Tennessee § 63-10-216 - Compounding pharmacies.

§ 63-10-216. Compounding pharmacies.

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 twelve (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 twelve (12) months. The board of pharmacy shall have the right to require additional information before issuing or renewing a pharmacy license to insure compliance with applicable laws of this state and any rules and policies of the board. Any compounding pharmacy having an active Tennessee license shall notify the board within fourteen (14) business days of receipt of any order or decision by a regulatory agency, other than the Tennessee board of pharmacy, imposing any disciplinary action, including any warning, on the pharmacy. Any pharmacies engaged in sterile compounding must comply with relevant United States Pharmacopeia (USP) guidelines as adopted by the board by rule or policy. Any pharmacies engaging in sterile compounding, except hospital pharmacies compounding for inpatients of a hospital, shall 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; provided, however, that the executive director of the board may request this information from a hospital pharmacy for cause and the hospital pharmacy shall be required to respond in a timely manner as defined by the executive director of the board. Acts 2013, ch. 266, § 3. Law Reviews. Seeing Through the Murky Vial: Does the FDA Have the Authority to Stop Compounding Pharmacies from Pirate Manufacturing?, 66 Vand. L. Rev. 1609 (2013). Attorney General Opinions. Inspection fees for out-of-state pharmacies licensed in Tennessee. OAG 14-05, 2014 Tenn. AG LEXIS 6 (1/9/14).