§40.85 What are the cutoff concentrations for urine drug tests?

Current as of Oct 29, 2026Last amended Jun 1, 2023Official text on eCFR ↗

(a) As a laboratory, you must use the cutoff concentrations displayed in the following table for initial and confirmatory drug tests. All cutoff concentrations are expressed in nanograms per milliliter (ng/mL). The table follows:

Initial test analyteInitial test cutoff 1Confirmatory test analyteConfirmatory test cutoff concentration
Marijuana metabolites (THCA) 250 ng/mL3THCA15 ng/mL.
Cocaine metabolite (Benzoylecgonine)150 ng/mL 3Benzoylecgonine100 ng/mL.
Codeine/ Morphine2000 ng/mLCodeine Morphine2000 ng/mL. 2000 ng/mL.
Hydrocodone/ Hydromorphone300 ng/mLHydrocodone Hydromorphone100 ng/mL. 100 ng/mL.
Oxycodone/ Oxymorphone100 ng/mLOxycodone Oxymorphone100 ng/mL. 100 ng/mL.
6-Acetylmorphine10 ng/mL6-Acetylmorphine10 ng/mL.
Phencyclidine25 ng/mLPhencyclidine25 ng/mL.
Amphetamine/ Methamphetamine500 ng/mLAmphetamine Methamphetamine250 ng/mL. 250 ng/mL.
MDMA 4/MDA 5500 ng/mLMDMA MDA250 ng/mL. 250 ng/mL.

1 For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff):

Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group.

Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.

2 An immunoassay must be calibrated with a target analyte.

3 Alternate technology (THCA and Benzoylecgonine): When using an alternate technology initial test for the specific target analytes of THCA and Benzoylecgonine, the laboratory must use the same cutoff for the initial and confirmatory tests (i.e., 15 ng/mL for THCA and 100ng/mL for Benzoylecgonine).

4 Methylenedioxymethamphetamine (MDMA).

5 Methylenedioxyamphetamine (MDA).

(b) On an initial drug test, you must report a result below the cutoff concentration as negative. If the result is at or above the cutoff concentration, you must conduct a confirmation test.

(c) On a confirmation drug test, you must report a result below the cutoff concentration as negative and a result at or above the cutoff concentration as confirmed positive.

(d) You must report quantitative values for morphine or codeine at 15,000 ng/mL or above.

Source: 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. Redesignated and amended at 88 FR 27643, May 2, 2023

Compiled from the Electronic Code of Federal Regulations (eCFR), an editorial compilation and not an official legal edition of the CFR. The official text is the Federal Register and the annual CFR edition. §40.85 on eCFR.

Sections that cite this one

  • §40.177 What does the second laboratory do with the split specimen when it is tested to reconfirm the presence of a drug or drug metabolite?