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Interpretation Response #PI-95-025

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

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Response text:

40.25 Office of Drug Enforcement and Program Compliance

49 CFR Part 40 Interpretation

Question: Are urine drug screens only to be collected at NIADA (sic) approved facilities?

Response: There exists no requirement that urine specimens be collected at Department of Health and Human Services (DHHS) certified laboratories (formerly National Institute of Drug Abuse, or NIDA, approved laboratories). However, 49 CFR Part 40 requires that urine specimens be tested in DHHS certified labs. DHHS laboratories do not collect urine specimens; they receive them from the collection facilities (by courier or mail service) and conduct the required tests.

Facilities that serve as collection sites and individuals who serve as collectors of urine specimens require no DHHS certification. Upon collecting the urine specimen from the donor, the collector must send the specimen to a DHHS certified laboratory for testing.

Regulation Sections