83R1649 SLB-F
By: Uresti S.B. No. 316
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 drug.
(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, 2013.
SECTION 3. The changes in law made by this Act apply only to
an opioid analgesic drug dispensed on or after January 1, 2014.
SECTION 4. This Act takes effect September 1, 2013.