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The Centers for Disease Control and Prevention (CDC) developed a Traceable Opioid Material® Kits (TOM Kits®) product line to support detection of emerging opioids. CDC maintains the contents of TOM Kits® products based on new needs identified, in part, through DEA Emerging Threat Reports. CDC contracted Cerilliant Corporation to manufacture and distribute the Opioid CRM Kit. The kit contains 44 solutions of opioids and their carbon-13, nitrogen-15 labeled standards. 32 of the solutions are US Drug Enforcement Administration (DEA) controlled standards.

These kits are reference materials and do not eliminate the need to meet analytical requirements of other federal agencies. The TOM Kits® product line are NOT for Diagnostic Use.

Update: Opioid CRM Compound Additions for Expanded Fentanyl Testing

As part of the Traceable Opioid Material® Kits, The Centers for Disease Control and Prevention (CDC) has added two additional compounds and their corresponding labeled internal standards to supplement the Opioid CRM Kit that became available from Cerilliant® in 2019. The additional compounds will expand laboratories ability to detect opioid exposure levels.

Opioid CRM Compound Additions:
     • Includes 1 mg/mL solution CRMs of Isotonitazene, Isotonitazene-13C6, NPP, and NPP-13C6
     • Expands national laboratory capacity to measure opioid exposure
     • Improves confirmation of mass spectrometry method analysis

Opioid Certified Reference Material Kit (Opioid CRM Kit) Fact Sheet

Certified Reference Materials

The Opioid CRM Kit includes solution based certified reference materials for the following:

Isotonitazene   NEW  
4'methyl acetyl fentanyl HCl
Acetyl fentanyl
Acryl fentanyl HCl
Benzylfentanyl HCl
Butyryl fentanyl
Carfentanil Oxalate
Cyclopropyl fentanyl
4-Fluoro fentanyl (4-FF)
Furanyl fentanyl HCl (FU-F)
(±)-beta-Hydroxythiofentanyl HCl
Methoxyacetyl fentanyl HCl
(±)-cis-3-Methyl fentanyl HCl
Norcarfentanil Oxalate
Norfentanyl oxalate
para-Fluorobutyryl fentanyl (p-FBF)
Remifentanil HCl
U-48800 HCl
Valeryl Fentanyl HCl
Isotonitazene-13C6   NEW  
NPP-13C6   NEW  
4-ANPP -13C6
4'methyl acetyl fentanyl-13C6 HCl
Acetyl fentanyl-13C6
Acryl fentanyl-13C6 HCl
Benzylfentanyl-13C6 HCl
Butyryl fentanyl-13C6
Carfentanil-13C6 oxalate
Cyclopropyl fentanyl-13C6 HCl
4-Fluoro fentanyl-13C6
Furanyl fentanyl-13C6 HCl
(±)-beta-Hydroxythiofentanyl-13C6 HCl
Methoxyacetyl fentanyl-13C6 HCl
3-Methyl fentanyl-13C6 HCl
Norcarfentanil-13C6 oxalate
Norfentanyl-13C6 oxalate
para-Fluorobutyryl fentanyl-13C6
Remifentanil-13C6 HCl
U-47700-13C3, 15N2
U-48800-13C3, 15N2 HCl
Valeryl Fentanyl-13C6 HCl

Cerilliant COAs & SDSs for Opioid CRM Kit

CDC Third Party COAs for Opioid CRM Kit

US DEA Registration Requirement

To receive this kit, a laboratory must be located in the US and hold a valid DEA controlled substance registration for both Schedule I and II controlled substances. Separate registrations may be used, but the registrant address must be the same on both registrations since all solutions will be shipped together as one kit. While most DEA registration categories do not require specification of the controlled substance basic classes to be handled, DEA may request that information during the application process. The basic drug classes in the Opioid CRM Kit include:

Schedule I: 9547, 9811, 9812, 9813, 9821, 9822, 9823, 9825, 9834, 9836, 9840, 9845, 9850
Schedule II: 8333, 9739, 9743, 9801

To start the application process for a new DEA controlled substance registration, go to https://apps.deadiversion.usdoj.gov/webforms/jsp/regapps/common/newAppLogin.jsp

For additional guidance, contact DEA’s Registration Call Center at 1-800-882-9539 or a local DEA field office. A description of the registration process and a link to DEA’s field office search tool can be found at https://www.deadiversion.usdoj.gov/drugreg/process.htm

How to complete the DEA 222 forms? view examples of the DEA 222 forms for the Opioid CRM Kit

, TRACEABLE OPIOID MATERIAL®, and TOM Kits®, are registered marks of the U.S. Department of Health and Human Services.

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