BILL ANALYSIS

C.S.H.B. 2838
Public Health Committee
C.S.H.B. 2838
Committee Report (Substituted)
04-19-95



BACKGROUND

The Texas Food, Drug and Cosmetic Act (Act) was first enacted in
1911 by the 32nd Legislature, and then recodified as Chapter 431,
Health and Safety Code in 1989 by the 71st Legislature. The Act is
a "cradle to grave" statute encompassing the manufacture, sale and
distribution to an end consumer of food, drugs, devices and
cosmetics. The Act conforms with the Federal Food, Drug and
Cosmetic Act and has been amended over the years to maintain
conformance with the Federal Act.

In recent years, a need to regulate persons selling products in
Texas has arisen. This bill would give the Texas Department of
Health (TDH) authority to regulate adulterated or misbranded
components, or those posing an immediate threat.

PURPOSE

H.B. 2838 as substituted, amends the Texas Food, Drug and Cosmetic
Act to conform with the Federal Food, Drug and Cosmetic Act, and
gives the TDH authority to regulate those selling a food, drug,
device, or cosmetic, with specified restrictions.

RULEMAKING AUTHORITY

It is the committee's opinion that this bill does not expressly
grant any additional rulemaking authority to a state officer,
department, agency, or institution.

SECTION BY SECTION ANALYSIS

SECTION 1. Amends Sec. 431.002(23), Health and Safety Code, by
defining "manufacture" as follows:

     (A) The specified processing of food.
     (B) The specified processing of drugs and drug products.
     (C) The specified processing of a device.
     (D) The specified making of any cosmetic product.

SECTION 2. Amends Sec. 431.021(h), Health and Safety Code, to add
that the sale within this state of any food, drug, device, or
cosmetic that is adulterated or misbranded is prohibited.

SECTION 3. Amends Sec. 431.042(b), Health and Safety Code, by
deleting the terms "prescription" and "restricted" from the
inspection authority of the Texas Department of Health (TDH), and
adding cosmetic to the items covered by this section.

SECTION 4. Amends Sec. 431.045(a) and (c), Health and Safety Code,
by adding that the Commissioner of the TDH may issue an emergency
order that is restrictive in nature in relation to the manufacture
or sale of specified items. Establishes that a hearing on any
emergency order issued under this provision is required to be held
under the Administrative Procedure Act (Chapter 2001, Government
Code), and the Texas Board of Health (Board) formal hearing rules.

SECTION 5. Amends Sec. 431.221(4), Health and Safety Code, to
include in the definition of "manufacture" repackaging or otherwise
changing the container, wrapper, or labeling of any food.

SECTION 6. Effective date: September 1, 1995.

SECTION 7.  Emergency clause.

COMPARISON OF ORIGINAL TO SUBSTITUTE

H.B. 2838 as substituted defines the different aspects of
"manufacture" to conform with the Federal Food, Drug, and Cosmetic
Act. The substitute also removes the provision in the original 
bill which allows the TDH to regulate financial data relating to
the manufacture of a food, drug, or a device, as the TDH only wants
to regulate the components in regard to where they come from and
where they will be sold. The substitute clarifies that the
Commissioner will regulate the sale of a food, drug, device or
cosmetic. The substitute also removes the original Section 4
regarding the actions to be taken to regulate violations of this
chapter, because this is covered by Section 2 of the substitute.

SUMMARY OF COMMITTEE ACTION

H.B. 2838 was considered by the Public Health Committee in a public
hearing on April 19, 1995. The committee considered a complete
substitute for the bill. The substitute was adopted without
objection.

The bill was reported favorably as substituted, with the
recommendation that it do pass and be printed and be sent to the
Committee on Local and Consent Calendars, by a record vote of 7
AYES, 0 NAYS, 0 PNV, 2 ABSENT.