§ 40.87 What validity tests must laboratories conduct on primary urine specimens?
Current wording, effective June 1, 2023.
LinkAs toa anlaboratory, amendmentwhen publishedyou atconduct 82validity FRtesting 52244,under Nov.§ 13, 201740.86, you must
(a) As a laboratoryuseconduct theit cutoffin concentrationsaccordance displayedwith in the followingrequirements tableof forthis initial and confirmatory drug testssection. All cutoff concentrations are expressed in nanograms per milliliter
(ng/mLa). TheYou tablemust follows:determine
Initialtestthe analytecreatinine
Initialtest cutoff concentration
Confirmatoryteston analyteeach
Confirmatorytestprimary cutoffspecimen. concentrationYou
Marijuanametabolites 50must ng/mL THCAalso
1 15ng/mL.determine
Cocainemetabolites 150its ng/mL Benzoylecgonine 100specific ng/mL.gravity
Opiatemetabolitesif
Codeine/Morphine
2 2000ng/mL Codeine 2000you ng/mL.find
Morphine 2000ng/mL.the
6-Acetylmorphine 10ng/mL 6-Acetylmorphine 10creatinine ng/mL.concentration
Phencyclidine 25ng/mL Phencyclidine 25to ng/mL.be
Amphetamines
3
AMP/MAMP
4 500ng/mL Amphetamine 250less ng/mL.than
Methamphetamine
5 250ng/mL.20
MDMA
6 500ngmg/mL MDMA 250 ng/mLdL. MDA(
7 250 ng/mL.
MDEA
8 250 ng/mL
1 Delta-9-tetrahydrocannabinol-9-carboxylic acid THCAb).
2MorphineYou ismust determine the targetpH analyteof foreach codeine/morphineprimary testingspecimen.3(c) EitherYou amust singleperform initialone test kit or multiplemore initialvalidity testtests kitsfor mayoxidizing beadulterants usedon providedeach theprimary singlespecimen.
(d) testYou kitmust detectsperform eachadditional targetvalidity analytetests independentlyon at the specifiedprimary cutoff.specimen
4Methamphetaminewhen is the targetfollowing analyteconditions forare amphetamine/methamphetamine testing.observed:5(1) ToAbnormal bephysical reportedcharacteristics;
(2) positiveReactions foror methamphetamine,responses acharacteristic specimenof mustan alsoadulterant containobtained amphetamineduring atinitial a concentration equal to or greaterconfirmatory thandrug 100tests ng/mL(e.g.,
6Methylenedioxymethamphetaminenon-recovery (MDMA).of
7Methylenedioxyamphetamineinternal (MDA).standards,
8Methylenedioxyethylamphetamineunusual (MDEAresponse).; or
(b3) OnPossible anunidentified initialinterfering drugsubstance test,or youadulterant.
(e) mustIf reportyou adetermine resultthat below the cutoffspecimen concentration as negative. If the result is atinvalid orand aboveHHS theguidelines cutoffdirect concentration, you mustto conductcontact athe confirmation test.MRO, you must
(c) On a confirmation drug testreportcontact a result below the cutoffMRO concentration as negative and atogether resultdecide atif ortesting above the cutoffprimary concentrationspecimen asby confirmedanother positive.HHS
(d)Youcertified mustlaboratory reportwould quantitativebe valuesuseful forin morphinebeing orable codeineto atreport 15,000a ng/mLpositive or aboveadulterated test result.
[65 FR 79526, Dec. 19, 2000, as amended at 7569 FR 4986264867, AugNov. 169, 2010;2004. 77Redesignated and amended at 88 FR 2647327643, May 42, 20122023]
As a laboratory, when you conduct validity testing under § 40.86, you must conduct it in accordance with the requirements of this section.
(a) You must determine the creatinine concentration on each primary specimen. You must also determine its specific gravity if you find the creatinine concentration to be less than 20 mg/dL.
(b) You must determine the pH of each primary specimen.
(c) You must perform one or more validity tests for oxidizing adulterants on each primary specimen.
(d) You must perform additional validity tests on the primary specimen when the following conditions are observed:
(1) Abnormal physical characteristics;
(2) Reactions or responses characteristic of an adulterant obtained during initial or confirmatory drug tests (e.g., non-recovery of internal standards, unusual response); or
(3) Possible unidentified interfering substance or adulterant.
(e) 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.
[65 FR 79526, Dec. 19, 2000, as amended at 69 FR 64867, Nov. 9, 2004. Redesignated and amended at 88 FR 27643, May 2, 2023]
Amendment history
7 distinct wordings on file since Oct. 1, 2001- [65 FR 79526, Dec. 19, 2000, as amended at 69 FR 64867, Nov. 9, 2004. Redesignated and amended at 88 FR 27643, May 2, 2023]
- [65 FR 79526, Dec. 19, 2000, as amended at 75 FR 49862, Aug. 16, 2010; 77 FR 26473, May 4, 2012; 82 FR 52244, Nov. 13, 2017]
- [65 FR 79526, Dec. 19, 2000, as amended at 75 FR 49862, Aug. 16, 2010; 77 FR 26473, May 4, 2012; 82 FR 52244, Nov. 13, 2017]
- [65 FR 79526, Dec. 19, 2000, as amended at 75 FR 49862, Aug. 16, 2010; 77 FR 26473, May 4, 2012]
- [65 FR 79526, Dec. 19, 2000, as amended at 75 FR 49862, Aug. 16, 2010; 77 FR 26473, May 4, 2012]
- [65 FR 79526, Dec. 19, 2000, as amended at 75 FR 49862, Aug. 16, 2010]
- Oct. 1, 2001 → Oct. 1, 2010annual editions 2001–2009
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.