2011S0631-1 03/08/11
By: Uresti S.B. No. 1644
A BILL TO BE ENTITLED
AN ACT
relating to the prescription of tamper-resistant opioid analgesic
drugs; providing an administrative penalty.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subchapter A, Chapter 562, Occupations Code, is
amended by adding Section 562.0143 to read as follows:
Sec. 562.0143. TAMPER-RESISTANT OPIOID ANALGESIC DRUG
SELECTION RESTRICTED. (a) In this section:
(1) "Interchange" means the substitution of an opioid
analgesic drug, whether brand name or generic, for a prescribed
tamper-resistant opioid analgesic drug.
(2) "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 a drug in immediate release or
extended release form and a drug combined with other drug
substances to form a single tablet or other dosage form.
(3) "Tamper-resistant opioid analgesic drug" means an
opioid analgesic drug included on the list created and maintained
by the board under Subsection (e).
(b) Except as provided by Subsection (c), a pharmacist may
not interchange an opioid analgesic drug for a tamper-resistant
opioid analgesic drug, regardless of whether:
(1) the substituted drug is rated as pharmaceutically
equivalent and therapeutically equivalent to the prescribed drug by
the United States Food and Drug Administration or the board; or
(2) the prescribed drug bears a labeling claim with
respect to reduction of tampering, abuse, or abuse potential.
(c) A pharmacist may interchange an opioid analgesic drug
for a tamper-resistant opioid analgesic drug if:
(1) the substituted drug is a tamper-resistant opioid
analgesic drug included on the list created by the board under
Subsection (e) and the board has determined under Subsection (f)
that the substituted drug provides substantially similar
tamper-resistant properties as the prescribed drug; or
(2) the pharmacist obtains prior written consent to
the interchange from the prescribing physician.
(d) To comply with Subsection (c)(2), a pharmacist shall
notify the prescribing practitioner orally or electronically to
secure permission to interchange a tamper-resistant opioid
analgesic drug. The practitioner's authorization or denial of
authorization must be documented in writing and signed by the
practitioner.
(e) The board shall create and maintain a list of
tamper-resistant opioid analgesic drugs based on evidence
submitted by drug manufacturers or distributors. To qualify for
inclusion on the list, a drug:
(1) must incorporate a tamper-resistant technology;
and
(2) be approved by the United States Food and Drug
Administration pursuant to an application including at least one
human tampering or abuse potential study or laboratory study
comparing the tamper-resistant or abuse-resistant properties of
the drug to one or more opioid analgesic drugs approved by the
administration and serving as a positive control.
(f) Based solely on evidence submitted by drug
manufacturers and distributors described by Subsection (e), the
board shall determine which tamper-resistant opioid analgesic
drugs included on the list required by Subsection (e) provide
substantially similar tamper-resistant properties. The board
shall include such information on the list.
(g) A drug is not required to bear a labeling claim with
respect to reduction of tampering, abuse, or abuse potential in
order to be included on the list required by Subsection (e).
SECTION 2. (a) The Texas State Board of Pharmacy shall
adopt rules necessary to administer the changes in law made by this
Act and shall create the list required by Subsection (e), Section
562.0143, Occupations Code, as added by this Act, not later than
December 1, 2011.
(b) The changes in law made by this Act apply only to an
opioid analgesic drug dispensed on or after January 1, 2012. An
opioid analgesic drug dispensed before January 1, 2012, is governed
by the law as it existed immediately before that date, and that law
is continued in effect for that purpose.
SECTION 3. This Act takes effect immediately if it receives
a vote of two-thirds of all the members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect September 1, 2011.