LOUISIANA BOARD OF DRUG AND DEVICE DISTRIBUTORS
12091 Bricksome Avenue, Suite B,   Baton Rouge, LA 70816
(225) 295-8567   Fax: (225) 295-8568   admin@Lsbwdd.org - http://www.Lsbwdd.org

APPLICATION for LICENSURE
DISTRIBUTOR of LEGEND DRUGS or DEVICES

NOTES:
New licenses issued by the board shall expire on December 31 of the calendar year issued.

Type of Application - Check All Appropriate Boxes:    
INITIAL LICENSE    
Location Change Effective Date: Current License Number:
Change of Ownership Effective Date: Current License Number:
    Attach a copy of the final transaction documents for the sell, merger, acquisition, trade, transfer, etc. which effected the change in ownership.
License Sub-Types (see bottom of page for descriptions) - Check All Appropriate Boxes
 Standard Distributor    
 Wholesale Distributor    
 Third Party Logistic Provider (3PLP) Distributor    
Fee-schedule - Check the appropriate box as determined by the # of license sub-types checked in the above section; pay amount noted for the selection:
 One License Sub-Type checked above - Fee:                                                                            $400
 Two License Sub-Types checked above - Fee:                                                                          $425
 Three License Sub-Types checked above - Fee:                                                                       $450
In-State Facilities Only: Facility Inspection for initial and location change - Fee:                      $100


Applicant Company Name:
    d/b/a or trade name (if applicable):

Primary Distribution Location from which product is shipped:
    Distribution Center Address:
    Distribution City, State, Zip Code: , ,
    If 3PL used, c/o (Name of 3PL service provider):
     Check here if additional 3PLs are also used for distribution, Upload list of additional 3PLs with distribution addresses.

Type of Business Conducted: (Mark all that apply):  Sales      Facilities Delivery (physically distributes)    
Sub-categories (Mark all that apply): (Does not apply if "Standard Distributor" license sub-type is not marked above.)
 Manufacturer/ Virtual      Re-Packager                           Broker/Agent    
 Freight Forwarder               Jobber/Private Labeler           Nuclear Pharmacy    
 Ship Chandlers                   Reverse Distributors               Retail Pharmacy Warehouse
 Pharmacy                            Compounder/503b
Standard Distributor:
        Not Applicable    
Type of Business:    
Type of Ownership:    

Owners:
    INDIVIDUAL(S) - List the name and the percent of ownership held for each individual person possessing greater than 10% interest in the applicant.
    CORPORATELY OWNED - List the name(s) of parent company(s).
    PUBLICLY TRADED - Provide the trading symbol.
    PRIVATELY HELD - List the name(s) of financial, investment, trust, etc entity(s).

Provide appropriate owner(s) information that applies:
FACILITIES LOCATED IN LOUISIANA ONLY:
  Submit via UPS/carrier to Board office, completed CRIMINAL HISTORY RECORDS CHECK authorization form, State Police criminal history records processing forms (forms available on Board's website), provide fingerprints as obtained from local law enforcement, and fees payment (payable to LA Dept of Public Works) for each individual owner possessing greater than 10% interest in the applicant company is enclosed with this application.
State of Incorporation (or Formation):
 Legend drugs or devices are sold and/or shipped directly to dispensing/administering parties
            (i.e. - pharmacies, hospitals, physician offices, maritime ships, etc.)
 Legend drugs or devices are sold and/or shipped to distributors
Manner of Distribution:
(mark all items that apply.)
 Legend Drugs      Legend Drugs (CS)1      Legend Devices      Medical Gases    
1 DEA and Louisiana state registration is required to distribute controlled substances in/into the state.
Changes in types of product being distributed must be reported to the Board office via letter, fax, or email.
Type of Product Distributed:
(mark all that apply)

OUT-OF-STATE FACILITIES ONLY:                                    NA- Applicant Facility Located in Louisiana
Current home state distributor (or manufacturer if applicable) license as issues by the state in which the applicant facility is located; attach copy of license.
License Number: Expiration Date:
 Check here if the state in which the applicant is located does not require distributor (or manufacturer, if applicable) licensing AND a 3PL is used for the distribution; must submit a copy of correspondence from the licensing agency of the state in which the applicant is located indicating that no license is required along with a copy of the 3PL license from the state in which the 3PL is located.
 Check here if the applicant is a legend device only distributor whose licensing agency of the state in which it is located does not require licensing; must submit a copy of correspondence from the licensing agency of the state in which the applicant is located indicating that no license in required. If the applicant is a manufacturer, submit a copy of an FDA establishment registration.

Federal DEA Number:                                                               Not Applicable
Louisiana State Controlled Substance Number:                     Not Applicable
    (as issued by the Louisiana Board of Pharmacy, CDS Program, if applicable)

Company/Corporate Officers and Board of Directors:
    Officers & Directors- List the name(s) and title(s) of the officers and directors.

List every state or territory, other than Louisiana, where the applicant holds a current license as a drug or device distributor. (Leave blank if only licensed in Louisiana)
Not licensed in any other states

Facility Contact Person:
Email Address:
Telephone Number: Fax Number:
Regulatory Contact is the same as Facility Contact Person
Regulatory Contact Person:
Email Address:
Telephone Number: Fax Number:

Designated Responsible Party:
Email Address:
Telephone Number: Fax Number:
Completed DRP QUALIFICATION REVIEW FORM for the individual noted in this section:  

     Same as Distribution Address
Mailing Address for license/regulatory:
Mailing City, State, Zip: , ,
     Same as Distribution Address     OR     Same as Mailing Address
Business Location Address:
Business City, State, Zip: , ,
Provide the License Number for this address if this address is different from the Primary Distribution Address above AND legend drugs/devices are physically distributed from this location as well.
LA License #: NOTE: ALL LOCATIONS THAT PHYSICALLY DISTRIBUTE PRODUCT MUST BE SEPARATELY LICENSED.

Disciplinary Actions: (For applying facility location)
Has the applicant ever been denied a license, certificate, registration, or permit for distribution of legend drugs (including controlled substances) or devices?
Has any license, certificate, registration, or permit for distribution of legend drugs (including controlled substances) or devices ever held by you or the applicant been sanctioned, fined, revoked, suspended, placed on probation and/or otherwise been the subject of disciplinary review or investigation in another state?
Is there any investigative or disciplinary action pending against any license, certificate, registration, or permit for distribution of legend drugs (including controlled substances) or devices held by the applicant in another state?
Has any owner, officer, director, designated responsible party, or other person in charge of drug distribution for the applicants ever been convicted of or plead guilty to or please nolo contendere to a felony or misdemeanor, other than a traffic violation, under any federal, state, or local laws, rules or ordinances?
 If the answer to any of the above questions is "Yes" please attach an explanation and any pertinent documentation related to the matter.  
 

Application Certification:     I hereby certify, (1) I, the undersigned, am a representative of the applicant authorized to execute on their behalf such documents as this; (2) by my name entered below, the applicant (a) will operate the facility in a manner prescribed by federal, state, and local laws and all rules promulgated by the Board, (b) assumes all responsibility for acts and/or omissions committed by any personnel employed by it, and (c) make certain personnel employed by the applicant have the appropriate education, training, and experience to assume responsibility for handling, distribution, and storage of legend drugs or devices; and (3) to the best of my knowledge and belief, the information provided in this application is true and correct in all respects. Authorization is hereby given to the Louisiana Board of Drug and Device Distributors or their agent to investigate the information contained in this application. It is understood that information provided in this application may be provided to other federal, state, or local government or enforcement agencies.

Name of Authorized Applicant Representative RESPONSIBLE for and SUBMITTING this application:  
Title of Authorized Representative:    
Date:    


Please PRINT a copy of this form for your files; THEN pay and submit.
     

DISTRIBUTORS OF LEGEND DRUGS OR DEVICES
Sub-Types:

STANDARD DISTRIBUTOR
Description: Any person (entity) that sales or facilitates the delivery of legend drugs or legend devices to persons other than the consumer or patient; including, but not limited to, manufacturers, repackagers, own-label distributors, jobbers, retail pharmacy warehouses, pharmacies, brokers, agents, freight forwarders, ship chandlers, reverse distributors, compounders/503b, and nuclear pharmacies.

WHOLESALE DISTRIBUTOR
Description: Any person (entity) that sales or facilitates the delivery of drug product to persons other than the consumer or patient excluding, but not limited to. manufacturers. repackagers, third-party logistic providers, distributors of devices, medical gases, intravenous drugs for replenishment or irrigation, blood or blood ocmponents, radioactive drugs or biologicals, imaging drugs, homeopathic drugs, and compounded drugs.

THIRD-PARTY LOGISTICS PROVIDER
Description: Any person (entity) that provides or coordinates warehousing, facilitates the delivery of, or other logistic services for a legend drug or legend device interstate and intrastate commerce on behalf of a manufacturer, distributor, or dispenser of a legend drug or legend device but does not take ownership of the legend drug or legend device nor have responsibility to direct the sale or disposition of the legend drug or legend device.