The supply of antibiotics is once again critical for certain medications because stocks of specific depot penicillins are expected to run out. The Federal Ministry of Health is reacting promptly to ensure that therapies are not interrupted. At the same time, the situation demonstrates how quickly a fragile supply chain can falter when only one approved product is available in Germany.
Antibiotics and Supply Shortages: Which Preparations Are Affected
The Federal Ministry of Health has identified a supply shortage of injectable medications containing the active ingredient benzylpenicillin benzathine, and therefore temporary special regulations apply. These regulations facilitate the import of comparable preparations, ensuring continued supply even after the remaining stocks are sold. Furthermore, packages without German labeling may be used if importing these medications can close the supply gap more quickly.
These medications are used for long-term treatment of streptococcal infections and protect against rheumatic heart inflammation. Furthermore, a single injection is standard in the treatment of syphilis, making a stable supply medically crucial. Alternatives exist, but they are often less effective, making these depot penicillins difficult to replace in cases of high relapse risk.
Supply chain on the verge of collapse – what to expect from 2026 onward
Since last summer, the Federal Ministry of Health has received indications that the availability of the only approved medication could plummet from the first quarter of 2026. This is due to delays in production changes, and such changes can disrupt delivery schedules. Although the marketing authorization holder has built up a bridging stock, this buffer will foreseeably be depleted.
To prevent a disruption of the supply chain, imports are intended to bridge the gap until production is running smoothly again. These imports can also include medications not labeled for the German market, provided that quality and application remain guaranteed. This is intended to prevent supply gaps before doctors’ offices have to change treatment plans.
Import regulations as a safety net for supply
The special regulations reduce bureaucratic hurdles, allowing for faster deployment of imported goods. This is crucial for supply because depot penicillins are not interchangeable. For patients, this means greater planning certainty, as established therapies should not be jeopardized by packaging issues.
The Ministry considers the measure the result of closely monitored shortage management, as early notifications enable targeted action. At the same time, the structural risk remains, because a small number of suppliers can quickly lead to new shortages in the event of disruptions. Therefore, the focus is not only on stock levels but also on reliable production and transport routes.
Difference Between Supply Shortage and Supply Shortage
A supply shortage is not automatically a supply shortage, because alternative medications with the same active ingredient are often available. A supply shortage is generally defined as an interruption of the usual delivery volume lasting more than two weeks, while a supply shortage significantly jeopardizes treatment. According to official data, there are currently around 550 reported supply shortages, out of a total of approximately 100,000 approved medications.
The Federal Ministry of Health describes the general supply of medications as largely stable, and the situation has further improved for pediatric medications. At the same time, critical situations have already been documented for several antibiotic active ingredients, including cefuroxime, clindamycin, cotrimoxazole, and erythromycin. Such cases remain rare; however, according to official figures, there have been fewer than 20 reported supply shortages since 2015.