LOUISIANA
BOARD OF WHOLESALE DRUG DISTRIBUTORS
12046 Justice
Avenue, Suite C
Baton Rouge,
LA 70816
Phone:
225-295-8567 Fax: 225-295-8568 Website: www.lsbwdd.org email: lsbwdd@bellsouth.net
In-State
Licensee Newsletter January
2004
2004 LICENSE RENEWAL
License renewal forms for the 2004-year were mailed
out the first week of November 2003.
Previously held licenses expired on December 31, 2003. If you have not yet renewed your wholesale
drug distributor license for Louisiana, you have until January 31, 2004 to
renew the license without penalty.
After January 31, 2004, a late renewal penalty of $50 per month must be
paid to complete renewal. After March
31, 2004, the license becomes null and void at which time an additional $200
reinstatement fee must be paid to reinstate and renew the license. Please contact the Board office if you will
not be renewing the license or if you need a copy of the renewal form.
PERPETUAL INVENTORY
As per Board
promulgated regulation, specifically LAC 46:XCI.311.A which reads:
“Wholesale drug distributors
shall establish and maintain perpetual inventories and records of all
transactions regarding the receipt and distribution or other disposition of
prescription drugs. These records shall
include the following information:
1. the source of the drugs, including the name and principle address of the seller or transferor, and the address of the location from which the drugs were shipped;
2.
the
identity and quantity of the drugs received and distributed or disposed of; and
3.
the
dates of receipt and distribution.”
Therefore,
your company will be found in violation of this regulation and could be
assessed a fine if during an inspection it is found that no perpetual inventory
of product is being kept or is not readily available and current.
Medical
gas distributors should note that you are not required to maintain a perpetual
inventory on oxygen, but you are required to maintain perpetual inventories on
all other medical gases.
You
can see full versions on the state statures and board promulgated regulations
governing wholesale drug distributors on the Board’s website at www.lsbwdd.org.
UNLICENSED SUPPLIERS
In
accordance with Board promulgated regulation, specifically LAC 46:XCI.311.F,
wholesalers located in Louisiana are responsible for verifying that their
legend drug product suppliers are licensed by the Louisiana Board of Wholesale
Drug Distributors to ship or sell product into Louisiana. Wholesalers are also responsible for notifying
the Board of any unlicensed wholesalers.
The
PREFERRED method of notification of a supplier of legend drugs that is not
licensed by the Louisiana Board of Wholesale Drug Distributors to sell or ship
product into Louisiana is for the receiving company to mail or fax a copy of
the invoice from that unlicensed supplier to the LBWDD Board office.
In accordance with Louisiana
Revised Statute 37:3480, all sales and distribution of prescription drugs must
be made to an authorized recipient. In
addition, any location to which prescription drugs are sent must be authorized
to possess prescription drugs. In
accordance with Board promulgated regulation, LAC 46.XCI.311.D, to ensure that
the customers you sell/distribute to are authorized to purchase and possess
legend drugs, copies of licenses for customers must be maintained for all
customers that are shipped or sold legend drugs.
There are different types of licenses or permits that the Board will
accept as verification of an authorized recipient of prescription/legend drugs
(excluding medical gases - see below).
These are as follows:
Medical Examiner’s License
Dental License
Veterinarian License
Pharmacy License (Do not use Drug Kit
Permit)
Louisiana Wholesale Drug Distributors License
Louisiana Dept. of Health & Hospitals Permit:
Food & Drug Permit 461
Food & Drug Permit 462
Food & Drug Permit 463
Food & Drug Permit 464
Food & Drug Permit 465
Food & Drug Permit 467
Food & Drug Permit 468
Emergency Medical Technician (EMT) Certification
First Responder Certification
Louisiana Dept. of Health & Hospitals
Food & Drug Permit 473
If a nursing
home or home health agency does not have one of the above listed licenses,
permits or certificates, a letter on nursing home or home health agencies’
letterhead stating the name of the designated Medical Director for the nursing
home or home health agency along with a copy of the appropriate Medical
Examiner’s License must be on file. For
nursing homes and hospitals, you do not use copies of the Louisiana Department
of Health and Hospitals license to operate/occupational license (is
generally, a 3-digit license number) that specifies a licensed capacity number
on file.
The BOARD’S WEBSITE AT
www.lsbwdd.org has many active functions and helpful links. You can print an application form, view
previous newsletters to licensees, view a list of the current Board Members and
staff, view and print the state statutes & Board regulations, verify
license information of wholesale drug distributors licensed by the Board, and
do various inquiries, such as verify and print licenses, using the links to
other agencies such as the Louisiana Board of Pharmacy, Louisiana Board of
Dentistry, Louisiana Board of Medical Examiners, and the Louisiana Controlled
Dangerous Substance Program. The
license information printed from these sites can be kept on file as customer
license verification copies for wholesalers in Louisiana. You can even download a spreadsheet list of
all Louisiana licensed wholesale drug distributors.
There is a link to the
FDA website so you can use it to review recalls and safety alerts issued by the
FDA. There is a link to get information
on product registration from the DHH, Office of Public Health, Food and Drug
Program. You can also get information
on applying for a license with the Louisiana Controlled Dangerous Substance
Program.
Board
inspector(s) do not announce or schedule inspectionS in advance. Your facility will be inspected during your
normal business hours. During that
time, there must be someone available that can produce records and assist the
Board inspector with the inspection. If
the owner/manager is not at the facility when the inspector arrives for the
inspection, there must be someone designated to act in his or her place to
allow an inspection as authorized in R.S. 37:3470 to take place. It is your responsibility to be in
compliance when the inspector arrives.
Non-compliance issues that are corrected during the inspection will
still be considered as violations found.
DISCIPLINARY ACTIONS -
2003
Disciplinary Docket No. 200305
– Voluntary Consent Agreement – Licensee was found to be in violation of LAC
46:XCI.311.A – the failure to maintain current inventory (perpetual) records
for medical gases. The licensee signed
a consent agreement and was assessed a fine of $1,000.
Disciplinary Docket No. 200306
– Voluntary Consent Agreement – Licensee was found to be in violation of LAC
46:XCI.311.E – the failure to properly maintain perpetual inventories for
medical gases other than oxygen. The licensee
signed a consent agreement and was assessed a fine of $1,000.
ARE ALL OF YOUR
LOCATIONS LICENSED
Both
sales locations and distribution locations of prescription drugs require
wholesale licensing. In come cases both
are not the same and both locations require licensing. Each location must be licensed on its
own. If you have multiple locations
that either sell or distribute prescription drug product, be sure they are all
licensed.
CHANGE OF FACILITY
LOCATION
If
you are planning to move your facility to a new location, you must notify this
Board in advance. A new location
requires inspection and issuance of a new license. Licenses are issued to facilities locations and are
non-transferable.