HBA-MPM H.B. 2179 76(R)    BILL ANALYSIS


Office of House Bill AnalysisH.B. 2179
By: Uresti
Public Health
3/31/1999
Introduced



BACKGROUND AND PURPOSE 

In 1990, Congress enacted the Safe Medical Devices Act (SMDA), which
amended the Federal Food, Drug, and Cosmetic Act to allow federal and state
governments to make improvements in the regulation of medical devices and
related products, including combination products (a combination of both
drug and device).  Amending Texas law will provide uniformity with federal
requirements and enable the state to take advantage of the improvements
resulting from SMDA, including a more streamlined approach to licensing and
inspecting manufacturers and distributors of combination products. 

H.B. 2179 amends Chapter 431, Health and Safety Code, to authorize the
Texas Department of Health to determine the appropriate state regulatory
process for manufacturers and distributors of combination products, thereby
making the code consistent with federal law. 

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. 

SECTION BY SECTION ANALYSIS

SECTION 1.  Amends Subchapter A, Chapter 431, Health and Safety Code, by
adding Section 431.006, as follows: 

Sec. 431.006.  CERTAIN COMBINATION PRODUCTS.  Specifies that if the United
States Food and Drug Administration (USFDA) determines, with respect to a
product that is a combination of a drug and device, that the primary mode
of action of the product is as a drug, the person engaging in wholesale
distribution of the product is subject to licensure under Subchapter I
(Wholesale Drug Distributors); and that the primary mode of action of the
product is as a device, a distributor or manufacturer of the product is
subject to licensure under Subchapter L (Device Distributors and
Manufacturers). 

SECTION 2.  Emergency clause.
  Effective date: upon passage.