Current through Register Vol. 48, 12, December 27, 2024
Section 61-106.III.3.6 - Replacement of Ultraviolet Lamps, Bulbs or Filters:3.6.1 The registrant shall only use lamps that have been certified with the Food and Drug Administration (FDA) as "equivalent" lamps under the FDA regulations and policies applicable at the time of the replacement of the lamps. The format for the equivalency document shall be in compliance with 21 CFR 1040.20 and shall be in the form of User Instructions.3.6.2 The registrant shall maintain manufacturer's literature demonstrating the equivalency of any replacement lamps that are not identified as original equipment. The documents for any lamps currently in use shall be kept at the facility and shall be readily available for Department review.3.6.3 Defective lamps or filters shall be replaced before further use of the tanning equipment.3.6.4 Lamps and bulbs designated for "medical use only" shall not be used.S.C. Code Regs. § 61-106.III.3.6