Frequently Asked Questions for the Public

The Revised Mandatory Guidelines for Federal Workplace Drug Testing using Urine 

Drugs to be tested

Question

What is the difference between opiates and opioids? 

Answer

The term “opiates” is used to describe naturally occurring substances known as alkaloids derived from the 

opium poppy plant (e.g., codeine; morphine; and heroin, which is produced by the acetylation of 

morphine) that bind to specific receptors in the central nervous system and have analgesic as well as 

narcotic effects. 

The term “opioids” has expanded in scope over time and is used broadly to describe various compounds 

that bind to specific receptors in the central nervous system and have analgesic as well as narcotic effects. 

The broadly used term “opioids” includes naturally occurring alkaloid compounds known as opiates (e.g., 

codeine, morphine, and heroin); semi-synthetic compounds (e.g., oxycodone, oxymorphone, 

hydrocodone, and hydromorphone); and synthetic compounds (e.g., fentanyl). Opioids may or may not 

have structural similarity to the opium alkaloids. 

Source

Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs, Appendix A: 

Glossary 

Question

Why were these four opioids chosen? 

Answer

The inclusion of additional Schedule II prescription medications (i.e., oxycodone, oxymorphone, 

hydrocodone and hydromorphone) in the list of authorized drug tests was recommended by the Drug 

Testing Advisory Board (DTAB), reviewed by the Department’s Prescription Drug Subcommittee of the 

Behavioral Health Coordinating Committee, and received by the SAMHSA Administrator in January 

2012. The inclusion of oxycodone, oxymorphone, hydrocodone and hydromorphone in the Mandatory 

Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG or Mandatory Guidelines) 

is supported by various data and seen in private sector experience with current drug abuse trends. HHS is 

continuing its efforts to prevent opioid addiction in support of President Trump’s commitment to combat 

the opioid crisis. The long-term impact of implementing these revised guidelines will help ensure safety 

in the workplace, especially in national security, public health, and public safety occupations that interact 

directly with the public 
Question

Will this detect heroin? 

Answer

Yes. Currently, the drug test panel tests for the metabolite of heroin (6-acetylmorphine). The current 

revisions to the Mandatory Guidelines do not require changes to the testing for 6-acetylmorphine that is 

currently being performed. 

Source

Mandatory Guidelines for Federal Workplace Drug Testing, Section 3.4 

Question

Will this detect fentanyl? 

Answer

No, testing for the synthetic opioid, fentanyl, is not included in the revised urine Mandatory Guidelines, 

effective on October 1, 2017. Fentanyl can be tested on a case-by-case basis under the Mandatory 

Guidelines, and the Division of Workplace Programs (DWP) is proposing to study the prevalence rate of 

fentanyl in regulated specimens in the next 2 months. 

Question

Are the laboratories prepared for the changes required under the Mandatory Guidelines? 

Answer

Yes. Certified laboratories in the National Certification Laboratory Program (NLCP) have been 

challenged with performance tests (PT) in the past year. The laboratories received 1 Practice Sample Set 

in March 2017, and 3 Qualifying PT Sets in May, mid-June, and late July. A post-implementation PT set 

will be sent to the laboratories after October 1, 2017. In addition, the reliability of the laboratories to 

meet Guideline requirements will be assessed every 3 months through maintenance PT sets. We do not 

anticipate any significant delays in test results for current federal employees or for individuals applying 

for federal employment. 

Impacts to employees and/or potential employees

Question

How many federal employees are in testing designated positions? Which occupations? 

Answer

The Drug Free Workplace Program covers all civilian employees in the Executive Branch agencies. 

However, only Testing Designated Positions (TDPs) are subject to random testing and these include any 

positions where a momentary lapse in judgment could result in a catastrophic event that could not be 

remediated by the administrative process. These are positions with public health, public safety and 
national security responsibilities. Due to differences in agency missions, structure and budget, TDPs 

differ among agencies. Generally speaking, there are approximately 400,000 employees in testing 

designated positions. See 2013 Guidance for the Selection of Tested Designated Positions for more 

information. 

Source

2013 Guidance for the Selection of Tested Designated Positions 

(https://www.samhsa.gov/workplace/workplace-programs) 

Question

How do I find out if this affects me or my agency? 

Answer

The revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine 

cover all civilian employees in the Executive Branch agencies. Employees should contact their federal 

agency (employer) for this information or refer to their employer’s Drug Free Workplace Program plan. 

Or contact: Drug Free Workplace Program (DFWP) Helpline 1-800-967-5752. 

Source

2013 Guidance for the Selection of Tested Designated Positions 

(https://www.samhsa.gov/workplace/workplace-programs) 

Question

If my doctor prescribed my opioid medication and I tested positive for opioids, will the results of my 

positive drug test be reported to my federal employer? 

Answer

Positive drug testing results that are explained by a legitimate medical explanation, such as a valid 

prescription, will not be reported to a federal agency. 

Source

Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

Question

What if I test positive for a prescription opioid but do not have a valid prescription? 

Answer

If a positive drug test result is not supported by a legitimate medical explanation, such as a valid 

prescription, the positive drug test result should be reported to the employee’s federal agency in 

accordance with the Mandatory Guidelines. 
Question

Do drug test results under the Mandatory Guidelines determine an employee’s fitness for duty? 

Answer

No, the Mandatory Guidelines are designed to detect an employee’s illicit drug use while on or off duty. 

Impact on public safety

Question

How will these guidelines affect public safety? 

Answer

The Drug Free Workplace Program covers all civilian employees in the Executive Branch agencies. In 

general, Testing Designated Positions (TDPs) are positions where a momentary lapse in judgment could 

result in significant harm. Due to differences in agency missions, structure and budget, TDPs differ 

among agencies. See 2013 Guidance for the Selection of Tested Designated Positions. Currently most 

TDPs are in Top Secret or above clearance. The revisions to the Mandatory Guidelines are intended to 

enhance public safety. 

Impact to non-federal employees

Answer

The Mandatory Guidelines address federal employees. 

Privacy issues

Question

Do HHS Certified Laboratories keep records regarding who tests positive and who is using what drugs? 

Answer

Personal identifiable drug testing information is maintained by HHS-certified laboratories for a period of 

time in accordance with Mandatory Guidelines requirements. Thereafter, total laboratory confirmed 

positive results (without personal identifiable information) for each drug will be recorded in aggregate 

form. 

Source

DWP Staff, 240-276-2600 (Workplace Helpline) 

Question

What is the authority for the federal drug-free workplace program? 

Answer
Executive Order 12564 and Title V, Section 503 of Public Law 100-71 authorize the Substance Abuse 

and Mental Health Services Administration to conduct the following activities: 

• Promulgate scientific and technical guidelines for drug testing programs under Executive Order 

12564; 

• Establish comprehensive standards for all aspects of laboratory drug testing and laboratory 

procedures to be applied in carrying out Executive Order 12564; 

• Specify the drugs for which Federal employees may be tested; and 

• Establish appropriate standards and procedures for periodic review of laboratories and criteria for 

certification and revocation of certification of laboratories to perform drug testing in carrying out 

Executive Order 12564. 

Source

E.O. 12564 and P.L. 100-71 

Other Topics

Question

How will these guidelines help the federal government address the opioid crisis? 

Answer

Misuse and abuse of psychotherapeutic prescription drugs, including opioid pain relievers, are issues of 

concern for all populations regardless of age, gender, ethnicity, race, or community. Recent data show 

that opioid-related overdose deaths in the United States now outnumber overdose deaths involving all 

illicit drugs such as heroin and cocaine combined. In addition to overdose deaths, emergency department 

visits, substance treatment admissions and economic costs associated with opioid abuse have all increased 

in recent years. These guidelines will help deter the illicit use of opioid drugs and can incentivize federal 

employees to seek opioid use disorder treatment. In this way, the Guidelines will further the Department 

activities in continuing to work with partners at the federal, state, and local levels to implement policies 

and programs to reduce prescription drug use and improve public health. Specifically, the Guidelines will 

screen for illicit opioid use among federal employees in safety sensitive positions with multiple agencies. 

Frequently Asked Questions for Industry 

Question

If an applicant or employee is unable to provide 45 mL of urine for a drug test, can they submit to and 

provide an oral fluid specimen? 

Answer
At this time, oral fluid is not approved as a federal drug testing specimen. Oral Fluid Mandatory 

Guidelines have been proposed (May 15, 2015; 80 FR 28101), but final Guidelines have not been 

published. The UrMG do not authorize oral fluid as an alternative specimen: references to the use of an 

alternate specimen type (e.g., oral fluid) are not applicable until final Guidelines have been implemented 

for the use of the alternate specimen type (see UrMG Section 8.7). UrMG Sections 8.5 and 8.6 include 

the steps to be taken when 45 mL urine is not collected. 

Source

UrMG Sections 8.5 and 8.6 

Question

What is the difference between an “Observer,” who observes the collection, and “Monitor,” who monitors 

the collection? 

Answer

An Observer is the person assigned to observe the collection of the specimen for a ‘direct observed’ 

collection according to UrMG Section 8.10. The observer’s gender must be the same as the donor’s 

(which is based on the donor’s gender identity). The observer is not required to be a trained collector, but 

must be trained as an observer. An observed collection is described in UrMG Section 8.9. It is the same 

as a routine collection except the observer is in the restroom or stall and watches the urine pass from the 

body of the donor to the collection container. The observer maintains visual contact with the specimen 

until the donor hands the container to the collector. The collection container cannot be handled by the 

observer unless the observer is also serving as the collector. 

A Monitor is the person assigned to monitor collection of the specimen for a ‘monitored’ collection 

according to UrMG section 8.12. The monitor’s gender must be the same as the donor’s (which is based 

on the donor’s gender identity), unless the monitor is a medical professional. The monitor is not required 

to be a trained collector. A monitored collection is described in UrMG Section 8.11. It is the same as a 

routine collection except the monitor provides visual privacy while being alert for signs of tampering. 

The monitor must not touch or handle the collection container, unless the monitor is also serving as the 

collector, and must not watch the donor urinate into the collection container. 

Source

UrMG Sections 8.9-8.12; Medical Review Officer Guidance Manual for Federal Workplace Drug Testing 

Programs, Appendix A: Glossary 

Question

What is the rationale for why the definition of opiates vs. opioids changed? Earlier, “opiates” was the 

umbrella category, and now “opioids” is the umbrella category that refers to both opiates and opioids. 

Answer

The term “opiates” is used to describe naturally occurring substances known as alkaloids derived from the 

opium poppy plant (e.g., codeine; morphine; and heroin, which is produced by the acetylation of 

morphine) that bind to specific receptors in the central nervous system and have analgesic as well as 

narcotic effects. 
The term “opioids” has expanded in scope over time and is used broadly to describe various compounds 

that bind to specific receptors in the central nervous system and have analgesic as well as narcotic effects. 

The broadly used term “opioids” includes naturally occurring alkaloid compounds known as opiates (e.g., 

codeine, morphine, and heroin); semi-synthetic compounds (e.g., oxycodone, oxymorphone, 

hydrocodone, and hydromorphone); and synthetic compounds (e.g., fentanyl). Opioids may or may not 

have structural similarity to the opium alkaloids. 

Source

Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs, Appendix A: 

Glossary 

Question

If notification is not received from the federal agencies of when they will expand their drug testing panel 

to include the four semi-synthetic opioids (oxycodone, oxymorphone, hydrocodone, hydromorphone), are 

federal specimens to be tested as currently stated on or after October 1, 2017, with the exception of 

removal of MDEA? 

Answer

SAMHSA provided guidance to HHS-certified laboratories to clarify testing of federal agency specimens 

as of October 1, 2017: 

1. Implement the revised pH cutoff for federal agency specimens. 

2. Discontinue testing federal specimens for MDEA. 

3. If a federal agency client has NOT notified the laboratory of its decision on when to begin testing the 

added opioids, the laboratory should contact the federal agency or Medical Review Officer. 

HHS-certified laboratories, applicant laboratories, Responsible Persons, and Medical Review Officers 

were sent NLCP Notices on August 18, 2017, September 8, 2017, and September 27, 2017 to clarify 

testing for federal agency specimens. 

Source

August 18, 2017 and September 8, 2017, and September 27, 2017 NLCP Notices to HHS-Certified and 

Applicant Laboratories and NLCP Inspectors 

Question

Will the pH decision point change be required on October 1, 2017, or at a date after October 1, 2017 

specified by notice from each federal agency? 

Answer

The revised pH cutoff must be implemented on October 1, 2017. On August 18, 2017 NLCP Notices 

were sent to HHS-certified and applicant laboratories and NLCP Inspectors. 

Source

August 18 2017 NLCP Notice to HHS-Certified and Applicant Laboratories and NLCP Inspectors 
Question

What are the privacy requirements when a urine specimen is collected? 

Answer

The following privacy requirements apply when a donor is providing a urine specimen: 

(a) Only authorized personnel and the donor may be present in the restricted access area where the 

collection takes place. (b) The collector is not required to be the same gender as the donor. The gender of 

the observer for purposes of a direct observed collection (i.e., as described in Section 8.10) must be the 

same as the donor’s gender, which is determined by the donor’s gender identity. The gender of the 

monitor for a monitored collection (i.e., as described in Section 8.12) must be the same as the donor’s 

gender, unless the monitor is a medical professional (e.g., nurse, doctor, physician's assistant, 

technologist, or technician licensed or certified to practice in the jurisdiction in which the collection takes 

place). 

The collector for an observed collection asks the donor to identify the donor’s gender on the Federal 

Custody and Control Form (CCF) and initial it. The collector will then select an observer whose gender 

matches the donor’s gender recorded on the Federal CCF. The collector documents the observer’s name 

and gender on the Federal CCF. The same procedure is used to select the monitor for a monitored 

collection unless the monitor is a medical professional. 

Source

UrMG Sections 8.1, 8.10, and 8.12 

Question

What is considered 1) a valid prescription and, 2) a legitimate medical explanation when dealing with 

testing for the four semi-synthetic opioids (oxycodone, oxymorphone, hydrocodone, hydromorphone)? 

Answer

Valid Prescription: When reviewing the positive test result, the MRO will take all reasonable and 

necessary steps to verify the authenticity of all medical records and other medical information provided 

by the donor that may be relevant to the medication being prescribed. The MRO should use reasonable 

medical judgment to make the decision that the provided prescription was generated in response to the 

donor’s current medical condition. Contact with the prescribing physician may be helpful for the MRO in 

coming to this decision if the donor has provided any consent that may be required. There are many 

critical components on how a prescription may be verified. This can be accomplished by the combination 

of the following: photos sent by text, e-mail, or fax showing enough angled shots of the bottle label that 

the MRO can verify the name of the donor on the label, prescription number, name of the drug, 

prescribing physician, date filled, number of pills in the prescription, number of refills, and the pharmacy 

name, address, and contact information. Equally effective is a verification call to the pharmacy (after the 

MRO has verbally obtained the information in the item above from the donor and documented it on the 

MRO record). Additionally, a copy of a pharmacy printout showing the medication dispensing history 

and/or a signed statement from, or phone discussion with, the prescribing physician. In all cases, the 

MRO should verify that the contact was with the prescribing physician. As an example, the MRO may 

request the physician’s state license number or DEA number. For additional security, the MRO may 

obtain the physician’s telephone number from another source (e.g., online search) and call the individual 

to verify identity. 
Legitimate Medical Explanation: When determining whether a legitimate medical explanation exists for a 

positive test, the MRO may consider whether a medication was used during the time period for which it 

was legitimately prescribed. If a donor’s use was not medically authorized, the specimen will be reported 

as positive. With respect to Schedule II medications, Schedule II includes drugs or other substances that 

have high potential for abuse, abuse of which may lead to severe psychological or physical dependence, 

and that have a currently accepted medical use in treatment in the United States (with or without severe 

restrictions). An MRO’s decision to contact a donor’s employer under these circumstances is not required 

or authorized by the Mandatory Guidelines. Rather, an MRO’s decision to contact an employer regarding 

safety issues related to a donor’s valid prescription is subject to the MRO’s voluntary choice and any 

obligations the MRO may have with the donor’s employing agency. 

Source

Medical Review Officer Guidance Manual for Federal Workplace Drug Testing; Section 4.5 

Question

Are agencies authorized to use oral fluids as an alternate drug testing specimen after Oct. 1, 2017? 

Answer

At this time, oral fluid is not approved as a federal drug testing specimen. Oral Fluid Mandatory 

Guidelines have been proposed (May 15, 2015; 80 FR 28101), but final Guidelines have not been 

published. The UrMG do not authorize oral fluid as an alternative specimen: references to the use of an 

alternate specimen type (e.g., oral fluid) are not applicable until final Guidelines have been implemented 

for the use of the alternate specimen type (see UrMG “Background” section of the Preamble and Section 

8.7). 

Source

UrMG, “Background” section of the Preamble and Section 8.7 

Frequently Asked Questions for Policy/Program 

Question

Is it within discretion of the federal agencies to decide if and when to expand the list of drugs routinely 

tested to include the four semi-synthetic opioids (oxycodone, oxymorphone, hydrocodone, 

hydromorphone)? 

Answer

Yes. UrMG Section 3.1 requires federal agencies to test each specimen for marijuana and cocaine, and 

authorizes federal agencies to test each specimen for opioids, amphetamines, and phencyclidine, as 

provided under Section 3.4. SAMHSA has strongly recommended the addition of the four semi-synthetic 
opioids (oxycodone, oxymorphone, hydrocodone, hydromorphone) and asked that agencies notify their 

service providers of their decision and, as appropriate, the implementation data, by September 15, 2017. 

Source

UrMG Sections 3.1 and 3.4; August 18 2017 NLCP Notice to HHS-Certified and Applicant Laboratories 

and NLCP Inspectors 

Question

Is it the responsibility of the federal agency to contact their service provider or laboratory to request the 

expanded testing (to include oxycodone, oxymorphone, hydrocodone, hydromorphone)? Must the 

recommended template titled “Decision Notification for the Addition of Semi-Synthetic Opioids to the 

Drugs Routinely Tested” provided in the August 16, 2017 letter sent to federal agencies and all HHScertified laboratories be used? 

Answer

Yes, agencies are responsible for advising their service providers. 

No, the template is not required and may be used or not used at the agency’s discretion. Since some 

agencies may not be prepared to add the additional analytes by October 1, SAMHSA instructed the 

agencies to notify their service providers of the date they will begin testing their workplace specimens for 

these drugs, and provided the template for the agency’s use. Subsequently, in a September 8, 2017 

Notice, SAMHSA instructed laboratories to contact federal agency clients who had not yet notified the 

laboratory of their decision. 

Source

UrMG Sections 3.1 and 3.4; SAMHSA letter emailed to Drug Program Coordinators on August 16, 2017; 

September 8, 2017 NLCP Notice to HHS-Certified and Applicant Laboratories and NLCP Inspectors 

Question

When will the MRO Manual be revised and how is it to be obtained? 

Answer

The revised MRO Guidance Manual has been posted on DWP’s website at 

https://www.samhsa.gov/workplace. 

Source

DWP Staff, 240-276-2600 (Workplace Helpline) 

Question

What MRO certifications are required for the revised Mandatory Guidelines effective October 1, 2017? 

Answer
To continue serving as an MRO for federal agency specimens, certified MROs must complete training on 

the UrMG prior to the October 1, 2017 effective date. 

Source

UrMG Section 13.3 

Question

Will federal agencies be required to report drug testing results of the four newly added semi-synthetic 

opioids (oxycodone, oxymorphone, hydrocodone, hydromorphone)? If so, will the Annual Survey Report 

be revised to reflect this? 

Answer

Yes. The Annual Survey Report has been revised to capture results of the added semi-synthetic opioids. 

Source

DWP Staff, 240-276-2600 (Workplace Helpline) 

Question

Do federal agencies have to submit their updated/revised Drug Free Workplace Program (DFWP) plans 

on or before 10/1/2017? Can they be submitted at a later date? Can agencies implement drug testing of 

oxycodone, oxymorphone, hydrocodone, hydromorphone before their revised plan receives HHS 

concurrence? 

Answer

There is no deadline for agencies to submit updated/revised Drug Free Workplace Program plans, but 

HHS requests that such plans be submitted as soon as practicable following any substantive changes made 

to an agency’s plan. Review by the Interagency Coordinating Group Executive Committee (ICGEC) is 

not needed in order for an agency to begin testing for the four semi-synthetic opioids (oxycodone, 

oxymorphone, hydrocodone, hydromorphone). 

Source

DWP Staff, 240-276-2600 (Workplace Helpline) 

Question

Is the addition of the four semi-synthetic opioids (oxycodone, oxymorphone, hydrocodone, 

hydromorphone) to the drug testing panel considered a “substantive change” to an agency plan? Define 

“substantive change”. 

Answer

A ‘substantive change’ is any alteration to a federal agency’s drug testing plan that affects the substance 

of the plan’s policy and/or procedures. It does not usually refer to purely editorial or other non- 
substantive updates. The addition of the four semi-synthetic opioids to an agency’s drug testing plan may 

constitute a substantive change. Federal agencies should contact DWP staff in order to receive tailored 

guidance that is specific to each agency’s plan. 

Question

Should federal agency employees be notified of the additional drugs to be tested? 

Answer

Federal agencies should consider, in consultation with their legal counsel, providing notice to federal 

agency employees of the panel of drugs that they will be tested for. Notably, Executive Order 12564, 

Section 4(b) states that, “before conducting a drug test, the agency shall inform the employee to be tested 

for the opportunity to submit medical documentation that may support a legitimate use of a specific 

drug.” 

Source

Executive Order 12564, Section 4(b) 

SAMHSA Note: These frequently asked questions (FAQs) and answers apply to federal agency drug 

testing programs that come under Executive Order 12564 dated September 15, 1986, section 503 of 

Public Law 100-71, 5 U.S.C. section 7301 note dated July 11, 1987, and the Department of Health and 

Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (82 

FR 7920) dated January 23, 2017 (effective October 1, 2017). 

This document does not apply to specimens submitted for testing under U.S. Department of 

Transportation (DOT) Procedures for Transportation Workplace Drug and Alcohol Testing Programs (49 

CFR Part 40). 

These FAQs are intended to assist Drug Program Coordinators, Collectors, Laboratory Responsible 

Persons, Medical Review Officers, and Federal Drug Testing Third Party Administrators in carrying out 

their responsibilities under the Mandatory Guidelines for Federal Workplace Drug Testing Programs 

using Urine (82 FR 7920). This guidance does not establish legally enforceable responsibilities, but may 

reference actions or responsibilities that are required under statutory or regulatory authorities. The use of 

the word “should” in this guidance means that something is suggested or recommended, but not 

necessarily required by law.