By: Uresti  S.B. No. 1756
         (In the Senate - Filed March 11, 2011; March 23, 2011, read
  first time and referred to Committee on Health and Human Services;
  May 13, 2011, reported adversely, with favorable Committee
  Substitute by the following vote:  Yeas 8, Nays 0; May 13, 2011,
  sent to printer.)
 
  COMMITTEE SUBSTITUTE FOR S.B. No. 1756 By:  Uresti
 
 
A BILL TO BE ENTITLED
 
AN ACT
 
  relating to the substitution by a pharmacist of certain opioid
  analgesic drugs.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Subchapter A, Chapter 562, Occupations Code, is
  amended by adding Section 562.016 to read as follows:
         Sec. 562.016.  SUBSTITUTION OF CERTAIN OPIOID DRUGS.  
  (a)  In this section, "opioid analgesic drug" means a drug in the
  opioid analgesic drug class that is prescribed to treat moderate to
  severe pain or other conditions, including:
               (1)  immediate-release and extended-release forms of
  the drug; and
               (2)  drugs formed by a combination of drugs, one of
  which is an opioid analgesic.
         (b)  The board by rule shall establish a list of opioid
  analgesic drugs that:
               (1)  incorporate a tamper-resistant technology; and
               (2)  have been approved by the United States Food and
  Drug Administration from an application that included at least:
                     (A)  one human tampering or abuse potential study;
  or
                     (B)  a laboratory study comparing the
  tamper-resistant or abuse-resistant properties of the drug to a
  control opioid analgesic drug approved by the United States Food
  and Drug Administration.
         (c)  The board shall include on the list under Subsection (b)
  a determination of which listed opioid analgesic drugs provide
  substantially similar tamper-resistant properties, based on the
  study described by Subsection (b)(2).
         (d)  Notwithstanding Section 562.008, a pharmacist may not
  substitute an opioid analgesic drug unless the pharmacist:
               (1)  verifies:
                     (A)  from the list under Subsection (b) that the
  substituted opioid analgesic drug has substantially similar
  tamper-resistant properties to the originally prescribed drug; and
                     (B)  from the most recent version of the United
  States Food and Drug Administration publication Approved Drug
  Products with Therapeutic Equivalence Evaluations that the
  substituted drug is considered to be equivalent to the prescribed
  drug; or
               (2)  obtains consent for the substitution from the
  prescribing physician.
         SECTION 2.  The Texas State Board of Pharmacy shall adopt the
  rules necessary to implement Section 562.016, Occupations Code, as
  added by this Act, not later than December 1, 2011.
         SECTION 3.  The changes in law made by this Act apply only to
  an opioid analgesic drug dispensed on or after January 1, 2012.
         SECTION 4.  This Act takes effect September 1, 2011.
 
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