Effective Date: August 17, 2020 

Revised March 4, 2021 

1 

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 2020 Federal Custody and Control Form (CCF) for 

Urine Specimens

Date: March 4, 2021

Table of Contents

1. When can a federally regulated program begin using the 2020 Federal CCF? ........ 2

2. What are the allowable formats for the 2020 Federal CCF?..................................... 2

3. Can the 2017 Federal CCF be used after August 31, 2020?.................................... 2

4. How does a test facility (laboratory or instrumented initial test facility, IITF) report

urine specimen test results using the 2017 Federal CCF during the period of

September 1, 2020 to August 30, 2021? .................................................................. 2

5. Where can a sample proof of the 2020 Federal CCF be viewed? ............................ 3

6. What statements must appear on the 2020 Federal CCF?....................................... 3

7. What are the requirements for tamper-evident labels/seals?.................................... 3

8. Can the 2020 Federal CCF be modified? ................................................................. 4

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

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

10. Has the HHS Specimen Collection Handbook been revised for use with the 2020

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

11. Has the HHS MRO Guidance Manual been revised for use with the 2020 Federal

CCF? ........................................................................................................................ 7

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

Procedure (SOP) manual for the 2020 Federal CCF?.............................................. 8

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

2020 Federal CCF? .................................................................................................. 8

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

MROs using the 2020 Federal CCF? ....................................................................... 9

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

2020 Federal CCF? .................................................................................................. 9

16. How does an MRO report a verified result to the employer? .................................. 10
Effective Date: August 17, 2020 

Revised March 4, 2021 

2 

1. When can a federally regulated program begin using the 2020 Federal CCF?

The Office of Management and Budget (OMB) has approved the use of the 2020

Federal CCF as of August 17, 2020. 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 2020 Federal CCF?

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

document (i.e., digital or in a combination electronic and paper format). All Federal 

CCFs must conform to the formatting requirements of the OMB-approved Federal CCF. 

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. 

3. Can the 2017 Federal CCF be used after August 31, 2020? 

Yes, OMB has granted an extension for using the 2017 Federal CCF for urine 

specimens only. The 2017 Federal CCF is not authorized for use with oral fluid 

specimens.

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 with the 

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

listed in Step 5A) is authorized for use until August 30, 2021.

The 2017 Federal CCF is not authorized for use with oral fluid specimens; the 2020 

Federal CCF should be used for oral fluid specimens. As of August 30, 2021, the 2020

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

(laboratory or instrumented initial test facility, IITF) must treat the use of the 2017

Federal CCF for urine specimens as a correctable discrepancy. NOTE: IITFs are not 

authorized to test oral fluid specimens.

4. How does a test facility (laboratory or instrumented initial test facility, IITF) 

report urine specimen test results using the 2017 Federal CCF during the 

period of September 1, 2020 to August 30, 2021?

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

period (i.e., through August 29, 2021), the laboratory or IITF must report the results 

using the same procedures used prior to the CCF’s extended date. (As noted under 

question 3 above, as of August 30, 2021, the test facility must treat the use of the 2017 

Federal CCF for urine specimens as a correctable discrepancy. The 2017 Federal CCF 

is not authorized for use with oral fluid specimens.) 
Effective Date: August 17, 2020 

Revised March 4, 2021 

3 

5. Where can a sample proof of the 2020 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. 

6. What statements must appear on the 2020 Federal CCF? 

a. 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.

b. 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: Privacy Act Statement (For Federal Employees Only) and Public 

Burden Statement. Wording must be identical to that on the OMB-approved 

Federal CCF.

7. What are the requirements for tamper-evident labels/seals? 

a. Once applied to the specimen bottles/tubes, 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. 

b. The label/seal material and ink must prevent smearing and smudging that could 

cause the specimen identification number to become illegible.

c. Labels/seals must be designed to not tear when the donor initials the label and 

the collector dates the label on the specimen bottle/tube. To conserve space and 

facilitate required annotations on labels/seals, a manufacturer may, but is not 

required to, provide specimen bottles or tubes with a tamper-evident label 

applied during production, with an area for the donor to initial and/or the collector 

to record the collection date. The donor and/or collector annotations may be 

made to the manufacturer-applied labels instead of the labels/seals applied by 

the collector during the collection. 

d. 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 (e.g., by the form manufacturer or when printed ondemand at the collection site). 

e. For an electronic CCF (digital or combination electronic and paper): The unique 

specimen identification number may be preprinted on the labels/seals and 

applied to the electronic Federal CCF by the collector (i.e., by typing or scanning 

the barcoded number on both the A and B specimen labels/seals into the 
Effective Date: August 17, 2020 

Revised March 4, 2021 

4 

system). Alternatively, the unique specimen identification number on the 

electronic CCF may be printed onto the A and B specimen labels/seals during 

the collection. 

f. A single pair of labels/seals may be provided (i.e., one for specimen A and one 

for specimen B), or two pairs of labels/seals may be provided (i.e., two for urine 

specimens A and B, and two for oral fluid specimens A and B) of which only one 

pair is used. The size of the tamper-evident labels/seals may vary, but each must 

be wide enough to serve as a tamper-evident seal and to include the humanreadable specimen identification number, with space for the donor to initial and 

the collector to date (i.e., unless a manufacturer-applied label is used for these 

annotations, as described in item c above). 

g. For a single pair of labels/seals (to be used for either specimen type): The 

labels/seals must be suitable as tamper-evident seals for both urine bottles and 

oral fluid tubes. The labels/seals may be perforated to enable the collector to 

apply the entire (longer) labels to urine bottles or tear at the perforation to create 

smaller (shorter) labels for oral fluid tubes. 

h. For two pairs of labels/seals (one A and B pair for urine bottles and one A and B 

pair for oral fluid tubes): The collector cannot have multiple pairs of 

labels/seals with the same specimen identifier. To ensure unique identifiers 

for each label/seal pair, each pair may have the same specimen identification 

number as the Federal CCF plus an alpha-numeric character added to 

distinguish urine specimen labels/seals from oral fluid specimen label/seals. It is 

not acceptable to use multiple labels with the same specimen identification 

number, distinguished only by color. When an electronic Federal CCF system is 

used, as described under item e above, the unique specimen identification 

number may be preprinted on the labels/seals and applied to the electronic 

Federal CCF, or the unique specimen identification number on the electronic 

Federal CCF may be printed on the labels/seals. Therefore, the label/seal pairs 

may be preprinted with different specimen identification numbers based on the 

specimen type, or the specimen identification number may be printed only on the 

label/seal pair designed for the specimen type collected. 

i. For oral fluid specimens: Labels/seals must be designed so the manufacturer’s 

expiration date on the specimen tube remains visible when the collector properly 

applies the label/seal. Transparent material may be used for all or part of the 

label/seal, providing the label/seal meets requirements in items a-c above.

8. Can the 2020 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. Certified test

facilities must request approval to use electronic processes that may conflict with 

current program guidance and requirements. The test facility must submit the request 

with proposed procedures and example documents to SAMHSA’s National Laboratory 
Effective Date: August 17, 2020 

Revised March 4, 2021 

5 

Certification Program (NLCP) and receive approval prior to implementing the revised 

procedures.

General

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

righthand corner of the form.

b. 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.

c. 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. 

d. 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. 

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

the collection site address may have lines.

f. The space for the donor’s SSN, Employee I.D. No., or Commercial Driver’s 

License (CDL) No. and State may have combs, boxes, or a single line. 

g. The size of each checkbox may vary slightly.

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

i. 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

a. 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.

b. 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). 

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

address, and collection site information is permitted.

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

location indicated on the OMB-approved Federal CCF.

e. 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 
Effective Date: August 17, 2020 

Revised March 4, 2021 

6 

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. 

f. 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.

Electronic Federal CCF

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

may be omitted. 

b. For oral fluid specimens: Either the collector or the laboratory accessioner must 

record the manufacturer’s expiration date on the A specimen tube as the 

Primary/Single Specimen Device Expiration Date in Step 4 of the Federal CCF 

and record the manufacturer’s expiration date on the B specimen tube as the 

Split Specimen Device Expiration Date in Step 4 of the Federal CCF. For an 

electronic CCF, the manufacturer’s expiration date on each specimen tube may 

be recorded on the Federal CCF by typing or scanning the barcoded date on 

each specimen tube into the system. An ECCF system may prompt the collector 

to type or scan the barcoded expiration date on each specimen tube (i.e., both A 

and B specimens) and record the information in Step 4 of the Federal CCF. This 

may be acceptable, providing that the expiration dates remain visible on each 

tube, to enable the laboratory accessioner to verify the date and document 

verification upon receipt. 

Labels/Seals

a. The unique specimen identification number on the tamper-evident labels/seals 

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

human-readable number only.

b. The color of the printed information on the “A” specimen bottle label/seal may be 

different than the color of the printed information on the “B” specimen bottle 

label/seal.

(See also question 7 above for acceptable options for labels/seals.)

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

electronic Federal CCF?

An electronic Federal CCF (i.e., digital or combination electronic and paper) 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 Federal CCFs, and their 

ECCF system providers, 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: 
Effective Date: August 17, 2020 

Revised March 4, 2021 

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a. System validation

b. 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)

c. Protection of records to enable accurate and ready retrieval through the records 

retention period

d. Limiting system access to authorized individuals

e. 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)

f. 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 

2020 ECCF, the test facility must submit updated ECCF information to the NLCP

including the Process Overview, Topic Outline of Proposed SOP Revisions, the 2020

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

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

2020 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

(UrMG) and a new HHS Oral Fluid Specimen Collection Handbook has been developed 

to reflect the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs 

using Oral Fluid (OFMG). Both handbooks describe how the collector completes the 

2020 Federal CCF. The handbooks are available on the SAMHSA website 

(www.samhsa.gov/workplace).

11.Has the HHS MRO Guidance Manual been revised for use with the 2020

Federal CCF?

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

Guidelines for Federal Workplace Drug Testing Programs using Urine and the HHS 

Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid, 
Effective Date: August 17, 2020 

Revised March 4, 2021 

8 

including how test facilities will be reporting results. The revised manual is available on 

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

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

Procedure (SOP) manual for the 2020 Federal CCF?

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

address the 2020 Federal CCF (e.g., accessioning, chain of custody, and reporting 

procedures). Since a laboratory or IITF may continue receiving urine specimens 

collected using the 2017 Federal CCF, the SOP manual will need to have procedures

applicable to both forms until August 30, 2021, when the 2017 Federal CCF is no 

longer approved for use. At that time, the laboratory must have procedures to handle 

urine specimens submitted with the 2017 Federal CCF as having a recoverable 

discrepancy. Because the 2017 Federal CCF is not authorized for use with oral fluid 

specimens, an oral fluid testing laboratory needs to address the 2020 Federal CCF 

throughout its SOP and include procedures for rejecting oral fluid specimens received 

with the 2017 Federal CCF. NOTE: IITFs are not authorized to test oral fluid 

specimens.

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

the 2020 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). For oral fluid specimens, the 

accessioner also records the device expiration date on the A specimen tube as the 

Primary/Single Specimen Device Expiration Date, and the expiration date on the B 

specimen tube as the Split Specimen Device Expiration Date. If the collector recorded 

the expiration dates in Step 4 of the CCF, the accessioner verifies the recorded 

expiration dates versus those on the A and B specimen tubes. If an expiration date 

differs from that on the tube, the accessioner makes a single line through the incorrect 

date, records the date that is on the tube, and initials and dates the annotation. 

Electronic CCF: 

a. Digital: 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 
Effective Date: August 17, 2020 

Revised March 4, 2021 

9 

an electronic signature, the accessioner marks the appropriate checkbox to 

document the condition of the primary specimen seal, records the expiration date 

of each collection device (i.e., on the A and B specimen tubes for oral fluid 

specimens), 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. Note: See also questions 8 and 9 above. 

b. Combination electronic and paper: The process described above for a paper 

CCF is used for the authoritative Test Facility copy (Copy 1) of a combination 

electronic and paper CCF.

Urine specimens received from an IITF

When forwarding a urine 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. 

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 a copy of the 

Federal CCF (copy of Copy 1) and the original 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. 

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

MROs using the 2020 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 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.

Urine specimens tested and 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.

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

the 2020 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 
Effective Date: August 17, 2020 

Revised March 4, 2021 

10

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. 

16.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

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.