Expanded Opiates for DOT Testing?

… SAMHSA Mandatory Guidelines Proposed Revision for Urine Testing… Are You Ready for Expanded Opiates for DOT Testing?

… After what seems a long wait, Substance Abuse and Mental Health Services Administration (SAMHSA) published in today’s (5-15-15) Federal Register a proposed revision to the urine testing guidelines.  The proposed revisions are 51 pages in length and with some subtle changes and also some major revisions to the analysis of the urine specimens.

The most important change and one that has been eagerly awaited for is the inclusion of the synthetic opiates (Hydrocodone, Hydromorphone, Oxycodone, Oxymorphone) into the HHS – DOT testing panel. There are some other proposed changes that include the changing to the pH level for urine specimens along with revised requirements for MRO requalification training.  One key change will be to allow Federal Agencies the ability to authorize the collection of an alternative specimen, specifically oral fluid when there is an inability to provide an adequate urine specimen.  Of note, there are changes in the wording and reorganization of the Mandatory Guidelines (MG).  There will be some new acronyms that the drug testing industry will have to learn to use for clarity and understanding of all the applicable regulations.

It should be noted that the SAMHSA MG directly apply to Federal Agencies for their workplace drug testing programs.  The MG also apply to DOT in accordance with the Omnibus Transportation Employee Testing Act (OTETA) of 1991.  This Act requires DOT and DOT regulated employers to follow the scientific guidelines.

There is a 60 day comment period for comments to be submitted to HHS/SAMHSA concerning these proposed changes to the MG.  All parties should read and comment where appropriate on issues that are of concern.  The address to send written comments to is:

SAMHSA, Attention Division of Workplace Programs (DWP)
1 Choke Cherry Rd., Rm. #7-1045
Rockville, MD 20857

Comments may also be submitted electronically to http://regulations.gov.  Please follow “Submit a Comment” instructions. 

Comments may also be submitted by overnight mail to the above address or hand-delivered to the above address.  If hand delivering please call ahead to make arrangements for acceptance.

Some of the changes in brief are as follows:

Proposed Addition of Schedule II Synthetic Prescription Opiates:

The synthetic opiates to be added are:

Synthetic Prescription Opiates

Screen Test Cutoff Level (ng/mL)

Confirmatory test cutoff concentration (ng/mL

Hydrocodone/Hydromorphone

300

100

Oxycodone/Oxymorphone

100

100

Methylenedioxamphetamine (MDA) and methylenedioxyethylamphetamine (MDEA)*

500

250

*Added as an initial analyte

There are some footnotes for the above analysis which will be the discussion in another article which will require some extensive discussion.

All of the other controlled substances and cut off levels will remain the same.

Another change is that the pH level for urine specimens will change from 3.0 to 4.0 to identify a specimen as adulterated.

The change for MROs is that MROs will have to take requalification training and examination every five years.

The major announcement is that the use of oral fluids in Federal Workplace test programs has been proposed.

Some of the new acronyms are:

MG – (Mandatory Guidelines)

OFMG – (Oral Fluid Mandatory Guidelines

UrMG – Urine Mandatory Guidelines

There is some changes in the organization and some cost analysis added.

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Expanded Opiates for DOT Testing?
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