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

 

RULE AMENDMENTS

A copy of the final rule amendments as published in the Louisiana Register on August 20, 2003

is included with this newsletter for your review.

 

Effective August 20, 2003, the Louisiana Board of Wholesale Drug Distributors has amended rules within the Louisiana Administrative Code Title 46, Part XCI, specifically:

• Section 103. Definitions – whereas the definition of Legend Drug was revised to included the product label as containing the statement “Rx Only” or the previously required “Caution: Federal Law Prohibits Dispensing Without a Prescription”; therefore a legend drug product is required to contain either one of these statements.
• Section 301. Licensing Requirements (Chapter 3. Wholesale Distributors) – whereas number B.4 was added to allow the Board to collect an additional fee of $200 along with the renewal fee of $200 to reinstate licenses that were not renewed by the April 1 deadline and that had been canceled.
• Section 303. Required Information – whereas number D was added to define the Board’s current policy that licenses are not transferable due to change of location of the licensed facility or change of ownership of the facility; therefore a new license application must be submitted and license fee paid when a licensed facility changes location or changes ownership.
• Section 309. Storage and Handling Requirements – whereas numbers 2.c and d were added and 2.b and e revised to clarify the requirements for security of facilities.  All facilities, except those distributing medical gas only, are required to be equipped with a monitored alarm system for detection of after-hour entry into the facility.  All facilities, full line and medical gas, must be equipped with security systems that provide protection against theft and division including theft and diversion facilitated or hidden by tampering with computers or electronic records.  Medical gas distributors must store medical gases under lock and key if product is stored inside a Board-approved storage facility that is not equipped with a monitored alarm system; and medical gas distributors who store product on open docks must equip the dock storage area with a monitored alarm system to detect after-hour entry.  Whereas minor wording changes were made in numbers 3.a and b with regards to room temperature and humidity monitoring; therefore, products with no storage requirements may be held at room temperature and the Board will no longer require humidity monitoring of storage areas.
• Section 311. Drug Distribution Recordkeeping – whereas number A was revised to require distributors to maintain a perpetual (continual) inventory of product; number B was revised requiring that distributors keep inventory records for a period of three years following disposition of drugs; number D was added to clarify La. R.S. 37:3480 in that distributors must only sell or distribute drugs to individuals, corporations, or entities who are authorized by law or regulation to procure or possess such drugs - to do this the distributor must maintain copies of current licenses for the customers they sell or ship drugs to; number E was added to clarify that medical gas distributors are required to maintain perpetual inventory on all medical gases except for oxygen; number F was added as a requirement that wholesale distributors domiciled within Louisiana must verify that their suppliers of drug products are licensed by the Louisiana Board of Wholesale Drug Distributors to sell or ship in/into Louisiana and that the distributor is responsible for notifying the Board of any unlicensed wholesalers. (See the article at the end of this newsletter regarding the preferred method of notification.)
• Section 313. Policy and Procedures – whereas number 4 was revised to require a procedure for the ensurance that outdated prescription drugs be segregated and either returned or destroyed and to provide that written documentation of this be kept and maintained for three years; item number 5 was added to require a procedure for validating customer licenses, for review of excessive or suspicious purchases, for inspection of all incoming and outgoing shipments, and for the monitoring and recording of the temperature of product storage areas.
• Section 503. Board Domicile; meetings – whereas the number of regular meetings held annually by the Board was revised to two per year.

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:

      D.E.A License

      Controlled Drug Substance License

      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

 

The types of licenses, permits, and certifications that can be used as verification of an authorized recipient of medical gases are the one listed above as well as:

      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.

 

BOARD WEBSITE

THE BOARD’S WEBSITE AT www.lsbwdd.org HAS SOME CHANGES.  The site 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 CDS (Controlled Dangerous Substance).  The license information printed from these sites can be kept on file as customer license verification copies for wholesalers in Louisiana.

NOW YOU CAN DOWNLOAD A SPREADSHEET LIST OF ALL LOUISIANA LICENSED WHOLESALE DRUG DISTRIBUTORS.  

 

A LINK TO THE FDA WEBSITE HAS BEEN ADDED SO YOU CAN USE IT TO REVIEW RECALLS AND SAFETY ALERTS. 

 

THERE IS NOW A LINK YOU CAN USE TO GET INFORMATION ON PRODUCT REGISTRATION FROM THE DHH, OFFICE OF PUBLIC HEALTH, FOOD AND DRUG PROGRAM.   

 

A LINK HAS BEEN ADDED YOU CAN USE TO GET INFORMATION ON APPLYING FOR A LICENSE WITH THE LOUISIANA CONTROLLED DANGEROUS SUBSTANCE PROGRAM.

 

INSPECTIONS

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. 200301 – Administrative Hearing – Licensee was found to be in violation of La. R.S. 37:3480 – the failure to maintain copies of licenses for all customers as proof that the customers sold to by the licensee are authorized by law or regulation to procure or possess federal legend drugs.  The licensee was assessed a fine of $2,000 and $500 in administrative/investigative costs.

 

Disciplinary Docket No. 200302 – Administrative Hearing – Licensee was found to be in violation of LAC 46:XCI.311 – the failure to provide adequate drug distribution record keeping.  The licensee was assessed a fine of $2,000 and $500 in administrative/investigative costs.

 

Disciplinary Docket No. 200303 – Voluntary Consent Agreement – Licensee was found to be in violation of La. R.S. 37:3480 – the failure to maintain copies of licenses for all customers as proof that the customers sold to by the licensee are authorized by law or regulation to procure or possess federal legend drugs.  The licensee was assessed a fine of $1,000.

 

Disciplinary Docket No. 200304 – Voluntary Consent Agreement – Licensee was found to be in violation of La. R.S. 37:3480 – the failure to maintain copies of licenses for all customers as proof that the customers sold to by the licensee are authorized by law or regulation to procure or possess federal legend drugs (medical gas).  The licensee signed a consent agreement and was assessed a fine of $1,000.

 

NOTIFICATION OF UNLICENSED SUPPLIERS

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.