§ 40.91 What validity tests must laboratories conduct on primary specimens?
Wording in the annual edition revised as of Oct. 1, 2005, superseded May 2, 2023.
As a laboratory, when you conduct validity testing under § 40.89, you must conduct it in accordance with the requirements of this section.
(a) You must testdetermine the creatinine concentration on each primary specimen for creatinine. You must also determine its specific gravity if you find that the creatinine concentration isto be less than 20 mg/dL.
(b) You must measuredetermine the pH of each primary specimen.
(c) You must testperform eachone primaryor specimenmore tovalidity determinetests iffor itoxidizing containsadulterants substanceson thateach mayprimary be used to adulterate the specimen.
(d) YourYou tests must haveperform theadditional capabilityvalidity oftests determiningon whetherthe anyprimary substancespecimen identifiedwhen inthe currentfollowing HHSconditions requirementsare orobserved:
(1) specimenAbnormal validityphysical guidance is present in the specimen.characteristics;
(d2) IfReactions youor suspectresponses thecharacteristic presence of an interfering substance/adulterant thatobtained couldduring makeinitial aor testconfirmatory resultdrug invalid,tests but you are unable to identify it (e.g., anon-recovery newof adulterant),internal you muststandards, asunusual theresponse); firstor
(3) laboratory,Possible sendunidentified theinterfering specimensubstance toor another HHS certified laboratory that has the capability of doing soadulterant.
(e) If you identifydetermine athat substancethe in a specimen thatis appearsinvalid toand beHHS anguidelines adulterant,direct butyou whichto iscontact notthe listed in current HHS requirements or guidanceMRO, you must reportcontact the findingMRO inand writingtogether todecide ODAPCif andtesting the Divisionprimary ofspecimen Workplaceby Programs,another HHS, withincertified threelaboratory businesswould days.be Youuseful mustin alsobeing completeable testingto ofreport thea specimenpositive foror drugs,adulterated totest the extent technically feasibleresult.(f)[65 YouFR must79526, conserveDec. as19, much2000, as possibleamended ofat the69 specimenFR for64867, possibleNov. future9, testing.2004]
As a laboratory, when you conduct validity testing under § 40.89, 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]
Amendment history
5 distinct wordings on file since Oct. 1, 1996- [88 FR 27643, May 2, 2023]
- [65 FR 79526, Dec. 19, 2000, as amended at 69 FR 64867, Nov. 9, 2004]
- [65 FR 79526, Dec. 19, 2000, as amended at 69 FR 64867, Nov. 9, 2004]
- 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.