How (and Why) Proper Pharmaceutical Storage Practices are Implemented

When picking up a prescription from the pharmacy, one might wonder how the drug arrived and whether it is safe and effective. The journey of these medications from the manufacturer to the patient is highly involved, especially since these drugs require careful storage and packaging. Proper pharmaceutical storage practices ensure their effectiveness, regulatory compliance and overall patient safety.

Methods might entail precise climate control and tight sealing. However, the industry must contend with not just the complexities of cold chain management but also warehouse practices and transportation protocols to uphold each medicine’s integrity. 

The Importance of Controlled Environments

Temperature control is critical in pharmaceutical storage to maintain drug potency and safety. Under excessive heat, medications may undergo a chemical reaction, while high humidity and moisture exposure may cause hydrolysis for some drugs, including common prescriptions like erythromycin and gabapentin.

Some drugs are also sensitive to light, especially ultraviolet radiation. For example, excessive light degrades dacarbazine — an important cancer therapy for Hodgkin’s disease, malignant melanoma, soft-tissue sarcoma and childhood solid tumors — and should be avoided during intravenous treatment. 

The World Health Organization and the United States Pharmacopeia (USP) set stringent guidelines for pharmaceutical storage and packaging conditions to maintain product quality and safety. Adherence to these standards is paramount to preventing harmful effects and guaranteeing each drug’s remedial benefit. 

Types of Pharmaceutical Packaging

All pharmaceuticals require specific packaging, whether solid, liquid or gas. For example, creams and other topical ointments often come in plastic or aluminum tubes and pump bottles that are easy to use.

Glass containers are particularly conducive for liquid drugs, delivering durable, transparent protection in various sizes and colors and safeguarding medicines that are light-sensitive. USP Type 1 Borosilicate Glass vials are excellent options for injectable solutions, and manufacturers can easily sterilize them.

Sachets, blister packs and ampoules — for air-sensitive drugs — are other commonly utilized packaging types. Pharmaceutical manufacturers might modify ampoules to filter UV light. Likewise, push-through blister packs are lightweight, inexpensive, and easy for people over 65 to open and take their medications.

Secondary packaging comprises labeling for drug identification and smaller cardboard boxes. For instance, Tylenol and Advil pill bottles usually come in a box at the point of sale. This offers another layer of protection and information printability.

Finally, there must be adequate packaging for bulk shipping, such as pallets, shrink wrap and cardboard or foam boxes. Some medicines also get shipped to pharmacies and providers in wood or plastic materials to ensure stability and durability.

Cold Chain Management

Cold chain management in pharmaceuticals refers to temperature control throughout the supply chain. It requires storage temperature precision ranging from 2 to 8 degrees Celsius, or 35.6 to 46.4 degrees Fahrenheit. Additionally, cryogenic temperature requirements range from –160 to –180 degrees C. 

Vaccines are prime examples of the importance of cold chain management. Influenza or COVID-19 vaccines must remain at a specific refrigeration setting until administration to avoid deterioration and the loss of efficacy. Cold chain failure might result in patients needing extra dosages, higher provider costs, and diminished public trust. Additionally, those who refuse to get vaccinated again may contribute to the spread of diseases. 

However, vaccines are not the only medications that require refrigeration. The latest weight loss drugs — Ozempic, Wegovy, Rybelsus and others — must remain cold during transportation and use. Patients can use Ozempic if not exposed to temperatures below 36 degrees or above 86 degrees F. 

Distributors might employ insulated containers, gel packs, dry ice and liquid nitrogen to keep medicines cold during transportation. Meanwhile, pharmacies and medical providers store the medication in reliable cooling systems. These refrigerators often come with cutting-edge technology that monitors temperature fluctuations, sets off notifications when temperatures are out of range and delivers backup power during outages.

Pharmaceutical Warehouses 

The pharmaceutical storage services market is rapidly expanding at a 6.48% compound annual growth rate from 2025 to 2030. Much of this growth is due to technological advancements in temperature-controlled storage and the integration of real-time monitoring and data analytics. 

Warehouses are especially critical for maintaining medicinal integrity. Each location’s design must optimize storage and retrieval, employ automated systems for sufficient inventory management, utilize robust security measures and come equipped with Internet of Things-enabled cooling systems. 

Blockchain technology is also improving product traceability and transparency so that the industry can decrease the risk of counterfeit medicines. Maintaining pharmaceutical storage practices — like first-in, first-out and first-expired, first-out methods — also reduces the expiration risk and supports patient safety.

Pharmaceutical warehouses must conduct regular audits and assessments to ensure the facility adheres to compliance standards, documenting findings to make the information regarding the products available throughout the entire supply chain.

Transportation Best Practices

Transporting pharmaceuticals in refrigerated trucks and airplanes is important to ensure temperature control. Simultaneously, confirming that shipping routes and lanes comply with temperature control regulations reduces the risk of delays, disasters and extreme weather. 

Real-time monitoring and tracking of all shipments allows manufacturers to intervene in an emergency. Deploying blockchain technology to trace products during distribution will also guarantee their integrity as they journey from the facility to their final destination.

In November 2024, Frontier Scientific Solutions announced it would construct a new pharmaceutical facility at Wilmington International Airport in Wilmington, North Carolina. The $1.5 billion project will eliminate frequent stops and improper storage along transportation routes and improve shipping times for temperature-sensitive drugs.

Prolonging Pharmaceutical Freshness and Shelf-Life

Preserving pharmaceutical freshness stems from microbial contamination and moisture vulnerability, which can spoil the medicines and make them go to waste. Oftentimes, manufacturers add antioxidants to prevent oxidation and chemical reactions that otherwise ruin their usefulness. 

Modified atmosphere packaging — swapping out ambient air for regulated gas solutions — is another way to package, store and prolong the shelf-life of many drugs. For instance, cell and gene therapy treatments may degrade because of oxidation and shifts in pH levels. Replacing the oxygen in packaging with nitrogen or other inert gases protects the medicine within the container.

Vials with leakage-controlled seals also stop moisture from seeping into the medicine. Likewise, light-protective packaging coatings — like amber-colored glass — can further avert degradation and maintain medicinal integrity until the product’s expiration date. 

Consequences of Improper Pharmaceutical Storage Practices

Of the 15,710 drug recalls that occurred from 2012 to 2023, 833 were due to inadequate packaging and storage, accounting for 15.7% of all cases. Unfortunately, improper packaging and storage practices result in significant waste and potential harm to the public. 

Pharmaceutical waste is also costly. In Jimma Zone, Ethiopia, unused medicines accounted for 4.87% of drugs in the fiscal year of 2019/202 and 2020/2021. This cost regional public hospitals $32,453.30 and $2,711.44 in expired drugs. When these instances occur, patients may not receive the healing benefits of the medicine, have prolonged illnesses or face several complications and adverse reactions.

Poor storage of pharmaceuticals may also disrupt the supply chain, leading to medicine shortages for communities in need. This is particularly dire for those with chronic conditions who require consistent access to prescriptions. 

Pharmaceutical companies’ public perceptions hinge on their commitment to safety and transparency, especially regarding their storage practices. The more drug recalls, defects and concerns arise, the more people mistrust the companies and the greater the damage to their reputations. The pharmaceutical industry is also susceptible to legal and financial penalties when it violates storage and handling regulations, which have implications for revenue and future operations.

More recently, in February 2025, Indian pharmaceutical manufacturer Granules received a warning letter from the U.S. Food and Drug Administration concerning an unclean facility and poor documentation. Inspectors found residues from previous drug products on the air handling unit’s ducts, causing concern about microbial contamination. 

Medicinal Safety Begins With Proper Pharmaceutical Storage

Proper pharmaceutical storage practices are essential for medication safety and efficacy. Manufacturers, distributors, pharmacists and medical professionals might coordinate efforts to follow storage guidelines. Likewise, patients should read medicine packaging carefully to understand each drug’s storage requirements. Contacting the prescribing doctor or the pharmacy is important for answering questions and concerns.