What is oral fluid validity testing, and are laboratories required to conduct it?

§ 40.92 What is oral fluid validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is the evaluation of the specimen to determine if it is consistent with normal human oral fluid. The purpose of validity testing is to determine whether certain adulterants or foreign substances were added to the oral fluid, if the oral fluid was altered. (b) If a specimen exhibits abnormal characteristics ( e.g., unusual odor or color), causes reactions or responses characteristic of an adulterant during initial or confirmatory drug tests ( e.g., non-recovery of internal standard, unusual response), or contains an unidentified substance that interferes with the confirmatory analysis, then you may conduct validity testing. (c) If you determine that the specimen is invalid and HHS guidelines direct you to contact the MRO, you must contact the MRO and together decide if testing the primary specimen by another HHS-certified laboratory would be useful in being able to report a positive or adulterated test result. [88 FR 27643, May 2, 2023]