BILL ANALYSIS Senate Research Center S.B. 1127 By: Van de Putte Health & Human Services 9/1/2009 Enrolled AUTHOR'S / SPONSOR'S STATEMENT OF INTENT The Texas State Board of Pharmacy (TSBP) is the state agency responsible for the licensure and discipline of Texas pharmacists and pharmacies. Its main responsibility is to protect the public's health, safety, and welfare by fostering the provision of quality pharmaceutical care to the citizens of Texas. In meeting this goal, TSBP randomly samples products that have been compounded by pharmacies and tests these products for accuracy of compounding. As part of this testing, TSBP collects the formulas used by the pharmacy for compounding the product. Under the current law, all information TSBP collects during this process is considered public information for purposes of the Public Information Act. However, many of the formulas and other processes used in compounding these compounded products are trademarked and the information collected is therefore proprietary. S.B. 1127 provides that all reports, formulas, and test results of samples of products compounded by pharmacies that TSBP obtains are confidential and are not public information, but authorizes TSBP to disclose the confidential information under certain circumstances. RULEMAKING AUTHORITY This bill does not expressly grant any additional rulemaking authority to a state officer, institution, or agency. SECTION BY SECTION ANALYSIS SECTION 1. Amends Section 556.053, Occupations Code, as follows: Sec. 556.053. New heading: EXTENT OF INSPECTION; CONFIDENTIALITY. (a) Creates this subsection from existing text. (b) Provides that reports, records, formulas, and test results of samples of products compounded by pharmacies obtained by the Texas State Board of Pharmacy (TSBP) 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 (Public Information), Government Code. Authorizes TSBP to create, use, or disclose statistical information from the test results of samples of compounded products. (c) Authorizes TSBP to disclose information confidential under Subsection (b) in a disciplinary hearing before TSBP or in a subsequent trial or appeal of a TSBP action or order, to a pharmacist licensing or disciplinary authority of another jurisdiction, or under a court order. (d) Requires TSBP to require a pharmacy to recall a compound product and authorizes TSBP to release the results of the test of the samples of the compounded product if TSBP determines that the tests results indicate a patient safety problem that may involve potential harm to a patient and the release of the test results is necessary to protect the public. (e) Requires TSBP to 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 TSBP's request under that subsection. SECTION 2. Effective date: upon passage or September 1, 2009.
BILL ANALYSIS
Senate Research Center S.B. 1127
By: Van de Putte
Health & Human Services
9/1/2009
Enrolled
AUTHOR'S / SPONSOR'S STATEMENT OF INTENT
The Texas State Board of Pharmacy (TSBP) is the state agency responsible for the licensure and discipline of Texas pharmacists and pharmacies. Its main responsibility is to protect the public's health, safety, and welfare by fostering the provision of quality pharmaceutical care to the citizens of Texas. In meeting this goal, TSBP randomly samples products that have been compounded by pharmacies and tests these products for accuracy of compounding. As part of this testing, TSBP collects the formulas used by the pharmacy for compounding the product. Under the current law, all information TSBP collects during this process is considered public information for purposes of the Public Information Act. However, many of the formulas and other processes used in compounding these compounded products are trademarked and the information collected is therefore proprietary.
S.B. 1127 provides that all reports, formulas, and test results of samples of products compounded by pharmacies that TSBP obtains are confidential and are not public information, but authorizes TSBP to disclose the confidential information under certain circumstances.
RULEMAKING AUTHORITY
This bill does not expressly grant any additional rulemaking authority to a state officer, institution, or agency.
SECTION BY SECTION ANALYSIS
SECTION 1. Amends Section 556.053, Occupations Code, as follows:
Sec. 556.053. New heading: EXTENT OF INSPECTION; CONFIDENTIALITY. (a) Creates this subsection from existing text.
(b) Provides that reports, records, formulas, and test results of samples of products compounded by pharmacies obtained by the Texas State Board of Pharmacy (TSBP) 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 (Public Information), Government Code. Authorizes TSBP to create, use, or disclose statistical information from the test results of samples of compounded products.
(c) Authorizes TSBP to disclose information confidential under Subsection (b) in a disciplinary hearing before TSBP or in a subsequent trial or appeal of a TSBP action or order, to a pharmacist licensing or disciplinary authority of another jurisdiction, or under a court order.
(d) Requires TSBP to require a pharmacy to recall a compound product and authorizes TSBP to release the results of the test of the samples of the compounded product if TSBP determines that the tests results indicate a patient safety problem that may involve potential harm to a patient and the release of the test results is necessary to protect the public.
(e) Requires TSBP to 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 TSBP's request under that subsection.
SECTION 2. Effective date: upon passage or September 1, 2009.