NY State Assembly Bill 2013-A9881A

Assembly Bill A9881A

2013-2014 Legislative Session

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

download bill text pdf

Archive: Last Bill Status - In Assembly Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Actions

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jun 16, 2014	print number 9881a
Jun 16, 2014	amend (t) and recommit to higher education
May 27, 2014	referred to higher education

Bill Amendments

Original

A (Active)

2013-A9881 - Details

See Senate Version of this Bill:: S7125
Current Committee:: Assembly Higher Education
Law Section:: Public Health Law
Laws Affected:: Add §3340, Pub Health L
Versions Introduced in 2015-2016 Legislative Session:: A7427

2013-A9881 - Summary

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

2013-A9881 - Bill Text download pdf

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

                                  9881

                          I N  A S S E M B L Y

                              May 27, 2014
                               ___________

Introduced by M. of A. CUSICK -- read once and referred to the Committee
  on Higher Education

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

A. 9881                             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.

2013-A9881A (ACTIVE) - Details

See Senate Version of this Bill:: S7125
Current Committee:: Assembly Higher Education
Law Section:: Public Health Law
Laws Affected:: Add §3340, Pub Health L
Versions Introduced in 2015-2016 Legislative Session:: A7427

2013-A9881A (ACTIVE) - Summary

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

2013-A9881A (ACTIVE) - Bill Text download pdf

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

                                 9881--A

                          I N  A S S E M B L Y

                              May 27, 2014
                               ___________

Introduced by M. of A. CUSICK -- read once and referred to the Committee
  on  Higher  Education  --  committee discharged, bill amended, ordered
  reprinted as amended and recommitted to said committee

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
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-

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

                                                           LBD14934-03-4

A. 9881--A                          2

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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