The
surety bond or irrevocable letter of credit required for all licensed
Wholesale Distributors of Prescription Drugs as of June 1, 2008,
has been reduced by the Wisconsin Pharmacy Examining Board to the
amount of Five Thousand Dollars, ($5,000). New forms
are available at http://drl.wi.gov/prof/pres/form.htm
For
distributors that have already submitted forms for a bond or letter
of credit in the amount of $75,000, please be advised that you may
re-submit a bond/letter of credit for $5,000.
Q:
Our company has more than one licensed facility that distributes
in Wisconsin . How many bonds do we need?
A:
Only one. A distributor that operates more than one facility
is not required to submit a bond or other security for each facility.
If the distributor has more than one facility licensed in Wisconsin
, the original bond should be submitted along with a cover letter
listing all the Wisconsin licensed facilities from which the distributor
operates. The records of the Board can then reflect the original
bond cross referenced to the individual licensed facilities. The
original bond MUST, however, indicate each licensed facility that
it covers.
DESIGNATED
REPRESENTATIVE FAQ's:
Q: Who
can be a Designated Representative? (The person is employed by the
applicant full time in a managerial level position.)
A: Aside
from meeting the other statutory requirements to become a Designated
Representative, a Designated Representative must:
Be physically
present at the wholesale prescription drug distributor's facility
during regular business hours and is involved in and aware of
the daily
operation of the wholesale prescription drug distributor. This does
not preclude the designated representative from taking authorized
sick leave
and vacation
time or from being absent from the facility for other authorized
business or personal purposes.
The person
must be actively involved in and aware of the daily operations of
the wholesale distributor.
Q:
Can a distributor have more than one designated representative?
A: No, a
licensed facility may only have one designated representative at
a time.
INSPECTIONS
FAQ's:
Q:
How do I arrange for an inspection of a facility located in Wisconsin?
A: For wholesale
distributors of prescription drugs physically located in Wisconsin,
inspection requests of the Department of Regulation and Licensing
should be submitted as soon as possible to allow time to plan for
an inspection. Due to limited staff resources and the anticipated
high volume of inspection requests before June 1, there may be a
delay in completing inspections beyond June 1. Completion of inspections
will depend on when the inspection request is received, availability
of Department staff, and the Department's inspection schedule. Contact
Gregory Raube to schedule an inspection (608) 261-4484, Gregory.Raube@wisconsin.gov
Q:
How do I arrange for an inspection of a facility located outside
of Wisconsin?
A:Wholesale Distributors are advised that they
must have an inspection completed before the application is filed
. An approved inspection must be completed and passed within
three years prior to the application date.
Approved inspections
include:
NOTE:
Distributors may experience delays in completing inspections by
the deadline date. Within 45 days of filing for renewal of
an existing license or filing an application for original licensure,
a distributor must submit proof to the department that an approved
inspection has been scheduled or the VAWD certification process
has been initiated. Failure to timely provide notification
to the department may result in the distributor being required to
discontinue doing business in Wisconsin pending completion of the
credentialing process.
National Association of Boards of
Pharmacy (NABP) Verified-Accredited Wholesale Distributors
(VAWD)
Go to:
http://www.nabp.net
and click on Accreditation Programs, then VAWD, or call the
NABP at 847-391-4406
Inspections
completed by another state
Other inspections
approved by the Board
MANUFACTURER
AND DISTRIBUTOR FAQ's:
Q:
Do I need to renew my medical device/drug manufacturer or medical
device distributor license?
A:
Prescription
Medical Device Distributors:
Will no longer
need a wholesale distributor of prescription drug license
effective 06-01-08 to ship medical device products into
Wisconsin. Print this web page for your records verifying
no license is needed.
Prescription
Medical Device or Drug Manufacturers:
Will need
to hold a WI drug/device manufacturer license* only
if your facility is physically located
in the state of WI.
.
Will
no longer need to hold the wholesale prescription drug
or device distributor license. Print this web page for
your records verifying no license is needed.
.
*Manufacturers
must maintain a list of distributors of record and
update the list monthly.
Q:
We hold a license as a drug manufacturer, do we need
a wholesale distributor drug license to distribute prescription
drugs?
A: No, manufacturers
are exempt from needing a prescription drug distributor
license in Wisconsin. If you are distributing drugs
other than your own, than you would have to be licensed
as a distributor.
Q:
We hold a license as a reverse distributor,
do we need a wholesale distributor drug license
to distribute prescription drugs?
A:
No, reverse distributors are exempt from needing
a prescription drug distributor license in
Wisconsin.
Q:
We were told in the past that we needed both
a distributor and manufacturer license as
we transfill liquid oxygen from a company
called Lifegas to liquid base containers for
use in the home by patients' under the direction/order
of a physician. Are you saying even though
this is true, we do not need a distributor
license?
A:
If, you are a manufacturer, and licensed as
such by the board, or out of state as a manufacturer,
and the FDA does not require a distributor license,
which they currently do not, than yes, as of
06-01-2008, you will not need a distributor
license to distribute prescription drugs in
Wisconsin.
OTHER
FAQ's:
Q: How can I find
out if a wholesale distributor of prescription drugs has a credential?
A: Visit the License Lookup
, click on and select from the Credential Type, type in the last
name or credential number to search.
Q:Can
credentials be transferred from other States/Countries?
A: No. A license may
not be transferred from one establishment or location to another
nor from one person to another. Each establishment is required
to have a separate license.
Q:
How long does it take to make a determination to provide credentials?
A: By law an original completed
application for a credential shall be reviewed within 60 business
days after having been received, but the average time for review
is 30 days. An application is considered complete when all materials
necessary to make a determination on the application and all requested
materials have been received.
Q:When
does a change of ownership occur and how do I file?
A: How
to file and when it occurs can be found in the form"Application
for Wholesale Prescription Drug Distributor" on the
formspage.
Q:
We would like to change our DBA name, how do we notify the Board?
A: Please
submit a letter to the board indicating that this is a name change
only and change of ownership has not occurred. Include your current
new name and license number. To receive a new license a $10.00 fee
is required. Make checks payable to the Department of Regulation and
Licensing.
Q:
We would like to close our facility, how do we notify the Board?
A: Please
submit a letter to the board requesting closure. Indicate your facility
name license number and reason for closure.
Q:
Do I need to obtain a manufacturer license if I am trans filling medical
gases from one container to another?
A: Yes,
please go to the drug manufacturer
web site to obtain an application.
