Iowa Admin. Code r. 657-17.3 - Wholesale distributor license
Every wholesale distributor that engages in wholesale distribution into, out of, or within this state must be licensed by the board before engaging in wholesale distribution. Where operations are conducted at more than one location by a single wholesale distributor, each such location shall be separately licensed. The applicant shall submit a completed application with a nonrefundable application fee of $750. A wholesale distributor that engages in wholesale distribution of controlled substances into, out of, or within this state shall also obtain a controlled substances Act registration pursuant to 657-Chapter 10.
(1)
Application. The
applicant shall complete an application which requires demographic information
about the wholesale distributor, ownership information, information about the
wholesale distributor's registered agent located in Iowa, information about the
wholesale distributor's licensure with other state and federal regulatory
authorities, criminal and disciplinary history information, information
regarding the facility manager, a detailed description of the services to be
provided in this state, and other necessary information as determined by the
board. An application for a wholesale distributor license, including an
application for registration pursuant to 657-Chapter 10, if applicable, will
become null and void if the applicant fails to complete the licensure process,
including opening for business, within six months of receipt by the board of
the required application(s). The following shall also be submitted by the
applicant for the application to be considered complete:
a. Criminal history record check. Upon
receipt of a licensure application, the board shall provide a fingerprint
packet to the applicant's facility manager, who shall submit the completed
fingerprint packet and a signed waiver form to facilitate a national criminal
history background check of the facility manager. The cost of the evaluation of
the fingerprint packet and the Iowa division of criminal investigation and the
United States Federal Bureau of Investigation criminal history background
checks will be assessed to the applicant.
b. Surety bond or equivalent security. The
applicant shall file with the board a $100,000 surety bond or evidence that the
wholesale distributor possesses the required bond in another state where the
wholesale distribution facility does business. If a wholesale distributor's
annual gross receipts from the previous tax year were $10 million or less, the
wholesale distributor need only file a $25,000 surety bond. In lieu of a surety
bond, the applicant may submit an irrevocable standby letter of credit in the
amount of $100,000 or $25,000 as applicable. A government-owned wholesale
distributor is exempt from the surety bond requirement.
c. Evidence of current verified-accredited
wholesale distributors (VAWD) accreditation by the National Association of
Boards of Pharmacy. This requirement does not apply to new applicants located
in Iowa which must undergo an opening inspection by a board compliance officer
or agent of the board prior to issuance of an initial license. Wholesale
distributors located in Iowa shall provide evidence of VAWD accreditation on or
before license renewal.
d.
Attestation by facility manager. The applicant shall submit attestation that
the facility manager has been employed full-time for at least three years in a
position related to prescription drug distribution; is actively involved in the
daily operation of the wholesale distribution facility; maintains a functional
understanding of federal and state laws, rules, and regulations pertaining to
wholesale drug distribution; and has no felony convictions or convictions
related to prescription drug distribution, including distribution of controlled
substances.
(2)License renewal. A
wholesale drug license shall be renewed before January 1 of each year and may
be renewed as early as November 1 prior to expiration. The wholesale
distributor shall submit a completed application and nonrefundable application
fee as required in this rule.
a.
Delinquent license grace period. If a wholesale drug license has not
been renewed or canceled prior to expiration, the license becomes delinquent on
January 1. A wholesale distributor that submits a completed license renewal
application, nonrefundable application fee, and nonrefundable late penalty fee
of $750 postmarked or delivered to the board by January 31 shall not be subject
to disciplinary action for continuing to provide services in this state in the
month of January.
b.
Delinquent license reactivation beyond grace period. If a
wholesale drug license has not been renewed prior to the expiration of the
one-month grace period identified in paragraph 17.3(2)"a, "
the wholesale distributor may not operate or do business in Iowa. A wholesale
distributor that continues to do business in Iowa without a current license may
be subject to disciplinary sanctions pursuant to the provisions of 657-subrule
36.6(22). A wholesale distributor without a current license may apply for
reactivation by submitting a license application for reactivation and a
nonrefundable $2,000 reactivation fee. As part of the reactivation application,
the wholesale distributor shall disclose the services, if any, that were
provided in this state while the license was delinquent.
(3)
License changes. When a
licensed wholesale distributor changes its name, ownership, facility manager,
or location, a wholesale drug license application with a nonrefundable
application fee as provided in subrule 17.3(1) shall be submitted to the board.
A change of ownership occurs when the owner listed on the wholesale
distributor's most recent application changes or when there is a change
affecting the majority ownership interest of the owner listed on the wholesale
distributor's most recent application. A change of wholesale distributor
location within Iowa, if the new location was not a licensed wholesale
distributor immediately prior to the relocation, shall require an on-site
inspection of the new location as provided in paragraph 17.3(1)"c.
"
a.
Locations in
Lowa. Applications for license changes shall be submitted to the board
as far in advance as possible prior to the anticipated change.
b.
Locations outside of
Lowa. Applications for license changes shall be submitted to the board
within ten days of the wholesale distributor's receipt of an updated license
from the home state regulatory authority.
c.
License change application
submission. Applications for license changes shall be timely submitted
pursuant to this subrule. A licensed wholesale distributor that has timely
submitted a license change application and fee may continue to service Iowa
customers while the license change is pending final approval. An applicant that
has submitted an application for license changes after the required date of
submission pursuant to this subrule but within 30 days of the required date of
submission shall be assessed a nonrefundable late penalty fee of $750 in
addition to the license fee. An applicant that has submitted an application for
license changes 31 days or later following the required date of submission
pursuant to this subrule shall be assessed a nonrefundable reactivation fee of
$2,000.
d.
Change in
facility manager. When a wholesale distributor has a change in
facility manager, a new facility manager shall be identified pursuant to this
paragraph. If a permanent facility manager is not currently the facility
manager of a licensed facility, the facility manager shall submit to a criminal
background check.
(1) If a permanent facility
manager has been identified at the time of the vacancy, a wholesale distributor
license application identifying the new permanent facility manager, along with
the appropriate fee, shall be submitted to the board within ten days of the
vacancy.
(2) If no permanent
facility manager has been identified at the time of the vacancy, a temporary
facility manager shall be identified and notice of such shall be submitted in
writing to the board within ten days of the vacancy. A temporary facility
manager shall not be required to submit a fingerprint packet and signed waiver
to facilitate a national criminal history check unless the temporary facility
manager subsequently is identified as the permanent facility manager. Within 90
days of the vacancy, a permanent facility manager shall be identified and a
wholesale distributor license application identifying the permanent facility
manager, along with the appropriate fee, shall be submitted to the
board.
(4)
License cancellation. A licensee intending to discontinue
wholesale distribution into, out of, or within this state shall notify the
board in writing of its intent as far in advance as possible of the
discontinuation of services and shall request that the license be
administratively canceled. Such notification shall include the name and license
number of the wholesale distributor, the anticipated date of discontinuation of
service, and the identification of the wholesale distributor to which drugs and
records will be transferred. To the extent possible to avoid unnecessary delays
in obtaining product for patients, a wholesale distributor that intends to
discontinue services in this state should provide advance notice to its
customers of the date that the wholesale distributor intends to cease
distribution in this state.
Notes
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