The board may inspect pharmacy records and products, keep certain compounded-product test information confidential, disclose it in limited situations, and must order a recall and release test results in specified safety cases.
Sec. 556.053. EXTENT OF INSPECTION; CONFIDENTIALITY. (a) Except as otherwise provided in an inspection warrant, the person authorized to represent the board may: (1) inspect and copy documents, including records or reports, required to be kept or made under this subtitle, Chapter 481 or 483, Health and Safety Code, or the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.) or rules adopted under one of those laws; (2) inspect, within reasonable limits and in a reasonable manner, a facility's storage, equipment, security, prescription drugs or devices, components used in compounding, finished and unfinished products, or records; or (3) perform an inventory of any stock of prescription drugs or devices, components used in compounding, or finished and unfinished products in a facility and obtain samples of those substances. (b) Reports, records, formulas, and test results of samples of products compounded by pharmacies obtained by the board may be provided to the pharmacy that compounded the product but otherwise are confidential and do not constitute public information for purposes of Chapter 552, Government Code. The board may create, use, or disclose statistical information from the test results of samples of compounded products. (c) The board may disclose information confidential under Subsection (b): (1) in a disciplinary hearing before the board or in a subsequent trial or appeal of a board action or order; (2) to a pharmacist licensing or disciplinary authority of another jurisdiction; or (3) under a court order. (d) The board shall require a pharmacy to recall a compounded product and may release the results of the tests of the samples of the compounded product if the board determines that: (1) the test results indicate a patient safety problem that may involve potential harm to a patient; and (2) the release of the test results is necessary to protect the public. (e) The board shall release the test results described by Subsection (d) if a pharmacy is unable to or does not recall the compounded product within 48 hours after the board's request under that subsection. Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999. Amended by: Acts 2005, 79th Leg., Ch. 28 (S.B. 492), Sec. 3, eff. September 1, 2005. Acts 2009, 81st Leg., R.S., Ch. 785 (S.B. 1127), Sec. 1, eff. June 19, 2009.