By: Van de Putte S.B. No. 1127
A BILL TO BE ENTITLED
AN ACT
relating to the confidentiality of test results of samples of
compounded products.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 556.053, Occupations Code, is amended to
read as follows:
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.
SECTION 2. This Act takes effect immediately if it receives
a vote of two-thirds of all the members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect September 1, 2009.