Can Any Doctor Prescribe Clozapine Now? Access After the REMS Ended

Creator: Ryan S. Sultan, MD
Published: 2026-11-12

By Ryan S. Sultan, MD
Psychiatrist · Columbia University Irving Medical Center
Published November 12, 2026 · 6-minute read

The FDA removed the clozapine REMS effective June 13, 2025. Prescribers no longer have to be enrolled in the program or enroll their patients, and pharmacists don't need to verify a patient's eligibility or blood count before dispensing.¹

In Medicaid claims from 45 states for 2002 through 2005, clozapine accounted for 2.5% of antipsychotic starts among people with schizophrenia spectrum disorders, and 5.5% of starts among those with treatment resistance.⁴

What the FDA says about enrollment and pharmacies

On February 24, 2025, the FDA announced that it no longer expected prescribers, pharmacies, and patients to participate in the REMS or to report blood test results before clozapine was dispensed.² The program was formally removed effective June 13, 2025, and the FDA described the removal in a Drug Safety Communication dated August 27, 2025.¹

The communication states:¹

Prescribers no longer have to be enrolled in the REMS or enroll their patients, and they don't have to submit absolute neutrophil count (ANC) results to the program.
Pharmacies don't need to be enrolled to order clozapine from wholesalers, and pharmacists don't need to verify patient eligibility, including ANC monitoring, before dispensing.
Patients no longer need to be enrolled to receive clozapine.

The REMS had required prescribers to undergo a certification process.¹² The FDA states that prescribers, pharmacies, and patients are no longer required to participate in the REMS program.¹ An individual pharmacy's own policies are outside the FDA statement.

Which clinicians can prescribe clozapine

The FDA communication addresses REMS enrollment and refers to prescribers of clozapine without naming professions.¹ Neither it nor the other sources reviewed for this page say which licensed clinicians may prescribe clozapine.

The FDA still recommends ANC monitoring on the label's schedule. For an ANC in the normal range, that is weekly for the first 6 months, every 2 weeks through month 12, and monthly after that.^{1, 3} The details are on the page about clozapine blood tests after the REMS.

Clozapine use has varied widely by state

In the 2002 to 2005 Medicaid study of 326,119 people, living in a county with historically high rates of clozapine use was among the strongest predictors of receiving it.⁴ In 2011 to 2012 Medicaid data on 357,914 adults with schizophrenia spectrum disorders, the adjusted proportion with a clozapine prescription ranged from 1% to 11% across states.⁵

During a New York State initiative, the proportion of new clozapine trials among all new outpatient antipsychotic trials increased 40% among adult Medicaid recipients with schizophrenia from 2009 to 2013.⁶

Black and Hispanic patients have been prescribed clozapine less often

In Maryland's public inpatient system from 1994 to 2000, 10.3% of African American patients with schizophrenia (150 of 1,458) received clozapine, compared with 15.3% of white patients (223 of 1,453).⁷ A 2020 systematic review identified 16 studies, and all of them reported clozapine underutilization in ethnic and racial minority patients compared with white patients. The authors concluded that the reasons remain unclear.⁸

A 2024 analysis of electronic health records from 224,212 adults found lower odds of a clozapine prescription for Black patients (odds ratio 0.40) and Hispanic patients (odds ratio 0.45) with schizophrenia than for white patients.⁹

Discontinuation for low blood counts has also differed by race. In Maryland between 1989 and 1999, 5.3% of African American patients (31 of 588) and 2.4% of white patients (31 of 1,287) had clozapine discontinued because of a low white blood cell count. None of the African American patients developed agranulocytosis. The authors considered it likely that some discontinuations were unnecessary and reflected benign ethnic neutropenia.¹⁰

The current label states that people with benign ethnic neutropenia are not at increased risk of clozapine-induced neutropenia.³ In a six-month prospective trial of 274 patients of African descent, there was one case of severe neutropenia (0.36%).¹¹

What prescribers report as barriers

A survey of US physicians who prescribed clozapine in 2021 or 2022, fielded from May 2022 to January 2023 while the REMS was in place, drew 196 responses from 750 contacted. Of the respondents, 115 (60%) reported frequent delays in medication access owing to required blood testing. About two-thirds agreed that the positives of the certification process (64%) and of the blood testing requirements (68%) outweighed the negatives.¹²

A 2018 report from a US work group listed a lack of prescriber knowledge and confidence, negative prescriber attitudes, special monitoring requirements, administrative burden, and unprepared health systems among the barriers.¹³ A systematic review of 15 papers added fear of serious side effects, service fragmentation, and inadequate training in or exposure to clozapine.¹⁴

One randomized trial tested education. A tele-mentoring program enrolled 266 prescribers from 43 mental health treatment settings in Maryland, and it did not increase the likelihood of clozapine prescribing during follow-up (P = .70).¹⁵

New clozapine starts after the REMS ended

One study of prescribing since the change was found as of November 2026. Among 201,335 adults with schizophrenia or schizoaffective disorder in a US health record network, identified between January 2024 and May 2026, there was no significant immediate change in new clozapine prescriptions after February 2025. The rate then rose gradually, from 12.14 to 26.45 per 10,000 person-months by April 2026.¹⁶

The authors reported that the overall prevalence of clozapine prescribing remained low and suggested that barriers beyond the REMS continue to limit use.¹⁶

Limitations of the evidence

This evidence has limitations. First, the national utilization figures come from Medicaid claims from 2002 to 2005 and 2011 to 2012, and no current national figure was found. Second, the post-REMS rise is an association in one health record network and can't establish that the policy change caused it. Nevertheless, the studies agree that clozapine use has differed by state and by race and ethnicity, and that prescribers report barriers of their own.

Finding a clozapine prescriber

One practical suggestion is to ask the current psychiatrist whether they prescribe clozapine and, if they don't, for a referral. The page on when to start clozapine lists questions to bring to that visit.

Frequently asked questions

Can any doctor prescribe clozapine now?

The FDA removed the clozapine REMS effective June 13, 2025, so prescribers no longer have to be enrolled in the program or enroll their patients. The FDA communication refers to prescribers of clozapine without naming professions, and the sources reviewed for this page don't say which licensed clinicians may prescribe it.¹

Is clozapine REMS certification still required?

The FDA removed the REMS effective June 13, 2025, and states that prescribers no longer have to be enrolled in it or to enroll their patients. The REMS had required prescribers to undergo a certification process. The FDA still recommends ANC monitoring on the label's schedule.^{1, 12}

Does a pharmacy still need blood test results to fill clozapine?

The FDA states that pharmacists do not need to verify patient eligibility, including ANC monitoring, before dispensing clozapine. An individual pharmacy's own policies are outside the FDA statement.¹

Why is clozapine hard to get?

Barriers listed in a 2018 report from a US work group include a lack of prescriber knowledge and confidence, monitoring requirements, administrative burden, and unprepared health systems. In a survey fielded from May 2022 to January 2023, while the REMS was in place, 115 of 196 US physicians who prescribed clozapine (60%) reported frequent delays in medication access owing to required blood testing.^{13, 12}

Are Black patients less likely to be prescribed clozapine?

Yes. A 2020 systematic review identified 16 studies, and all reported clozapine underutilization in ethnic and racial minority patients compared with white patients. The authors concluded that the reasons remain unclear.⁸

In a crisis: call or text 988, or go to the nearest emergency department. A first episode of psychosis belongs in a hospital-based or coordinated specialty care program.

I start and manage clozapine in an outpatient practice in Chelsea, Manhattan. Details are on the schizophrenia care in NYC page. Clozapine should not be stopped, skipped, or restarted without the prescriber. This page is general information and does not replace an evaluation.