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Reclassification of Etomidate as a Controlled Drug under the MDA

29 August 2025  |  Controlled Drugs & Prescribing  |  MOH Cir 54/2025


Summary

1. Notice - Reclassification of Etomidate as Controlled Drug

MOH announces reclassification of Etomidate from non-controlled to Controlled Drug (CD) under the Misuse of Drugs Act. Effective immediately, all etomidate possession, supply, and use requires compliance with CD regulations and CNB oversight.

2. Background & Rationale

  • Etomidate: Ultra-short-acting intravenous anesthetic agent
  • Evidence of increasing misuse and abuse potential identified
  • International regulatory trend toward stricter controls on ultra-short-acting anesthetics
  • Aligns national drug control framework with international standards

3. Key Changes Effective Immediately

  • Classification: Etomidate now classified as Schedule II/III Controlled Drug
  • Licensing: All facilities must register etomidate stocks with Central Narcotics Bureau (CNB)
  • Record Keeping: Detailed administration records required; every dose must be documented
  • Storage Requirements: Locked, secure storage with restricted access controls
  • Supply Chain: Only authorized wholesalers and pharmaceutical distributors can supply
  • Accountability: All discrepancies must be reported to CNB within 24 hours

4. Compliance Requirements for Practitioners & Facilities

  • Immediate: Secure all etomidate stocks in approved controlled drug storage
  • Register any existing etomidate holdings with CNB if not previously done
  • Establish detailed administration and destruction records for all doses
  • Restrict access to authorized personnel only with access logs
  • Report any losses, thefts, or suspected misuse to CNB immediately
  • Maintain proper labeling and secure packaging

5. Transition & Enforcement

Non-compliance may result in penalties and loss of license. Existing stocks must be registered and secured immediately. Continued supply only through authorized CNB-approved channels. MOH may conduct unannounced inspections.

Action Items: Secure all etomidate stocks immediately; register with CNB; establish controlled records; audit inventory; train staff on CD handling procedures; update prescribing guidelines.

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𝟭. 𝗡𝗼𝘁𝗶𝗰𝗲 - 𝗥𝗲𝗰𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗘𝘁𝗼𝗺𝗶𝗱𝗮𝘁𝗲 𝗮𝘀 𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝗹𝗲𝗱 𝗗𝗿𝘂𝗴
MOH announces reclassification of Etomidate from non-controlled to Controlled Drug (CD) under the Misuse of Drugs Act. Effective immediately, all etomidate possession, supply, and use requires compliance with CD regulations and CNB oversight.

𝟮. 𝗕𝗮𝗰𝗸𝗴𝗿𝗼𝘂𝗻𝗱 & 𝗥𝗮𝘁𝗶𝗼𝗻𝗮𝗹𝗲
• Etomidate: Ultra-short-acting intravenous anesthetic agent • Evidence of increasing misuse and abuse potential identified • International regulatory trend toward stricter controls on ultra-short-acting anesthetics • Aligns national drug control framework with international standards

𝟯. 𝗞𝗲𝘆 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗜𝗺𝗺𝗲𝗱𝗶𝗮𝘁𝗲𝗹𝘆
• Classification: Etomidate now classified as Schedule II/III Controlled Drug • Licensing: All facilities must register etomidate stocks with Central Narcotics Bureau (CNB) • Record Keeping: Detailed administration records required; every dose must be documented • Storage Requirements: Locked, secure storage with restricted access controls • Supply Chain: Only authorized wholesalers and pharmaceutical distributors can...

𝟰. 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗳𝗼𝗿 𝗣𝗿𝗮𝗰𝘁𝗶𝘁𝗶𝗼𝗻𝗲𝗿𝘀 & 𝗙𝗮𝗰𝗶𝗹𝗶𝘁𝗶𝗲𝘀
• Immediate: Secure all etomidate stocks in approved controlled drug storage • Register any existing etomidate holdings with CNB if not previously done • Establish detailed administration and destruction records for all doses • Restrict access to authorized personnel only with access logs • Report any losses, thefts, or suspected misuse to CNB immediately •...

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