1 | 1 | | S.B. No. 1127 |
---|
2 | 2 | | |
---|
3 | 3 | | |
---|
4 | 4 | | AN ACT |
---|
5 | 5 | | relating to the confidentiality of test results of samples of |
---|
6 | 6 | | compounded products. |
---|
7 | 7 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
---|
8 | 8 | | SECTION 1. Section 556.053, Occupations Code, is amended to |
---|
9 | 9 | | read as follows: |
---|
10 | 10 | | Sec. 556.053. EXTENT OF INSPECTION; CONFIDENTIALITY. |
---|
11 | 11 | | (a) Except as otherwise provided in an inspection warrant, the |
---|
12 | 12 | | person authorized to represent the board may: |
---|
13 | 13 | | (1) inspect and copy documents, including records or |
---|
14 | 14 | | reports, required to be kept or made under this subtitle, Chapter |
---|
15 | 15 | | 481 or 483, Health and Safety Code, or the Comprehensive Drug Abuse |
---|
16 | 16 | | Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.) |
---|
17 | 17 | | or rules adopted under one of those laws; |
---|
18 | 18 | | (2) inspect, within reasonable limits and in a |
---|
19 | 19 | | reasonable manner, a facility's storage, equipment, security, |
---|
20 | 20 | | prescription drugs or devices, components used in compounding, |
---|
21 | 21 | | finished and unfinished products, or records; or |
---|
22 | 22 | | (3) perform an inventory of any stock of prescription |
---|
23 | 23 | | drugs or devices, components used in compounding, or finished and |
---|
24 | 24 | | unfinished products in a facility and obtain samples of those |
---|
25 | 25 | | substances. |
---|
26 | 26 | | (b) Reports, records, formulas, and test results of samples |
---|
27 | 27 | | of products compounded by pharmacies obtained by the board may be |
---|
28 | 28 | | provided to the pharmacy that compounded the product but otherwise |
---|
29 | 29 | | are confidential and do not constitute public information for |
---|
30 | 30 | | purposes of Chapter 552, Government Code. The board may create, |
---|
31 | 31 | | use, or disclose statistical information from the test results of |
---|
32 | 32 | | samples of compounded products. |
---|
33 | 33 | | (c) The board may disclose information confidential under |
---|
34 | 34 | | Subsection (b): |
---|
35 | 35 | | (1) in a disciplinary hearing before the board or in a |
---|
36 | 36 | | subsequent trial or appeal of a board action or order; |
---|
37 | 37 | | (2) to a pharmacist licensing or disciplinary |
---|
38 | 38 | | authority of another jurisdiction; or |
---|
39 | 39 | | (3) under a court order. |
---|
40 | 40 | | (d) The board shall require a pharmacy to recall a |
---|
41 | 41 | | compounded product and may release the results of the tests of the |
---|
42 | 42 | | samples of the compounded product if the board determines that: |
---|
43 | 43 | | (1) the test results indicate a patient safety problem |
---|
44 | 44 | | that may involve potential harm to a patient; and |
---|
45 | 45 | | (2) the release of the test results is necessary to |
---|
46 | 46 | | protect the public. |
---|
47 | 47 | | (e) The board shall release the test results described by |
---|
48 | 48 | | Subsection (d) if a pharmacy is unable to or does not recall the |
---|
49 | 49 | | compounded product within 48 hours after the board's request under |
---|
50 | 50 | | that subsection. |
---|
51 | 51 | | SECTION 2. This Act takes effect immediately if it receives |
---|
52 | 52 | | a vote of two-thirds of all the members elected to each house, as |
---|
53 | 53 | | provided by Section 39, Article III, Texas Constitution. If this |
---|
54 | 54 | | Act does not receive the vote necessary for immediate effect, this |
---|
55 | 55 | | Act takes effect September 1, 2009. |
---|
56 | 56 | | ______________________________ ______________________________ |
---|
57 | 57 | | President of the Senate Speaker of the House |
---|
58 | 58 | | I hereby certify that S.B. No. 1127 passed the Senate on |
---|
59 | 59 | | April 20, 2009, by the following vote: Yeas 30, Nays 0. |
---|
60 | 60 | | ______________________________ |
---|
61 | 61 | | Secretary of the Senate |
---|
62 | 62 | | I hereby certify that S.B. No. 1127 passed the House on |
---|
63 | 63 | | May 27, 2009, by the following vote: Yeas 148, Nays 0, one |
---|
64 | 64 | | present not voting. |
---|
65 | 65 | | ______________________________ |
---|
66 | 66 | | Chief Clerk of the House |
---|
67 | 67 | | Approved: |
---|
68 | 68 | | ______________________________ |
---|
69 | 69 | | Date |
---|
70 | 70 | | ______________________________ |
---|
71 | 71 | | Governor |
---|