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Amend SB 943 (House Committee Report) as follows:
(1) In SECTION 2 of the bill, in amended Section 431.4031, Health and Safety Code (page 7, line 4), strike "431.4045" and
substitute "431.4045(2)".
(2) In SECTION 4 of the bill, in added Subdivision (1),
Section 431.4045, Health and Safety Code (page 10, line 22),
between "431.404" and the underlined semicolon, insert the
following:
or determines that an inspection is unnecessary after thoroughly
evaluating the information in the application, the compliance
history of the applicant and the applicant's principals, and the
risk of counterfeiting in the applicant's product
(3) In SECTION 5 of the bill, in amended Section 431.405,
Health and Safety Code (page 11, line 1), strike "To" and substitute
the following:
(a) The department may not issue a wholesale distributor
license to an applicant without considering the minimum federal
information and related qualification requirements published in
federal regulations at 21 C.F.R. Part 205, including:
(1) factors in reviewing the qualifications of persons
who engage in wholesale distribution, 21 C.F.R. Section 205.6;
(2) appropriate education and experience for
personnel employed in wholesale distribution, 21 C.F.R. Section
205.7; and
(3) the storage and handling of prescription drugs and
the establishment and maintenance of prescription drug
distribution records, 21 C.F.R. Section 205.50.
(b) In addition to meeting the minimum federal requirements
as provided by Subsection (a), to [To]
(4) In SECTION 5 of the bill, in amended Subdivision (6),
Section 431.405, Health and Safety Code (page 11, line 20), between
"in a circumstance" and "in which", insert ", as the department
determines reasonable,".