Glossary · Regulation
Compounded medicine (pharmacy preparation)
In short
A compounded medicine (in German: Rezepturarzneimittel) is prepared by the pharmacy itself for an individual patient on a doctor’s prescription. It does not need its own marketing authorization because it is not an industrially manufactured finished medicine.
Compounding fills gaps: when a strength, dosage form or combination of substances is not available as a finished product. The pharmacy checks the prescription for plausibility, is responsible for quality and documents the preparation according to the German Pharmacy Operations Ordinance.
For the ingredient itself, compounding does not replace proof of efficacy. Whether a substance helps is still decided in studies. In the US, which substances may be used for compounding is regulated separately.
The pharmacy vouches for the preparation, not for the effect.
Where this comes up in the fact checks
- Low-Dose Naltrexone – LDN is prescribed by doctors as a compounded medicine and prepared in the pharmacy.
- BPC-157 – In July 2026 an FDA advisory committee discussed whether BPC-157 should be allowed for compounding in the US; the FDA experts advised against it, the committee voted in favour by majority.
Sources
Related terms: Off-label use · Marketing authorization (EMA, FDA, BfArM) · Gray market
Information only, not medical advice. The BK-Score is a subjective assessment according to disclosed rules – not a scientific evaluation. Scoring rules