H.B. 1891 78(R)    BILL ANALYSIS


H.B. 1891
By: Zedler
Public Health
Committee Report (Unamended)



BACKGROUND AND PURPOSE 

In 1997, the United States Congress enacted the Food and Drug
Administration Modernization Act in which numerous sections of the Federal
Food Drug and Cosmetic Act were either deleted or modified.  Modifications
of the required labeling on certain prescription drugs were made to
improve readability of overcrowded labels.  One of the requirements of the
Food and Drug Administration Modernization Act was to change the phrase
"Caution: Federal Law Prohibits Dispensing Without Prescription" to the
shorter phrase "RX Only".  House Bill 1891 also replaces the phrase "
Caution: State Law Prohibits Dispensing Without Prescription" in favor of
the "RX Only" phrase. 

House Bill 1891 amends several sections of the Health and Safety Code,
Chapter 431, Texas Food Drug and Cosmetic Act to achieve uniformity with
labeling requirements for prescription drugs as required by the Federal
Food Drug and Cosmetic Act.  The bill will delete certain defunct labeling
requirements for insulin, antibiotics and narcotic drugs; and, will modify
a required statement on prescription drug labels to be uniform with the
Federal Food Drug and Cosmetic Act.  This bill will make prescription drug
labels easier to read and understand.  


RULEMAKING AUTHORITY

It is the committee's opinion that this bill does not expressly grant any
additional rulemaking authority to a state officer, department, agency, or
institution. 

ANALYSIS

Health and Safety Code, Chapter 431, Texas Food Drug and Cosmetic Act
(TFDCA) is amended to bring it into uniformity with the Federal Food Drug
and Cosmetic Act (Federal Act) as amended by the Food and Drug
Administration Modernization Act (Public Law 105-115) of 1997.  The bill
makes changes to a misbranded drug or device, labeling and updates
language to reflect the changes in federal law.  Sections are renumbered
and references updated to conform with the Federal  Act. 

EFFECTIVE DATE

September 1, 2003