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.