Bill Text: NY S01753 | 2013-2014 | General Assembly | Introduced

---

Bill Title: Prohibits the substitution of opioid analgesic drugs for an opioid analgesic drug incorporating tamper resistance technology; requires pharmacist to verify equivalence or obtain written consent of prescribing physician.

Spectrum: Partisan Bill (Republican 4-0)

Status: (Introduced - Dead) 2014-01-08 - REFERRED TO HEALTH [S01753 Detail]

Download: New_York-2013-S01753-Introduced.html

---

                           S T A T E   O F   N E W   Y O R K
       ________________________________________________________________________
                                         1753
                              2013-2014 Regular Sessions
                                   I N  S E N A T E
                                      (PREFILED)
                                    January 9, 2013
                                      ___________
       Introduced  by Sens. MARTINS, LAVALLE -- 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  prohibiting  the
         substitution  of  opioid  analgesic drugs for an opioid analgesic drug
         incorporating tamper resistance technology
         THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
       BLY, DO ENACT AS FOLLOWS:
    1    Section  1.  The  public health law is amended by adding a new section
    2  3346 to read as follows:
    3    S 3346. CERTAIN OPIOID SUBSTITUTIONS PROHIBITED.   1. DEFINITIONS.  A.
    4  "INTERCHANGE  OR  SUBSTITUTION  OF  AN  OPIOID ANALGESIC DRUG" MEANS THE
    5  SUBSTITUTION OF ANY OPIOID ANALGESIC DRUG, BRAND  OR  GENERIC,  FOR  THE
    6  OPIOID  ANALGESIC  DRUG  INCORPORATING  A  TAMPER-RESISTANCE  TECHNOLOGY
    7  ORIGINALLY PRESCRIBED, IRRESPECTIVE OF WHETHER THE SUBSTITUTED  DRUG  IS
    8  RATED  AS  PHARMACEUTICALLY  AND  THERAPEUTICALLY EQUIVALENT BY THE U.S.
    9  FOOD AND DRUG ADMINISTRATION OR STATE BOARD OF PHARMACY OR  WHETHER  THE
   10  OPIOID ANALGESIC DRUG WITH TAMPER-RESISTANCE TECHNOLOGY BEARS A LABELING
   11  CLAIM WITH RESPECT TO REDUCTION OF TAMPERING, ABUSE OR ABUSE POTENTIAL.
   12    B.  "OPIOID  ANALGESIC DRUG" MEANS A DRUG IN THE OPIOID ANALGESIC DRUG
   13  CLASS PRESCRIBED TO TREAT MODERATE TO SEVERE PAIN OR  OTHER  CONDITIONS,
   14  WHETHER IN IMMEDIATE RELEASE OR EXTENDED RELEASE FORM AND WHETHER OR NOT
   15  COMBINED  WITH  OTHER  DRUG  SUBSTANCES TO FORM A SINGLE TABLET OR OTHER
   16  DOSAGE FORM.
   17    C. "OPIOID ANALGESIC DRUG INCORPORATING A TAMPER-RESISTANCE  TECHNOLO-
   18  GY"  MEANS AN OPIOID ANALGESIC DRUG LISTED AS SUCH BY THE STATE BOARD OF
   19  PHARMACY BASED UPON A SUBMISSION OF EVIDENCE BY THE DRUG MANUFACTURER OR
   20  DISTRIBUTOR THAT THE DRUG: (I) INCORPORATES A TAMPER-RESISTANCE TECHNOL-
   21  OGY; AND (II) HAS BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION
   22  PURSUANT TO AN APPLICATION THAT INCLUDES AT LEAST ONE HUMAN TAMPERING OR
   23  ABUSE POTENTIAL STUDY OR A LABORATORY STUDY  COMPARING  THE  TAMPER-  OR
        EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                             [ ] is old law to be omitted.
                                                                  LBD04583-01-3
       S. 1753                             2
    1  ABUSE-RESISTANCE  PROPERTIES OF THE DRUG TO ONE OR MORE OPIOID ANALGESIC
    2  DRUGS THAT (A) HAVE BEEN APPROVED BY THE U.S.  FOOD  AND  DRUG  ADMINIS-
    3  TRATION; AND (B) SERVE AS A POSITIVE CONTROL.
    4    D.  "PHARMACIST"  FOR PURPOSES OF THIS SECTION INCLUDES ANY PHARMACIST
    5  DISPENSING DRUGS UNDER THE JURISDICTION OF THE STATE BOARD OF  PHARMACY,
    6  INCLUDING  BUT  NOT  LIMITED  TO,  COMMUNITY PHARMACISTS, PHARMACISTS IN
    7  HOSPITAL-BASED PHARMACIES WHEN FILLING PRESCRIPTIONS  FOR  INPATIENT  OR
    8  OUTPATIENT  CARE,  AND  PHARMACISTS IN MAIL ORDER PHARMACIES LICENSED BY
    9  THE STATE TO DISTRIBUTE IN THE STATE.
   10    2. LIST OF OPIOID ANALGESIC DRUGS  INCORPORATING  A  TAMPER-RESISTANCE
   11  TECHNOLOGY.    THE STATE BOARD OF PHARMACY SHALL CREATE A LIST OF OPIOID
   12  ANALGESIC DRUGS FOR WHICH INFORMATION HAS BEEN SUBMITTED CONSISTENT WITH
   13  PARAGRAPH C OF SUBDIVISION ONE OF THIS SECTION. INCLUSION OF A  DRUG  ON
   14  SUCH  LIST  SHALL  NOT  REQUIRE  THAT  A DRUG BEAR A LABELING CLAIM WITH
   15  RESPECT TO REDUCTION OF TAMPERING, ABUSE OR ABUSE POTENTIAL AT THE  TIME
   16  OF LISTING. SUCH LIST SHALL ALSO INCLUDE A DETERMINATION BY THE BOARD AS
   17  TO  WHICH  LISTED OPIOID ANALGESIC DRUGS INCORPORATING TAMPER-RESISTANCE
   18  TECHNOLOGIES PROVIDE SUBSTANTIALLY SIMILAR TAMPER-RESISTANCE PROPERTIES,
   19  BASED SOLELY UPON STUDIES SUBMITTED BY THE DRUG MANUFACTURER  CONSISTENT
   20  WITH PARAGRAPH C OF SUBDIVISION ONE OF THIS SECTION.
   21    3.  PROHIBITION. NOTWITHSTANDING THE PROVISIONS OF SECTION SIXTY-EIGHT
   22  HUNDRED SIXTEEN-A OF THE EDUCATION LAW, NO PHARMACIST SHALL  INTERCHANGE
   23  OR  SUBSTITUTE  AN  OPIOID  ANALGESIC  DRUG, BRAND OR GENERIC, OTHERWISE
   24  ELIGIBLE FOR SUCH INTERCHANGE OR SUBSTITUTION UNDER SECTION  SIXTY-EIGHT
   25  HUNDRED  SIXTEEN-A  OF  THE  EDUCATION  LAW FOR AN OPIOID ANALGESIC DRUG
   26  INCORPORATING A TAMPER-RESISTANCE TECHNOLOGY THAT IS LISTED PURSUANT  TO
   27  SUBDIVISION TWO OF THIS SECTION WITHOUT:
   28    A.    VERIFYING  THAT THE OPIOID ANALGESIC DRUG HAS BEEN LISTED BY THE
   29  STATE BOARD OF PHARMACY:   UNDER SUBDIVISION  TWO  OF  THIS  SECTION  AS
   30  PROVIDING  TAMPER-RESISTANCE  PROPERTIES  SUBSTANTIALLY  SIMILAR  TO THE
   31  PRESCRIBED OPIOID ANALGESIC DRUG INCORPORATING A TAMPER-RESISTANCE TECH-
   32  NOLOGY; OR
   33    B. OBTAINING WRITTEN, SIGNED CONSENT FROM  THE  PRESCRIBING  PHYSICIAN
   34  FOR SUCH INTERCHANGE OR SUBSTITUTION.
   35    S 2. This act shall take effect immediately.