An opioid treatment program is a place, not a pill. Federal rules define an OTP as a program that treats opioid use disorder with medicine, and that is registered under the Controlled Substances Act [1]. Everything else about it follows from that.
The rules sit in part 8 of title 42 of the Code of Federal Regulations. The part is called Medications for the Treatment of Opioid Use Disorder [1]. Those rules took effect in 2001. A new final rule came out in February 2024 [2].
This page walks through what the rules ask of a program, who checks on it, what it has to offer, how take-home medicine is decided, and how to find one. If you want to compare settings rather than rules, start with our guide to medication-assisted treatment.
What an opioid treatment program is, in federal terms
Note the word the rules avoid: clinic. They say program, and they spell out what a program has to be.
Full care, in their words, means the ongoing use of medicine plus a range of harm reduction, medical, behavioral health and recovery support services [1]. Medicine is one item on a list of five.
The rules also split two things people mix up. Ongoing medicine treatment means care that does not stop, at steady levels, for more than 21 days [1]. Withdrawal management means giving smaller and smaller amounts to bring a person to an opioid-free state [1]. They are two paths, with two sets of rules. Medical detox is the second one.
A program may also run a medication unit. That is a site set up as part of the program, but in another place, where staff or a local pharmacist can hand out medicine, take test samples, or offer other services [1]. It can be a building or a van [1].
Who has to say yes before a program opens
Three bodies sign off, which is why a new program cannot appear overnight.
First, accreditation. To be eligible, an applicant has to be accredited by a body the Secretary of Health and Human Services has approved [6]. An accreditation survey is a review of the program on site or online, against the federal standards [1].
Second, certification. The applicant has to get a certificate from the Secretary, or by delegation from the Assistant Secretary for Mental Health and Substance Use, saying it is qualified and will follow the standards [6]. SAMHSA says it plainly. To serve patients, programs must finish both steps and meet the other rules in part 8 [2].
Third, drug registration. The program is registered under the Controlled Substances Act [1]. On top of that, each state has a State Opioid Treatment Authority. That is the agency the governor names to oversee this care inside the state [1].
Two jobs carry the weight inside the walls. Every program has to name a program sponsor and a medical director [3]. The medical director is a doctor, licensed in that state, who is answerable for all the medical and behavioral health care the program gives [1]. The sponsor does not have to be a doctor. The sponsor does have to make sure a licensed doctor holds the medical director’s chair [1].
The system is bigger than most people picture. SAMHSA backs more than 1,900 of these programs, and they treat more than 600,000 patients a year [2].
Which medications a program gives out
The rules name three: methadone, buprenorphine and its combination products, and naltrexone [3]. That matches the Food and Drug Administration, which says three medications are approved to treat opioid use disorder [4]. The FDA puts the number of people who have the disorder at more than 6.1 million aged 12 or older [4].
Methadone is why this whole system exists. It is a long-acting full opioid agonist and a schedule II controlled medicine [5]. The rules say it may be given only by mouth, and made up so that it is harder to misuse by needle [3].
Buprenorphine is the contrast. SAMHSA calls it the first medicine for opioid use disorder that a doctor can prescribe or hand out in an office, which widened access a great deal [5]. So a person can be treated with buprenorphine outside this system. Methadone for opioid use disorder is a different story. Our pages on methadone and buprenorphine cover each one.
How long do people stay on them? SAMHSA says these medications are safe for long-term use, from months to a lifetime, and that people should talk to their doctor before stopping [5]. This page gives no amounts and no schedule. Those belong to a doctor and a patient in a room.
Getting in: who qualifies, consent, and the first exams
Getting a place is not first come, first served. It is also not a rubber stamp.
Staff have to decide, on accepted medical grounds, that the person meets the criteria for a moderate to severe opioid use disorder. The person must have an active case, or one in remission, or be at high risk of a return to use or of overdose [3]. Risk counts, in other words, not just current use.
If someone is having a seizure, is unresponsive or has trouble breathing, call 911. For a mental-health crisis call or text 988.
Consent is written into the rules. A clinician has to make sure the person chooses this treatment freely. The facts about the medicine have to be explained clearly. The person has to give informed consent [3]. For anyone under 18, a parent, guardian or named responsible adult has to agree in writing, unless state law lets a young person agree alone [3].
Then come the exams. The first medical exam has two halves. One is a screening exam, to check the person qualifies and that nothing rules the medicine out. The other is a full history and exam, to see the wider health picture [3]. If nothing rules it out, treatment can begin once the screening half is done [3].
Two more steps follow fast. A full in-person physical exam has to be done within 14 days of joining [3]. A full mental health and social assessment, which screens for any near-term risk of harm to self or others, is due in the same 14 days [3].
Telehealth is allowed for those exams, where a clinician judges that a good enough check can be done that way [3]. The bar is higher for schedule II medications such as methadone. There, video has to be used, unless the patient cannot get to video [3].
Pregnancy moves a person up the queue. Programs have to give pregnant patients priority for a place, and must offer prenatal care and other care either in house or by referral [3].
Comparing treatment settings in Washington
The Recovery Village Ridgefield is our campus in Ridgefield, Washington. Its own Levels of Care list publishes medical detox, inpatient treatment, a partial hospitalization program, intensive outpatient programming, dual diagnosis treatment and medication-assisted treatment. Admissions will confirm what the campus can offer on the call.
See treatment options in Washington
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The Recovery Village Ridgefield is part of our family of treatment centers. See the Recovery Village Ridgefield campus.
What every certified program has to offer
This is the floor that all of them stand on, and it is worth reading before you pick one.
Counseling comes first, and so does a line that surprises people. Programs have to offer counseling and teaching about the illness, as the clinical picture calls for and as the patient agrees, and that includes harm reduction advice [3]. Then this: patient refusal of counseling shall not preclude them from receiving medication [3]. Counseling is a duty on the program. It is not a hoop a patient has to jump through to be treated.
Programs also have to counsel on how HIV, viral hepatitis and sexually transmitted infections spread. If a test comes back positive, they either treat it or link the patient to care [3]. They have to offer job training, schooling and work help too, in house or by referral, where a patient asks for it or the need is agreed [3].
Care has to be written down and revisited. The assessment leads to a care plan built around the patient’s own goals and agreed steps. It covers harm reduction, and needs in school, training, work, housing and legal matters. It is reviewed and updated as life changes [3]. A check-up physical exam should happen at least once a year [3].
Two rules bear on patients directly. Random drug tests have to use tests the FDA has cleared, as often as good practice and the person’s stability call for, but no fewer than eight random tests per patient a year [3]. And a program has to make a good faith check on whether someone is signed up elsewhere. A patient at one program may not get treatment at a second one, except in set cases such as work travel, a temporary move, or a program closing for a while [3].
Every program also keeps a diversion control plan. That is a written set of steps to cut the odds that medicine is passed on or shared with someone it was not meant for [1]. Our overview of what the treatment process is like covers how this feels from the patient’s side, and our guide to opioid addiction treatment covers the wider picture.
Take-home medicine, and what the rules say about it
Take-home medicine is the first thing people ask about. The rules answer in stages.
One piece does not depend on time served. Any patient in full care may take home their own doses for days the clinic is shut, and that covers one weekend day plus state and federal holidays, whatever their length of time in treatment [3].
Past that, a licensed clinician or the medical director decides. They weigh whether the good outweighs the risk, against a list in the rules [3]. The list covers: no active substance use disorder or other condition that raises the risk of harm; a steady record of showing up; no serious behavior that puts the patient or others in danger; no known recent passing on of medicine; whether it can be carried and stored safely; and anything else that bears on the patient’s safety and the public’s health [3]. The thinking behind the call has to go in the record [3].
How much a person may take home grows in stages over the early weeks. The clinician decides where inside each stage a given patient sits [3]. This page does not set out those stages. A supply limit read off a web page is not the same thing as a plan made with the clinician who answers for it.
Safety rules travel with the medicine. The label has to carry the program’s name, address and phone number [3]. Each take-home dose has to be packed to cut the risk of a child swallowing it, which means child-proof lids [3]. The program has to teach the patient how to carry it home and store it, including steps to keep children safe [3]. SAMHSA adds a detail worth saying out loud. Liquid methadone is colored, and can be mistaken for fruit juice. A child who takes it by mistake may overdose or have a bad reaction [5].
If someone is having a seizure, is unresponsive or has trouble breathing, call 911. For a mental-health crisis call or text 988.
There is also a rule for waiting lists. Where full services are not within reach, and not available within 14 days, a program may take a person on for interim care [3]. That is capped at 180 days [1].
Finding a certified program, and where other care fits
SAMHSA runs an opioid treatment program directory and a state-by-state list of State Opioid Treatment Authorities [2]. Those are the two places to start. A state authority can answer questions about its own state’s rules.
A program is one option among several, and for many people it is not the first. Residential and inpatient care suits someone who needs a bed and daily clinical review. Outpatient rehab keeps work and family in place while the clinical hours go on. Our guide to levels of care sets out how the tiers differ, and opioid replacement therapy covers the medicine side across settings.
Cost is answered per plan, not in general. Our pages on insurance coverage for rehab and what treatment costs explain the terms before a benefits call. How admission works sets out the steps on our side, and our treatment centers lists the campuses we run.
Frequently Asked Questions
What is an opioid treatment program? Federal rules define it as a program that treats opioid use disorder with medicine, registered under the Controlled Substances Act. It is a setting with a federal certificate, not a medicine. The rules sit in part 8 of title 42 of the Code of Federal Regulations. They took effect in 2001, and a new final rule came out in February 2024.
Do you have to go to a clinic every day for methadone? Not always. Any patient in full care may take home doses for days the clinic is shut, and that covers one weekend day plus state and federal holidays, whatever their length of time in treatment. Past that, a licensed clinician or the medical director decides. They weigh things like attendance, safe storage and transport, and whether medicine has been passed on.
Do you have to attend counseling at an opioid treatment program? The program has to offer it. You do not have to accept it to be treated. Programs must provide counseling and teaching about the illness, as the clinical picture calls for and as the patient agrees, including harm reduction advice. The rules then state that patient refusal of counseling shall not preclude them from receiving medication. It is a duty on the program, not a test for the patient.
Who certifies an opioid treatment program? The Secretary of Health and Human Services, or the Assistant Secretary for Mental Health and Substance Use, gives the certificate that says a program is qualified and will follow the federal standards. To be eligible, the program first has to be accredited by an approved body. Registration under the Controlled Substances Act and a State Opioid Treatment Authority round out the picture.
How do you find a certified opioid treatment program? SAMHSA runs an opioid treatment program directory and a state-by-state list of State Opioid Treatment Authorities. SAMHSA backs more than 1,900 of these programs, and they treat more than 600,000 patients a year. So there is often more than one within reach. A state authority can answer questions about local rules.
Sources
- Office of the Federal Register. (2024). 42 CFR 8.2 — Definitions, in Part 8, Medications for the Treatment of Opioid Use Disorder. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-8/subpart-A/section-8.2
- Substance Abuse and Mental Health Services Administration. (2026). Opioid Treatment Program Information for Providers. SAMHSA. https://www.samhsa.gov/substance-use/treatment/opioid-treatment-program
- Office of the Federal Register. (2024). 42 CFR 8.12 — Federal Opioid Use Disorder treatment standards. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-8/subpart-C/section-8.12
- U.S. Food and Drug Administration. (2024). Information about Medications for Opioid Use Disorder (MOUD). FDA. https://www.fda.gov/drugs/information-drug-class/information-about-medications-opioid-use-disorder-moud
- Substance Abuse and Mental Health Services Administration. (2025). Treatment Options for Substance Use Disorder. SAMHSA. https://www.samhsa.gov/substance-use/treatment/medications-substance-use-disorders
- Office of the Federal Register. (2024). 42 CFR 8.1 — Scope, in Part 8, Medications for the Treatment of Opioid Use Disorder. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-8/subpart-A/section-8.1
This page is for general information and is not medical advice. Only a licensed clinician who knows your history can tell you what is right for you. If you or someone you know is in immediate danger, call 911. For free, confidential support 24/7, call or text 988.
Author
Chief Medical Officer,
The Recovery Village
