Application Process Transparency - CDS License - Researchers

Every person who conducts research with, manufactures, distributes, procures, possesses, prescribes, or dispenses any controlled dangerous substance within this state, including third-party logistics providers, or who proposes to engage in the research, manufacture, distribution, procurement, possession, prescribing, or dispensing of any controlled dangerous substance within this state shall obtain a controlled dangerous substance (CDS) license from the board prior to engaging in such activities. Only persons actually engaged in such activities are required to obtain a CDS license; related or affiliated persons, e.g., stockholder in manufacturing corporation, who are not engaged in such activities, are not required to be licensed. The performance of such activities in the absence of a valid CDS license shall be a violation of R.S. 40:973.

 

Application: Application for New Louisiana Controlled Dangerous Substance (CDS) License for Researcher. This application is available in electronic format online through the Online Services Portal.

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Fee: $30.00

Required Attachments (Checklist):

• Social Security Card – A legible copy of the social security card is required.
• Employment Verification – One of the follow verifications of employement is required. 
  • Verification from your employer university of current research and the need for controlled substance authority for the research. This must come from the department chair, be on university letterhead, and include a list of needed schedules.
  • Louisiana Wildlife and Fisheries employees may upload verification from the employer verifying and explaining the need for controlled substance authority. The verification should also include a list of schedules needed.
  • If you are not employed by a either of the above, you may upload verification of employment from the director of your organization. The verification should identify your role within the organization as well as your need for controlled substance authority.
• Research Description - The issuance of a CDS license to a researcher, and the renewal thereof, shall require a description of the research conductedthe following information is required.
  • 1.Researcher
    a) Name, address, and DEA registration number, if any
    b) Institutional ( or company) affiliation
    c) Qualifications, including curriculum vitae with list of publications
  • 2. Research Project
    a) Title of project
    b) Statement of purpose of research
    c) Name of controlled substances (CS) involved, amount (with justification) of each CS needed and source of CS
    d) Detailed description of procedures, including number and species of research subjects
    e) Dosage to be administered, route and method of administration, duration of project
    f) Location where research will be conducted
    g) Statement of security provisions for storing the CS (in accordance with 21 CFR 1301.75) and dispensing the CS in order to prevent diversion
• Research Approval – When human test subjects are used, a copy of Institutional Review Board (IRB) approval for clinical studies which clearly delineates the drugs used is required. When animal research is done, a copy of the Approval from Institutional Animal Care and Use Committee (IACUC) for animal studies is required. 
• Prior Actions - If the applicant provided an affirmative response to any questions regarding prior actions:
• Letter of explanation.
• Certified copies of documents from relevant court or government agency.

Criminal Background Check:  The board will supply the applicant with information necessary to perform a criminal background check (CBC) with the Louisiana State Police (LSP) and the Federal Bureau of Investigation (FBI).  The CBC will be waived for applicants that have previously completed the requirement through this agency or who have a professional healthcare license issued by another Louisiana agency. 

 Criminal history may be used as a basis for denial. All factors outlined in LA:R.S. 37:2950 shall be considered.

 Board Review: A review of prior actions and criminal history is completed when all documents have been received and payment processed.

Inspection: In the event that there are no matters preventing the issuance, the applicant shall be instructed to contact the pharmacist compliance officer for that part of the state to arrange a site inspection at a mutually agreeable time.

Issuance: When the compliance officer has verified compliance with the minimum standards, the license will be issued.

 

You may select Apply to start the application process. 

 

Inquiries regarding the Controlled Dangerous Substance License may be submitted to:

• Ashley Moses, Licensing Analyst - Amoses@pharmacy.la.gov