senate Bill S7125A

2013-2014 Legislative Session

Provides for the substitution of opioid drugs incorporating abuse-deterrent technology for opioid drugs under certain circumstances

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Sponsored By

Archive: Last Bill Status - Passed Senate


  • Introduced
  • In Committee
  • On Floor Calendar
    • Passed Senate
    • Passed Assembly
  • Delivered to Governor
  • Signed/Vetoed by Governor

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Actions

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Assembly Actions - Lowercase
Senate Actions - UPPERCASE
Jun 19, 2014 referred to higher education
returned to assembly
repassed senate
Jun 16, 2014 amended on third reading (t) 7125a
vote reconsidered - restored to third reading
Jun 16, 2014 returned to senate
recalled from assembly
Jun 09, 2014 referred to higher education
delivered to assembly
passed senate
Jun 03, 2014 ordered to third reading cal.1126
committee discharged and committed to rules
Apr 30, 2014 referred to health

Votes

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Jun 3, 2014 - Rules committee Vote

S7125
23
0
committee
23
Aye
0
Nay
1
Aye with Reservations
0
Absent
1
Excused
0
Abstained
show committee vote details

Bill Amendments

Original
A (Active)
Original
A (Active)

Co-Sponsors

S7125 - Bill Details

See Assembly Version of this Bill:
A9881A
Current Committee:
Assembly Higher Education
Law Section:
Public Health Law
Laws Affected:
Add §3340, Pub Health L

S7125 - Bill Texts

view summary

Provides for the substitution of opioid drugs incorporating abuse-deterrent technology for opioid drugs under certain circumstances.

view sponsor memo
BILL NUMBER:S7125

TITLE OF BILL: An act to amend the public health law, in relation to
the use of abuse-deterrent technology for analgesic opioids as a
mechanism for reducing abuse and diversion of opioid drugs.

PURPOSE OR GENERAL IDEA OF BILL:

To help prevent the abuse and diversion of opioid analgesic drugs by
ensuring that opioid analgesic drugs which incorporate abuse-deterrent
technologies are dispensed whenever possible.

SUMMARY OF SPECIFIC PROVISIONS:

Section 1 adds a new section 3340 to the Public health law to prohibit
the substitution of opioids which have abuse-deterrent technologies
with those which do not have such abuse-deterrent technologies without
the consent of the prescribing physician.

Section 2 is the effective date of the bill.

JUSTIFICATION:

While pain management is an important and integral part of the health
care system, abuse and diversion of opioids has necessitated the
implementation of anti-abuse policies. These policies need to be
approached comprehensively by government, law enforcement, health care
providers and manufacturers and an important component is to ensure
that opioids incorporating abuse-deterrent technologies are dispensed
whenever possible.

The U.S. Food and Drug Administration (FDA) has recognized that the
development and implementation of abuse-deterrent technologies is an
important "step towards the goal of creating safer opioid analgesics".
In recently published FDA guidance on abuse-deterrent technologies for
opioids, the FDA provided that they "consider(s) the development of
these products a high public health priority".

Under this proposal, when a physician prescribes an opioid analgesic
drug that incorporates abuse-deterrent technologies, no substitution
or interchange shall be permitted for that drug without the pharmacy,
(1) verifying that the substitute provides substantially similar
abuse-deterrent properties, or (2) obtaining the prior, written
consent of the prescribing physician.

While New York State has been at the forefront of fighting
prescription drug abuse, it is imperative that the State continue to
strengthen its laws and protect against abuse while enhancing the
integrity of its health care system. Enacting this proposal will be
consistent with these goals and with the priorities set out by the
FDA.

PRIOR LEGISLATIVE HISTORY: a

New Bill.

FISCAL IMPLICATIONS:


None

EFFECTIVE DATE:

This act shall take effect immediately.

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                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  7125

                            I N  S E N A T E

                             April 30, 2014
                               ___________

Introduced  by  Sen.  HANNON -- read twice and ordered printed, and when
  printed to be committed to the Committee on Health

AN ACT to amend the public health law, in relation to the use of  abuse-
  deterrent technology for analgesic opioids as a mechanism for reducing
  abuse and diversion of opioid drugs.

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. The public health law is amended by adding  a  new  section
3340 to read as follows:
  S  3340.  SUBSTITUTION OF OPIOIDS WITH ABUSE-DETERRENT TECHNOLOGY.  1.
NOTWITHSTANDING THE PROVISIONS OF SECTION SIXTY-EIGHT HUNDRED  SIXTEEN-A
OF  THE  EDUCATION LAW, NO PHARMACIST SHALL INTERCHANGE OR SUBSTITUTE AN
OPIOID ANALGESIC DRUG, BRAND OR GENERIC,  OTHERWISE  ELIGIBLE  FOR  SUCH
INTERCHANGE  OR  SUBSTITUTION UNDER SUCH SECTION FOR AN OPIOID ANALGESIC
DRUG INCORPORATING ABUSE-DETERRENT TECHNOLOGY WITHOUT:
  (A) VERIFYING THAT THE DRUG TO BE SUBSTITUTED IS AN  OPIOID  ANALGESIC
DRUG  INCORPORATING  ABUSE-DETERRENT  TECHNOLOGY  WITH  THE  SAME DEGREE
(TIER) OF FEDERAL FOOD AND DRUG ADMINISTRATION APPROVED  LABELING  CLAIM
RELATED TO ABUSE DETERRENCE AS THE PRESCRIBED OPIOID ANALGESIC DRUG; OR
  (B)  OBTAINING  WRITTEN, SIGNED CONSENT FROM THE PRESCRIBING PHYSICIAN
FOR SUCH INTERCHANGE OR SUBSTITUTION.
  2. A PRESCRIPTION SHALL NOT BE ISSUED OR FILLED FOR ANY  OPIOID  ANAL-
GESIC  DRUG  THAT  IS  FORMULATED  AS A NON-ABUSE DETERRENT OPIOID DRUG,
UNLESS AN OPIOID ANALGESIC DRUG INCORPORATING ABUSE-DETERRENT TECHNOLOGY
IS NOT AVAILABLE AS A SUBSTITUTE FOR THE INDICATED DRUG OR SUBSTANCE.
  3. DEFINITIONS. AS USED IN THIS SECTION:
  (A) "OPIOID ANALGESIC DRUG" MEANS A DRUG IN THE OPIOID ANALGESIC  DRUG
CLASS  PRESCRIBED  TO TREAT MODERATE TO SEVERE PAIN OR OTHER CONDITIONS,
WHETHER IN IMMEDIATE RELEASE OR EXTENDED RELEASE FORM AND WHETHER OR NOT
COMBINED WITH OTHER DRUG SUBSTANCES TO FORM A  SINGLE  TABLET  OR  OTHER
DOSAGE FORM.
  (B)  "OPIOID  ANALGESIC DRUG INCORPORATING ABUSE-DETERRENT TECHNOLOGY"
MEANS AN OPIOID ANALGESIC DRUG APPROVED AS SUCH BY THE FEDERAL FOOD  AND
DRUG  ADMINISTRATION  WITH  LABELING  CLAIMS RELATED TO ABUSE-DETERRENCE

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD14934-01-4

S. 7125                             2

BASED UPON AN APPLICATION THAT  INCLUDES  LABORATORY,  PHARMACOKINECTIC,
CLINICAL ABUSE POTENTIAL, AND/OR POST MARKETING STUDIES.
  (C)  "INTERCHANGE  OR  SUBSTITUTION OF AN OPIOID ANALGESIC DRUG" MEANS
THE SUBSTITUTION OF ANY OPIOID ANALGESIC DRUG, BRAND OR GENERIC, FOR THE
OPIOID  ANALGESIC  DRUG  INCORPORATING  AN  ABUSE-DETERRENT   TECHNOLOGY
ORIGINALLY  PRESCRIBED,  AS DETERMINED TO BE PHARMACEUTICALLY AND THERA-
PEUTICALLY EQUIVALENT BY THE FEDERAL FOOD  AND  DRUG  ADMINISTRATION  OR
STATE BOARD OF PHARMACY TO THE PRESCRIBED DRUG. ANY SUBSTITUTABLE OPIOID
ANALGESIC  DRUG  SHALL  CONTAIN  THE  SAME  OPIOID ACTIVE PHARMACEUTICAL
INGREDIENT AND THE SAME DRUG  RELEASE  CHARACTERISTICS  WITH  REGARD  TO
IMMEDIATE RELEASE, OR EXTENDED RELEASE/LONG-ACTING PROPERTIES.
  (D)  "PHARMACIST"  INCLUDES  ANY PHARMACIST DISPENSING DRUGS UNDER THE
JURISDICTION OF THE STATE BOARD OF PHARMACY, INCLUDING BUT  NOT  LIMITED
TO, COMMUNITY PHARMACISTS, PHARMACISTS IN HOSPITAL-BASED PHARMACIES WHEN
FILLING  PRESCRIPTIONS FOR INPATIENT OR OUTPATIENT CARE, AND PHARMACISTS
IN MAIL ORDER PHARMACIES LICENSED BY THE  STATE  TO  DISTRIBUTE  IN  THE
STATE.
  (E) "ABUSE-DETERRENT TECHNOLOGY OR FORMULATION" MEANS THE FRAMEWORK OF
ABUSE-DETERRENT  PROPERTIES,  AS  DESCRIBED BY THE FEDERAL FOOD AND DRUG
ADMINISTRATION.
  (F)  "LABELING  CLAIMS  FOR  OPIOID  ANALGESIC   DRUGS   INCORPORATING
ABUSE-DETERRENT  TECHNOLOGIES"  MEANS  THE  FOUR GENERAL TIERS OR CLAIMS
AVAILABLE TO DESCRIBE THE POTENTIAL ABUSE  DETERRENT  PROPERTIES  FOR  A
DRUG, AS DESCRIBED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION.
  S 2. This act shall take effect immediately.

Co-Sponsors

S7125A (ACTIVE) - Bill Details

See Assembly Version of this Bill:
A9881A
Current Committee:
Assembly Higher Education
Law Section:
Public Health Law
Laws Affected:
Add §3340, Pub Health L

S7125A (ACTIVE) - Bill Texts

view summary

Provides for the substitution of opioid drugs incorporating abuse-deterrent technology for opioid drugs under certain circumstances.

view sponsor memo
BILL NUMBER:S7125A

TITLE OF BILL: An act to amend the public health law, in relation to
the use of abuse-deterrent technology for opioids as a mechanism for
reducing abuse and diversion of opioid drugs

PURPOSE OR GENERAL IDEA OF BILL: To help prevent the abuse and
diversion of opioid drugs by ensuring that opioid drugs which
incorporate abuse-deterrent technologies are dispensed whenever
possible.

SUMMARY OF SPECIFIC PROVISIONS: Section 1 adds a new section 3340 to
the Public health law to prohibit the substitution of opioids which
have abuse-deterrent technologies with those which do not have such
abuse-deterrent technologies without the consent of the prescribing
physician.

Section 2 is the effective date of the bill.

JUSTIFICATION: While pain management is an important and integral part
of the health care system, abuse and diversion of opioids has
necessitated the implementation of anti-abuse policies. These policies
need to be approached comprehensively by government, law enforcement,
health care providers and manufacturers and an important component is
to ensure that opioids incorporating abuse-deterrent technologies are
dispensed whenever possible.

The U.S. Food and Drug Administration (FDA) has recognized that the
development and implementation of abuse-deterrent technologies is an
important "step towards the goal of creating safer opioid(s)...." In
recently published FDA guidance on abuse-deterrent technologies for
opioids, the FDA provided that they "consider[s] the development of
these products a high public health priority."

Under this proposal, when a physician prescribes an opioid drug that
incorporates abuse-deterrent technologies, no substitution or
interchange shall be permitted for that drug without the pharmacy, (1)
verifying that the substitute provides substantially similar
abuse-deterrent properties, or (2) obtaining the prior, written
consent of the prescribing physician.

While New York State has been at the forefront of fighting
prescription drug abuse, it is imperative that the State continue to
strengthen its laws and protect against abuse while enhancing the
integrity of its health care system. Enacting this proposal will be
consistent with these goals and with the priorities set out by the
FDA.

PRIOR LEGISLATIVE HISTORY: New Bill.

FISCAL IMPLICATIONS: None

EFFECTIVE DATE: This act shall take effect immediately.

view full text
download pdf
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 7125--A
    Cal. No. 1126

                            I N  S E N A T E

                             April 30, 2014
                               ___________

Introduced  by  Sens.  HANNON, GIPSON -- read twice and ordered printed,
  and when printed to be committed to the Committee on Health -- commit-
  tee discharged and said bill committed to the Committee  on  Rules  --
  reported  favorably  from  said committee, ordered to a third reading,
  passed by Senate and delivered to the Assembly, recalled, vote  recon-
  sidered,  restored  to  third  reading, amended and ordered reprinted,
  retaining its place in the order of third reading

AN ACT to amend the public health law, in relation to the use of  abuse-
  deterrent technology for opioids as a mechanism for reducing abuse and
  diversion of opioid drugs

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. The public health law is amended by adding  a  new  section
3340 to read as follows:
  S  3340.  SUBSTITUTION  OF OPIOIDS WITH ABUSE-DETERRENT TECHNOLOGY. 1.
NOTWITHSTANDING THE PROVISIONS OF SECTION SIXTY-EIGHT HUNDRED  SIXTEEN-A
OF  THE  EDUCATION LAW, NO PHARMACIST SHALL INTERCHANGE OR SUBSTITUTE AN
OPIOID DRUG, BRAND OR GENERIC, OTHERWISE ELIGIBLE FOR  SUCH  INTERCHANGE
OR  SUBSTITUTION  UNDER  SUCH  SECTION  FOR AN OPIOID DRUG INCORPORATING
ABUSE-DETERRENT TECHNOLOGY WITHOUT:
  (A) VERIFYING THAT THE DRUG TO BE SUBSTITUTED IS AN OPIOID DRUG INCOR-
PORATING ABUSE-DETERRENT TECHNOLOGY  WITH  THE  SAME  DEGREE  (TIER)  OF
FEDERAL  FOOD AND DRUG ADMINISTRATION APPROVED LABELING CLAIM RELATED TO
ABUSE DETERRENCE AS THE PRESCRIBED OPIOID DRUG; OR
  (B) OBTAINING WRITTEN, SIGNED CONSENT FROM THE  PRESCRIBING  PHYSICIAN
FOR SUCH INTERCHANGE OR SUBSTITUTION.
  2.  A  PRESCRIPTION  SHALL NOT BE ISSUED OR FILLED FOR ANY OPIOID DRUG
THAT IS FORMULATED AS A  NON-ABUSE  DETERRENT  OPIOID  DRUG,  UNLESS  AN
OPIOID DRUG INCORPORATING ABUSE-DETERRENT TECHNOLOGY IS NOT AVAILABLE AS
A SUBSTITUTE FOR THE INDICATED DRUG OR SUBSTANCE.
  3. DEFINITIONS. AS USED IN THIS SECTION:
  (A)  "OPIOID DRUG" MEANS A DRUG IN THE OPIOID DRUG CLASS PRESCRIBED TO
TREAT MODERATE TO SEVERE PAIN OR OTHER CONDITIONS, WHETHER IN  IMMEDIATE

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD14934-02-4

S. 7125--A                          2

RELEASE  OR EXTENDED RELEASE FORM AND WHETHER OR NOT COMBINED WITH OTHER
DRUG SUBSTANCES TO FORM A SINGLE TABLET OR OTHER DOSAGE FORM.
  (B)  "OPIOID  DRUG  INCORPORATING ABUSE-DETERRENT TECHNOLOGY" MEANS AN
OPIOID DRUG APPROVED AS SUCH BY THE FEDERAL FOOD AND DRUG ADMINISTRATION
WITH LABELING CLAIMS RELATED TO ABUSE-DETERRENCE BASED UPON AN  APPLICA-
TION  THAT  INCLUDES  LABORATORY, PHARMACOKINETIC, CLINICAL ABUSE POTEN-
TIAL, AND/OR POST MARKETING STUDIES.
  (C) "INTERCHANGE OR SUBSTITUTION OF AN OPIOID DRUG" MEANS THE  SUBSTI-
TUTION  OF ANY OPIOID DRUG, BRAND OR GENERIC, FOR THE OPIOID DRUG INCOR-
PORATING AN ABUSE-DETERRENT TECHNOLOGY ORIGINALLY PRESCRIBED, AS  DETER-
MINED  TO  BE  PHARMACEUTICALLY  AND  THERAPEUTICALLY  EQUIVALENT BY THE
FEDERAL FOOD AND DRUG ADMINISTRATION OR STATE BOARD OF PHARMACY  TO  THE
PRESCRIBED  DRUG.  ANY  SUBSTITUTABLE OPIOID DRUG SHALL CONTAIN THE SAME
OPIOID ACTIVE PHARMACEUTICAL INGREDIENT AND THE SAME DRUG RELEASE  CHAR-
ACTERISTICS    WITH   REGARD   TO   IMMEDIATE   RELEASE,   OR   EXTENDED
RELEASE/LONG-ACTING PROPERTIES.
  (D) "PHARMACIST" INCLUDES ANY PHARMACIST DISPENSING  DRUGS  UNDER  THE
JURISDICTION  OF  THE STATE BOARD OF PHARMACY, INCLUDING BUT NOT LIMITED
TO, COMMUNITY PHARMACISTS, PHARMACISTS IN HOSPITAL-BASED PHARMACIES WHEN
FILLING PRESCRIPTIONS FOR INPATIENT OR OUTPATIENT CARE, AND  PHARMACISTS
IN  MAIL  ORDER  PHARMACIES  LICENSED  BY THE STATE TO DISTRIBUTE IN THE
STATE.
  (E) "ABUSE-DETERRENT TECHNOLOGY OR FORMULATION" MEANS THE FRAMEWORK OF
ABUSE-DETERRENT PROPERTIES, AS DESCRIBED BY THE FEDERAL  FOOD  AND  DRUG
ADMINISTRATION.
  (F)  "LABELING  CLAIMS  FOR OPIOID DRUGS INCORPORATING ABUSE-DETERRENT
TECHNOLOGIES" MEANS THE  FOUR  GENERAL  TIERS  OR  CLAIMS  AVAILABLE  TO
DESCRIBE  THE  POTENTIAL  ABUSE  DETERRENT  PROPERTIES  FOR  A  DRUG, AS
DESCRIBED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION.
  S 2. This act shall take effect immediately.

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