HHS Proposes Revisions to the Federal Urine Drug Testing Guidelines

The Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), published proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine (UrMG) in the Federal Register on October 29, 2026. The notice is Federal Register document 2026-22122 (91 FR 68398), RIN 0930-AA40, docket SAMHSA-2026-0002. HHS is accepting comments on or before December 28, 2026.

This is a proposed rule. Nothing changes unless and until HHS finalizes the revisions. Until then, the current UrMG, published October 12, 2023 (88 FR 70768), are the guidelines in effect.

The full notice is available on the Federal Register at Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine (UrMG).

Who the UrMG Cover

The UrMG set the standards for federal agency workplace drug testing programs and for the HHS-certified laboratories, instrumented initial test facilities (IITFs), collectors and Medical Review Officers (MROs) that support them. HHS estimates that federal agencies test about 275,000 urine specimens each year.

HHS states that the proposal may affect industries regulated by the Department of Transportation (DOT) and the Nuclear Regulatory Commission (NRC), depending on those agencies' decisions to incorporate the final UrMG revisions. The notice does not itself change DOT or NRC drug testing rules.

Proposed Change to the pH Invalid Cutoff

The most significant proposed change concerns specimen pH, a measure of how acidic or alkaline urine is. Under the current UrMG, a specimen with a pH equal to or greater than 9.0 and less than 11 is reported as invalid. HHS proposes raising the lower end of that range to 9.5, so a specimen would be reported invalid when its pH is equal to or greater than 4 and less than 4.5, or equal to or greater than 9.5 and less than 11.

HHS explains that specimens with a pH from 9.0 to 9.5 currently require laboratory confirmatory pH testing and MRO review for possible explanations. Specimens without a legitimate explanation, and specimens that require a valid negative result for pre-employment, return-to-duty or follow-up tests, must be recollected. HHS describes this as a significant burden for laboratories, MROs and federal agencies that does not result in identifying additional adulterated specimens.

HHS based the proposal on data presented at the December 2024 meeting of SAMHSA's Drug Testing Advisory Board. According to the notice, the data show that:

• Extended time at high temperature after collection can cause urine pH in the acceptable range to rise to 9.1 to 9.3.
• Specimens in the pH range of 9.0 to 9.5 occur more often in summer months.
• About 0.2 percent of specimens fall in the pH range of 9.0 to 9.5.
• A pH above 9.5 does not occur due to elevated temperature and increased shipping time.

Consistent with the new cutoff, HHS proposes deleting the MRO action for invalid results based on a pH of 9.0 to 9.5 in Section 13.5(f).

Proposed Biomarker and Split Specimen Changes

HHS proposes several changes related to biomarker testing, which it expects to lead to definitive results and reduce the need for recollection:

• MRO-authorized biomarker testing. A specimen with an invalid result based on inconsistent creatinine and specific gravity results may be tested for an HHS-authorized biomarker to determine substitution. The laboratory would contact the MRO for authorization before conducting the additional biomarker test or sending the specimen to another certified laboratory.
• Split (B) specimen testing. When a primary (A) specimen was reported substituted based on a biomarker test, the split testing laboratory may test for any HHS-authorized biomarker. It would not be necessary to test for the same biomarker used on the primary specimen.
• New biomarkers. A new Section 3.3 would require an HHS-certified laboratory or IITF to obtain HHS authorization before implementing testing for a biomarker for federal agency specimens.

Proposed Laboratory and Testing Panel Changes

• Laboratory certification. The revised definition of an HHS-certified laboratory states that HHS may certify a laboratory that tests split (B) specimens only and/or conducts additional drug or specimen validity tests.
• Initial test quality control. For initial drug test batches, HHS proposes lowering the percentage of controls from 10 percent to 4 percent of the total controls and specimens in the batch. The 10 percent control requirement for confirmatory test batches would remain.
• Testing panels. HHS proposes removing the drug testing panel from the UrMG text and deleting the requirement to publish the authorized testing panels annually. Under the proposal, HHS would publish a Federal Register notice when the drug or biomarker testing panels change. The current panels were published January 16, 2025 (90 FR 4662).

Proposed Collection and Program Changes

• Direct observed and monitored collections. HHS proposes revising Sections 4.4, 8.1, 8.10 and 8.12 to refer to the sex of the observer and donor. The current UrMG refer to gender, as determined by the donor's gender identity, and HHS proposes deleting the "Gender Identity" definition.
• Invalid result explanations. HHS proposes removing the word "medical" from Section 8.9(a)(2), because there may be a legitimate non-medical explanation for an invalid result.
• Pre-employment tests. Revised Section 2.2(a) would clarify that pre-employment tests are performed for all individuals applying for a testing designated position, including federal agency employees.
• Refusal to test. Section 1.7 would include additional examples of circumstances that constitute a refusal to test.

HHS states that the proposed revisions are not expected to increase current stakeholder costs, although laboratories and MROs would have some one-time administrative costs from the pH cutoff change, which HHS expects the savings to greatly exceed.

Companion Oral Fluid Proposal

On the same date, HHS published a companion proposal revising the Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid (OFMG), Federal Register document 2026-22121 (91 FR 68364), RIN 0930-AA41, docket SAMHSA-2026-0001. Comments on that proposal are also due December 28, 2026. It is a separate docket, so comments on oral fluid testing are filed there.

How to Submit Comments

HHS accepts comments on the urine proposal through December 28, 2026:

• Online: at regulations.gov under docket SAMHSA-2026-0002.
• Mail, express mail or hand delivery: SAMHSA, Center for Substance Abuse Prevention (CSAP), Division of Workplace Programs (DWP), 5600 Fishers Lane, Room 16N02, Rockville, MD 20857.

Commenters are asked to refer to docket number SAMHSA-2026-0002 and to choose only one submission method. SAMHSA cannot accept comments by fax, and hand or courier deliveries should be scheduled with SAMHSA in advance. According to the notice, comments are posted in their entirety on regulations.gov, including any personal or confidential business information they contain.