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Approved Risk Evaluation and Mitigation Strategies (REMS)

Sublocade (buprenorphine extended-release)
NDA #209819
REMS last update: 04/19/2024

What is the purpose of the REMS?

The goal of the SUBLOCADE REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:

  1. Ensuring healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
04/19/2024 Modified to update the product storage conditions (from 7 days to 12 weeks) to align with currently approved labeling, affecting the following materials: Healthcare Provider REMS Letter, Fact Sheet: How to Obtain SUBLOCADE and REMS Website.
07/03/2023 Modified to align with the repeal of the Drug Addiction Treatment Act of 2000 (DATA-2000) through the enactment of the Mainstreaming Addiction Treatment (MAT) Act of 2021, thereby removing the DATA 2000 waiver requirement for qualifying practitioners in order to dispense certain narcotic drugs used for treatment of opioid use disorders.
01/27/2023 Revised to reflect editorial changes.
01/06/2023 Modified to change all of the REMS materials to clarify certification requirements, reorganize information for better understanding of the content, and change the healthcare setting audit requirement.
09/30/2021 Editorial change.
09/22/2021 Modified to make changes in response to recent updates with the Drug Enforcement Administration (DEA) interim final rule (IFR) published on November 2, 2020, that amended regulations for consistency with the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (the SUPPORT Act). REMS materials were updated to clarify that the pharmacy can deliver SUBLOCADE to either the prescribing practitioner or the practitioner administering the controlled substance, as applicable.Materials affected include the REMS Fact Sheet and the REMS Website.
12/02/2020 Revised to reflect editorial changes.
06/15/2020 Modified to change the REMS Document to update audit plans for healthcare settings and pharmacies.
01/28/2020 Revised to make an editorial change.
11/07/2019 Revised to make an editorial c hange.
03/08/2018 Editorial change.
02/09/2018 Revised to update mailing address.
11/30/2017 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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