SAMHSA Proposes Overhaul of Federal Oral Fluid Drug Testing Guidelines

The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency of the Department of Health and Human Services (HHS), is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid. The proposal, filed under RIN 0930–AA41 and docket SAMHSA–2026–0001, was published in the Federal Register on 29 October 2026, and sets a comment deadline of 28 December 2026. It is signed by Robert F. Kennedy, Jr., Secretary of Health and Human Services.

The framework being amended

The oral fluid guidelines were first published on 25 October 2019 (84 FR 57754) with an effective date of 1 January 2020, and were revised on 12 October 2023 (88 FR 70814). HHS derives its authority from Section 503 of Public Law 100–71, 5 U.S.C. 7301 and Executive Order 12564, which together underpin the scientific and technical standards for federal workplace testing and for certifying laboratories that serve federal agencies.

The market the proposal governs is still almost entirely urine-based: the Department estimates that 275,000 urine specimens are tested annually by federal agencies. According to the notice, no laboratories have yet been certified to test oral fluid. A companion proposal covering the urine guidelines (RIN 0930–AA40, docket SAMHSA–2026–0002) is being published concurrently with parallel changes.

What the revisions change

• A minimum of 1 mL of undiluted (neat) oral fluid must be collected for each specimen, designated Tube A (primary) and Tube B (split), either simultaneously or serially.
• Collection must follow the time limit specified by the device manufacturer, replacing the previous fixed 15-minute limit for donors unable to produce sufficient volume.
• The drug testing panel is removed from the oral fluid guidelines, and the requirement to publish the Authorized Drug Testing Panels annually is deleted; HHS will instead publish a Federal Register notice when panels change.
• A split specimen laboratory may test for any HHS-authorized biomarker to reconfirm a substitution result, rather than being required to use the same biomarker as the primary specimen.
• The percentage of controls in each initial drug test batch drops from 10 percent to 4 percent of total controls and specimens, while the 10 percent requirement is kept for confirmatory batches.
• Medical review officers gain clarified procedures for invalid, adulterated and substituted results, including when a split specimen cannot be tested by a second laboratory.
• Pre-employment testing is clarified as applying to all individuals applying for a testing designated position, including federal agency employees.

Laboratories, paperwork and cost

The proposal is accompanied by a Paperwork Reduction Act analysis submitted to the Office of Management and Budget (OMB) under control number 0930–0158. Burden estimates assume 10,500 donors, 100 collectors, 10 oral fluid specimen testing laboratories and 100 medical review officers, for a total of 13,267 annual burden hours tied to oral fluid testing; the overall approved estimate adjusts from 1,686,483 to 1,684,363 hours.

SAMHSA states that the proposed revisions are not expected to increase current stakeholder costs, and that the quality-control change and the biomarker flexibility should reduce laboratory time, materials and the need for specimen recollection. The agency also notes that the new guidelines may affect Department of Transportation and Nuclear Regulatory Commission regulated industries, depending on whether those agencies incorporate the final revisions under their own authority.

How to comment

Comments must be submitted on or before 28 December 2026, referencing docket SAMHSA–2026–0001, through regulations.gov, by mail, by express mail, or by hand delivery to SAMHSA’s Division of Workplace Programs in Rockville, Maryland. Fax submissions are not accepted; questions on the docket may be directed to Eugene D. Hayes of SAMHSA’s Center for Substance Abuse Prevention.

The proposal matters because it sets the technical ground rules for the first federal oral fluid testing regime at a moment when no laboratory has yet been certified to run it. Until certified capacity exists, agencies subject to the guidelines have no operational alternative to urine collection, and the revisions on collection volume, device timing and split-specimen retesting will shape how quickly that capacity can be stood up.

Source: Federal Register, Vol. 91, No. 208, 29 October 2026, Proposed Rules, p. 68364 (official reference: 2026–22121).