to follow these policies and procedures for the health and safety of the patient. Refer to Rule 1140-02-.01(11), which states in part “ . . . A pharmacist shall provide pharmaceutical service: (a) which is as complete as the public may reasonably expect; (b) without discriminating in any manner between patients or groups of patients; and (c) without compromising the kind or extent of services or facilities made available. . .”
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