SRC-DBM S.B. 1236 76(R)   BILL ANALYSIS


Senate Research Center   S.B. 1236
76R3429  DLF-FBy: Nelson
Health Services
3/22/1999
As Filed


DIGEST 

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.  In
1990, Congress enacted the SMDA; this act amended 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 would subject wholesale
distributors or manufacturers to either Chapter 431I or Chapter 431L
depending upon whether or not the respective primary mode of action of a
product is considered a drug or a device. 

PURPOSE

As proposed, S.B. 1236 regulates a product that is a combination of a drug
and a device. 

RULEMAKING AUTHORITY

This bill does not grant any additional rulemaking authority to a state
officer, institution, or agency. 

SECTION BY SECTION ANALYSIS

SECTION 1.  Amends Chapter 431A, 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 determines, with respect to a product
that is a combination of a drug and a device, that the primary mode of
action of the product is a drug, then a person who engages in wholesale
distribution of the product is subject to licensure under Subchapter I; and
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. 

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