SRC-TJG, VRA S.B. 1400 78(R)BILL ANALYSIS


Senate Research CenterS.B. 1400
By: Nelson
Health & Human Services
8/25/2003
Enrolled



DIGEST AND PURPOSE 

In 1997, the United States Congress enacted the Food and Drug
Administration Modernization Act which deleted or modified numerous
sections of the Federal Food and Drug and Cosmetic Act.  S.B. 1400 revises
the Texas Food and Drug and Cosmetic Act to conform Texas prescription
drug labels to current federal statutes. 

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 Subdivision (8), Section 431.002, Health and Safety
Code, to delete references in the definition of  "consumer commodity." 

SECTION 2.  Amends Subsection (c), Section 431.042, Health and Safety
Code, to delete a reference to current statute from existing text. 

SECTION 3.  Amends Subsection (b), Section 431.059, Health and Safety
Code, to delete and add a new reference to existing text. 

SECTION 4.  Amends Section 431.112, Health and Safety Code, as follows:

(d)  Deletes entire text of existing Subsection (d).  Redesignates
Subsections (e)-(u) as Subsections (d)-(t).  

 (j)  Deletes Subdivisions (1) and (2) from existing text.

 (k)  Deletes Subdivisions (1) and (2) from existing text.

 (o)  Makes a nonsubtantive and a clarifying change.

SECTION 5.  Amends Subsection (c), Section 431.113, Health and Safety
Code, to delete text from Subsection (c)(1)(a) and renumber subsequent
subdivisions accordingly.  Makes conforming changes to Subsection (c)(2).
Deletes current text of (c)(3) and requires a drug that is subject to
Subdivision (1) to be deemed to be misbranded if at any time prior to
dispensing its label fails to bear at a minimum, the symbol "RX Only." 

SECTION 6.  Amends Subsection (b), Section 431.114, Health and Safety
Code, to delete a reference in existing text. 

SECTION 7.  Makes application of this Act prospective.

SECTION 8.(a) and (b)  Make application of this Act prospective.

SECTION 9.  Effective date:  September 1, 2003.