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A BILL TO BE ENTITLED
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AN ACT
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relating to the confidentiality of test results of samples of |
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compounded products. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 556.053, Occupations Code, is amended to |
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read as follows: |
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Sec. 556.053. EXTENT OF INSPECTION; CONFIDENTIALITY. |
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(a) Except as otherwise provided in an inspection warrant, the |
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person authorized to represent the board may: |
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(1) inspect and copy documents, including records or |
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reports, required to be kept or made under this subtitle, Chapter |
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481 or 483, Health and Safety Code, or the Comprehensive Drug Abuse |
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Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.) |
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or rules adopted under one of those laws; |
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(2) inspect, within reasonable limits and in a |
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reasonable manner, a facility's storage, equipment, security, |
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prescription drugs or devices, components used in compounding, |
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finished and unfinished products, or records; or |
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(3) perform an inventory of any stock of prescription |
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drugs or devices, components used in compounding, or finished and |
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unfinished products in a facility and obtain samples of those |
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substances. |
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(b) Reports, records, formulas, and test results of samples |
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of products compounded by pharmacies obtained by the board may be |
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provided to the pharmacy that compounded the product but otherwise |
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are confidential and do not constitute public information for |
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purposes of Chapter 552, Government Code. The board may create, |
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use, or disclose statistical information from the test results of |
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samples of compounded products. |
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(c) The board may disclose information confidential under |
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Subsection (b): |
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(1) in a disciplinary hearing before the board or in a |
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subsequent trial or appeal of a board action or order; |
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(2) to a pharmacist licensing or disciplinary |
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authority of another jurisdiction; or |
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(3) under a court order. |
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(d) The board shall require a pharmacy to recall a |
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compounded product and may release the results of the tests of the |
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samples of the compounded product if the board determines that: |
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(1) the test results indicate a patient safety problem |
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that may involve potential harm to a patient; and |
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(2) the release of the test results is necessary to |
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protect the public. |
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(e) The board shall release the test results described by |
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Subsection (d) if a pharmacy is unable to or does not recall the |
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compounded product within 48 hours after the board's request under |
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that subsection. |
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SECTION 2. This Act takes effect immediately if it receives |
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a vote of two-thirds of all the members elected to each house, as |
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provided by Section 39, Article III, Texas Constitution. If this |
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Act does not receive the vote necessary for immediate effect, this |
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Act takes effect September 1, 2009. |