| (a) The department shall assess administrative penalties
in accordance with the requirements of:
(1) Texas Health and Safety Code Chapter 441;
(2) this subchapter;
(3) Texas Government Code, Chapter 2001; and
(4) the department's formal hearing procedures in §§1.21,
1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).
(b) The department shall assess administrative penalties
based upon one or more of the following criteria:
(1) the Pharmaceutical Drug Manufacturer's previous
violations;
(2) the seriousness of the violation;
(3) the Pharmaceutical Drug Manufacturer's demonstrated
good faith; and
(4) any other matters as justice may require.
(c) Each day a violation continues may be considered
a separate violation.
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