AUTHORIZED RECIPIENTS

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. This means that you must have on file an applicable license or permit to comply with this requirement. Many of these licenses can be acquired by using the www.lsbwdd.org Website.

The types of licenses and permits that can be used to verify an authorized recipient of PRESCRIPTION DRUGS (excluding medical gases) 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

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 verify an authorized recipient of MEDICAL GASES 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)

EMT Certification

First Responder Certification

Louisiana Wholesale Drug Distributors License

Louisiana Dept. of Health & Hospitals

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

Food & Drug Permit 473

For Nursing Homes or Home Health Agencies

If they do not have one of the above mentioned licenses or permits, you must have a copy of the contracted Medical Examiner’s License along with a letter on their letterhead designating their Medical Director.

For Nursing Homes or Hospitals

You cannot use the Louisiana Department of Health and Hospitals license to operate that specifies a licensed capacity number. (Generally, a 3-digit license number.)

DEA LICENSE WEBSITE

There is a service that provides a DEA License database online. You can subscribe to this service for a fee. The products advertised on this Web site contain the complete official DEA database of persons and organizations certified to handle controlled substances under the Controlled Substances Act. The DEA authorizes the use of this database, and the inclusion of any individual or organization in the database, as proof of that entity's registration with the DEA. Information on this service can be found at http://www.ntis.gov/products/types/dea/

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 prescription drugs, be sure they are both licensed.

LOCATION CHANGE

If you plan to move to a new location, you must notify this Board in advance. A new location requires a new license and inspection. The license is issued to the location and is non-transferable.

INSPECTIONS

Our inspector(s) do not announce or schedule an inspection in advance. Your facility will be inspected during your normal business hours. During that time, you must have someone available that can produce records and assist in the inspection performed by an inspector of this Board. If the owner/manager is out of the facility, 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 corrected during the inspection will be considered to be in violation.

Disciplinary Actions

Violation Doc. 2002-01 – Administrative Hearing – Licensee found to be in violation of La. R.S. 37:3480 – failure to maintain copies of current licenses for all customers as evidence that they are authorized by law or regulation to procure or possess federal legend drugs – Licensee fined $5,000.00

Violation Doc. 2002-02 – Voluntary Consent Agreement – Licensee found to be in violation of La. R.S. 37:3480 – failure to maintain copies of current licenses for all customers as evidence that they are authorized by law or regulation to procure or possess federal legend drugs – Licensee paid assessed fine $1,000.00

Violation Doc. 2002-03 – Administrative Hearing – Licensee found to be in violation of La. R.S. 37:3480 – failure to maintain copies of current licenses for all customers as evidence that they are authorized by law or regulation to procure or possess federal legend drugs – Licensee fined $5,000.00

Violation Doc. 2002-04 – Administrative Hearing – Licensee found to be in violation of La. R.S. 37:3480 – failure to maintain copies of current licenses for all customers as evidence that they are authorized by law or regulation to procure or possess federal legend drugs – Licensee fined $5,000.00 and placed on a 90 day probation beginning July 16, 2002

Violation Doc. 2002-05 – Administrative Hearing – Licensee found to be in violation of LAC 46:XCI. 309.2 – failure to provide adequate security from unauthorized entry – Licensee fined $5,000.00 and placed on a 90 day probation beginning July 16, 2002

Violation Doc. 2002-06 – Administrative Hearing – Licensee found to be in violation of LAC 46:XCI. 309.3 – failure to maintain proper documentation that validates the temperature storage of federal legend drugs – Licensee fined $5,000.00

Violation Doc. 2003-01 – Administrative Hearing – Licensee found to be in violation of La. R.S. 37:3480 – failure to maintain copies of current licenses for all customers as evidence that they are authorized by law or regulation to procure or possess federal legend drugs – Licensee fined $2,000.00 and assessed $500.00 administrative and investigative costs

Violation Doc. 2003-02 – Administrative Hearing – Licensee found to be in violation of LAC 46:XCI. 311 – failure to provide adequate drug distribution record keeping – Licensee fined $2,000.00 and assessed $500.00 administrative and investigative costs

Violation Doc. 2003-03 – Voluntary Consent Agreement – Licensee found to be in violation of La. R.S. 37:3480 – failure to maintain copies of current licenses for all customers as evidence that they are authorized by law or regulation to procure or possess federal legend drugs – Licensee paid assessed fine $1,000.00

Proposed Rule Changes

The following is the Notice of Intent published in the April 20, 2003 Louisiana Register.

Notice of Intent

Department of Health and Hospitals

Board of Wholesale Drug Distributors

License Procedure

(LAC 46:XCI.103, 301, 309, 311, 313 and 503)

The Louisiana Board of Wholesale Drug Distributors proposes to amend LAC 46:XCI.103, 301, 309, 311, 313 and 503 in accordance with the provisions of the Administrative Procedures Act, R.S. 49:950 et seq, and La. R.S. 37:3467 et seq of the Louisiana Board of Wholesale Drug Distributors revised statutes. These proposed rule amendments will help define the requirements for wholesale distribution and will further assist the Board in its ability to license, inspect wholesale drug distribution facilities in the state of Louisiana, and regulate licensees in the promotion of the public welfare. The proposed rule amendments have no known impact on family formation, stability, and autonomy as described in R.S. 49:972. The proposed amendments to the rule are set forth below.

Title 46

PROFESSIONAL AND OCCUPATION STANDARDS

Part XCI. Wholesale Drug Distributors

Chapter 1. General Provisions

§103. Definition

As used in this regulation, unless the context otherwise requires:

****

Legend Drug -

a. ...

b. The product label of a legend drug is required to contain the statement “Rx Only” or “CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.

c. ...

*****

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:381 (April 1992); amended LR __:____ (____ 20__).

Chapter 3. Wholesale Distributors

§301. Licensing Requirements

A. - B.3. ...

4. All licenses being reinstated must pay a reinstatement fee of $200 plus the renewal fee of $200.

C. ...

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992); amended LR __:____ (____ 20__).

§303. Required Information

A. - C. ...

D. Licenses are not transferable for change of location of the facility licensed or change of ownership. A new license application and required license fee must be submitted for location changes or change of ownership of a currently licensed facility.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992); amended LR __:____ (____ 20__).

§309. Storage and Handling Requirements

The following are required for the storage and handling of prescription drugs, and for the establishment and maintenance of prescription drug distribution records by wholesale drug distributors and their officers, agents, representatives, and employees.

1. - 2.a.iii. ...

b. All facilities, with the exception of those facilities distributing medical gases only, shall be equipped with a monitored alarm system to detect entry after hours.

c. Medical gas distributors shall store medical gases under lock and key if all medical gases are stored inside a Board-approved storage facility that is not equipped with a monitored alarm system to detect entry after hours.

d. Medical gas distributors that store medical gases on an open dock shall be equipped with a monitored alarm system to detect entry after hours.

e. All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion and provide protection against theft or diversion that is facilitated or hidden by tampering with computers and electronic records.

3. ...

a. If no storage requirements are established for a prescription drug, the drug may be held at room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

b. Appropriate manual, electromechanical, or electronic temperature recording equipment, devices, and logs shall be utilized to document proper storage of prescription drugs.

c. - 5.d. ...

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992); amended LR __:____ (____ 20__).

§311. Drug Distribution Recordkeeping

A. 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. - 3. ...

B. Inventories and records shall be made available for inspection and photocopying by any official authorized by the Louisiana Board of Wholesale Drug Distributors for a period of three years following disposition of the drugs.

C. ...

D. Copies of licenses for customers who are authorized by law or regulation to procure or posses federal legend drugs shall be maintained for all customers that are shipped or sold federal legend drugs. If customer licenses are maintained off site, a list of customer names, addresses, license numbers and license expiration dates shall be maintained for all customers that are shipped or sold federal legend drugs.

E. Medical gas distributors are not required to maintain a perpetual inventory on oxygen, but are required to maintain perpetual inventories on all other medical gases.

F. Wholesales domiciled in Louisiana must verify that their suppliers of legend drugs are licensed by the Louisiana Board of Wholesale Drug Distributors to ship or sell in or into Louisiana; and are responsible for notifying the Board of any unlicensed wholesalers.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992); amended LR __:____ (____ 20__).

§313. Policy and Procedures

Wholesale drug distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale drug distributors shall include in their written policies and procedures the following:

1. - 3. ...

4. A procedure to ensure that any outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for three years after disposition of the outdated drugs.

5. A procedure to validate customer licenses, to review excessive or suspicious purchases, to inspect all incoming and outgoing shipments, and to monitor and record the temperature of product storage.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992); amended LR __:____ (____ 20__).

Chapter 5. Powers and Functions of the Board

§503. Board Domicile; Meetings

The Board shall be domiciled in Baton Rouge, Louisiana. The regular meetings of the Board shall be held at least two times a year in accordance with applicable law and at any other time the Board deems necessary, at a time and place designed by the chairman. Special meetings may be called by the Chairman upon giving at least 72 hours notice, sent by registered or certified mail to the post office address of each member of the Board and to any persons who have previously indicated that they have business before the Board.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:382 (April 1992); amended LR __:____ (____ 20__).

Interested parties may submit written comments to John Liggio, Executive Director, Louisiana Board of Wholesale Drug Distributors, 12046 Justice Avenue, Suite C, Baton Rouge, Louisiana 70816. Comments will be accepted through the close of business on May 21, 2003. If it becomes necessary to convene a public hearing to receive comments in accordance with the Administrative Procedures Act, the hearing will be held on May 28, 2003, at 11:00 am at the office of the Louisiana Board of Wholesale Drug Distributors, 12046 Justice Avenue, Suite C, Baton Rouge, Louisiana.

John Liggio

Executive Director

BOARD WEBSITE

D.E.A License

Controlled Drug Substance License

The types of licenses, permits, and certifications that can be used verify an authorized recipient of MEDICAL GASES are as follows:

D.E.A License

Controlled Drug Substance License

You cannot use the Louisiana Department of Health and Hospitals license to operate that specifies a licensed capacity number. (Generally, a 3-digit license number.)

If you plan to move to a new location, you must notify this Board in advance. A new location requires a new license and inspection. The license is issued to the location and is non-transferable.