Mail-order pharmacy: Amendment to the pharmacy operating regulations raises questions
11.11.2025 14:57
The Federal Ministry of Health is planning amendments to the Pharmacy Operations Ordinance and the Drug Price Ordinance. The new paragraph to be added to Section 17 (2a) No. 1 of the Pharmacy Operations Ordinance requires that, for refrigerated medications, a transport company suitable for refrigerated transport be used. This company must maintain the temperatures specified by the pharmacy, ensure these temperatures are maintained even in the event of delayed delivery, and provide complete temperature documentation. Martin Schulze, pharmacist and head of pharmaceutical customer service at mycare.de, explains why a misinterpretation of this regulation could increase costs and worsen the quality of care.
What the new version could mean
„"The wording can be interpreted to mean that only vehicles with active temperature control will be permitted in the future. This would be stricter than current practice, in which active systems and validated passive cooling packaging are considered equally safe options, provided they are qualified, risk-based, and documented. We have relied on validated passive cooling for years. This method is proven, safe, and complies with the existing Pharmacy Operations Ordinance, which already stipulates in Section 17, Paragraph 2 that medicinal products must be packaged and transported in such a way as to maintain their quality and efficacy. Additional GDP or GMP compliance is deliberately not included here, as both sets of regulations apply to other stages of the supply chain."“
Passive cooling: Proven and validated practice
„"For over 20 years, refrigerated pharmaceuticals have been transported reliably and safely using passive cooling in mail-order pharmacies, without a single documented case of a patient being harmed by a medication that became too warm. The transport process is regularly validated, continuously monitored, and meets all quality and risk management requirements. Pharmaceutical wholesalers also use this risk-based approach without being obligated to use active cooling or data loggers.".
Passive cooling is therefore by no means a simplified procedure, but a qualified process with validated packaging systems and defined packing patterns. It is perfectly adequate and has proven itself for decades.”
Consequences for supply, costs and competition
„In the B2C sector, there is currently practically only one provider of active cooling solutions. Delivery costs approximately 20 to 30 euros per package, making it at least twice as expensive as validated passive solutions. This would restrict competition and generate significant additional costs. For patients, shipping refrigerated medications has so far been cost-neutral. Furthermore, if mail-order pharmacies were required to use active cooling in the future, the same would have to apply to delivery services. Millions of pharmacy delivery drivers daily, some of them bicycle couriers, would need to be equipped with data loggers and active cooling technology. This is neither practical nor proportionate. Such a regulation would therefore not only affect mail-order pharmacies but also weaken comprehensive local healthcare provision.“
Equal treatment and risk-based verification
„"The argument that courier services are only responsible for short distances, while shipping takes longer, doesn't hold water: Refrigerated pharmaceuticals are delivered via express shipping with scheduled delivery, so the transport time is usually less than 24 hours. Good Distribution Practice (GDP) also doesn't distinguish between 30 minutes and several hours; transport is transport.".
The fact is: there is no temperature problem. Additional controls or documentation requirements would not increase drug safety, but would create bureaucracy, costs, or unequal treatment.
We therefore demand a practical, risk-based design for temperature verification instead of blanket technical specifications. Active refrigerated vehicles and validated passive cooling packaging must continue to be treated equally, provided that the temperature requirements can be demonstrably met. Only in this way can supply remain secure, affordable, and competitively neutral.“
About mycare.de
As one of the first mail-order pharmacies in Germany, mycare.de mycare.de has been a driving force in the German market since 2001. In addition to a comprehensive online shop with over 90,000 medications and health products, mycare.de offers a wide range of services for personal healthcare. In a modern pharmacy laboratory, mycare.de prepares customized medications to the highest pharmaceutical standards, including prescriptions for hormone therapies, homeopathic remedies, skin creams, and medical cannabis. Every medication order is individually prepared and tested by qualified personnel to the highest pharmaceutical standards. Other services offered by mycare.de include medication and home medicine cabinet checks, as well as the MEDPAC tablet delivery service. As a major regional supplier, mycare.de provides medical facilities throughout Germany with medications, medical aids, and dressings, and also ensures comprehensive care for patients at home. Personal consultations are available by phone, email, and at three pharmacy locations in Lutherstadt Wittenberg.