Sustainable Disposal of Expired Medicines: Regulations
18 dezembro, 2025
Each year, tons of expired medicines are generated. If not managed properly, they can pose a risk to public health and the environment, as improper disposal may contaminate soil and water and facilitate unauthorized access to pharmaceuticals.
This highlights the importance of proper disposal of expired or damaged medicines and the need for regulation of these processes by the relevant authorities.
The destruction of medicines is a matter of public health and safety, helping to prevent poisoning, self-medication, and the illegal circulation of drugs. It also minimizes the environmental impact, since active ingredients can alter aquatic and terrestrial ecosystems, generate bacterial resistance, and release pollutants if discarded in landfills or drains.
Current Regulations on Pharmaceutical Waste Management
In Spain, pharmaceutical waste management is regulated by various laws that must be applied in all processes and controls, including the identification, classification, collection, transport, and final treatment of these products. Therefore, companies involved in the supply chain must ensure that the entire process is safe and complies with legal requirements.
The Spanish legal framework includes regulations such as Law 22/2011 on waste and contaminated soils, Royal Decree 180/2015 regulating the transfer of waste, and Royal Decree 833/1988 establishing basic rules for the management of hazardous waste.
Additionally, Spain has the SIGRE system, an entity responsible for ensuring the proper environmental management of packaging and leftover medicines generated in households. This system involves the pharmaceutical industry, pharmacies, and pharmaceutical distribution companies, promoting a more effective and efficient reverse logistics model.
Regarding international regulations, the Directive 2008/98/EC and the Basel Convention apply, establishing principles for the management of pharmaceutical waste, as well as Good Distribution Practices (GDP).
Proper application of these regulations ensures complete traceability from the origin of the waste to its final treatment, which is essential to avoid legal and environmental issues.
Methods for Destroying Expired Medicines
Various destruction methods are used, with technology playing an increasingly important role in developing energy recovery systems that make these processes more sustainable.
Some common methods include controlled incineration, inertization, and packaging recycling. These techniques allow for waste recovery and emission reduction.
Best Practices in Disposal and Management
In storage and inventory control processes, it is important to apply FEFO (First Expired, First Out) systems to minimize expirations and avoid unnecessary accumulation. At Logista Pharma, we do this so that units with the shortest expiration period are distributed first.
Education and public awareness are essential, with pharmacies playing a key role by informing about the use of SIGRE Points (available in more than 22,000 pharmacies) and the importance of not disposing of medicines in the trash or toilet. All this ensures safe collection through reverse logistics.
The Role of Distributors
Pharmaceutical distributors, such as Logista Pharma, play a key role in reverse logistics: safe collection in pharmacies and hospitals, specialized transport, and destruction at authorized plants. We also promote sustainable processes, including incineration with energy recovery, contributing to the circular economy and reducing the carbon footprint.
At Logista Pharma, we work to ensure responsible and safe medicine management, aligned with regulations and sustainability goals. We are committed to technological innovation and collaboration with public and private entities to reduce environmental impact and protect public health.
FAQs
Why is it risky to improperly dispose of expired medicines?
Because they can contaminate soil and water, generate bacterial resistance, and facilitate unauthorized access to drugs, posing risks to public health and the environment.
What does European regulation require for the disposal of expired medicines?
It requires complete traceability, classification, and safe treatment of hazardous waste, in accordance with Directive 2008/98/EC, the Basel Convention, Good Distribution Practices (GDP), and local legislation.
What are the most environmentally friendly disposal methods?
- Controlled incineration with energy recovery
- Inertization to neutralize active ingredients
- Packaging recycling to reduce waste and emissions
How do business intelligence, predictive analysis, and AI contribute to pharmaceutical waste management?
They allow for anticipating expirations, optimizing inventories with FEFO systems, reducing losses, and planning reverse logistics, improving efficiency and sustainability.
What practical steps should organizations prioritize?
- Implement FEFO to minimize expirations
- Ensure complete traceability throughout the chain
- Collaborate with systems like SIGRE
- Adopt sustainable processes and technology for energy recovery
- Educate and raise awareness about proper disposal