La. Admin. Code tit. 46 § LIII-2447

Current through Register Vol. 50, No. 3, March 20, 2024

Section LIII-2447 - Licensing Procedures

A. Application for Initial Issuance of Permit

1. The board shall develop an application form suitable for the marijuana pharmacy permit. The board may revise that application form on its own initiative in order to collect the information it deems necessary to properly evaluate an applicant.

2. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fee.

3. The applicant shall fully disclose the ownership of the entity that will own the permit as well as any additional holding companies that may exist, such that any natural person with any ownership interest shall be fully identified.

4. In the event any person holding any ownership interest in the entity submitting an application for a marijuana pharmacy permit has engaged in any of the following activities, the entity shall be disqualified and the board shall not issue a marijuana pharmacy permit to that applicant:

a. within the two-year period preceding the date of the application, the person or any member of the persons immediate family served as a member of the board or its staff.

5. The applicant shall provide a complete street address reflecting the location at which the applicant proposes to operate the marijuana pharmacy.

6. The applicant shall provide the following information and records in the application process:

a. a detailed description of any other services or products to be offered by the marijuana pharmacy;

b. details regarding the applicants plans to maintain adequate control against the diversion, theft, or loss of marijuana;

c. documents or information sufficient to establish the applicant is authorized to conduct business in Louisiana and that all applicable state and local building, fire and zoning requirements, and local ordinances will be met;

d. text and graphic materials showing the exterior appearance of the proposed marijuana pharmacy and its site compatibility with commercial or residential structures already constructed or under construction within the immediate neighborhood;

e. - e.xi. Repealed.

f. such other documents and information reasonably required by the board to determine the applicants suitability for permitting or to protect the publics health and safety.

7. The owners managing officer and the pharmacist-in-charge shall be fully identified within the application and they both shall sign and date the application form.

8. The applicant shall direct the following persons to submit to the criminal history record check process used by the board, at the applicants expense:

a. the owners managing officer;

b. the pharmacist-in-charge; and

c. any person holding any share of ownership in the entity; provided however that any person not holding any share of ownership but holding a corporate officer position in the entity may be required to submit to the criminal history record check.

9. The requirement for a criminal history record check may be waived by the board in the event the person has already completed that process for the board within the two-year period prior to the date of the application.

10. - 10.c. Repealed.

11. In the event any information contained in the application or accompanying documents changes after being submitted to the board, the applicant shall immediately notify the board in writing and provide corrected information in a timely manner so as not to disrupt the application processing or permit selection process.

12. - 12.e. Repealed.

13. The application shall be accompanied by payment of the permit fees and administrative hearing fee authorized by LAC 46:LIII.115 and R.S. 40:1013.

14. When the staff has determined an entitys application package is complete, the application shall be referred to the boards application review committee, and further, the applicant shall be properly notified at least 30 days prior to the committees hearing during which their application will be considered.

15. During the hearing held by the boards application review committee, the members shall consider, but are not limited to, the following criteria when evaluating an application for a marijuana pharmacy permit:

a. the character and fitness of the owners managing officer, the pharmacist-in-charge, any of the owners and any other person who may have control or influence over the operation of the proposed marijuana pharmacy;

b. the location for the proposed marijuana pharmacy including, but not limited to:

i. its proximity to previously approved marijuana pharmacies or locations of proposed marijuana pharmacies with pending applications;

ii. whether the patient population in the area proposed by the marijuana pharmacy permit applicant justifies the need for a marijuana pharmacy, or an additional marijuana pharmacy, in that area;

iii. whether the proximity of the proposed marijuana pharmacy will have a detrimental effect upon any place used primarily for religious worship, public or private school, convent, charitable institution, whether supported by private or public funds, hospital or veterans' home or any camp or military establishment; or

iv. whether the number of marijuana pharmacies in the locality is such that the granting of a permit is detrimental to the public interest. In reaching a conclusion in this respect, the board may consider the population of, the number of like permits and number of all permits existent in, the particular municipality and the immediate neighborhood concerned, the effect that a new permit may have on such town or neighborhood or on like permits existent in such municipality or neighborhood;

c. the applicants ability to maintain adequate control against the diversion, theft and loss of marijuana;

d. the applicants ability to maintain the knowledge, understanding, judgment, procedures, security controls and ethics to ensure optimal safety and accuracy in the dispensing and sale of marijuana; and

e. the extent to which the applicant or any of the applicants owners have a financial interest in any other permittee, licensee, registrant, or other applicant currently or previously credentialed by the board; and

f. Any other reason provided by any federal law or rule or state law or rule that is not inconsistent with R.S. 40:1046 or 40:1047 or this Subchapter.

16. Following their evaluation of the applications for a marijuana pharmacy permit, the committee shall develop a recommendation for presentation to the board at the boards next meeting. The board may accept the committees recommendation, select an alternative applicant, reject all of the applicants, or return all the applicants to the committee for their reconsideration.

17. The board may disqualify any applicant who:

a. submits an incomplete, false, inaccurate, or misleading application;

b. fails to submit an application by the published deadline; or

c. fails to pay all applicable fees.

18. The decision of the board to award or not to award a marijuana pharmacy permit to an applicant shall be final.

19. Upon the approval of an application, the board shall award the marijuana pharmacy permit and state controlled dangerous substance license to the applicant. Upon completion of a satisfactory inspection of the pharmacy premises, the board shall issue the marijuana pharmacy permit and state controlled dangerous substance license to the applicant awarded the permit.

20. If an applicant has been awarded a marijuana pharmacy permit and has not commenced operation of such pharmacy within 310 days of being notified of the marijuana pharmacy permit award, the board may, in the boards discretion, rescind such marijuana pharmacy permit, unless such delay was caused by force majeure. A marijuana pharmacy shall be deemed to have commenced operation if the pharmacy is capable of operating in accordance with the applicants approved application. In the event a marijuana pharmacy permit is rescinded pursuant to this Subsection, the board shall award a marijuana pharmacy permit by selecting among the qualified applicants who applied for the marijuana pharmacy permit that was rescinded. If no other qualified applicant applied for such marijuana pharmacy permit or satisfied the criteria for awarding a permit, the board shall publish, in accordance with this Section, a notice of open applications for marijuana pharmacy permits.

B. Application for Renewal of Permit

1. All marijuana pharmacy permits expire at midnight on December 31 of every year, regardless of the date of its initial issuance.

2. The owner's managing officer and pharmacist-in-charge of the marijuana pharmacy permit shall complete, sign and date a permit renewal application form supplied by the board, and further, shall include all information requested on the form and attach the pharmacy permit renewal fee and state controlled dangerous substance license renewal fee authorized in LAC 46:LIII.115 and the prescription monitoring program fee authorized in R.S. 40:1013, and further, shall submit the renewal application package to the board office prior to the expiration date of the pharmacy permit.

3. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fees.

4. In the event the pharmacy does not submit a properly completed renewal application form and fee to the board prior to the expiration of the permit, the permit shall be rendered null and void. A marijuana pharmacy shall not operate with an expired permit. Evidence it has done so will provide sufficient basis for the board to discipline the permit for violation of R.S. 37:1241(12).

5. An application for the late renewal of an expired (lapsed) marijuana pharmacy permit that is received in the board office no later than 30 days after the expiration date of the permit may be processed by the board staff, provided the appropriate delinquent fee authorized in LAC 46:LIII.115 is included with the application.

6. A marijuana pharmacy permit not renewed by 30 days after the expiration date shall be automatically terminated by the board.

7. An application for the reinstatement of a terminated marijuana pharmacy permit shall be referred to the boards reinstatement committee for its consideration.

C. Application for Reinstatement of Terminated, Suspended, or Revoked Marijuana Pharmacy Permits

1. The applicant shall complete an application form for this specific purpose supplied by the board; the application shall require the inclusion of the annual renewal fee, the delinquent fee, the administrative hearing fee, and the reinstatement fees authorized in LAC 46:LIII.115 and the program fee authorized in R.S. 40:1013.

2. An application for the reinstatement of a marijuana pharmacy permit previously terminated, suspended or revoked by the board may only be approved following a preliminary hearing to determine whether the reinstatement of the permit is in the publics best interest.

D. Maintenance of Marijuana Pharmacy Permit

1. A marijuana pharmacy permit is valid only for the entity or person to whom it is issued and shall not be subject to sale, assignment or other transfer, voluntary or involuntary, nor shall the permit be valid for any premises other than the business location recorded thereon.

2. Repealed.

3. Prior to making any change in the marijuana pharmacy's name or trade name, the owner of the permit shall notify the board and request approval of the contemplated name or trade name. The board shall reasonably accommodate such requests, unless there is cause not to do so (e.g., duplicative or misleading names). The marijuana pharmacy shall not change its name or trade name until approved by the board.

4. Prior to any modification, remodeling, expansion, reduction, or other physical, non-cosmetic alteration of the marijuana pharmacy, the owner of the permit shall notify the board and request approval of the contemplated change(s). The board shall reasonably accommodate such request, unless there is cause not to do so (e.g., inconsistent with operating requirements). The marijuana pharmacy shall not make such changes until approved by the board.

5. Prior to any change in the location of a marijuana pharmacy, the owner of the permit shall submit an application form for that purpose supplied by the board and pay the appropriate fee authorized in LAC 46:LIII.115. The board may require an inspection of the new location prior to the issuance of the permit for the new location. No marijuana pharmacy shall commence operation in a new location until approved by the board.

6. The owner of the pharmacy permit shall notify the board no later than 30 days following a change in the pharmacist-in-charge for the marijuana pharmacy permit.

7. The owner of the pharmacy permit shall notify the board no later than 30 days following a change in the owner's managing officer for the marijuana pharmacy permit.

8. In the event a marijuana pharmacy contemplates permanent closure, the pharmacist-in-charge shall notify the board in accordance with the rules governing the permanent closure of a pharmacy as described in Chapter 11 of this Part.

La. Admin. Code tit. 46, § LIII-2447

Promulgated by the Department of Health, Board of Pharmacy, LR 431544 (8/1/2017), Amended LR 46577 (4/1/2020), Amended LR 482102 (8/1/2022), Amended LR 491720 (10/1/2023).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1046.