HLS 12RS-1198 ORIGINAL
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Regular Session, 2012
HOUSE BILL NO. 607
BY REPRESENTATIVE ANDERS
DRUGS/PRESCRIPTION: Regulates substitution of certain opioid drugs
AN ACT1
To enact R.S. 37:1182(A)(25) and R.S. 40:1238.5, relative to opioid drugs; to provide for2
definitions; to provide for certain duties of the Louisiana Board of Pharmacy; to3
prohibit substitution for certain prescription drugs; to provide for exceptions; to4
require promulgation of rules; to provide for effective dates; and to provide for5
related matters.6
Be it enacted by the Legislature of Louisiana:7
Section 1. R.S. 37:1182(A)(25) is hereby enacted to read as follows:8
§1182. Powers and duties of the board9
A. The board shall be responsible for the control and regulation of the10
practice of pharmacy and shall:11
* * *12
(25) Establish and maintain a listing of opioid drugs which incorporate a13
tamper-resistant technology for the purpose of regulating substitution of opioid drugs14
in accordance with R.S. 40:1238.5.15
* * *16
Section 2. R.S. 40:1238.5 is hereby enacted to read as follows: 17
§1238.5. Substitution of certain opioid drugs18
A. As used in this Section, the following terms shall have the meaning herein19
ascribed to them:20 HLS 12RS-1198 ORIGINAL
HB NO. 607
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(1) "Board" means the Louisiana Board of Pharmacy.1
(2) "FDA" means the United States Food and Drug Administration.2
(3) "Opioid drug" shall mean a drug in the opioid drug class that is3
prescribed to treat moderate to severe pain or other conditions. "Opiod drug" shall4
include the following:5
(a) Immediate-release and extended-release forms of the drug.6
(b) A drug formed by a combination of drugs, one of which is an opioid.7
B. The board shall promulgate such rules as are necessary to establish a list8
of opioid drugs which meet all of the following criteria:9
(1) Incorporate a tamper-resistant technology.10
(2) Have been approved by the FDA based upon an application which11
included at least one of the following:12
(a) A human tampering or abuse potential study.13
(b) A laboratory study comparing the tamper-resistant or abuse-resistant14
properties of the drug to a control opioid drug approved by the FDA.15
C. The board shall include on the list provided for in Subsection B of this16
Section, an indication of which listed opioid drugs provide substantially similar17
tamper-resistant properties. The board shall base such indication on a study provided18
for in Paragraph (B)(2) of this Section. When the board considers a drug for19
inclusion on the list provided for in Subsection B of this Section, the board shall not20
require that the drug bear on its FDA-approved labeling a claim regarding the21
reduction of tampering, abuse, or abuse potential.22
D. Notwithstanding the provisions of R.S. 37:1241(17), a pharmacist shall23
not substitute an opioid drug unless he obtains consent for the substitution from the24
prescribing physician and verifies all of the following:25
(1) That according to the list provided for in Subsection B of this Section,26
the opioid drug to be substituted has tamper-resistant properties which are27
substantially similar to the originally prescribed drug.28 HLS 12RS-1198 ORIGINAL
HB NO. 607
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(2) That the opioid drug to be substituted is equivalent to the originally1
prescribed drug as indicated in the most recent publication of the Approved Drug2
Products with Therapeutic Equivalence Evaluations of the FDA.3
Section 3. The Louisiana Board of Pharmacy shall promulgate, in accordance with4
the Administrative Procedure Act, any rules necessary to implement the provisions of this5
Act on or before December 1, 2012.6
Section 4. The provisions of this Act enacting R.S. 40:1238.5(D), relative to7
dispensing of opioid drugs, shall become effective on January 1, 2013; otherwise, this Act8
shall become effective on September 1, 2012.9
DIGEST
The digest printed below was prepared by House Legislative Services. It constitutes no part
of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute
part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)]
Anders HB No. 607
Abstract: Regulates substitution of certain opioid drugs.
Proposed law provides that the La. Board of Pharmacy shall establish and maintain a listing
of opioid drugs which meet all of the following criteria:
(1) Incorporate a tamper-resistant technology.
(2)Have been approved by the FDA based upon an application which included at least
one of the following:
(a)A human tampering or abuse potential study.
(b)A laboratory study comparing the tamper-resistant or abuse-resistant
properties of the drug to a control opioid drug approved by the FDA.
Proposed law requires such listing to indicate which opioid drugs provide substantially
similar tamper-resistant properties.
Proposed law provides that, notwithstanding the provisions of present law (R.S.
37:1241(17)), a pharmacist shall not substitute an opioid drug unless he obtains consent for
the substitution from the prescribing physician and verifies all of the following:
(1)That per the list provided for in proposed law, the opioid drug to be substituted has
tamper-resistant properties which are substantially similar to the originally
prescribed drug.
(2)That the opioid drug to be substituted is equivalent to the originally prescribed drug
as indicated in the most recent publication of the Approved Drug Products with
Therapeutic Equivalence Evaluations of the FDA. HLS 12RS-1198 ORIGINAL
HB NO. 607
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are additions.
Proposed law requires the La. Board of Pharmacy to promulgate, in accordance with the
APA, any rules necessary to implement the provisions of proposed law on or before Dec. 1,
2012.
Proposed law provides that the provisions of proposed law relative to dispensing of opioid
drugs become effective on Jan. 1, 2013. Otherwise, provides that proposed law becomes
effective on Sept. 1, 2012.
(Adds R.S. 37:1182(A)(25) and R.S. 40:1238.5)