Office of House Bill AnalysisH.B. 2278
By: Coleman
Public Health


The Food and Drug Administration (FDA) is responsible for approving all
prescription drugs in the United States for dispensing by pharmacists,
including both brand drugs and their generic equivalents.  Some generic
drugs have been rated as bioequivalent by the FDA (having the same impact
on a patient as a brand drug).  Some manufacturers of brand drugs have
claimed that bioequivalent drugs falling into a class known as narrow
therapeutic index (NTI) drugs are unsafe. NTI drugs are those drugs which
must be closely monitored by the prescribing physician because a small
change in the dosage may significantly affect a patient's condition.   

In 1997, the 75th Texas Legislature passed legislation designed to protect
patients receiving NTI drugs by requiring the patients seeking generic
refills to go through additional procedures to obtain them, even if the
original prescription by the doctor was signed "product selection
permitted." There is concern that this legislation has had a chilling
effect on the use of NTI generic drugs, even though they are often less
expensive than brand drugs. 

H.B. 2278 repeals language in the Texas Pharmacy Act requiring the State
Board of Pharmacy to establish a list of NTI drugs and to require patients
to follow certain procedures when refilling NTI drugs on the list. 


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 1.  Repealer:  Subsection (m), Section 40, Article 4542a-1, 1-5
V.T.C.S. (Texas Pharmacy Act), as amended by Section 21, Chapter 1180, Acts
of the 75th Legislature, 1997.  This subsection makes Section 40
(Substitution) inapplicable to the refill of a prescription for a narrow
therapeutic index (NTI) drug, as well as the requirement that the State
Board of Pharmacy, in consultation with the Texas Board of Medical
Examiners, establish, by rule, a list of NTI drugs subject to this
subsection.  Further authorizes an NTI drug prescription to be refilled
only by using the same drug product by the same manufacturer that the
pharmacist last dispensed under the prescription, unless otherwise agreed
to by the prescribing physician.  Deletes text authorizing a pharmacist, if
the same drug product by the same manufacturer is not in stock, to dispense
a drug product that is generically equivalent if the pharmacist, before
dispensing it, notifies the patient and prescribing practitioner of the
substitution within a certain time frame. 

SECTION 2.Emergency clause.
  Effective date: 90 days after adjournment.