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

                                   877

                       2013-2014 Regular Sessions

                          I N  A S S E M B L Y

                               (PREFILED)

                             January 9, 2013
                               ___________

Introduced  by M. of A. BRONSON -- read once and referred to the Commit-
  tee on Higher Education

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:

  Section  1.  The  public health law is amended by adding a new section
3346 to read as follows:
  S 3346. CERTAIN OPIOID SUBSTITUTIONS PROHIBITED.   1. DEFINITIONS.  A.
"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  A  TAMPER-RESISTANCE  TECHNOLOGY
ORIGINALLY PRESCRIBED, IRRESPECTIVE OF WHETHER THE SUBSTITUTED  DRUG  IS
RATED  AS  PHARMACEUTICALLY  AND  THERAPEUTICALLY EQUIVALENT BY THE U.S.
FOOD AND DRUG ADMINISTRATION OR STATE BOARD OF PHARMACY OR  WHETHER  THE
OPIOID ANALGESIC DRUG WITH TAMPER-RESISTANCE TECHNOLOGY BEARS A LABELING
CLAIM WITH RESPECT TO REDUCTION OF TAMPERING, ABUSE OR ABUSE POTENTIAL.
  B.  "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.
  C. "OPIOID ANALGESIC DRUG INCORPORATING A TAMPER-RESISTANCE  TECHNOLO-
GY"  MEANS AN OPIOID ANALGESIC DRUG LISTED AS SUCH BY THE STATE BOARD OF
PHARMACY BASED UPON A SUBMISSION OF EVIDENCE BY THE DRUG MANUFACTURER OR
DISTRIBUTOR THAT THE DRUG: (I) INCORPORATES A TAMPER-RESISTANCE TECHNOL-
OGY; AND (II) HAS BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION
PURSUANT TO AN APPLICATION THAT INCLUDES AT LEAST ONE HUMAN TAMPERING OR
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

A. 877                              2

ABUSE-RESISTANCE  PROPERTIES OF THE DRUG TO ONE OR MORE OPIOID ANALGESIC
DRUGS THAT (A) HAVE BEEN APPROVED BY THE U.S.  FOOD  AND  DRUG  ADMINIS-
TRATION; AND (B) SERVE AS A POSITIVE CONTROL.
  D.  "PHARMACIST"  FOR PURPOSES OF THIS SECTION 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.
  2. LIST OF OPIOID ANALGESIC DRUGS  INCORPORATING  A  TAMPER-RESISTANCE
TECHNOLOGY.    THE STATE BOARD OF PHARMACY SHALL CREATE A LIST OF OPIOID
ANALGESIC DRUGS FOR WHICH INFORMATION HAS BEEN SUBMITTED CONSISTENT WITH
PARAGRAPH C OF SUBDIVISION ONE OF THIS SECTION. INCLUSION OF A  DRUG  ON
SUCH  LIST  SHALL  NOT  REQUIRE  THAT  A DRUG BEAR A LABELING CLAIM WITH
RESPECT TO REDUCTION OF TAMPERING, ABUSE OR ABUSE POTENTIAL AT THE  TIME
OF LISTING. SUCH LIST SHALL ALSO INCLUDE A DETERMINATION BY THE BOARD AS
TO  WHICH  LISTED OPIOID ANALGESIC DRUGS INCORPORATING TAMPER-RESISTANCE
TECHNOLOGIES PROVIDE SUBSTANTIALLY SIMILAR TAMPER-RESISTANCE PROPERTIES,
BASED SOLELY UPON STUDIES SUBMITTED BY THE DRUG MANUFACTURER  CONSISTENT
WITH PARAGRAPH C OF SUBDIVISION ONE OF THIS SECTION.
  3.  PROHIBITION. 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 SECTION  SIXTY-EIGHT
HUNDRED  SIXTEEN-A  OF  THE  EDUCATION  LAW FOR AN OPIOID ANALGESIC DRUG
INCORPORATING A TAMPER-RESISTANCE TECHNOLOGY THAT IS LISTED PURSUANT  TO
SUBDIVISION TWO OF THIS SECTION WITHOUT:
  A.    VERIFYING  THAT THE OPIOID ANALGESIC DRUG HAS BEEN LISTED BY THE
STATE BOARD OF PHARMACY:   UNDER SUBDIVISION  TWO  OF  THIS  SECTION  AS
PROVIDING  TAMPER-RESISTANCE  PROPERTIES  SUBSTANTIALLY  SIMILAR  TO THE
PRESCRIBED OPIOID ANALGESIC DRUG INCORPORATING A TAMPER-RESISTANCE TECH-
NOLOGY; OR
  B. OBTAINING WRITTEN, SIGNED CONSENT FROM  THE  PRESCRIBING  PHYSICIAN
FOR SUCH INTERCHANGE OR SUBSTITUTION.
  S 2. This act shall take effect immediately.