FDA regulates a type of IVD referred to as drugs of abuse tests that are sold to consumers or healthcare professionals in the United States FDA reviews many of these tests before they are sold for use. In its review, the FDA evaluates the design and performance of tests and sample collection systems to help ensure that they produce accurate results. The FDA also reviews the test instructions and package inserts to help ensure that the end users can understand how to perform the tests easily and successfully.
Link to Accu-Tell
FDA does not review drugs of abuse tests intended for employment and insurance testing provided they include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
The information on this webpage may be helpful to anyone who performs drugs of abuse testing, including consumers, employers, or trained medical professionals. In addition, the manufacturers of these tests may also be interested in the types of data typically submitted for FDA review.
FDA maintains a website called Device Advice that provides information on many aspects of tests that are regulated by FDA, including drugs of abuse tests. Within this website you may want to refer to the section entitled Overview of IVD Regulation.
For information specific to drugs of abuse, please refer to the following:
In addition, you can find Decision Summaries for all drugs of abuse tests that FDA cleared for marketing. To find a Decision Summary, follow the steps below:
Some drugs of abuse tests may be sold under different brand names although the test itself is identical. If you want to search by a brand name, navigate to: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/Search.cfm, type the brand name into the “Test System / Manufacturer” field and select “Search.” This will produce a list of all of the tests with that name that have been cleared by FDA for marketing.
FDA also maintains a database of tests that have been cleared for over-the-Counter (OTC) use. If you want to find a specific over-the-counter test, navigate to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm and enter any combination of the test (brand) name, the manufacturer name, or the document number (FDA clearance number) and select “Search.” This will display a list of all cleared OTC tests for the fields you entered. You may then select a specific test name. You can also search for all of the OTC tests for a particular drug by selecting it from the “Test Type” drop-down list.
The FDA categorizes all regulated drug tests with a unique 3 letter product code. The following table lists commonly used product codes for drugs of abuse tests.
You may search for additional product codes using the Classification database. To use this database, navigate: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm, type the name of the drug in the “Device” box, and select “Search.”
Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical products. If you suspect problems with a Drugs of Abuse Testing device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's device user facility reporting requirements should follow the reporting procedures established by their facilities. For more information, please see How to Report a Problem (Medical Devices)
A drug test looks for the presence or absence of a drug in a biological sample, such as urine, blood, or hair. Drug tests may also look for drug metabolites in the sample. A drug metabolite is a substance made or used when the body breaks down (or “metabolizes”) a drug.
Drug tests target only specific drugs or drug classes above a predetermined cutoff level.1 A cutoff level is a point of measurement at or above which a result is considered positive and below which a result is considered negative. For example, in workplace drug testing the federal cutoff level for a cannabis drug test in urine is 50ng/mL. A test result below 50ng/mL will be reported as negative even if the result is above 0. This cutoff level helps to limit false positives.2
Drug testing is different than “drug checking,” which helps people who use drugs determine which chemicals are found in the substance they intend to take. Drug checking is a type of harm reduction.
Usually, drug testing involves a two-step process: an initial drug screen and a confirmatory test.
If an initial drug screen is positive, a second round of more precise confirmatory testing is done to confirm or rule out that positive result.
Drug tests are commonly used to detect five categories of drugs as defined by the federally mandated workplace drug testing guidelines, although health care providers can order additional tests, if needed.2,3 This list may also change as new drugs enter the drug supply.4
These drug tests are usually urine tests, though other biological samples can also be used:2
Drug tests can also detect additional categories of drugs:
For more information, please visit Drug Of Abuse Tests.
Drug testing is used to find out whether a person has used a substance in the recent past. Drug testing can sometimes also detect passive exposure to drugs, such as secondhand smoke or prenatal exposure. The length of time following exposure that a drug can be detected during testing can vary.
Drug testing cannot diagnose a substance use disorder.2
A drug test may be used for different reasons, including:
Urine is the preferred and most used biological sample for drug testing, as it is available in large amounts, contains higher concentrations of drugs and metabolites than blood, and does not require needles.11 Urine drug tests are also available during point-of-care, or outside the laboratory (e.g., doctor’s office, hospital, ambulance, at home).12
Less commonly, drug testing may use blood or serum, oral fluid (saliva), breath, sweat, hair, or fingernails.1
There are FDA-approved at-home drug tests (urine or saliva) readily available at pharmacies. It is important to follow specific instructions and send a urine sample to a laboratory for confirmation.
Urine drug screening can be an important tool for substance use disorder treatment.13 Health care providers can use urine drug screens to follow a patient’s progress. Test results are used to determine whether dosing adjustments or other treatment interventions are needed. After unexpected results, patients and health care providers can speak openly about treatment and progress to better tailor the treatment to the patient’s needs.10,13
Federal guidelines for Opioid Treatment Programs require drug testing. Urine drug tests are often administered as part of the intake process to confirm substance use history and as a routine part of therapy.14
Understanding the limits of urine drug screening and other toxicology testing is an important part of making treatment decisions. Drug testing is never the sole determinant when making patient care decisions.10
Contingency management is a behavioral therapy that uses motivational incentives including tangible rewards for drug-negative urine specimens. Contingency management has been demonstrated to be highly effective in the treatment of substance use disorders including addiction to stimulants.15
If a drug test result is positive during substance use disorder treatment, health care providers may prescribe additional or alternative treatments. Drug test results should not be used as the sole factor when making patient care decisions, including discharge decisions.10,13 It is best practice for addiction treatment providers to avoid responding punitively to a positive drug test or using it as the basis for expelling someone from treatment. However, actual consequences of a positive drug test during substance use treatment may depend on state laws and the individual program.
Recovery residences (e.g., sober living homes) may also use drug testing to monitor the abstinence of residents, and residents may be expelled on the basis of positive drug tests. However, it is important that expulsion should not prevent or interfere with the individual continuing to receive outpatient addiction treatment.10
Urine drug tests do not provide information regarding the length of time since last ingestion, overall duration of use, or state of intoxication.16
Sometimes urine can be difficult to obtain due to dehydration, urinary retention (the person is unable to empty their bladder), or other reasons.17
Drug testing can be a useful tool, but it should not be the only tool for making decisions. Drug testing results should be considered alongside a patient’s self-reports, treatment history, psychosocial assessment, physical examination, and a practitioner’s clinical judgment.2,18
Drug testing can also produce false positives and false negatives.
An essential component of any drug testing program is a comprehensive final review of laboratory results.18 In federally mandated drug testing programs, this role is often filled by a medical review officer, who will review, verify, and interpret positive test results. Medical review officers provide quality assurance and evaluate medical explanations for certain drug test results. The medical review officer should be a licensed physician with a knowledge of substance use disorders.21
To avoid misinterpreting drug test results, health care providers can use experts in the field. This includes clinical chemists or medical toxicologists at hospitals, clinics, or poison control centers. Expert assistance with toxicology interpretations can improve the accuracy of drug test results.
NIDA is a biomedical research organization and does not provide personal medical advice, legal consultation, or medical review services to the public. While NIDA-supported research may inform the development and validation of drug-screening technologies, NIDA does not manufacture, regulate, or distribute laboratory or at-home drug screening products. The U.S. Food and Drug Administration (FDA) regulates most of these products in the United States. Those with concerns about drug screening results may consider reaching out to the drug-screening program or a qualified health care professional. For more information on workplace drug screening, please visit the Substance Abuse and Mental Health Services Administration (SAMSHA) Division of Workplace Programs website.
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