Destruction register for controlled substances: witnesses, records and what inspectors check

Why destruction gets special attention

Every other movement in a controlled-substance stock book has a counterparty. A receipt has a supplier, a dispatch has a licensed recipient, a production use has a batch record. Destruction removes stock from the book with no one on the other side. That is why national law adds safeguards around it, and why inspectors ask to see the destruction records early in a visit.

The UN Single Convention of 1961 sets the base: Article 34 requires manufacturers, traders and others to keep records of each individual acquisition and disposal of drugs for at least two years. How a destruction must be carried out and witnessed is left to national law. This guide uses the German Narcotics Act (BtMG) as the worked example, because its rule is short and precise, and the BfArM publishes a model record that shows what it expects to receive.

The German rule: section 16 of the BtMG

Section 16 has three parts that matter to a licence holder:

• Who and how. The owner of controlled substances that are no longer marketable must destroy them at their own cost, in the presence of two witnesses, in a way that rules out even partial recovery and protects people and the environment from harmful effects.
• The record. A written record (Niederschrift) of the destruction is made and kept for three years.
• Surplus stock. The same applies when the owner simply wants to dispose of controlled substances that are no longer needed.

The BfArM can also require the owner to send the substances to it for destruction, at the owner's cost. If the owner cannot be identified, or does not destroy or send the substances within a three-month deadline set by the authority, the authority takes the necessary measures itself.

What the destruction record contains

The BfArM's model record, "Vernichtungsniederschrift gem. § 16 BtMG", is a single page. Its use shows what the authority expects to see in any format you choose:

The model record states that the substances were destroyed in the presence of two witnesses, in a way that rules out even partial recovery. It also says that licence holders under section 3 of the BtMG attach a signed printout of the record to their half-yearly report under section 18.

The BfArM's notes for manufacturers completing the half-yearly report are more explicit: the destruction record must carry three signatures, with each name also written legibly. Breakage and faulty product from manufacturing that is set aside for separate destruction is reported in the same line as destruction, supported either by the destruction record or by a written explanation of the breakage, signed by those responsible and initialled by the witnesses.

How destruction reaches the half-yearly report

Section 18 of the BtMG requires licence holders to report to the BfArM, per site and per substance, the quantities that were manufactured, imported, exported, acquired, supplied and destroyed, and the stock at the end of the half-year. Reports for each half-year are due by 31 January and 31 July, on the BfArM's official forms. Quantities are given by weight for substances and bulk preparations, and by number of units for divided preparations.

So the destruction register has to agree with two other records: the running stock book under section 17, where the destruction is a disposal like any other, and the destroyed quantity in the report. If the three do not match, the difference will be queried.

Medical cannabis in Germany

Since 1 April 2024, medical cannabis in Germany is governed by the Medical Cannabis Act (MedCanG) rather than the BtMG. The MedCanG requires running records of every receipt and disposal with the resulting stock (section 16), but it has no destruction section comparable to section 16 of the BtMG. Section 10 allows the BfArM to attach conditions to a permit. Check your permit for conditions on destruction and confirm the expected procedure with the BfArM before the first destruction. Recording a destruction to the same standard as under the BtMG, with two witnesses and a signed record, is the cautious choice.

What inspectors typically check

Expect an inspector to pick a destruction from the register and follow it through every record that should reflect it. In practice that means being ready to show:

• the reason the stock became unusable (expiry, a failed test, a rejected batch, breakage, a return) and the decision to destroy it;
• the quarantine or hold status of the lot between that decision and the destruction, so it could not be picked or shipped;
• the destruction record with three signatures and legible names, and the method used;
• the matching disposal entry in the stock book, with the same date, lot and quantity;
• the destroyed quantity in the half-yearly report, with the signed record attached where required;
• for a waste contractor, the handover documents that link the collection to the destruction.

Witnesses who were not present for the whole destruction, or a witness who is also the person who carried it out, weaken the record. Choose witnesses who can confirm what they saw, and make sure the three people on the record are three different people.

Checklist for each destruction

1. Decide and document why.Record the reason and the decision, and place the lot on hold.
2. Weigh or count before destruction.Use the same unit as the stock book: weight for substances, units for packs.
3. Assemble the people.The person carrying out the destruction and two witnesses, three different people.
4. Destroy so that nothing can be recovered.Record the method and protect people and the environment.
5. Sign the record on the day.Date, substance, lot, quantity, method, three signatures and legible names.
6. Post the disposal to the stock book.Same date, lot and quantity as the record.
7. Carry it into the report.Include the quantity in the next half-yearly report and attach the signed record where required.
8. Keep the record.At least three years in Germany; check your national rule.

Where 365Phyta fits

365Phyta Licensing keeps the destruction register inside Microsoft Dynamics 365 Business Central. Every destruction is recorded against the lot and posts to the controlled-substance stock book, which reconciles to the item ledger to the gram. A destruction cannot be recorded without a second witness who is a different person, and 365Phyta Core keeps lots on hold and records electronic signatures with re-authentication in the audit trail. Destroyed quantities feed the period close and regulatory reporting; national report formats come with the country packs for Germany and Portugal, which are in development. See controlled substances, the narcotics stock book guide, the glossary term destruction register and pricing.

FAQ

Sources

1. UNODC, Single Convention on Narcotic Drugs, 1961, as amended, Article 34 (records of acquisition and disposal).
2. Betäubungsmittelgesetz (gesetze-im-internet.de): § 16 Vernichtung, § 17 Aufzeichnungen, § 18 Meldungen.
3. BfArM, Bundesopiumstelle: Vernichtungsniederschrift gem. § 16 BtMG (model record).
4. BfArM, Bundesopiumstelle: Hinweise zur Betäubungsmittelmeldung nach § 18 BtMG für Hersteller (Form A), January 2012, line 33 (destruction and breakage).
5. Medizinal-Cannabisgesetz (gesetze-im-internet.de): § 10 Befristung der Erlaubnis; Auflagen und Beschränkungen, § 16 Aufzeichnungen und Meldungen.

Last reviewed: September 2026. General information, not legal advice. Terms are defined in the glossary.