Department of Health and Human Services

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Prevention

Division of Workplace Programs

Subject: Guidance for Using the 2017 Federal Custody and Control Form (CCF)

for Urine Specimens

Date: August 8, 2017

Table of Contents

1. When can a federally regulated program begin using the 2017 Federal CCF? ......... 3

2. What are the allowable formats for the 2017 Federal CCF?...................................... 3

3. Can the 2014 Federal CCF be used after August 31, 2017?..................................... 3

4. How does a test facility (laboratory or IITF) report results using the 2017 Federal 

CCF during the period of August 8, 2017 to October 1, 2017?.................................. 3

5. How does a test facility (laboratory or IITF) report results using the 2014 Federal 

CCF during the period of August 8, 2017 to October 1, 2017?.................................. 3

6. How does a test facility (laboratory or IITF) report results using the 2014 Federal 

CCF during the period of October 1, 2017 to July 1, 2018?....................................... 4

7. Where can a sample proof of the 2017 Federal CCF be viewed? ............................. 4

8. What statements must appear on the 2017 Federal CCF?........................................ 4

9. Can the 2017 Federal CCF be modified? .................................................................. 4

10.What are the responsibilities of service providers choosing to use an electronic 

Federal CCF? ............................................................................................................ 6

11.Has the HHS Urine Specimen Collection Handbook been revised for use with the 

2017 Federal CCF? ................................................................................................... 7

12.Has the HHS MRO Manual been revised for use with the 2017 Federal CCF?......... 7

13.Does a test facility (laboratory or IITF) need to change its Standard Operating 

Procedure (SOP) manual for the 2017 Federal CCF? ............................................... 8

14.How does a test facility (laboratory or IITF) document specimen receipt using the 

2017 Federal CCF? ................................................................................................... 8

15.How does a test facility (laboratory or IITF) report primary specimen results to MROs 

using the 2017 Federal CCF?.................................................................................... 9

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16.How does a laboratory report split (Bottle B) specimen results to MROs using the 

2017 Federal CCF? ................................................................................................... 9

17.What are tamper-evident labels/seals?...................................................................... 9

18.How does an MRO report a verified result to the employer? ..................................... 9

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1. When can a federally regulated program begin using the 2017 Federal CCF?

The Office of Management and Budget (OMB) has approved the use of the 2017

Federal CCF as of August 8, 2017. Additional information is available at

www.reginfo.gov (enter the OMB number 0930-0158 in the search area).

2. What are the allowable formats for the 2017 Federal CCF?

The Federal CCF may be used as a paper (hardcopy) or electronic (digital) document, 

or in a combination electronic and paper format.

A paper Federal CCF may be either 1) a preprinted, multiple-part carbonless form or 2) 

a multiple-part CCF that is printed for a specific drug test (i.e., printed “on-demand” for 

the collection), usually at the collection site. A paper CCF must conform to the 

formatting requirements of the OMB-approved Federal CCF.

3. Can the 2014 Federal CCF be used after August 31, 2017?

Yes, OMB has granted an extension for using the 2014 Federal CCF.

TERMS OF CLEARANCE: OMB approves the revised Federal Drug Testing Custody 

and Control Form (CCF). In addition, the previous version of the CCF (the CCF without 

the four new analytes - oxycodone, oxymorphone, hydrocodone, and hydromorphone -

listed in Step 5A) is authorized for use until June 30, 2018. As of July 1, 2018, the 2017 

Federal CCF must be used for federally regulated specimens, and the laboratory must 

treat the use of the 2014 Federal CCF as a correctable discrepancy.

4. How does a test facility (laboratory or IITF) report results using the 2017

Federal CCF during the period of August 8, 2017 to October 1, 2017?

If a specimen is received at the test facility with the 2017 Federal CCF during this period

(i.e., through September 30, 2017), the laboratory or IITF must report the results using

the same procedures as for a specimen received with the 2014 Federal CCF (also see

questions 15 and 16 below). The laboratory or IITF must include the following comment

on the Remarks line in Step 5a of the Federal CCF and on any electronic report: “This 

specimen was analyzed and reported in accordance with the HHS Mandatory 

Guidelines effective October 1, 2010.” In addition, if the specimen is positive for 

methylenedioxyethylamphetamine (MDEA), the laboratory must record “MDEA” and the 

concentration on the Remarks line in Step 5a of the Federal CCF.

5. How does a test facility (laboratory or IITF) report results using the 2014 

Federal CCF during the period of August 8, 2017 to October 1, 2017?

If a specimen is received at the test facility with the 2014 Federal CCF during this period

(i.e., through September 30, 2017), the laboratory or IITF must report the results using 

the same procedures used prior to the CCF’s extended date. 

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6. How does a test facility (laboratory or IITF) report results using the 2014 

Federal CCF during the period of October 1, 2017 to July 1, 2018?

If a specimen is received at the test facility with the 2014 Federal CCF during this 

period, the laboratory or IITF must report the results on the 2014 Federal CCF using the 

same procedures as for a specimen received with the 2017 Federal CCF (also see 

questions 15 and 16 below). The laboratory or IITF must include the following comment 

on the Remarks line in Step 5a of the Federal CCF and on any electronic report: “This 

urine specimen was analyzed and reported in accordance with the HHS Mandatory 

Guidelines effective October 1, 2017.” In addition, if the specimen is positive for an 

opioid analyte that is not listed on the CCF, the laboratory must record the analyte name 

and concentration on the Remarks line in Step 5a of the Federal CCF. (As noted under 

question 3 above, as of July 1, 2018, the test facility must treat the use of the 2014 

Federal CCF as a correctable discrepancy.)

7. Where can a sample proof of the 2017 Federal CCF be viewed?

A sample of the Federal CCF is available on the SAMHSA drug testing website

www.samhsa.gov/workplace and at www.reginfo.gov. 

8. What statements must appear on the 2017 Federal CCF?

• The Public Burden Statement must appear on all Federal Government forms 

that place a reporting burden on gathering information. This statement must be 

included on the back of each paper copy of the Federal CCF (i.e., Copies 1 

through 4). If an electronic Federal CCF is used, this statement must be provided 

as a separate page. Wording must be identical to that on the OMB-approved 

Federal CCF.

• The following must be printed on the back of the donor copy (Copy 5) of a paper 

Federal CCF or, if an electronic Federal CCF is used, be provided as a separate 

page: Instructions for Completing the Federal Drug Testing Custody and 

Control Form for Urine Specimen Collection, Privacy Act Statement (For 

Federal Employees Only), and Public Burden Statement. Wording must be 

identical to that on the OMB-approved Federal CCF.

9. Can the 2017 Federal CCF be modified?

Yes. SAMHSA recognizes that suppliers use different hardware and software for paper 

and for electronic forms. Minor differences in appearance from SAMHSA’s Federal CCF 

proof are permitted provided that they do not significantly impact the required format. 

The following lists some acceptable differences and modifications:

General

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1. The OMB number may appear either vertically or horizontally in the upper right 

hand corner of the form.

2. The unique specimen identification number at the top of the form may be either a 

bar code with an associated human-readable number or a human-readable 

number only.

3. The data entry/information fields may be highlighted using different colors to 

show where the collector, donor, and test facility will provide information. The 

colors used to highlight the fields may be different for different fields but must not 

prevent making clear facsimiles and photocopies of the information that is printed 

or handwritten in those fields. 

4. If a test facility uses the unique specimen identification number to track 

specimens after receipt and does not assign a separate accession number, the 

words ACCESSION NO. are not required on the top of the form. 

5. The spaces for the employer name and address, MRO name and address, and 

the collection site address may have lines.

6. The space for the donor’s SSN or Employee I.D. No. may have combs, boxes, or 

a single line. 

7. The size of each checkbox may vary slightly.

8. The font size and style used for letters may vary to enhance readability.

9. The form may include a designated space for a collector identification number 

(e.g., as assigned by a collector training organization) in Step 4 beside the 

collector’s signature or printed name.

Paper Federal CCF

1. For preprinted paper CCFs, the name and address of the test facility and the 

unique specimen identification number at the top of the form may be printed 

during the original printing process or added by overprinting after the form is 

assembled.

2. For individually printed (“on-demand”) paper CCFs, the unique specimen 

identification number must be printed on the form to irrevocably link the same 

specimen identification number on the form and the labels/seals (i.e., it is not 

sufficient to place a label on the printed Federal CCF). 

3. Preprinting and/or overprinting the employer name and address, MRO name and 

address, and collection site information is permitted.

4. The exact location for each item on the printed form may vary slightly from the 

location indicated on the OMB-approved Federal CCF.

5. The legend (i.e., copy number and name) at the bottom of Copies 2 through 5 

may be printed using different colors, or a different color stripe may be printed at 

the bottom of Copies 2 through 5. To ensure consistency and correct distribution

of the copies, if different color stripes or legends are used at the bottom of each 

copy, the following colors must be used: MRO Copy - pink, Collector Copy -

yellow, Employer Copy - blue, Donor Copy - green. 

6. Reference mark(s) may be used to position the form in a printer to overprint 

information in the correct location or to optically scan the information in the 

various fields.

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Electronic Federal CCF

1. The legend (i.e., copy number and name) at the bottom of Copies 2 through 5 

may be omitted.

Labels/Seals

1. The unique specimen identification number on the tamper-evident label(s)/seal(s) 

may be either a bar code with an associated human-readable number or a 

human-readable number only.

2. The size of the two tamper-evident labels/seals may vary, but each must be at 

least 3⁄4 inch wide.

3. The color of the preprinted information on the “A” specimen bottle label/seal may 

be different than the color of the preprinted information on the “B” specimen 

bottle label/seal.

4. The unique specimen identification number must be preprinted on labels/seals

for a paper Federal CCF. If the labels/seals are attached at the bottom of the 

paper Federal CCF, the specimen identification number may be preprinted during 

the original printing and form assembly process, or added by overprinting after 

the form is assembled. For a combination electronic/paper CCF: The unique 

specimen identification number may be preprinted or may be printed on the 

labels/seals when the collector prints Copy 1 to be sent to the test facility with the 

specimen.

10.What are the responsibilities of service providers choosing to use an 

electronic Federal CCF?

An electronic Federal CCF must be the functional equivalent of a paper Federal CCF 

with respect to integrity, accuracy, and accessibility. Federally regulated employers and 

drug testing service providers (e.g., collectors, test facilities, MROs) who use electronic 

or combination electronic and paper Federal CCFs must implement procedures and 

controls to ensure the authenticity, integrity, and confidentiality of electronic records, 

and to ensure that electronic signatures are the legally binding equivalent of traditional 

handwritten signatures. These procedures and controls include, but are not limited to:

• System validation

• The ability to generate accurate and complete copies of records in both human 

readable and electronic form suitable for inspection, review, and copying upon 

request of authorized parties (e.g., the MRO, federal agency, or SAMHSA)

• Protection of records to enable accurate and ready retrieval through the records 

retention period

• Limiting system access to authorized individuals

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• Secure, computer-generated, time-stamped audit trails to independently record 

the date and time of operator entries and actions that create, modify, or delete 

records from the time of initiation of the Federal CCF (changes should be evident 

when reviewing the original record, and any electronic or paper copy of the 

original record)

• Use of authority checks to ensure that only authorized individuals can use the 

system, electronically sign a record, access the operation or computer system 

input or output device, alter a record, or perform the operation at hand.

Before implementing an electronic Federal CCF, HHS-certified IITFs and laboratories

must submit information including a detailed plan and proposed standard operating 

procedures (SOPs) for SAMHSA review and approval (i.e., through SAMHSA’s National 

Laboratory Certification Program, NLCP). The review of validation records, specimen 

records, the collection process, SOPs, staff training records, and practices associated 

with the electronic Federal CCF will be part of the NLCP inspection process. 

For test facilities approved to use an ECCF system: Before implementing the revised 

2017 ECCF, the test facility must submit updated ECCF information to the NLCP

including the Process Overview, Topic Outline of Proposed SOP Revisions, the 2017 

ECCF, Training Plans for Federal ECCF Users, and System Validation Plan.

11.Has the HHS Urine Specimen Collection Handbook been revised for use with 

the 2017 Federal CCF?

Yes. The HHS Urine Specimen Collection Handbook has been revised to reflect the 

HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine

and how the collector completes the CCF. The revised handbook is available on the 

SAMHSA website (www.samhsa.gov/workplace).

12.Has the HHS MRO Manual been revised for use with the 2017 Federal CCF?

Yes. The HHS MRO Manual has been revised to reflect the HHS Mandatory Guidelines 

for Federal Workplace Drug Testing Programs using Urine and how test facilities will be 

reporting results. The revised manual is available on the SAMHSA website 

(www.samhsa.gov/workplace).

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13.Does a test facility (laboratory or IITF) need to change its Standard Operating 

Procedure (SOP) manual for the 2017 Federal CCF?

Yes. A certified laboratory or IITF must revise all SOP sections, where appropriate, to 

address the 2017 Federal CCF (e.g., accessioning, chain of custody, and reporting 

procedures). Since the laboratory may continue receiving 2014 Federal CCF, the SOP 

manual will need to have procedures applicable to both forms until July 1, 2018, when 

the 2014 Federal CCF is no longer approved for use. At that time, the laboratory must 

have procedures to handle specimens submitted with the 2014 Federal CCF as having 

a recoverable discrepancy.

14.How does a test facility (laboratory or IITF) document specimen receipt using

the 2017 Federal CCF?

Specimens received from a collection site

Paper CCF: The test facility that receives the specimen package from the collection site 

continues the specimen’s chain of custody by completing the appropriate chain of 

custody entries in Step 4 (i.e., “Received at Lab or IITF).” In addition to signing and 

printing his or her name, the accessioner records the receipt date, marks the 

appropriate checkbox to document the condition of the primary specimen seal, and 

releases custody of the specimen (e.g., to a storage area). This process is also used for 

Combination (electronic/paper) ECCFs.

Electronic CCF: To facilitate linkage of the specimen package to the electronic Federal 

CCF sent to the test facility, the collector either 1) includes a printed copy of the Test 

Facility copy (i.e., Copy 1) of the Federal CCF with the specimen; or 2) applies a label to 

the outside of the specimen package, with the specimen identification number, test 

facility name and contact information, and collection site name and contact information.

The test facility that receives the specimen package from the collection site continues 

the specimen chain of custody on the electronic Federal CCF. In addition to 

documenting receipt of the specimen using an electronic signature, the accessioner 

documents the condition of the primary specimen seal and releases custody of the 

specimen (e.g., to a storage area). Note: If a printed copy of Copy 1 is included in the 

specimen package, the accessioner may, but is not required to, annotate this form. This

is only a replica of the Federal CCF which contains the collector’s electronic signature

and is not the chain of custody for the specimen.

Specimens received from an IITF

When forwarding a specimen to a laboratory, an IITF sends both the original Federal 

CCF (Copy 1) and an IITF Supplemental CCF with the specimen. The laboratory that 

receives the specimen package from the IITF continues the specimen chain of custody 

on the IITF Supplemental CCF. This may be a paper or electronic form. 

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Specimens or aliquots received from another certified laboratory for retesting

When forwarding a specimen or aliquot to another laboratory for retesting, the 

laboratory that tested and reported the primary specimen (Lab A) sends both a copy of 

the Federal CCF (copy of Copy 1) and the transmittal chain of custody form with the 

specimen or aliquot. The laboratory that receives the specimen package continues the 

specimen chain of custody on the transmittal chain of custody form. This may be a 

paper or electronic form.

15.How does a test facility (laboratory or IITF) report primary specimen results to 

MROs using the 2017 Federal CCF?

A test facility must fax, courier, mail, or electronically transmit the completed Federal 

CCF (copy of Copy 1) to the MRO, with one exception. The test facility may report 

specimens that were received with a paper Federal CCF as negative using only a 

computer-generated electronic report, provided that the report contains sufficient 

information to ensure that the test result is properly associated with the MRO copy 

(Copy 2) of the Federal CCF.

Specimens forwarded by an IITF: A laboratory must also send a copy of the completed 

IITF Supplemental CCF to the MRO for all results. The laboratory may fax, courier, mail, 

or electronically transmit a legible image or copy of this form.

16.How does a laboratory report split (Bottle B) specimen results to MROs using 

the 2017 Federal CCF?

For all split specimen results, the split testing laboratory must fax, courier, mail, or 

electronically transmit the completed Federal CCF (i.e., the copy of Copy 1) to the 

MRO. For “Failed to Reconfirm” results, the laboratory must also complete and send a 

laboratory Split Specimen Report Form to the MRO and include a reference to this 

separate laboratory report in the “Reason” line in Step 5b of the Federal CCF. 

17.What are tamper-evident labels/seals? 

Once applied, tamper-evident labels/seals cannot be removed and replaced without 

visible evidence that tampering has occurred. It is the responsibility of the supplier of the 

labels/seals to ensure that they are tamper-evident. However, HHS-certified test 

facilities must perform a study to verify that the labels/seals are tamper-evident.

Tamper-evident specimen bottle labels/seals must be at least 3⁄4-inch wide.

18.How does an MRO report a verified result to the employer?

For all verified results, an MRO may fax, courier, mail, or electronically transmit a legible 

image or copy of the report to the agency/employer.

The result sections on the MRO Copy (Copy 2) of the Federal CCF (Step 6 for the

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primary specimen and Step 7 for the split specimen) are formatted in accordance with 

MRO reporting requirements in the HHS Mandatory Guidelines. To complete the 

Federal CCF, the MRO marks the appropriate checkbox(es) for the verified result and 

records information in the designated spaces to specify the test results (i.e., drug 

analytes, substitution, adulteration). The MRO includes any explanatory comments on 

the “Remarks” line and signs and dates the CCF.

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