BILL NUMBER:S7436

TITLE OF BILL:  An act to amend the public health law, in relation to
designating hydrocodone bitartrate as a schedule I controlled substance

PURPOSE: To designate hydrocodone bitartrate (also known as Zohydro ER)
as a schedule I controlled substance.

SUMMARY OF PROVISIONS:

Section 1. Subdivision (b) of schedule I of section 3306 of the public
health law is amended by adding a new paragraph 56, which includes
hydrocodone bitartrate in the list of controlled substances.

Section 2. Subparagraph 10 of paragraph 1 of subdivision (b) of schedule
II of section 3306 of the public health law, as amended by section 1 of
part C of chapter 447 of the laws of 2012, is amended to differentiate
hydrocodone (also known as dihydrocodeinone) from hydrocodone bitar-
trate.

Section 3 sets forth the effective date.

JUSTIFICATION: Hydrocodone bitartrate extended release capsules (also
known as Zohydro ER) were approved in October, 2013 by the U.S. Food and
Drug Administration (FDA) for the management of pain. Zohydro ER is the
first single-entity prescription pain drug, meaning not combined with an
              

analgesic such as acetaminophen like other pain management drugs. The
larger amount of hydrocodone present in Zohydro ER exposes patients to
the risk of opioid addiction, abuse and misuse, which can then lead to
overdose and death. The highest available dosage of Zohydro ER contains
5 to 10 times more hydrocodone than Vicodin or Lortab. An individual
unaccustomed to taking opioids could suffer a fatal overdose from just
two capsules while just a single capsule could be fatal if swallowed by
a child.

Lawmakers in Ohio have introduced legislation to ban Zohydro ER from the
state. Members of Congress from Kentucky, West Virginia and Massachu-
setts have introduced bills to ban the drug.

Lawmakers are also trying to limit the drug's availability through other
avenues, including utilizing the state Boards of Registration in Medi-
cine that would require doctors to complete a risk assessment and pain
management treatment agreement with patients before prescribing Zohydro
ER. Physicians who want to prescribe Zohydro ER would also have to
participate in the Prescription Monitoring Program.

In addition, at least 29 state attorneys general have asked the FDA to
reconsider its approval of the drug.

This bill will protect patients and individuals with a propensity for
drug addiction from obtaining and misusing this powerful and dangerous

prescription painkiller by establishing hydrocodone bitartrate as a
schedule I controlled substance.

LEGISLATIVE HISTORY: New legislation

FISCAL IMPLICATIONS: To be determined

EFFECTIVE DATE: This act shall take effect immediately.