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.