S.B. 803 78(R)    BILL ANALYSIS

S.B. 803
By: Janek
Public Health
Committee Report (Unamended)

Currently, Texas law allows advertising and marketing by compounding
pharmacists to promote the provision of nonsterile prescription
compounding services. Previous advertising restrictions on compounding
pharmacists were enacted in accordance with the Food and Drug
Administration Modernization Act (FDAMA) which exempts compounded drugs
from the FDA's standard drug approval requirements under the Federal Food,
Drug, and Cosmetic Act (FDCA), so long as the providers of the compounded
drugs abide by several restrictions. However, the United States Supreme
Court held in Thompson v. Western States Medical Center that the FDAMA's
prohibitions on soliciting prescriptions for and advertising of compounded
drugs amounted to an unconstitutional restriction on commercial speech.
The Act would change Texas law to reflect the U.S. Supreme Court decision. 

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

Chapter 562, Occupations Code is amended by adding Subchapter D.  A
compounding pharmacist or pharmacy may advertise or promote nonsterile
prescription compounding services and specific compounded drug products. 

September 1, 2003