Amends TCA Section 63-10-216.

This bill revises provisions governing compounding pharmacies, as described below.<br /> <br /> OUT-OF-STATE PHARMACIES<br /> <br /> Present law requires that prior to initial licensure in this state as a compounding pharmacy, a pharmacy located outside of this state must have an inspection by the regulatory or licensing agency of the state in which the pharmacy practice site is physically located. Out-of-state pharmacy practice sites must provide a copy of the most recent inspection by the regulatory or licensing agency of the state in which the pharmacy practice site is physically located, which must have been within the previous 12 months. Prior to renewal of its license in this state, an out-of-state pharmacy practice site must provide the most recent inspection by the regulatory or licensing agency of the state in which the pharmacy practice site is physically located or equivalent regulatory entity, and which must have been within the previous 12 months. <br /> <br /> This bill authorizes out-of-state pharmacy practice sites, for initial licensure or renewal, to provide to the board an equivalent inspection accepted by the Tennessee board of pharmacy as an alternative to a copy of a recent inspection by the regulatory or licensing agency of the state where the pharmacy is physically located. <br /> <br /> NOTIFICATION OF DISCIPLINARY ACTION<br /> <br /> Present law requires that a compounding pharmacy having an active Tennessee license notify the board within 14 business days of receipt of any order or decision by a regulatory agency, other than the board, imposing any disciplinary action, including any warning, on the pharmacy. This bill extends this provision to apply in cases of any such action by a licensing agency (other than the board), in addition to a regulatory agency. <br /> <br /> STERILE COMPOUNDING<br /> <br /> Present law requires pharmacies engaged in sterile compounding to comply with relevant United States Pharmacopeia (USP) guidelines as adopted by the board by rule or policy. This bill expands the scope of such compliance to pharmacies engaging in "compounding" in general, rather than only "sterile compounding."<br /> <br /> Under present law, pharmacies engaging in sterile compounding, except hospital pharmacies compounding for inpatients of a hospital, must report on a quarterly basis to the board the quantity of sterile compounded products dispensed in a defined time period in accordance with policies adopted by the board. <br /> <br /> This bill removes the requirement that a pharmacy engaging in sterile compounding submit quarterly reports on the quantity of products dispensed and instead requires that a pharmacy engaging in sterile compounding make such information available to the board upon request.<br />