La. Admin. Code tit. 46 § LIII-1203

Current through Register Vol. 50, No. 8, August 20, 2024

Section LIII-1203 - Automated Medication System Registration

A. Requirement for Registration

1. A pharmacy intending to supply medications for use within an automated medication system, as defined at R.S. 37:1164, shall obtain an automated medication system (AMS) registration prior to engaging in such activity.

2. The placement of medications within an automated medication system in the absence of an AMS registration shall substantiate a violation of R.S. 37:1241(A)(12) and shall subject the pharmacy to disciplinary action by the board.

3. A pharmacy intending to supply controlled substances for use within an automated medication system shall obtain a controlled dangerous substance (CDS) license in addition to the AMS registration. The pharmacy shall also obtain a federal registration from the U.S. Drug Enforcement Administration (DEA) prior to placing controlled substances within the automated medication system.

4. The placement of controlled substances within an automated medication system in the absence of an AMS registration, CDS license, and DEA registration shall substantiate a violation of R.S. 37:1241(A)(12) and R.S. 40:973 and shall subject the pharmacy to disciplinary action by the board.

5. The operation of a remote dispensing system without an AMS registration shall substantiate a violation of R.S. 37:1241(A)(12) and shall subject the pharmacy to disciplinary action by the board.

B. Eligibility for Registration; Exemption

1. A pharmacy intending to supply medications for use within an automated medication system may do so when the AMS is placed at any of the following locations:

a. within a facility in possession of a controlled dangerous substance license issued by the board;

b. within a hospital or other institutional facility in possession of an operating license issued by the state department of health;

c. within a detention or correctional facility operated by or under contract with the state department of public safety and corrections or other local governmental entity.

2. A pharmacy may operate a remote dispensing system when the system is placed within a healthcare setting where the pharmacist-in-charge can ensure the security and environmental integrity of the medications and devices placed within the system as well as the security and confidentiality of the protected health information used therein.

3. A pharmacy intending to supply medications for use within an AMS which is placed within the building housing that pharmacy shall not be required to obtain an AMS registration; however, the pharmacist-in-charge of the pharmacy shall be responsible for compliance with the operational standards in this Chapter.

C. Application for Initial Issuance of Registration

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

2. The application shall be accompanied by payment of the registration fee authorized by R.S. 37:1184.

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

4. The submission of a false or fraudulent application shall substantiate a violation of R.S. 37:1241(A)(2) and shall subject the applicant to disciplinary action by the board.

5. When determined appropriate by the board, the applicant may be required to meet with a committee or agent of the board prior to the issuance of the registration.

D. Maintenance of Registration

1. A registration shall be valid only for the pharmacy to which it was issued and the physical location of the AMS identified on the application. The registration shall not be subject to sale, assignment or other transfer, voluntary or involuntary, nor shall the registration be valid for any premises other than the physical location for which it was issued.

2. A duplicate or replacement registration shall be issued upon the written request of the owner of the registration and payment of the fee authorized by R.S. 37:1184. A duplicate or replacement registration shall be marked as such, and it shall not serve or be used as an additional or second registration.

3. In the event a pharmacy intends to relocate an automated medication system to a different address, the pharmacy shall notify the board of its intent to do so, providing both current and new addresses. A change in business address may require an inspection by the board or its designee.

E. Application for Renewal of Registration

1. The pharmacy shall complete an application for the renewal of the registration and submit it to the board prior to the expiration date of the registration. The application shall be accompanied by the fee authorized by R.S. 37:1184.

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

3. An AMS registration not renewed by the expiration date shall be classified as expired. The operation of an automated medication system with an expired registration shall substantiate a violation of R.S. 37:1241(A)(12) and shall subject the pharmacy to disciplinary action by the board.

F. Relinquishment of Registration

1. In the event a pharmacy intends to cease supplying medications or devices to an automated medication system, it shall relinquish the registration to the board no later than 10 days following the effective date of such decision.

2. A pharmacy may not transfer a registration to another pharmacy.

G. Application for Reinstatement of Suspended or Revoked Registration

1. An application for the reinstatement of an AMS registration previously suspended or revoked by the board may only be approved in compliance with R.S. 37:1249.

2. The applicant shall complete an application form for this specific purpose supplied by the board and shall attach any documentation requested by the board and fees identified in R.S. 37:1184.

La. Admin. Code tit. 46, § LIII-1203

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 26:1271 (June 2000), effective July 1, 2000, amended LR 38:1235 (May 2012), Amended by the Department of Health, Board of Pharmacy, LR 47241 (2/1/2021).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1184.A.