La. Admin. Code tit. 46 § LIII-1905

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

Section LIII-1905 - Nuclear Pharmacy Permit Requirements

A. A nuclear pharmacy permit shall be required to operate a nuclear pharmacy department. The permit shall be applied for, and renewed, in the manner prescribed by the board in Chapter 11 of these regulations.

1. A nuclear pharmacy shall have a Louisiana Radioactive Material License.

2. Nuclear Pharmacist-in-Charge. A pharmacist-in-charge of a nuclear pharmacy operation shall be a qualified nuclear pharmacist, as defined in §1907, and shall be responsible for the entire nuclear pharmacy operation.

3. Structural Requirements. A nuclear pharmacy shall provide adequate space separate and apart from other areas commensurate with the scope of service and with the following space requirements.

a. Dispensing Area. The radiopharmaceutical compounding or preparation area shall be separate and apart from other facility areas and shall be not less than 300 square feet, which may include storage and decay areas. The pharmacy area shall be sufficient to provide a work environment for the safe handling, compounding, and dispensing of radiopharmaceuticals. This area shall be separate and inaccessible to non-pharmacy personnel.

b. Delivery and Receipt Area. An area designated for the delivery and receipt of materials requiring after-hours handling by non-pharmacy personnel. This area shall be separate from the dispensing area of the pharmacy.

c. Storage Area. A storage area sufficient to maintain the scope and content of unused and returned material for decay and disposal commensurate with the compounding and dispensing requirements of the facility.

d. Maintenance. A nuclear pharmacy shall be well maintained, clean, orderly, lighted, and properly ventilated.

e. Plumbing. A sink equipped with hot and cold running water shall be located within the nuclear pharmacy. A sink located in a pharmacy lavatory or restroom shall not be sufficient to satisfy this requirement.

4. Equipment. There shall be adequate equipment commensurate with the scope of services required and provided by the facility.

5. Supplies. There shall be adequate supplies commensurate with the compounding and dispensing needs of the facility, as well as any other services provided for by the facility, including appropriate shielding and safety devices and any other supplies necessary for the safe and legal transport of materials compounded or dispensed from the facility. There shall be appropriate supplies for the safe handling and disposal of used and unused material by employees and staff of the facility. The appropriateness of personal protective equipment shall be reviewed on an annual basis.

La. Admin. Code tit. 46, § LIII-1905

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2097 (October 2003), effective January 1, 2004.

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