§ 40.87 What validity tests must laboratories conduct on primary urine specimens?
Current wording, effective June 1, 2023.
(a) As a laboratory, when you mustconduct usevalidity thetesting cutoffunder concentrations§ displayed40.86, inyou themust followingconduct tableit forin initialaccordance andwith confirmationthe drugrequirements testsof this section.
(a) AllYou cutoffmust concentrationsdetermine arethe expressedcreatinine inconcentration nanogramson pereach milliliterprimary (ng/mL)specimen. TheYou tablemust follows:also
Typeofdetermine drugits orspecific metabolite Initialgravity test Confirmationif testyou
(1)Marijuanafind metabolites(i)the Delta-9-tetrahydrocanna-binol-9-carboxyliccreatinine acidconcentration (THC)to
50
15
(2)Cocainebe metabolitesless (Benzoylecgonine) 300 150than
(3)Phencyclidine20 (PCP) 25 25mg/dL.
(4b) Amphetamines 1000You
(i)Amphetamine 500must determine the pH of each primary specimen.
(iic) Methamphetamine 500You (Specimen must alsoperform containone amphetamineor atmore avalidity concentrationtests offor greateroxidizing thanadulterants oron equaleach toprimary 200 ng/mLspecimen.)
(5d) OpiateYou metabolites 2000must
(i)Codeine 2000perform
(ii)Morphine 2000additional
(iii)6-acetylmorphinevalidity (6-AM) 10tests (Teston forthe 6-AMprimary inspecimen when the specimen.following Conductconditions thisare testobserved:
(1) onlyAbnormal whenphysical specimencharacteristics;
(2) containsReactions morphineor atresponses acharacteristic concentrationof greateran thanadulterant obtained during initial or equalconfirmatory todrug 2000tests ng/mL(e.g., non-recovery of internal standards, unusual response); or
(b3) OnPossible anunidentified initialinterfering drugsubstance test,or youadulterant.
(e) mustIf reportyou adetermine resultthat below the cutoffspecimen concentrationis asinvalid negative.and IfHHS theguidelines resultdirect isyou atto orcontact above the cutoff concentrationMRO, you must conductcontact athe confirmationMRO test.and
(c)Ontogether adecide confirmationif drugtesting test,the youprimary mustspecimen reportby aanother resultHHS belowcertified thelaboratory cutoffwould concentrationbe asuseful negativein andbeing aable resultto atreport a positive or aboveadulterated thetest cutoffresult.
[65 concentrationFR 79526, Dec. 19, 2000, as confirmedamended positive.at
(d)You69 mustFR report64867, quantitativeNov. values9, for2004. morphineRedesignated orand codeineamended at 1588 FR 27643,000 ng/mLMay or2, above.2023]
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.