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 May
2004
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.
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.
AUTHORIZED
RECIPIENTS
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
A Divers Alert Network (DAN) certificate or
a certificate issued by the American Red Cross cannot be used and is not
medical authorization for the holder to refill oxygen cylinders with medical
grade oxygen in Louisiana. These two
certificates are not acceptable.
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.
DISCIPLINARY ACTIONS - 2004
Disciplinary Docket No. 200401 – Voluntary Consent Agreement – Licensee was found to be in violation of LAC 46:XCI.311.D – copies of licenses for customers who are authorized by law or regulation to procure or possess federal legend drugs (approximately 90% of copies on file) were not being maintained for all customers that were shipped or sold federal legend drugs. The licensee signed a consent agreement and was assessed a fine of $1,000.
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.
INSPECTION FORM CHANGES
The inspection form used by the Board’s inspectors has been modified to included two more items which are required in the Board promulgated regulations:
·
A list of the company’s current responsible persons
– officers, directors, managers (LAC 46:XCI.315), and
·
A security crisis/disaster plan as part of the
required policies and procedures (LAC 46:XCI.313).
ARE ALL OF YOUR LOCATIONS
LICENSED
Both sales locations and distribution locations of prescription drugs require wholesale licensing. In some 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 legend/prescription drug product, be sure they are all licensed.
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.