Controlled substances (narcotics)

Controlled substances (Betäubungsmittel, abbreviated BTM) are narcotic drugs under German law. Legally, a BTM is any substance or preparation listed in Anlage I, II or III of the Betäubungsmittelgesetz (BtMG). The Anlage a substance sits in decides whether it may be traded at all, whether a doctor may prescribe it, and what a pharmacy has to do with it.

That last point is where most confusion starts. "BTM" is not a pharmacological class. It is not a synonym for "strong painkiller", "addictive", or "psychiatric medicine". It is a purely legal status, assigned by a list. A substance is a BTM because it appears in an Anlage, and for no other reason. This is why several drugs with obvious abuse potential are not BTM, and why some unremarkable-looking preparations are.

Which medicines are BTM?

Paragraph 1(1) BtMG states it plainly: "Betäubungsmittel im Sinne dieses Gesetzes sind die in den Anlagen I bis III aufgeführten Stoffe und Zubereitungen." Three Anlagen, three regimes.

Anlage III is where day-to-day pharmacy practice happens. But reading the substance name alone is not enough, and this is the single most expensive misreading in the field.

Why the Anlage alone does not answer the question

Most Anlage III entries carry an ausgenommen clause: an exemption threshold below which a preparation is not treated as a BTM. The active substance is listed, but the specific product in your hand may fall under the exemption and then needs an ordinary prescription, not a BtM-Rezept. The threshold is set per dosage unit or per pack, and it applies only if no other substance from Anlagen I to III is present.

Cannabis is the change that has not reached most reference material yet. With effect from 1 April 2024, the position "Cannabis" was deleted from Anlagen I and III of the BtMG. Medical cannabis is now governed by the Medizinal-Cannabisgesetz (MedCanG). It remains prescription-only, but it is no longer a Betäubungsmittel and no longer needs a BtM-Rezept. Anything published before April 2024 that tells you otherwise is out of date.

What must appear on a BtM-Rezept?

The yellow BtM-Rezept is a three-part official form. Under Paragraph 8(1) BtMVV, narcotics for patients, for practice supply and for animals may only be prescribed on it. Parts I and II go to the pharmacy, part III stays with the prescriber. The forms are numbered and issued by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) to the individual prescriber on request. They are personal, may only be transferred in cases of representation, must be secured against theft, and must be returned to the BfArM when practice activity ends. Part III and any incorrectly completed forms are kept for three years.

Paragraph 9(1) BtMVV lists what has to be on the form.

Entries must be permanent and identical on all parts of the form. Entries 1 to 8 may be made by someone other than the prescriber. Only the signature may not. If the prescription is changed, the prescriber must note the change on all parts and confirm it by signature.

The Höchstmenge rule is gone, and most sources have not caught up

Ask almost any reference work and it will tell you a doctor may prescribe a BTM only up to a maximum quantity within 30 days, and must mark exceptions with the letter "A". That is no longer the law.

The Verordnung zur Änderung der Betäubungsmittel-Verschreibungsverordnung und der Tierärztegebührenordnung entered into force on 8 April 2023. As the BfArM puts it: "Die bisherige Begrenzung der ärztlichen Verschreibung bestimmter Betäubungsmittel der Anlage III des BtMG auf eine Höchstverschreibungsmenge innerhalb von 30 Tagen (Paragraphen 2, 3 und 4 BtMVV) ist entfallen." Because the maximum quantities no longer exist, the "A" marking has no purpose and has been removed too. The current BtMVV, last amended on 14 February 2025, contains the word Höchstmenge nowhere.

What replaced it is professional judgement rather than a table: the prescribed quantity must be medically justified in the individual case, by daily dose and treatment duration. Paragraph 2(1) BtMVV now simply says a doctor may prescribe the narcotics listed in Anlage III for a patient, except Alfentanil, Cocain, Etorphin, Remifentanil and Sufentanil. The remaining quantity limits concern practice supply, not patients: for Praxisbedarf a doctor may prescribe up to an average two-week requirement, at minimum the smallest pack, and stock should not exceed a month's requirement.

What the four letters mean

Only four letter markings remain in Paragraph 9(1) No. 6 BtMVV, and each one has an exact trigger.

• "S" for substitution prescriptions, and for diamorphine under Paragraph 5a(1).
• "T" additionally, for take-home cases under Paragraph 5(8) sentence 10.
• "K" for narcotics supplied to equip merchant ships, prescribed retrospectively.
• "N" for the prescription submitted after an emergency prescription.

How does an emergency prescription work?

Paragraph 8(6) BtMVV allows a doctor to depart from the official form in an emergency, restricted to the quantity needed to resolve it. The sequence is fixed and each step is a legal duty.

1. The prescriber issues the prescription outside the official form, includes all entries required under Paragraph 9(1), and marks it with the word "Notfall-Verschreibung".
2. The pharmacy informs the prescriber about the supply without delay after the prescription is presented, and if possible before the narcotic is handed over.
3. The prescriber submits a proper BtM-Rezept to the same pharmacy without delay, marked with the letter "N".
4. The pharmacy attaches the emergency prescription permanently to the part of the subsequent prescription that remains in the pharmacy.

Failing to submit the subsequent prescription without delay is an administrative offence under Paragraph 17 BtMVV, not a formality.

Storage, security and documentation

Paragraph 15 BtMG is short and broad: anyone participating in narcotics traffic must store the narcotics in their possession separately and secure them against unauthorised removal. The BfArM may order specific security measures depending on the nature and scope of the traffic, the risk, and the quantities involved. The law names no safe class. The obligation is on the holder to achieve the result.

The documentation duty is more precise. Under Paragraph 1(3) BtMVV, the whereabouts and stock of narcotics must be evidenced without gaps in pharmacies and veterinary dispensaries, in doctors', dentists' and vets' practices, on hospital and animal clinic wards, in care homes and hospices, in emergency service facilities, and on merchant ships flying the German flag. Paragraph 13 BtMVV then sets the mechanics.

1. Record every change of stock without delay, on the official form. Card files or numbered narcotics ledgers are permitted, as is electronic processing, provided a printout in the order of the official form can be produced at any time.
2. Enter, per Paragraph 14, the designation, the date of receipt or issue, the quantity and the resulting stock, and the name and address of the supplier or recipient. Pharmacies additionally record the prescriber and the number of the BtM-Rezept.
3. Check the entries and the agreement of stock with the records at the end of every calendar month. Where the stock has changed, confirm with initials and the date of the check. Under electronic record keeping, the check runs on month-end printouts.
4. Retain records for three years from the last entry, and present or send them to the competent Land authority on request.

Substitution treatment

Substitution is regulated separately in Paragraphs 5 to 5d BtMVV, and it is the area that has moved most. The prescription is marked "S". Take-home prescriptions for a patient's own responsible use carry the additional "T" marking under Paragraph 5(8) sentence 10, and prescribing doctors must meet minimum qualification requirements or involve a consultant. Since the 2023 amendment, telemedical consultation is possible, with at least one in-person consultation required within any 30-day period, and take-home reach durations were extended. Where a substitute is handed over for immediate consumption, the whereabouts must be evidenced per patient, not just per stock.

Travelling with a BTM

Patients regularly ask, and the answer differs by destination. For travel of up to 30 days within the Schengen area, the patient carries a certificate under Article 75 of the Schengen Implementing Convention, completed by the prescribing doctor and certified before departure by the highest Land health authority or its delegate. A separate form is needed for each medicine, and the certificate is valid for a maximum of 30 days. Outside the Schengen area there is no harmonised instrument: the BfArM refers travellers to the INCB Travellers' Guide and to the embassy or consulate of the destination country. In every case, only a quantity appropriate to the duration of the trip may be carried, and never for someone else.

Where is the E-Rezept in all this?

Nowhere yet, and that is the honest state of play in July 2026. Paragraph 8(1) BtMVV still requires the three-part official paper form. The gematik lists BtM-Verordnungen under features still in preparation for the E-Rezept. The originally planned mandatory date of 1 June 2025 passed without effect, and a draft law, the Gesetz für Daten und digitale Innovation im Gesundheitswesen, proposes 1 March 2028 instead. The design under discussion drops the three-part structure in favour of a two-part electronic model, an E-BtM-Verschreibungsnachweis plus an E-BtM-Abgabenachweis. Until that is law and live, the yellow form remains the only valid route.

How BTM status is flagged on pharmazie.com

The legal classification of an article is not something you should have to reconstruct from the Anlagen by hand for every PZN. On pharmazie.com, the Rechtsinformationen tab of each article detail page carries it as a structured field.

• Field: "Betäubungsmittel" flag in the Rechtsinformationen tab, alongside the neighbouring legal flags T-Rezept, Explosivgrundstoff, CMR-Gefahrstoff, Dokumentationspflicht Transfusionsgesetz, Apothekenpflicht, Verschreibungspflicht and Verkehrsfähigkeitsstatus.
• Granularity: per PZN.
• Source: ABDA article master data (ABDATA Pharma-Daten-Service).
• Updated: daily, with a source and date stamp on every detail page.
• Access: web app, REST API, data export.

One honest limitation: the flag answers "is this article subject to the BtMG", per PZN, which is the question that arises at the counter and in an ERP check. It does not tell you which Anlage the substance sits in, and it does not reproduce the ausgenommen clauses that decide borderline strengths. For those, the Anlagen themselves remain the authority, and you should read them.

Sources

• Betäubungsmittelgesetz (BtMG) (Paragraph 1(1) definition via Anlagen I to III, Paragraph 15 security measures)
• BtMG Anlage I (Anlage headings and substance entries; Anlagen II and III are linked from the same law)
• Betäubungsmittel-Verschreibungsverordnung (BtMVV) (Paragraph 8 BtM-Rezept, Paragraph 9 mandatory entries, Paragraphs 13 and 14 record keeping, last amended 14 February 2025)
• BfArM: Verordnung zur Änderung der BtMVV und der Tierärztegebührenordnung (Höchstverschreibungsmengen and the "A" marking abolished, in force 8 April 2023)
• BfArM: Reisen mit Betäubungsmitteln (Article 75 Schengen certificate, maximum 30 days, certification by the highest Land health authority)