HHS Publishes Revised Federal Drug Testing Custody and Control Form (CCF)

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HHS Publishes Revised Federal Drug Testing Custody and Control Form (CCF)

The Department of Health and Human Services recently announced that their revised Federal Drug Testing Custody and Control Form (CCF) was approved by the Office of Management and Budget (OMB).  

To view the 2026 CCF and learn more about what this means for DOT-required drug testing, visit our web page at Revised CCF Notice.


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Updated Urine Collection Specimen Procedures Guidelines

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The Office of Drug & Alcohol Policy & Compliance posted its updated “Urine Collection Specimen Procedures Guidelines”. The document has been updated to reflect certain provisions addressed in the Department of Transportation (DOT) final rule, published on May 2, 2023, and May 11, 2026, as well as President Trump’s Executive Order 14168. A listing of the updates to the Urine Collection Specimen Procedures Guidelines can be found on the last page of the document. The document can be found at https://www.transportation.gov/odapc/collectors


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FDA Announced It Is Seeking Public Comment on Its Intent to Remove the 510(k) Clearance Requirement for Federally Regulated Drug Testing Programs

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The Food and Drug Administration (FDA) announced it is seeking public comment on its intent to remove the 510(k) Clearance requirement for federally regulated drug testing programs.

  • Current State: Before a laboratory can use a screening assay/reagent in drug testing, FDA requires that the assay/reagent meet the requirements of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360(k). These are more commonly known as FDA’s “510(k) clearance” requirements, “Premarket Notification,” or “PMN”. The only exemption to the 510(k) clearance requirement is when drug testing is related to private employment and insurance. Drug testing programs such as Federal employee drug testing programs and the U.S. Department of Transportation’s industry testing program are not included in the exemption.
  • Proposed Change: On May 1, 2026, the FDA published a notice seeking public comment in the Federal Register https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08499.pdf. Specifically, FDA announced its intent to remove the exception to the 501(k) exemption for devices intended for Federal drug testing programs. These Federal drug testing programs include, among others, the programs run by the Department of Transportation.  

Currently, laboratories using screening assays for Federal drug testing programs (like for the U.S. DOT drug testing program) must use screening assays that are FDA 510(k) cleared. The FDA proposed change would remove the 510(k) clearance requirement.

We believe that employers, employees, and testing service providers involved in the DOT testing program should be aware of the FDA Federal Register notice. We recommend that DOT program participants review the FDA proposal and, if they have views or concerns to express, provide comments to the FDA at https://www.regulations.gov/docket/FDA-2026-N-4268 . Comments are due by June 30, 2026.


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DOT publishes Final Rule to Amend the Oral Fluid Rule and to Update Terminology

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On May 11, 2026, the Department of Transportation (DOT) published a final rule in the Federal Register to update the terminology in DOT’s drug and alcohol testing regulations to be consistent with Executive Order 14168 (E.O. 14168) (Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government) and added a provision that would require a directly observed urine collection in situations where oral fluid tests are currently required but oral fluid testing is not yet available.  This final rule is effective on June 10, 2026. 

To learn more about this final rule, view the rule at https://www.transportation.gov/odapc/frpubs  


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ODAPC Publishes Official Q&A Today

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The Office of Drug and Alcohol Policy and Compliance, with the Office of the General Counsel, issued a 49 CFR Part 40 Question and Answer. Like all ODAPC/OGC Qs & As, this Q&A constitutes official guidance and interpretation concerning 49 CFR Part 40.

The Q&A issued today is available on our website at: https://www.transportation.gov/odapc/part40QandA.

The Q&A explains what a MRO is not to consider when verifying a marijuana positive result.


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DEA’s Take Back Day: April 25

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DEA’s National Rx Take Back Day

The Drug Enforcement Administration will host the 30th National Prescription Drug Take Back Day on Saturday, April 25, 2026, from 10 a.m. to 2 p.m. (regardless of time zone) at nearly 4,200 locations nationwide. To find the Take Back Day location nearest you visit www.DEATakeBack.com.  

DEA and its partners will collect tablets, capsules, patches, and other forms of prescription drugs. Liquid products, such as cough syrup, should be securely sealed in their original container. 

Syringes, sharps, or illicit drugs are not collected. To learn how to properly dispose of these items visit FDA.gov

For those unable to participate in this month’s National Prescription Drug Take Back Day, there are more than 16,500 pharmacies, hospitals, and businesses that offer safe medication disposal year-round. In addition, many police departments also provide permanent drop boxes to ensure Every Day is Take Back Day.


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