2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 2-A - Opioid Stewardship Act › 3323 - Opioid Stewardship Fund.

* § 3323. Opioid stewardship fund. 1. Definitions:
(a)  "Opioid  stewardship  payment"  shall mean the total amount to be
paid into the opioid stewardship fund for each state fiscal year as  set
forth in subdivision two of this section.
(b)  "Ratable  share"  shall mean the individual portion of the opioid
stewardship payment to be paid  by  each  manufacturer  and  distributor
licensed  under  this  article  that sells or distributes opioids in the
state of New York.
(c) Notwithstanding any inconsistent provision of law to the contrary,
"distribute" shall mean to deliver a controlled substance other than  by
administering   or   dispensing   to   the   ultimate   user,  including
intra-company transfers between  any  division,  affiliate,  subsidiary,
parent  or other entity under complete common ownership and control. For
purposes of this section,  "distribute"  shall  not  include  controlled
substances  surrendered to reverse distributors, or donated to recipient
entities  or  third-party  intermediaries   pursuant   to   the   unused
prescription  drug  donation  and  redispensing  program  of section two
hundred eighty-b of this chapter.
2.  Opioid  stewardship   payment   imposed   on   manufacturers   and
distributors.    All  manufacturers and distributors licensed under this
article  (hereinafter  referred  to  as  "licensees"),  that   sell   or
distribute  opioids in the state of New York shall be required to pay an
opioid stewardship payment. On an annual basis, the  commissioner  shall
certify  to  the  state comptroller the amount of all revenues collected
from opioid stewardship payments and any penalties imposed.  The  amount
of  revenues  so  certified shall be deposited quarterly into the opioid
stewardship fund established pursuant to section  ninety-seven-aaaaa  of
the  state finance law. No licensee shall pass the cost of their ratable
share amount to a purchaser, including the ultimate user of the  opioid,
or  such  licensee shall be subject to penalties pursuant to subdivision
ten of this section.
3. Determination of  opioid  stewardship  payment.  The  total  opioid
stewardship   payment  amount  shall  be  one  hundred  million  dollars
annually, subject to downward adjustments pursuant to  subdivision  nine
of this section.
4.  Reports  and  records.  Each manufacturer and distributor licensed
under this article that sells or distributes opioids in the state of New
York shall provide to the commissioner a report  detailing  all  opioids
sold  or distributed by such manufacturer or distributor in the state of
New York. Such report shall include:
(a) the manufacturer's or distributor's name, address,  phone  number,
federal Drug Enforcement Agency (DEA) registration number and controlled
substance license number issued by the department;
(b)  the  name,  address  and DEA registration number of the entity to
whom the opioid was sold or distributed;
(c) the date of the sale or distribution of the opioid;
(d) the gross receipt total,  in  dollars,  of  all  opioids  sold  or
distributed;
(e)  the  name  and  National  Drug  Code  (NDC) of the opioid sold or
distributed;
(f) the number of containers and the strength and metric  quantity  of
controlled   substance   in   each  container  of  the  opioid  sold  or
distributed;
(g) the total number of morphine milligram equivalents (MMEs) sold  or
distributed; and
(h) any other elements as deemed necessary by the commissioner.
4-a.  Initial  and  future  reports.  (a)  Such  information  shall be
reported annually to the department in  such  form  as  defined  by  the

commissioner, provided however that the initial report provided pursuant
to  subdivision four shall consist of all opioids sold or distributed in
the state of New York for the two thousand seventeen calendar year,  and
must  be submitted by August 1, 2018. Subsequent annual reports shall be
submitted on April first of each year based on the actual  opioid  sales
and distributions of the prior calendar year.
(b) For the purpose of such annual reporting, MMEs shall be determined
pursuant  to a formulation to be issued by the department and updated as
the department deems appropriate.
5. Determination of ratable share. Each manufacturer  and  distributor
licensed  under  this  article  that sells or distributes opioids in the
state of New York shall pay a portion of the  total  opioid  stewardship
payment amount. The ratable share shall be calculated as follows:
(a)  The  total amount of MMEs sold or distributed in the state of New
York by the licensee for the preceding calendar year, as reported by the
licensee pursuant to subdivision four of this section, shall be  divided
by  the  total  amount  of  MME  sold  in  the  state of New York by all
licensees pursuant to this article to  determine  the  licensee  payment
percentage.  The  licensee payment percentage shall be multiplied by the
total opioid stewardship payment. The product of such calculation  shall
be the licensee's ratable share. The department shall have the authority
to  adjust  the  total  number  of  a licensee's MMEs to account for the
nature and use of the product, as well as the type of entity  purchasing
the product from the licensee, when making such determination and adjust
the ratable share accordingly.
(b) The licensee's total amount of MME sold or distributed, as well as
the  total amount of MME sold or distributed by all licensees under this
article, used in the calculation of the ratable share shall not  include
the  MME of those opioids which are: (i) manufactured in New York state,
but whose final point of delivery or sale is outside of New York  state;
(ii)  sold  or  distributed to entities certified to operate pursuant to
article thirty-two of the mental hygiene law, or article  forty  of  the
public  health  law;  or  (iii)  the MMEs attributable to buprenorphine,
methadone or morphine.
(c) The department shall provide to the licensee, in  writing,  on  or
before  October fifteenth, two thousand eighteen, the licensee's ratable
share for the two thousand  seventeen  calendar  year.  Thereafter,  the
department  shall  notify  the licensee in writing annually on or before
October fifteenth of each year based on the opioids sold or  distributed
for the prior calendar year.
6.  Payment  of  ratable  share.  The  licensee  shall  make  payments
quarterly to the department with the first payment of the ratable share,
provided that the amount due on January  first,  two  thousand  nineteen
shall  be  for  the  full  amount  of  the  first  annual  payment, with
additional payments to be due and  owing  on  the  first  day  of  every
quarter thereafter.
7.  Rebate  of  ratable  share. In any year for which the commissioner
determines that a licensee failed  to  report  required  information  as
required  by  this  section, those licensees complying with this section
shall receive a  reduced  assessment  of  their  ratable  share  in  the
following  year  equal to the amount in excess of any overpayment in the
prior payment period.
8. Licensee opportunity to appeal. A licensee  shall  be  afforded  an
opportunity  to  submit information to the department to justify why the
ratable share provided to the licensee, pursuant  to  paragraph  (c)  of
subdivision  five  of  this  section,  or amounts paid thereunder are in
error  or  otherwise  not  warranted.  If  the   department   determines
thereafter that all or a portion of such ratable share, as determined by

the  commissioner  pursuant  to subdivision five of this section, is not
warranted, the department may: (a) adjust the ratable share; (b)  adjust
the  assessment  of the ratable share in the following year equal to the
amount  in excess of any overpayment in the prior payment period; or (c)
refund amounts paid in error.
9. Department annual review. The department shall annually review  the
amount  of  state  operating funds spent in the office of alcoholism and
substance abuse services (OASAS) budget for opioid prevention, treatment
and recovery. The commissioner of OASAS shall certify to the  department
the  amount  of  annual  spending for such services, utilizing available
information on patient demographics and  the  actual  cost  of  services
delivered  by the state and by state-funded providers. The certification
of  such  spending  shall  begin  in  state  fiscal  year  two  thousand
eighteen-nineteen, and continue annually thereafter. The total amount of
such spending shall be provided to the department by the commissioner of
OASAS  no  later  than  June  thirtieth  of each year. There shall be no
stewardship fund payments beginning on July first  in  the  event  state
operating  funds  spent  in  the  OASAS  budget  for  opioid prevention,
treatment and recovery in the most recently reported year is equal to or
less than state operating funds spent for such purposes in state  fiscal
year two thousand nine-ten.
10.  Penalties.  (a)  The  department may assess a civil penalty in an
amount not to exceed one thousand dollars per day against  any  licensee
that fails to comply with subdivisions four and four-a of this section.
(b)  In  addition  to  any other civil or criminal penalty provided by
law, where a licensee has failed to pay its ratable share in  accordance
with  subdivision  six of this section, the department may also assess a
penalty of no less than ten percent and no greater  than  three  hundred
percent of the ratable share due from such licensee.
(c)  Where  the ratable share, or any portion thereof, has been passed
on to a purchaser by a licensee, the commissioner may impose  a  penalty
not to exceed one million dollars per incident.
* NB Repealed June 30, 2029