§ 40.95 What are the adulterant cutoff concentrations for initial and confirmation tests?
Wording in the annual edition revised as of Oct. 1, 2008, superseded May 2, 2023.
(a) As a laboratory, you must consideruse the primarycutoff specimenconcentrations tofor bethe adulteratedinitial ifand youconfirmation determineadulterant that—testing
(1)Aas substancerequired thatby isthe notHHS expectedMandatory toGuidelines beand presentyou inmust humanuse urinetwo isseparate identifiedaliquots—one infor the specimen;initial
(2)Atest substanceand thatanother isfor expectedthe toconfirmation betest.
(b) presentAs in human urine is identified at a concentrationlaboratory, soyou highmust thatreport itresults isat notor consistentabove withthe humancutoffs urine; or(3)or Thefor physicalpH, characteristicsat ofor theabove specimenor arebelow outside the normalvalues, expectedas range for human urine.appropriate)
(bInas makingadulterated yourand determinationprovide underthe paragraphnumerical (a)value ofthat thissupports section, you must apply the criteriaadulterated inresult.
[73 currentFR HHS35970, requirementsJune or25, specimen validity guidance.2008]
(a) As a laboratory, you must use the cutoff concentrations for the initial and confirmation adulterant testing as required by the HHS Mandatory Guidelines and you must use two separate aliquots—one for the initial test and another for the confirmation test.
(b) As a laboratory, you must report results at or above the cutoffs (or for pH, at or above or below the values, as appropriate) as adulterated and provide the numerical value that supports the adulterated result.
[73 FR 35970, June 25, 2008]
Amendment history
4 distinct wordings on file since Oct. 1, 1996- [73 FR 35970, June 25, 2008]
- [73 FR 35970, June 25, 2008]
- 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.