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Current textSource: eCFR

§ 40.93 What validity tests must laboratories conduct on primary oral fluid specimens?

Current wording, effective June 1, 2023.

eCFR (current) ↗
What changedOct. 1, 2005 wording → June 1, 2023 wording (current)+55 added−109 removedHide

(a) As a laboratory, if you mustconduct considervalidity thetesting primaryunder specimen§ to40.92, beyou dilutemust when:
(1)conduct Theit creatininein concentrationaccordance iswith greaterthe thanrequirements orof equalthis to 2 mg/dL but less than 20 mg/dL, andsection.
(2a) TheYou specificmay gravitytest isfor greatera thanbiomarker 1.0010such butas lessalbumin thanor 1.0030immunoglobulin onG a single aliquot.
(bIgG) Asor a laboratory,test youfor musta consider the primary specimen to be substituted when the creatinine concentration is less than 2 mg/dL and the specific gravity is less than or equal to 1adulterant.0010
(b) orYou greatermust thanfollow or equal to 1.0200 on both the initialapplicable andHHS confirmatoryrequirements creatininefor testsany andadditional onvalidity both the initial and confirmatory specific gravity tests on two separate aliquotstesting.
[6988 FR 6486727643, Nov.May 92, 20042023]

49 CFR § 40.93 — What validity tests must laboratories conduct on primary oral fluid specimens?. Text current through October 22, 2026. This wording effective June 1, 2023 to present. Source: eCFR (current), https://www.ecfr.gov/current/title-49/section-40.93. Retrieved from FMCSR.com, https://fmcsr.com/reg/40.93, on October 26, 2026. Unofficial compilation; verify against the official source.

As a laboratory, if you conduct validity testing under § 40.92, you must conduct it in accordance with the requirements of this section.

(a) You may test for a biomarker such as albumin or immunoglobulin G (IgG) or a test for a specific adulterant.

(b) You must follow the applicable HHS requirements for any additional validity testing.

[88 FR 27643, May 2, 2023]

Amendment history

5 distinct wordings on file since Oct. 1, 1996
  1. June 1, 2023 → presenteCFR, day-precisediff vs. previousviewing
    [88 FR 27643, May 2, 2023]
  2. May 2, 2023 → June 1, 2023eCFR, day-precisediff vs. previous
    [69 FR 64867, Nov. 9, 2004]
  3. Oct. 1, 2005 → May 2, 2023annual editions 2005–2016diff vs. previous
    [69 FR 64867, Nov. 9, 2004]
  4. Oct. 1, 2001 → Oct. 1, 2005annual editions 2001–2004diff vs. previous
  5. Oct. 1, 1996 → Oct. 1, 2001annual editions 1996–2000

A new entry appears whenever the regulatory words change between government snapshots. Day-precise from the eCFR (2017 onward); before that, one snapshot per annual CFR edition (revised as of October 1). Bracketed citations are the Federal Register history printed with the section. Set a case date in the header to read any earlier wording.