La. Admin. Code tit. 46 § LIII-1525

Current through Register Vol. 50, No. 9, September 20, 2024

Section LIII-1525 - Hospital Off-Site Satellite Pharmacy

A. Issuance and Maintenance of Permit

1. A hospital pharmacy may establish a hospital off-site satellite pharmacy within a facility bearing the same hospital license number as the facility housing the provider pharmacy.

2. The provider pharmacy, acting through its pharmacist-in-charge, shall make application for the satellite pharmacy permit using a form and process specified by the board.

3. The applicant shall pay the fee for the initial issuance and renewal as specified in R.S. 37:1184.

4. Once issued, the satellite pharmacy permit shall expire at midnight on December 31 of each year, unless suspended or revoked earlier by the board.

5. The satellite pharmacy shall renew its permit using the form and process specified by the board.

6. The operation of a hospital off-site satellite pharmacy without a pharmacy permit, or with an expired permit, shall constitute a violation of R.S. 37:1241(A)12.

7. In the event a provider pharmacy sustains a change of ownership sufficient to require a new pharmacy permit, the hospital off-site satellite pharmacy shall also obtain a new pharmacy permit.

8. In the event a provider pharmacy closes permanently and surrenders its permit, the hospital off-site satellite pharmacy shall also close and surrender its permit.

B. General Requirements

1. The hospital off-site satellite pharmacy shall be of sufficient size and shall contain sufficient fixtures, equipment and supplies commensurate with the scope of practice for that pharmacy, provided:

a. the pharmacy shall be of sufficient size to allow for the safe and proper storage of prescription drugs and/or controlled substances;

b. all areas where drugs and devices are stored shall be dry, well-lighted, well ventilated, and maintained in a clean and orderly condition, and more specifically, storage areas shall be maintained at temperatures which will ensure the integrity of the drugs prior to their dispensing as stipulated by the United States Pharmacopeia (USP) and/or the manufacturer's or distributor's product labeling unless otherwise indicated by the board;

c. the pharmacy shall be secured by either a physical barrier with suitable locks and/or an electronic barrier to detect entry at a time when the pharmacist is not present; and

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

2. The pharmacist-in-charge of the provider pharmacy shall be responsible for all pharmacy operations involving the hospital off-site satellite pharmacy including supervision of pharmacy personnel.

3. The hospital off-site satellite pharmacy shall have at least one licensed pharmacist on duty and physically present in the pharmacy at all times the hospital off-site satellite pharmacy is open for the transaction of business.

4. The hospital off-site satellite hospital pharmacy shall have a sufficient number of pharmacists on duty to operate the pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy.

5. When the hospital off-site satellite pharmacy is closed or there is no pharmacist on duty, other individuals shall not have access to the hospital off-site satellite pharmacy except for temporary absences as provided for in Chapter 11 of this Part.

6. The provider pharmacy and the hospital off-site satellite pharmacy shall have:

a. the same owner; and

b. share a common electronic file or have the appropriate technology to allow access to sufficient information necessary or required to process a prescription or medical order.

7. The hospital off-site satellite pharmacy shall comply with the recordkeeping provisions identified in Chapter 11 of this Part.

8. The compounding of preparations in a hospital off-site satellite pharmacy shall be accomplished in compliance with the current federal standards applicable to such practices, USP, chapter 797, or its successor, for the compounding of sterile preparations, and USP, chapter 795, or its successor, for the compounding of non-sterile preparations.

La. Admin. Code tit. 46, § LIII-1525

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 39:1283 (May 2013), Amended by Department of Health, Board of Pharmacy, LR 46583 (4/1/2020).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.