June 2022 CFTN

Read the June 2022 issue of CFTN

Clinical Laboratory-Based Drug Checking Services and the Overdose Crisis (page 1)

Accidental substance poisonings and related deaths have risen significantly in North America over the last 10 years. In response to the overdose crisis, "harm reduction" services have been utilized to help reduce drug poisonings and overdose deaths, and drug checking services are gaining popularity as a key component of the harm reduction toolkit.

Proposed FDA Regulation of LDTs and the Potential Impact for Toxicology Laboratories (page 6)

Under Clinical Laboratory Improvement Amendments (CLIA), laboratories are allowed to develop, validate, and implement laboratory-developed tests (LDTs). Although the FDA has historically claimed regulatory authority over LDTs, they typically utilize “enforcement discretion” and do not require clinical laboratories to submit documentation to the FDA. That paradigm may soon shift with Congress's introduction of the Verifying Accurate Leading-edge IVCT Development (VALID) Act.

Department of Transportation Proposes Changes to Drug Testing Rule 49CFR Part 40 to Include Oral Fluid (page 9)

In the March 2020 issue, Clinical and Forensic Toxicology News reported on revisions to the Department of Health and Human Services and Substance Abuse and Mental Health Services Administration’s Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG), effective January 1, 2020. On February 28, 2022, the Department of Transportation published a notice of proposed rulemaking on oral fluid testing in the Federal Register, which proposed adding oral fluid as an alternative specimen type for workplace drug testing programs in the transportation industry.

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