Current through Register Vol. 46, No. 19, March 20, 2024
Beginning January 1, 2019, no person other than a licensed
wholesale distributor, licensed pharmacy, or practitioner shall engage in any
of the activities found herein in this state without a limited distributor
license. Where operations are conducted at more than one location by a single
distributor, each location shall be separately licensed. The applicant shall
submit a completed application along with a nonrefundable fee of $175. A
limited distributor that engages in 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)
License required. A
person engaged in the following activities shall obtain a limited distributor
license prior to distribution in or into Iowa:
a. Distribution of a medical gas or device at
wholesale or to a patient pursuant to a prescription drug order.
b. Wholesale distribution of a prescription
animal drug.
c. Wholesale
distribution of a prescription drug, or brokering the distribution of a
prescription drug at wholesale, by a manufacturer, a manufacturer's co-licensed
partner, or a repackager.
d.
Intracompany distribution of a prescription drug, including pharmacy chain
distribution centers.
e.
Distribution at wholesale of a combination product as defined by the United
States Food and Drug Administration, medical convenience kit, intravenous fluid
or electrolyte, dialysis solution, radioactive drug, or irrigation or sterile
water solution to be dispensed by prescription only.
f. Distribution of a dialysis solution by the
manufacturer or the manufacturer's agent to a patient pursuant to a
prescription drug order, provided that a licensed pharmacy processes the
prescription drug order.
(2)License optional. A
person engaged in the following activities may, but is not required to, obtain
a limited distributor license for distribution in or into Iowa:
a. Distribution of nonprescription drugs or
devices with or without a patient-specific prescription.
b. Distribution of medical devices
exclusively to a health care practitioner for use in the normal course of
professional practice ("professional use").
c. Distribution of blood and blood products
that are not subject to the federal Drug Supply Chain Security Act
(DSCSA).
(3)
Application. The applicant shall complete an application which
requires demographic information about the limited distributor, ownership
information, information about the limited distributor's registered agent
located in Iowa, information about the limited distributor's licensure with
other state and federal regulatory authorities, criminal and disciplinary
history information, information regarding the facility manager, and a detailed
description of the services to be provided in this state. An application for a
limited 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. Evidence of the
mandatory physical inspection of the distribution facility pursuant to subrule
42.3(7).
b. Attestation by facility
manager. The applicant shall submit attestation that the facility manager has
adequate experience in prescription drug and device distribution; is actively
involved in the daily operation of the distribution facility; maintains a
functional understanding of federal and state laws, rules, and regulations
pertaining to drug and device distribution, as applicable; and has no felony
convictions or convictions related to prescription drug and device
distribution, including distribution of controlled substances.
(4)License renewal.
A limited distributor license shall be renewed before January 1 of
each year and may be renewed as early as November 1 prior to expiration. The
limited distributor shall submit a completed application and nonrefundable
application fee as required in this rule.
a.
Delinquent license grace period. If a limited distributor
license has not been renewed or canceled prior to expiration, the license
becomes delinquent on January 1. A limited distributor that submits a completed
license renewal application, nonrefundable application fee, and nonrefundable
late penalty fee of $175 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 limited distributor license has not been
renewed prior to the expiration date of the one-month grace period identified
in paragraph 42.3(4)"a," the limited distributor may not
operate or do business in Iowa, unless the activities conducted are those
identified in subrule 42.3(2). A limited distributor that continues to do
business in Iowa without a current license as required in subrule 42.3(1) may
be subject to disciplinary sanctions pursuant to the provisions of 657-subrule
36.6(2). A limited distributor without a current license may apply for
reactivation by submitting a license application for reactivation and a
nonrefundable reactivation fee of $500. As part of the reactivation
application, the limited distributor shall disclose the services, if any, that
were provided in this state while the license was delinquent.
(5)
License
changes. If a distributor has a change of name, ownership, or
location, a limited distributor license application with a nonrefundable
application fee as provided in subrule 42.3 (3) shall be submitted to the
board. A change of ownership occurs when the owner listed on the limited
distributor's most recent application changes or when there is a change
affecting the majority ownership interest of the owner listed on the limited
distributor's most recent application. A change of limited distributor location
within Iowa, if the new location was not a licensed limited distributor
immediately prior to the relocation, shall require a self-inspection as
provided in subrule 42.3(7). A limited distributor that has submitted a license
change application may continue to service Iowa customers while its license
change is pending final approval.
a. For a
distributor located in Iowa, a completed application shall be submitted to the
board as far in advance as possible prior to the change of name, ownership, or
location.
b. For a distributor
located outside of Iowa:
(1) If the home state
licenses or registers the facility, a completed application shall be submitted
within ten days of receipt of an updated license or registration from the home
state.
(2) If the home state does
not license or register the facility, a completed application shall be
submitted as far in advance as possible prior to the change of name, ownership,
or location.
c. When a
distributor changes its name or location, the distributor shall provide advance
written notice of the change to each Iowa customer and patient.
d. Applications for license changes shall be
timely submitted pursuant to this subrule. A licensed limited 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 $175 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 $500.
(6)
License cancellation. If
a limited distributor intends to discontinue service into, out of, or within
this state, it shall:
a. Notify the board as
far in advance as possible of the limited distributor's intent to discontinue
services and shall request that the license be administratively canceled. The
notification shall include the name, address, and Iowa license number of the
pharmacy or distributor at which prescription, patient, and distribution
records will be maintained.
b.
Ensure that prescription and patient records are transferred to another
Iowa-licensed distributor or pharmacy.
c. To the extent possible to avoid
unnecessary delays in the availability of services to Iowa customers and
patients, provide advance written notice to customers and patients of the date
that the distributor intends to cease provision of services.
(7)
Inspection of limited
distributor facility. Each limited distributor location seeking
initial or renewal licensure shall, prior to issuance of a license certificate,
complete and submit for evaluation a self-inspection packet provided by the
board.
(8)Change in
facility manager. If a distributor has a change in facility manager,
the licensee shall provide notice to the board on forms provided by the board
within ten days of the change.
