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TL;DRPharmacy compounding inside a German pharmacy takes two forms: individual compounding (Rezeptur) is prepared in the individual case for one named patient on a specific prescription, while stock compounding (Defektur) is produced in advance as a batch stock item in anticipation of frequent demand.
Both sit outside the world of the industrially produced Fertigarzneimittel, and both are still routine practice: dermatological creams, oral liquids for paediatrics, capsules in non-marketed strengths, nasal sprays, and above all patient-individual parenteral preparations such as cytostatics in hospital pharmacies. The two terms are frequently used loosely in everyday pharmacy language, but German medicines law draws a sharp line between them, and that line has direct consequences for marketing authorisation, for quality documentation, and for how the preparation is priced and billed.
The difference is the trigger and the timing. A Rezeptur is made because a specific prescription arrived, so production follows demand and is patient-individual. A Defektur is made because demand is known to recur, so production precedes demand and is held in stock.
That distinction is not cosmetic. A Rezeptur is never a Fertigarzneimittel in the sense of §4 Abs. 1 AMG, because it is not produced in advance in a pack intended for the consumer. It therefore never touches the authorisation requirement of §21 Abs. 1 AMG at all. A Defektur, by contrast, is produced in advance in dispensing-ready packs, so it would fall under §21 Abs. 1 AMG, and it needs an explicit statutory exemption to be lawful without a marketing authorisation. That exemption is §21 Abs. 2 Nr. 1 AMG.
| Criterion | Rezeptur (extemporaneous) | Defektur (stock preparation) |
|---|---|---|
| Trigger | A concrete prescription or a request in the individual case | Demonstrably frequent medical or dental prescription |
| Timing | Produced on demand, for immediate dispensing | Produced in advance, held in stock |
| Patient reference | One named patient | None at the time of production |
| Legal status | Not a Fertigarzneimittel under §4 Abs. 1 AMG | A Fertigarzneimittel, exempted by §21 Abs. 2 Nr. 1 AMG |
| Quantity limit | None as such, the individual case defines the amount | Up to 100 dispensing-ready packs per day, within normal pharmacy operation |
| Operating rules | §7 ApBetrO | §8 ApBetrO |
| Batch designation | Documented per preparation | Batch designation mandatory |
Because the cap is what makes the exemption defensible. §21 Abs. 2 Nr. 1 AMG allows a medicine to be produced without authorisation if it is made, in its essential production steps, in a pharmacy, on the basis of demonstrably frequent medical or dental prescription, in a quantity of up to one hundred dispensing-ready packs in a single day, and in the frame of normal pharmacy operation.
Each of those elements is a limiting condition, not decoration. The prescription frequency has to be provable. The essential production steps have to happen in the pharmacy itself. The volume ceiling is a daily one, not a monthly average. And the whole activity has to remain recognisable as pharmacy practice rather than industrial manufacturing. A pharmacy that exceeds the ceiling, or that produces for a market rather than for its own supply, has left the exemption and needs a manufacturing authorisation and, for the product, an authorisation of its own.
The Apothekenbetriebsordnung (ApBetrO) governs the practice, with §7 for the Rezeptur and §8 for the Defektur. The duties run in a fixed sequence:
The asymmetry is deliberate. A Rezeptur is released against a single patient, so the individual assessment carries the weight. A Defektur is released against an unknown future patient, so a formal batch test carries it instead.
Not by the ordinary retail markup that produces the pharmacy retail price of a finished medicine. §5 AMPreisV sets its own markup regime for preparations produced in the pharmacy from substances, with fixed surcharges, a compounding surcharge and additional fees. On top of that, §5 Abs. 4 and Abs. 5 AMPreisV let the relevant peak organisation of pharmacists and the GKV-Spitzenverband agree deviating purchase prices and deviating surcharges. That agreement is the Hilfstaxe, formally a contract on price formation for substances and preparations from substances. §129 Abs. 5c SGB V then makes the prices agreed on that basis the ones that apply in statutory health insurance billing, with a fallback to actually agreed purchase prices where no agreement covers the case.
Annex 3 of the Hilfstaxe is the one most hospital and cytostatics teams work with, because it governs parenteral preparations. It has been the subject of repeated termination and continuation notices between the DAV and the GKV-Spitzenverband, so the version in force at a given billing date has to be checked rather than assumed.
For billing, a compounded preparation does not carry an ordinary article identifier the way a finished pack does. Because no marketed pack exists, German pharmacy billing uses dedicated special identifiers in the PZN field rather than a product PZN, with the priced components itemised alongside. The precise identifier depends on the preparation type and on the billing agreement in force.
In hospital pharmacies. Patient-individual parenteral preparations, cytostatics above all, are compounding at industrial cadence: dose calculated per body surface area, produced under aseptic conditions, released the same day, billed under Annex 3. The same institution also runs a Defektur line for its recurring standard preparations. A hospital pharmacy therefore lives on both sides of the §7 and §8 divide simultaneously, which is why the documentation regimes have to be kept separate in practice even where the same cleanroom is used.
Compounding decisions are substance decisions, not pack decisions, which is where an aggregated data platform earns its place. On pharmazie.com the relevant material is the substance layer rather than the article layer: substance dossiers, interaction checks, contraindications, and the dosage form and strength data of the finished medicines that are used as starting material for parenteral preparations. Where a required strength or form is unavailable, the availability and supply shortage data is what drives the decision to compound in the first place.
One honest limitation: pharmazie.com is a data platform, not a compounding system. It does not produce production or testing instructions, it does not run the plausibility check for you, and it does not calculate Hilfstaxe prices or generate billing records. Those belong in the pharmacy software and in the Hilfstaxe annexes themselves. What the platform contributes is the substance and article evidence that a pharmacist needs before and around the compounding decision.
