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Government Response to ACMD 3 Medicines Reports on Drug Scheduling

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Summary

The UK government agrees with ACMD recommendations to control three growth hormones (somapacitan, lonapegsomatropin, somatrogon) under Class C of the Misuse of Drugs Act 1971 and Schedule 4 (Part 2) of the Misuse of Drugs Regulations 2001. Ganaxolone will not be scheduled at this time. Zuranolone will be controlled under Class C and Schedule 4 (Part I) for treatment of post-natal depression.

What changed

The government accepted all ACMD recommendations regarding the control and scheduling of five medicines. Three growth hormones (somapacitan, lonapegsomatropin, somatrogon) will be classified as Class C controlled substances under Schedule 4 Part 2 of the Misuse of Drugs Regulations 2001. Zuranolone, used for post-natal depression, will also be controlled under Class C but scheduled under Schedule 4 Part I. Ganaxolone, for a rare form of epilepsy, will not be scheduled at this time pending further review.

Affected parties including pharmaceutical manufacturers, distributors, and healthcare providers must implement compliance controls for the newly scheduled substances. Class C controls impose record-keeping, storage, and reporting obligations. Parties handling ganaxolone should continue to monitor for future scheduling determinations.

What to do next

  1. Pharmaceutical manufacturers must comply with Class C control requirements for somapacitan, lonapegsomatropin, somatrogon, and zuranolone
  2. Healthcare providers must follow Schedule 4 storage and prescribing requirements for affected medicines
  3. Monitor for ganaxolone scheduling updates as review continues

Archived snapshot

Apr 16, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Correspondence

Government response to 3 medicines reports

This response agrees with recommendations from the Advisory Council on the Misuse of Drugs (ACMD) in 3 reports about the control and scheduling of 5 medicines.

From: Advisory Council on the Misuse of Drugs Published 23 February 2026 Get emails about this page

Documents

Government response to 3 ACMD reports (accessible)

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Government response to 3 ACMD reports

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Details

The government accepts the ACMD ’s recommendations in relation to the classification and scheduling of the 5 medicines featured in the ACMD ’s reports:

  • Somapacitan, lonapegsomatropin and somatrogon: ACMD advice
  • Ganaxolone: ACMD advice
  • Zuranolone: ACMD advice
    The ACMD recommended that:

  • the 3 growth hormones somapacitan, lonapegsomatropin, and somatrogon should be controlled under Class C of the Misuse of Drugs Act 1971 and scheduled under Schedule 4 (Part 2) to the Misuse of Drugs Regulations 2001

  • ganaxolone, a neuroactive steroid to treat a rare form of epilepsy, should not be controlled under the Misuse of Drugs Act 1971 nor scheduled under the Misuse of Drugs Regulations 2001 at this time

  • zuranolone, an oral, synthetic neuroactive steroid (NAS) with rapid antidepressant effects used to treat post natal depression, should be controlled under Class C of the 1971 Act and scheduled under Schedule 4, (Part I) of the 2001 Regulations

Published 23 February 2026 Get emails about this page Print this page

Named provisions

Class C Control Requirements Schedule 4 Provisions

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Last updated

Classification

Agency
ACMD
Published
February 23rd, 2026
Instrument
Rule
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Drug manufacturers Healthcare providers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Controlled substance scheduling Drug classification Pharmaceutical distribution
Geographic scope
United Kingdom GB

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Medical Devices Healthcare Public Health

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