La. Admin. Code tit. 46 § LIII-2457

Current through Register Vol. 50, No. 11, November 20, 2024

Section LIII-2457 - Standards of Practice

A. Environmental Standards

1. The prescription department shall be of sufficient size commensurate with the nature and scope of practice. The space occupied by the prescription department shall be restricted to authorized personnel only, as determined by the pharmacist-in-charge, and shall not be accessible to the general public. A marijuana pharmacy shall not permit any person less than eighteen years of age to enter the prescription department, with the exception of patients being counseled by the pharmacist.

2. The prescription department shall contain sufficient fixtures, equipment, and supplies commensurate with the nature and scope of practice for that pharmacy.

3. The prescription department shall include a sink with a hot and cold water supply, exclusive of restroom facilities, with approved sewage disposal.

4. All areas where drugs and devices are stored shall be dry, well-lighted, well-ventilated, and maintained at temperatures which will ensure the integrity of drugs during their storage and prior to their dispensing as stipulated by the United States Pharmacopeia and/or manufacturers or distributors product labeling unless otherwise indicated by the board.

5. The prescription department shall be secured by one or more physical barriers with suitable locks and a monitored alarm system capable of detecting unauthorized entry.

6. Prescription and other patient healthcare information shall be maintained in a manner that protects the integrity and confidentiality of such information.

B. Minimum Staffing Requirements

1. There shall be at least one pharmacist on duty at all times the pharmacy is open for business.

2. Every pharmacist practicing in the pharmacy shall possess a Louisiana pharmacist license in active status as well as access privileges to the state prescription monitoring program.

3. A pharmacy intern, pharmacy technician or pharmacy technician candidate may assist the pharmacist in the prescription department, but only when in possession of valid credentials issued by the board. The supervising pharmacist may establish a delegate credential in the state prescription monitoring program for any licensed pharmacy personnel affiliated with that pharmacy.

4. Additional clerical personnel may also be present at the pharmacy.

5. No person shall be employed by, or affiliated with, a marijuana pharmacy prior to their eighteenth birthday.

C. Operational Standards

1. The marijuana pharmacy shall comply with the provisions of Chapters 11, 25, 27, 29, and 31 of this Part except when this Subchapter grants exceptions or imposes more stringent requirements.

2. In the event the marijuana pharmacy intends to close permanently, the pharmacist-in-charge (PIC) shall comply with the pharmacy closure procedures described in Chapter 11 of this Part, and further, the owner of the pharmacy permit shall not prevent or interfere with the PICs performance of those tasks.

a. In addition to the other closure requirements, the closing pharmacy shall include in its notice to the board and to the public the identification of the destination pharmacy where the closing pharmacys prescription records will be transferred. That destination pharmacy shall be the marijuana pharmacy nearest the closing pharmacy, unless otherwise approved by the board.

D. Recordkeeping Requirements

1. When the pharmacy receives a request for marijuana from a recommending authorized clinician in written form, the pharmacist shall cause the form to be scanned and filed using an electronic imaging system in compliance with §1123 of this Part.

2. Request forms (and electronic images thereof) shall be retained on the pharmacys premises for at least two years after the date of dispensing, and further, shall be readily retrievable upon request by the board.

3. Inventory of Marijuana Product

a. The pharmacist-in-charge shall develop and maintain a perpetual inventory of all marijuana products acquired, held, dispensed, and disposed by the pharmacy.

b. The pharmacy shall access the LMMTS and enter all acquisitions and product transfer transactions in that system.

c. In the event the pharmacist-in-charge designates an agent to retrieve new marijuana product inventory from the production facility, the pharmacist shall verify the agent is at least 21 years of age and is eligible to drive on public roadways.

d. The pharmacist-in-charge shall conduct an annual inventory of all marijuana products in the possession of the pharmacy on any date which is within one year of the previous annual inventory, and further, shall conduct additional inventory counts on the following occasions:

i. arrival of a new pharmacist-in-charge;

ii. discovery of any significant loss, disappearance, or theft of marijuana product;

iii. departure of a pharmacist-in-charge; and

iv. permanent closure of the pharmacy.

e. Inventory records shall be retained on the pharmacys premises for at least two years after the most recent entry.

4. The pharmacy shall develop and maintain sufficient records to fully reveal the business transactions related to marijuana products, including their procurement and sale, for the current tax year as well as the two immediately preceding tax years, all of which shall be made available to the board upon request.

5. The board may require any pharmacy or its owners to furnish such information as the board considers necessary for the proper administration of R.S. 40:1046, and may require a financial audit of the business of any marijuana pharmacy, and the expense thereof shall be paid by the marijuana pharmacy.

E. Professional Practice Standards

1. Recommendation/Opinion (hereinafter, "request") for Therapeutic Marijuana

a. The pharmacist may accept any request for a marijuana product which has been:

i. issued by an authorized clinician in possession of a current and unrestricted license to practice in this state as well as a current and unrestricted state controlled substance license with therapeutic marijuana privileges from the board; and

ii. received directly from the authorized clinician and not from the patient or any third party other than the entity transmitting the request, either by electronic means conforming with the provisions of 21 CFR 1311 or its successor, or in the alternative, by facsimile bearing a handwritten or digital signature of the authorized clinician.

b. The request shall disclose the following information at a minimum:

i. name, address, telephone number, and national provider identifier (NPI) number of the authorized clinician issuing the request;

ii. name, address, and date of birth (or age) of the patient for whom the request was issued;

iii. identification of the debilitating medical condition for which the treatment has been requested;

iv. type of marijuana product requested;

v. date request was issued;

vi. self-certification the authorized clinician holds a current and unrestricted license to practice in this state; and vii. signature of the authorized clinician issuing the recommendation, excluding any proxy or agent.

c. Requests for marijuana products shall expire one year after the date of issue, unless a shorter period of time is indicated by the authorized clinician. A pharmacist shall not dispense marijuana product pursuant to an expired request.

d. Requests for raw or crude marijuana products intended for persons under 21 years of age shall specifically indicate a recommendation for raw or crude forms of marijuana for such persons.

e. A marijuana pharmacy shall transfer an unexpired request for marijuana product to another marijuana pharmacy when requested by the patient or his caregiver.

2. Upon request by the patient or caregiver and prior to dispensing any marijuana product to a patient, the pharmacist shall provide product testing results available to the pharmacist for the product contemplated for dispensing.

3. Dispensing Marijuana Products

a. Prior to dispensing any marijuana product to a patient, the pharmacist shall review the patient's records in the state prescription monitoring program. The pharmacist shall resolve any concerns identified in that review by consultation with the recommending authorized clinician.

b. Dispensing Limitations

i. A pharmacist shall not dispense more than two and one-half ounces, or 71 grams, of raw or crude marijuana every 14 days to any person.

ii. Subject to the above limitation on dispensing raw or crude marijuana products, a pharmacist may dispense marijuana products on multiple occasions as indicated by the authorized clinician and needed by the patient until the request expires; however, the pharmacist shall not dispense more than a 90-day supply of marijuana product at one time nor more than a one-year supply pursuant to a single request.

c. Dispensing Marijuana Products to Visiting Qualifying Patients.

i. A visiting qualifying patient may obtain medical marijuana from a marijuana pharmacy, subject to the dispensing limitations of Subparagraph 3.b of this Subsection, upon producing evidence of his valid medical marijuana registry identification card, or its equivalent, which has been issued under the medical marijuana laws of another state, district, territory, commonwealth, or insular possession of the United States and in compliance with R.S. 40:1046.1.

ii. A pharmacist may dispense medical marijuana to a visiting qualifying patient, subject to the dispensing limitations of Subparagraph 3.b of this Subsection, upon obtaining evidence of his valid medical marijuana registry identification card, or its equivalent, which has been issued under the medical marijuana laws of another state, district, territory, commonwealth, or insular possession of the United States and in compliance with R.S. 40:1046.1.

4. Labeling of Marijuana Product Dispensed

a. The pharmacist shall not dispense any marijuana product that does not bear the producer label required by LDH, and further, the pharmacy dispensing label shall not overlay or obscure the producer label in any way.

b. The pharmacy's dispensing label shall contain, at a minimum, the following data elements:

i. name and address of the pharmacy dispensing the product;

ii. telephone number or other contact information of the pharmacy dispensing the product;

iii. name of the recommending authorized clinician;

iv. name of the patient;

v. date the product was dispensed;

vi. prescription number, which shall be a unique identifier for that specific transaction;

vii. name of the marijuana product, including any concentration, strength, or other identifiers of the marijuana product;

viii. quantity of marijuana dispensed;

ix. directions for use of the product;

x. expiration date of the product, which shall not exceed the expiration date determined by the producer of the product; and

xi. other information selected by the dispensing pharmacist to inform the patient as to the best use of the product for the intended purpose.

5. The pharmacist shall comply with the rules on drug utilization review and patient counseling in Chapter 5 of this Part.

6. Reporting transactions to state prescription monitoring program. The pharmacy shall comply with the reporting requirements as found in Chapter 29 of this Part.

7. Disposal of Marijuana Product

a. A pharmacy may refuse to accept the delivery of marijuana product from a producer when it is determined to be misbranded, adulterated, expired, deteriorated, undesired, excess, unauthorized, or unfit for dispensing.

b. When the pharmacist determines a marijuana product is no longer suitable for dispensing, the product shall be removed from active dispensing stock and quarantined in the pharmacy pending its disposal

c. The pharmacist-in-charge shall render the waste unusable by grinding and incorporating the waste with other ground materials so the resulting mixture is at least 50 percent non-marijuana waste by volume. Material used to grind with the waste may include:

i. yard waste;

ii. paper waste;

iii. cardboard waste;

iv. plastic waste; or

v. soil or sand.

d. Waste shall be rendered unusable prior to leaving the pharmacy. Waste rendered unusable shall be disposed of by delivery to an approved solid waste facility for final disposition.

i. Examples of acceptable permitted solid waste facilities include:

(a). compost; anaerobic digester;

(b). landfill, incinerator; or

(c). waste-to-energy facility.

e. The pharmacist-in-charge shall prepare a record of each disposal, and that record shall contain, at a minimum, the following information:

i. brand name and other specific identifiers of the marijuana product disposed;

ii. quantity of product disposed;

iii. manner of disposal; and

iv. signatures of the pharmacist-in-charge disposing the product plus at least one witness who is either a credentialed staff member of that pharmacy or an agent of the board.

La. Admin. Code tit. 46, § LIII-2457

Promulgated by the Department of Health, Board of Pharmacy, LR 431550 (8/1/2017), Amended LR 451473 (10/1/2019), Amended LR 47246 (2/1/2021), Amended by LR 471111 (8/1/2021), Amended LR 481903 (7/1/2022), Amended LR 482103 (8/1/2022), Amended LR 491721 (10/1/2023).

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