The Spravato REMS requirements decide who can give esketamine and how. An outpatient clinic has to be certified before it can order Spravato, enroll each patient before the first dose, have a prescriber onsite, and monitor every patient for at least two hours after every dose. None of it is optional, and all of it shapes how you schedule and market the service.
This guide covers the outpatient version: certification, what happens at each visit, and what the rules mean for your calendar, your booking page and your ads.
What is the Spravato REMS?
A REMS (Risk Evaluation and Mitigation Strategy) is a safety program the FDA requires for some drugs. Spravato is available only through one, because of the risks of sedation, dissociation and respiratory depression after a dose, and of abuse and misuse. It is never dispensed for home use.
Janssen, the drug's maker, runs the program. The FDA's REMS listing for Spravato shows it was first approved in March 2019 and last modified on 24 June 2026, a change to the website's workflows. We re-checked the listing on 8 October 2026 and no newer modification was posted.
Spravato REMS program details
- Run by: Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, under a REMS the FDA requires for NDA 211243.
- Website: spravatorems.com, where settings enroll, enroll patients and submit monitoring forms. The REMS document requires that all three can also be done by fax.
- Phone: 1-855-382-6022, Monday to Friday, 8 a.m. to 8 p.m. Eastern.
- Fax: 1-877-778-0091.
- Current version: modified 24 June 2026, per REMS@FDA, checked 8 October 2026.
- Spanish: a 13 April 2026 modification added Spanish translations of the REMS materials to the program website.
The requirements below come from the REMS document and program overview the FDA published with that change. Read them yourself before you enroll. This guide is a map, not legal advice.
How to become a Spravato treatment center
Certification belongs to the setting, not to an individual clinician. For an outpatient medical office or clinic, the REMS document sets out these steps:
- Have the people and equipment in place. A prescriber onsite during administration and monitoring, healthcare providers to monitor patients onsite, and a pulse oximeter.
- Name an authorized representative. This person carries out certification and oversees compliance for the setting.
- Read the source documents. The representative reviews the Spravato prescribing information and the REMS Program Overview.
- Enroll the setting. The representative completes the Outpatient Healthcare Setting Enrollment Form, which asks for the DEA license number tied to the setting's address, and submits it to the REMS.
- Write the processes and train the staff. Procedures for enrolling patients, counseling them, checking enrollment before each dose and submitting monitoring forms, with training for everyone involved in prescribing, dispensing and administering.
Once the form is in, the REMS notifies you of certification and tells you the further requirements for ordering and receiving Spravato; the REMS document gives Janssen 7 calendar days to notify a newly certified setting. Certification then has upkeep: training records, records of every shipment and every dose given, audits by Janssen or someone acting for it, and a new enrollment form if your authorized representative changes. Under the same document, Janssen must audit 15% of certified settings within 180 days of their first dispensing or shipment, and 15% of active settings every year.
Spravato REMS requirements for every patient visit
Once you're certified, the rules move to the patient. This is the sequence the REMS document and overview set out for outpatients:
| When | What the REMS requires |
|---|---|
| Before the first dose | A healthcare provider counsels the patient on the risks, the monitoring and the need to arrange a safe way to leave. A prescriber enrolls the patient with the Patient Enrollment Form. |
| Before every dose | Counsel the patient on monitoring again, and verify they are enrolled. |
| During and after every dose | The patient self-administers under the direct supervision of a healthcare provider. A healthcare provider monitors for sedation, dissociation, respiratory depression and other changes in vital signs, using pulse oximetry, for at least two hours and until those effects resolve. |
| Within 7 calendar days | Submit a Patient Monitoring Form for that dose. |
| Before a transfer | Tell the REMS in advance if the patient's treatment moves to another certified setting. |
The two hours are a floor. The REMS requires monitoring until those effects resolve, and the Spravato prescribing information adds an assessment after monitoring to decide when the patient is clinically stable and ready to leave.
Spravato REMS forms: which one, who, and when
An outpatient center works with three forms. Each has a different owner and a different deadline, so it helps to see them side by side:
| Form | Who completes it | When |
|---|---|---|
| Outpatient Healthcare Setting Enrollment Form | The setting's authorized representative | Once, to certify the setting, and again by a new authorized representative if the current one leaves |
| Patient Enrollment Form | A prescriber | Before the patient's first dose |
| Patient Monitoring Form | The certified setting | Within 7 calendar days of every dose |
Each form says to complete it online at spravatorems.com. The links here go to the PDFs on REMS@FDA, which is where to confirm you have the current version: every file name carries the date of the REMS modification it belongs to, 24 June 2026 as of 8 October 2026.
Outpatient Healthcare Setting Enrollment Form
The Outpatient Healthcare Setting Enrollment Form certifies the setting. Your authorized representative completes it once, after reviewing the prescribing information and the REMS Program Overview, and any new authorized representative completes it again. It is for outpatient medical offices and clinics only; emergency departments within hospitals are certified through the inpatient form. Besides the setting's name, address and contacts, it asks for:
- the DEA license number tied to the setting's address, the license holder's name if different, and the expiration date;
- the setting type: mental health facility, outpatient clinic, independent practice, group practice or hospital outpatient department;
- how you will get Spravato: a patient-specific prescription sent to a REMS-certified pharmacy that delivers patient-named product to you, or bulk supply from a REMS-qualified distributor;
- a page for each additional location the same authorized representative will be responsible for.
One line on this form matters for marketing. Your setting's name, location and phone number are listed on a location finder of certified settings, available to healthcare professionals and patients seeking Spravato treatment, unless you call 1-855-382-6022 to opt out. For a new center, that is a listing in front of people already looking for the treatment, so put the name and phone number on the form that you want patients to use.
Patient Enrollment Form
The Patient Enrollment Form enrolls each outpatient before the first dose. It is for outpatient offices and clinics, excluding emergency departments, and has two parts:
- The prescriber's page: the setting's name, address and DEA license number, the prescriber's credentials, specialty and own DEA number, a signature, any referring provider, all pre-existing medical and psychiatric conditions, and concomitant medications.
- The patient's page: contact details and a signed agreement covering the counseling and monitoring the REMS requires, and permission for Janssen and its agents to use and share the patient's health information to run the REMS, including releasing it to the FDA as necessary. A healthcare provider helps the patient complete it and gives them a copy.
The REMS@FDA update history shows the patient consent statements were added in March 2025, and the materials have been modified several times since, so download the current PDF rather than reusing an old printout.
Patient Monitoring Form
The Patient Monitoring Form is the one that recurs. The setting completes it after every treatment session for every enrolled outpatient and submits it within 7 calendar days, together with the Patient Enrollment Form if it was the patient's first session. It asks for:
- the monitoring healthcare provider and the setting's DEA number;
- the treatment date, the dose (56 mg, 84 mg or other) and the lot number;
- total treatment time in minutes, from the first device to the end of monitoring, and a reason if monitoring ran under two hours;
- whether vital signs were in an acceptable range before dosing and at the end, and pulse oximetry before, during and at the end;
- any current medications that can cause sedation, dissociation, respiratory depression or blood pressure changes;
- any serious adverse event of interest: sedation, dissociation, respiratory depression or hypertension that led to death, hospitalization, disability or an important medical event, or was life-threatening. Janssen's safety department follows up on these.
The REMS watches for gaps. Under the REMS document, Janssen must notify an outpatient setting if no monitoring forms have arrived within 60 calendar days of a patient's enrollment, and check every 60 days that all expected forms are in. Record the lot number and the start and end times while the patient is in the chair, not at the end of the week.
Inpatient and pharmacy forms
Hospitals, including their emergency departments, certify with the Inpatient Healthcare Setting Enrollment Form, and an inpatient pharmacy under the same DEA license and address is certified along with it. Community, retail and specialty pharmacies certify with the Pharmacy Enrollment Form. If you choose the pharmacy route on your setting enrollment form, the pharmacy you send prescriptions to must be REMS-certified.
What the rules do to your schedule
The REMS sets the length of a visit. The label sets how often visits happen. For treatment-resistant depression in adults, the recommended schedule is twice a week in weeks one to four, once a week in weeks five to eight, then every two weeks or weekly after that, with the later frequency set per patient.
Put those together and the constraint is plain. Under the label's recommended schedule, a new patient starts with two monitored visits a week for the first four weeks, each at least two hours long, with a prescriber onsite. Your capacity is set by monitoring space and staff, not by how many people ask.
That matters for marketing. If new inquiries outpace the monitored chairs you have for the first month, you get a waitlist, not a fuller schedule. Pace new starts against the chairs you have, and keep in touch with anyone waiting. That second part is what patient follow-up is for.
What patients need to know before they book
Several REMS and label requirements land on the patient. Say them before anyone takes a slot:
- Time. At least two hours onsite after each dose, plus the check before leaving.
- Transport. The label says not to drive or operate machinery until the next day after a restful sleep, so patients need a ride home.
- Frequency. Twice-weekly visits for the first month under the label's schedule for treatment-resistant depression.
- Enrollment. Every outpatient is enrolled in the REMS, on a form completed with a healthcare provider.
These belong on your booking page, in plain words, next to the button. Someone who can't manage the rides or the schedule should find out there, not at the consult. If you also send ad traffic to that page, the Google rules in the advertising section below apply to it.
One thing does not belong there: clinical detail. The Patient Enrollment Form asks the prescriber for pre-existing conditions and current medications. That is clinical intake, done with a provider. A website or ad lead form should take contact details and a preferred time, and no health information.
Certification is not permission to advertise
REMS certification lets you order and give Spravato. It doesn't cover your ads.
- Google. Its Healthcare and medicines policy restricts prescription drug terms in ads, landing pages and keywords. For US campaigns, the restricted drug terms policy lets advertisers use drug names in ads and landing pages without certification, in line with the law, but only certified advertisers may target them as keywords. Google's examples of certification types are online pharmacy, addiction services, telemedicine, health insurance and pharmaceutical manufacturer, and it says not to apply for one that doesn't match your business (checked 8 October 2026). An in-office treatment center matches none of them, so ask Google before you plan a campaign around Spravato as a keyword.
- LegitScript. Google and Meta rely on LegitScript certification for telehealth providers and online pharmacies that promote prescription drugs. LegitScript's healthcare certification FAQ says in-person-only clinics that don't prescribe through telemedicine or take card-not-present payments for prescription drugs are generally not eligible (checked 8 October 2026). A Spravato-only center treats patients in person by definition, so it usually falls in that group.
- Meta. Its drugs and pharmaceuticals ad standards allow prescription drug ads from online pharmacies and telehealth providers certified with LegitScript, and from pharmaceutical manufacturers, which can use LegitScript certification or Meta's own review. All need Meta's authorization; none may target under-18s. The policy doesn't name in-office treatment centers, and it bars ads that promote prescription drugs from advertisers that aren't LegitScript-certified or, for manufacturers, reviewed by Meta, so a center without LegitScript certification can't run Meta ads that promote Spravato. Ads that only educate about prescription drugs don't need written authorization (checked 8 October 2026).
- Johnson & Johnson. The REMS sets no rules for a certified setting's ads. J&J's communications guide for treatment centers says to include Spravato's indications, limitations of use and Important Safety Information when you communicate about it, and that using its materials gives you no right or license to its logos, trademarks or images (checked 8 October 2026).
- The FTC and the FDA. The FTC's Health Products Compliance Guidance says health claims need competent and reliable scientific evidence, and that individual consumers' experiences are never enough to back one up. The FDA's prescription drug ad requirements in section 502(n) of the FD&C Act, including the brief summary of side effects, contraindications and effectiveness, are duties of a drug's manufacturer, packer or distributor, for the ads it issues or causes to be issued (checked 8 October 2026).
The REMS doesn't approve ads, and ad approval doesn't cover the REMS. They are two separate checks.
Keep Spravato and IV ketamine claims apart
If you offer both, treat them as two services. To a regulator they are different products.
Spravato's label indicates it for treatment-resistant depression in adults, alone or with an oral antidepressant, and for depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior, alongside an oral antidepressant. The same label says its effectiveness in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated.
Ketamine is another matter. In a warning letter dated 23 June 2026, the FDA restated that ketamine is approved as an injectable general anesthetic and is not FDA-approved for the treatment of any psychiatric disorder.
Don't let an IV ketamine page borrow Spravato's approval. "FDA-approved" belongs next to Spravato and its labeled uses only, and the Spravato REMS covers Spravato, not ketamine infusions.
We don't certify settings or complete REMS forms. How we hold ad and landing page to one claim set, and run Spravato and IV ketamine as separate campaigns, is on our page on Spravato marketing for REMS-certified treatment centers.
Sources
- FDA — REMS@FDA: Spravato (esketamine) REMS listing, materials and modification history, checked 8 October 2026
- FDA — Spravato REMS document, updated June 2026, checked 8 October 2026
- FDA — Spravato REMS Program Overview, as posted with the 24 June 2026 modification, checked 8 October 2026
- FDA — Spravato REMS Outpatient Healthcare Setting Enrollment Form, checked 8 October 2026
- FDA — Spravato REMS Patient Enrollment Form, outpatient use, checked 8 October 2026
- FDA — Spravato REMS Patient Monitoring Form, outpatient use, checked 8 October 2026
- DailyMed (National Library of Medicine) — Spravato (esketamine) nasal spray prescribing information, revised March 2026, checked 8 October 2026
- Janssen — Spravato REMS program website, checked 8 October 2026
- FDA — Warning letter 725147, 23 June 2026 (ketamine approval status), checked 8 October 2026
- Google Ads Help — Healthcare and medicines policy, checked 8 October 2026
- Google Ads Help — Restricted drug terms, checked 8 October 2026
- Google Ads Help — Prescription drug services, and how to apply for healthcare certification, checked 8 October 2026
- LegitScript — Healthcare Certification FAQs (eligibility), checked 8 October 2026
- Meta Transparency Center — Drugs and pharmaceuticals ad standards, checked 8 October 2026
- Johnson & Johnson — Digital and Traditional Media Communications FAQ for Spravato treatment centers (October 2025), checked 8 October 2026
- GovInfo — 21 U.S.C. 352(n), prescription drug advertisements, checked 8 October 2026
- FTC — Health Products Compliance Guidance, checked 8 October 2026