Understanding Key Shipping Regulations for Cold Chain Logistics

Effective cold chain logistics depend on strict regulatory compliance, particularly in the perishable and pharmaceutical sectors. Cold chain regulations maintain product integrity, ensure patient safety, and minimize spoilage or contamination. Compliance requires a structured approach to documentation, packaging, monitoring and contingency planning.

The primary challenges in cold chain logistics involve temperature control, contamination prevention and timely delivery. To address these challenges, United States federal agencies enforce directives that govern transportation, storage and distribution.

Who Creates Cold Chain Shipping Regulations?

Multiple agencies oversee cold chain shipping rules in the U.S. Each enforces specific requirements tailored to food and pharmaceutical transportation. Businesses shipping perishable food and pharmaceuticals must comply with regulatory frameworks established by the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA) and the Department of Transportation (DOT). The U.S. Customs and Border Protection (CBP) and the Transportation Security Administration (TSA) also shape these regulations when products are transported across borders.

Understanding these requirements mitigates risk and augments operational efficiency.

Key Cold Chain Regulations

Cold chain shipping laws focus on setting minimum temperature requirements for specific products to keep them stable, ensure intact packaging during transit and ensure the process can be monitored consistently. Gel packs can help businesses adhere to cold chain rules by maintaining consistent thermal conditions throughout transit. High-quality options provide predictable, long-lasting thermal protection for your cold chain shipments.

Explore key regulations and how gel packs can help with compliance.

Food Shipments: FSMA Compliance and Best Practices

The Food Safety Modernization Act (FSMA), enforced by the FDA, sets standards for food transportation under the Sanitary Transportation of Human and Animal Food (STF) Rule, referring to Title 21 of the Code of Federal Regulations (CFR). These regulations apply to shippers, loaders, carriers and receivers handling temperature-sensitive food products. Requirements include:

• Temperature control: Shippers must establish and document proper temperature conditions before transport. Carriers must maintain conditions throughout transit and provide proof upon request.
• Sanitation: To prevent contamination, vehicles and transportation equipment must be cleaned and maintained. This process includes ensuring insulation and proper airflow and avoiding cross-contamination with nonfood cargo.
• Training: Personnel must be trained in sanitary transportation practices, including procedures for handling and monitoring temperature deviations.
• Recordkeeping: Companies must keep at least 12 months of records on temperature data, maintenance logs and compliance training.

Pharmaceutical Shipments: CGMP and GDP Regulations

Pharmaceuticals, including vaccines, biologics and other temperature-sensitive drugs, are subject to Current Good Manufacturing Practices (CGMP) under 21 CFR Parts 210 and 211 and Good Distribution Practices (GDP), which are enforced by the FDA. Key requirements include:

• Temperature management: Shipping conditions must align with drug manufacturer stability data. Products requiring refrigeration or freezing must be shipped in validated packaging and monitored.
• Validation and qualification: Cold chain packaging must undergo validation studies to confirm that temperature parameters stay within acceptable limits under worst-case conditions.
• Electronic transaction records: Supply chain partners must document transactions to ensure traceability from manufacturer to dispenser.
• Corrective actions: Corrective actions are procedures for addressing excursions, including quarantine and disposal of compromised products.

The Drug Supply Chain Security Act (DSCSA) also applies to the regulation and distribution of prescription drugs. Gel packs for shipping can help businesses adhere to the DSCSA by helping maintain correct temperatures during transport.

Cryogenic and Hazardous Shipments: DOT and IATA Regulations

Certain pharmaceuticals, such as mRNA vaccines, require ultra-low temperature shipping that often uses cryogenic storage. Gel packs and refrigerants offer a compliant alternative for maintaining cold chain stability in this case, reducing reliance on potentially hazardous cooling agents like dry ice. These shipments must comply with:

• DOT Hazardous Materials Regulations (HMR): HMR ensures safe handling and transport of cryogenic substances.
• International Air Transport Association (IATA): These Temperature Control Regulations (TCRs) provide global guidelines for air transport of pharmaceuticals.

Why Compliance Matters

Failure to comply with shipping regulations can result in financial penalties, product losses and reputational damage. For pharmaceuticals, temperature excursions can compromise drug efficacy, posing serious health risks. Noncompliance with DSCSA can lead to regulatory action, product recalls and supply chain disruptions.

Failure to adhere to FSMA regulations in the perishable food sector can result in spoilage, foodborne illnesses and legal action. The FDA has the authority to suspect facility registrations, effectively halting operations for noncompliant businesses.

Beyond regulatory risks, maintaining compliance improves supply chain efficiency, reduces waste and enhances consumer trust. Reliable cold chain logistics help prevent costly disruptions and ensure product integrity.

How Pelton Shepherd’s Ice and Gel Packs Can Help

Businesses shipping pharmaceuticals and perishables must integrate reliable temperature control solutions to meet regulatory standards. Innovative and sustainable ice and gel packs provide extended cooling durations to ensure regulatory temperature compliance and minimize temperature fluctuations. Additionally, nontoxic cooling solutions reduce potential risks associated with hazardous refrigerants, and customizable formulations are tailored to specific temperature requirements.

By integrating high-performance gel and ice packs from Pelton Shepherd that help meet CGMP, FSMA or GDP standards, you can benefit from the following:

• Cost-efficiency: Vortec Ice™ drain-safe gel packs contribute to sustainability, offer cost efficiency and have a eutectic point of 32 degrees Fahrenheit.
• Fast freezing and slow thawing: Glacier Ice™ puncture-resistant film-covered gel packs are slow to thaw and have an eutectic point of 30 degrees Fahrenheit.
• Operational flexibility: For a space-saving solution, Glacier Foam Bricks retain their shape throughout the freeze-thaw cycle, dissipate heat and limit transit movement while providing cushioning to reduce impact damage during transit.
• Sustainability for end users: Terra Ice™ compostable gel packs consist of materials that align with the American Society for Testing and Materials standard D6400 while delivering reliable cooling.

Maintain Cold Chain Integrity With Pelton Shepherd

Compliance with U.S. cold chain shipping regulations is essential to maintaining the safety, efficacy and quality of perishable and pharmaceutical products. Businesses can use validated packaging, monitor technology and implement best practices for temperature control to adhere to these requirements.

Gel packs help ensure safety, cost-effectiveness and compliance during transport. They offer temperature consistency and added operational flexibility to support cold chain needs. Pelton Shepherd products provide consistent, reliable temperature control for perishable and pharmaceutical shipments. Our family-operated business has been innovating shipping gel packs for more than 70 years, and our products are designed to meet your industry’s unique needs. We also have a Conditioning Operations, Logistics and Delivery (COLD) program that uses forecasting strategies to anticipate your demand and ensure you have ready-to-use products when you need them.

Contact us today for assistance with your cold chain shipping needs.