HBA-DMH H.B. 1673 77(R)    BILL ANALYSIS


Office of House Bill AnalysisH.B. 1673
By: Burnam
Public Health
3/8/2001
Introduced



BACKGROUND AND PURPOSE 

Currently, the Texas Department of Health (TDH) regulates both perishable
and nonperishable food, drug, medical device, and cosmetic items.  For
consumer safety, it is important that TDH establish and maintain minimum
standards for perishable items.  However, there is a significant difference
between the regulation of food items, cosmetics, and drugs, and the
regulation of medical devices.  House Bill 1673 establishes guidelines for
the regulation of medical devices as distressed merchandise.  

RULEMAKING AUTHORITY

It is the opinion of the Office of House Bill Analysis that this bill does
not expressly delegate any additional rulemaking authority to a state
officer, department, agency, or institution. 

ANALYSIS

House Bill 1673 amends the Health and Safety Code to modify the definition
of distressed merchandise for the purpose of regulation under the Texas
Food, Drug, Device, and Cosmetic Salvage Act.  The bill provides that a
medical device is distressed merchandise only if the device is offered for
sale or distribution to a person who does not hold a salvage operator
license, and is misbranded or mislabeled, or rendered unsuitable for use
according to the original manufacture's published recommendations or
specifications. Before the Texas Department of Health (TDH) may treat a
device in the possession of a person who holds a salvage operator license
as distressed merchandise, TDH must provide to the person a statement of
proof that establishes that the device is distressed merchandise. 

EFFECTIVE DATE

September 1, 2001.