HBA-MPM S.B. 1236 76(R)    BILL ANALYSIS


Office of House Bill AnalysisS.B. 1236
By: Nelson
Public Health
4/27/1999
Engrossed



BACKGROUND AND PURPOSE 

Currently, the Safe Medical Devices Act (SMDA) recognizes that some
products are actually a combination of two or more products traditionally
regulated separately as either drugs, medical devices, or biologics.
In1990, Congress enacted the SMDA, in turn amending the Federal Food, Drug,
and Cosmetic Act to allow federal and state governments to make significant
improvements in the regulation of medical devices and other related
products, including combination products. S.B. 1236 subjects wholesale
distributors or manufacturers to either Subchapter I (Wholesale Drug
Distributors) or Subchapter L (Device Distributors and Manufacturers),
Chapter 431, Health and Safety Code, depending on whether the respective
primary mode of action of a product is considered a drug or a device. 

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.  Provides that if the United
States Food and Drug Administration (USFDA) determines, with respect to a
product which is both 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), Chapter 431 (Texas Food, Drug, and Cosmetic Act), Health and
Safety Code.  Provides that if the USFDA determines that the primary mode
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), Chapter 431, Health and Safety Code. 

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