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Senate Bill S6062

2011-2012 Legislative Session

Prohibits the substitution of opioid analgesic drugs for an opioid analgesic drug incorporating tamper resistance technology

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Archive: Last Bill Status - In Senate Committee Health Committee

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2011-S6062 (ACTIVE) - Details

See Assembly Version of this Bill:
A7634
Current Committee:
Senate Health
Law Section:
Public Health Law
Laws Affected:
Add ยง3346, Pub Health L
Versions Introduced in 2013-2014 Legislative Session:
S1753, A877

2011-S6062 (ACTIVE) - Summary

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.

2011-S6062 (ACTIVE) - Sponsor Memo

2011-S6062 (ACTIVE) - Bill Text download pdf 

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

                                  6062

                            I N  S E N A T E

                               (PREFILED)

                             January 4, 2012
                               ___________

Introduced  by  Sens. MARTINS, 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  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
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.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets

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