HHS Proposes Revisions to the Federal Oral Fluid 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 Oral Fluid (OFMG) in the Federal Register on October 29, 2026. The notice is Federal Register document 2026-22121 (91 FR 68364), RIN 0930-AA41, docket SAMHSA-2026-0001. 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 OFMG, published October 12, 2023 (88 FR 70814), are the guidelines in effect.

The official Federal Register version of the notice is available from GovInfo: FR Doc. 2026-22121.

Where Oral Fluid Testing Stands

The OFMG set the standards for oral fluid testing in federal agency workplace drug testing programs and for the laboratories, collectors and Medical Review Officers (MROs) that support them. According to the notice, no laboratories have been certified to test oral fluid at this time.

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 OFMG revisions into their own programs. The notice does not itself change DOT or NRC drug testing rules.

HHS published a companion proposal for the Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine (UrMG) on the same date, Federal Register document 2026-22122 (91 FR 68398), RIN 0930-AA40, docket SAMHSA-2026-0002. The two proposals share several of the same or similar revisions, but each has its own docket.

Proposed Collection Changes

The most practical change for collectors concerns a donor who cannot provide enough oral fluid. Current Section 8.6(b) provides that a donor demonstrates an inability to provide a specimen when there is an insufficient volume or no oral fluid after 15 minutes of using the collection device. Because device manufacturers may set different time limits for their devices, HHS proposes replacing the 15-minute limit with "the time limit specified by the device manufacturer."

HHS also proposes revising Section 8.1(b) to refer to the sex of the collector and donor, and deleting the "Gender Identity" definition, which HHS describes as enhancing the clarity of direct observed collection procedures. 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, and Section 1.7 would include additional examples of circumstances that constitute a refusal to test.

Proposed MRO and Split Specimen Changes

Several proposed revisions address what an MRO does when an oral fluid result cannot be used:

• Invalid results. Revised Section 13.5(e) would set different MRO actions for invalid specimens depending on the reason for the test. Under Section 13.5(e)(1)(ii), the MRO may direct an unobserved urine collection based on the reason for the invalid oral fluid result, if the agency allows urine testing. Under Section 13.5(e)(2)(ii), when both the first oral fluid specimen and a second recollected oral fluid specimen are invalid, the MRO would report the second specimen as test cancelled and recommend that the agency collect a urine specimen under direct observation. If the agency does not authorize another specimen type, the MRO would consult with the agency to arrange a clinical evaluation under Section 13.7.
• Insufficient specimens. Section 13.6(b) would be revised to clarify different MRO actions depending on the reason for the test.
• Split (B) specimens. When a primary (A) specimen was reported substituted based on a biomarker test, revised Section 14.4 would allow the split testing laboratory to test for any HHS-authorized biomarker rather than the same biomarker.
• Split results. Section 14.6 would be reorganized to describe when the MRO directs testing at another HHS-certified laboratory. HHS would keep the current requirement for immediate recollection using a direct observed collection procedure, and would add that the MRO recommends an observed urine collection if the agency allows urine testing. HHS also proposes removing the requirement for the MRO to contact the HHS office responsible for drug-free workplace program coordination throughout that section.

Proposed Laboratory and Testing Panel Changes

• Laboratory certification. The revised definition of "Laboratory" states that HHS may certify laboratories that test split (B) specimens only and/or conduct additional drug or specimen validity tests.
• Initial test quality control. Under revised Section 11.11(b), the required percentage of controls in each initial drug test batch would drop from 10 percent to 4 percent of the total controls and specimens in the batch. The 10 percent requirement for confirmatory test batches would remain.
• Testing panels. HHS proposes removing the drug testing panel from the OFMG text and deleting the requirement to publish the authorized testing panels annually. HHS would instead publish a Federal Register notice when the drug or biomarker testing panels change. The current panels were published January 16, 2025 (90 FR 4662).
• New biomarkers. A new Section 3.3 would describe how an HHS-certified laboratory or instrumented initial test facility (IITF) obtains HHS approval to test for a biomarker not in the biomarker testing panel.

HHS states that the proposed OFMG revisions are not expected to increase current stakeholder costs.

How to Submit Comments

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

• Online: at regulations.gov under docket SAMHSA-2026-0001.
• 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-2026-0001 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, including any personal or confidential business information they contain. Comments on the urine proposal are filed separately under docket SAMHSA-2026-0002.