(A)
Each producer shall participate in a stewardship plan. Each producer must:
(1)
Operate, individually or jointly with other producers, a stewardship plan approved
by the director; or
(2)
Enter into an agreement with a stewardship organization to operate, on the producer's
behalf, a stewardship Plan approved by the Director.
(B)
Each stewardship plan must be approved by the director as described in section 18C-23 before the entity administering the plan starts collecting unwanted covered drugs.
Once approved, each stewardship plan must have prior written approval of the director
for proposed changes as described in section 18C-24.
(C)
By six months after the effective date of this article, or by six months after a producer
starts selling or distributing a covered drug in the county, a producer must notify
the director in writing of the producer's intent to participate in a stewardship plan,
or to form a new stewardship plan.
(D)
By whichever occurs first, either, six months after the effective date of this article,
or by six months after a retail pharmacy whose label appears on a covered drug, or
a retail pharmacy's packaging starts selling the covered drug in the county, or by
six months after a repackaged covered drug is first sold in the county and thereafter,
upon request from the director, a retail pharmacy or repackager whose label appears
on a covered drug or its packaging must provide to the director:
(1)
The contact information of the producer from whom the retail pharmacy or repackager
obtains the covered drug, including the telephone number, mailing address, and email
address of the retail pharmacy's or repackager's point of contact at the producer;
and
(2)
Written notification as to whether the producer, from whom the retail pharmacy or
repackager obtains a covered drug, has provided its (producer's) notice of intent
to participate or to form a new stewardship plan; or
(3)
Documentation that the retail pharmacy or repackager made best efforts to meet the
requirements of section 18C-14(D)(2) above.
(E)
A producer, either individually or jointly with other producers, or through a stewardship
organization shall:
(1)
By whichever occurs first, either, six months after the effective date of this article,
or by six months after starting sale of or distributing a covered drug in the county,
identify in writing to the director, a plan operator, including the telephone number,
mailing address and email contact information, that is authorized to be the official
point of contact for the stewardship plan;
(2)
By whichever occurs first, either, nine months after the effective date of this article,
or by nine months after starting sale of or distributing a covered drug in the county,
notify all retail pharmacies and law enforcement agencies in the county of the opportunity
to participate as a drop-off site in accordance with section 18C-16 and provide a process for forming an agreement between the stewardship plan and interested
collectors; and annually thereafter, make the same notification to any nonparticipating
or new retail pharmacies in the county;
(3)
By whichever occurs first, either, twelve months (one year) after the effective date
of this article or twelve months after starting sale of or distributing a covered
drug in the county, submit a proposed stewardship plan to the director for review
as described in section 18C-23 or identify an existing stewardship plan in which the producer will participate;
(4)
Within three months after the director's approval of a stewardship plan, operate or
participate in a stewardship plan in accordance with this article; and
(5)
At least every three years after a stewardship plan starts operations, submit an updated
stewardship plan to the director listing any substantive changes. The updated stewardship
plan shall be accompanied by the applicable fee(s) in accordance with section 18C-26 of this article. The director shall review updated stewardship plans using the process
described in section 18C-23.
(F)
A producer, either individually or jointly with other producers, may:
(1)
Enter into contracts and agreements with stewardship organizations, other service
providers, or other entities as necessary, useful or convenient to carry out all or
portions of a stewardship plan;
(2)
Notify the director of any producer selling or distributing covered drugs being manufactured
by a producer(s) in the county that is failing to participate in a stewardship plan;
and
(3)
Perform any other functions as may be necessary or proper to carry out a stewardship
plan and to fulfill any or all of the purposes for which the plan is organized.
(G)
After the first full year of participation in a stewardship plan, a producer, either
individually or jointly with other producers, or stewardship organization may notify
the director in writing of intent to form a new stewardship plan, and identify a stewardship
plan operator, including the plan operator's telephone, mailing address, and email
contact information, that is authorized to be the official point of contact for the
proposed new stewardship plan. Within three months of such notification, the producer,
either individually or jointly with other producers, or stewardship organization shall
submit a proposed stewardship plan as described under section 18C-15 to the director for review in accordance with section 18C-23.
(H)
A producer must notify the director within 30 days of any changes to producer contact
information.
(I)
The director may, on a case-by-case basis, approve in writing, requests for extensions
of time for the submission dates and deadlines for the submission of stewardship plans,
plan revisions and/or plan changes. An approved extension of time shall not exceed
three months.
(J)
The director may audit the records of a producer(s) or stewardship organization related
to a stewardship plan or request that the producer(s) or stewardship organization
arrange for the director to inspect, at reasonable times, a stewardship plan's or
a collector's facilities, vehicles, and equipment used in carrying out a stewardship
plan.
