Pharmaceuticals, the Cold Chain, and the FDA

Published by: Vanesia Adkins, Chief Executive Officer, 01/09/2021

In the pharmaceutical industry, a company can’t underestimate the importance of regulations. One regulatory body that plays a large role is the Food and Drug Administration (FDA) . While certain practices are standardly followed in your warehouses and factories; it is also essential to follow the regulations when your products are in transport. In this article, we’ll cover some of the different laws you’ll need to know when it comes to the cold chain and FDA for your pharmaceutical products.

Importance of Adhering to FDA Regulations

Pharmaceuticals are required to follow specific regulations from the FDA, from the manufacturing process to the sale of the product to the consumer. Failure to do so could spell grave consequences for your company. It’s essential to follow these practices to protect your customers as well as your business.

The FDA issues many different enforcement actions when a company is found guilty of non-compliance with these regulations. These vary from warning letters to criminal prosecution, depending on the violation and convictions. In the case of a warning letter, a company needs to verify the steps they will take to correct the violation. However, in a more severe breach or repeated violation, companies can be subject to seizure, injunctions, fines, or imprisonment.

Documentation is the number one key in following FDA regulations for pharmaceutical companies and distribution partners.  To ensure they’re compliant at all steps of the process to include detailed records of temperature, time, conditions during transport, contingency plans for delays, and strategies for potential problems and deviations, throughout the entire cold chain.

FDA Regulations to Note For Cold Chain

When your pharmaceutical products are in the cold chain, there are several FDA regulations to pay attention to, specifically from Title 21: Food and Drugs. They include

21 CFR 205.50

21 CFR 205.50 is titled “Minimum requirements for the storage and handling of prescription drugs and the establishment and maintenance of prescription drug records.” It references the different aspects of the supply and cold chains you will have to note for your company. Your business should note these regulations, among others listed in the section:

  • Facilities
    • Your facilities should be well equipped to handle your product.
    • This includes all aspects of your business, from storage to marketing to transport.
    • You will need a quarantined area for prescription drugs that are damaged or otherwise unusable.
  • Security
    • Security should be a top priority, and your products secure from the threat of unauthorized entry.
    • This section refers to lighting, security systems, and strategies against theft or diversion.
  • Storage
    • Throughout all parts of the supply chain and cold chain, your products should be at appropriate temperatures and conditions.
    • All products should be appropriately labeled.
    • A company should have the correct equipment to properly monitor their products and the conditions in which they are held.
  • Recordkeeping
    • Documentation is central to FDA compliance.
    • Documents should reference the source of the drugs, the product’s name, quantity, and dates of receipt and distribution.

The section also focuses on ensuring that your products can be easily examined before transport and ensure they’re fit for distribution. Pharmaceutical companies should have well outlined written procedures and policies to adhere to the section’s regulations and other laws.

21 CFR 203.32

203.32 refers to “Drug sample storage and handling requirements.” Manufacturers, distributors, and others involved in the cold chain must store the pharmaceutical products under conditions that will maintain stability. The products should also be cared for to ensure their integrity and effectiveness while keeping them free of contamination or other issues.

Throughout all steps in transport, the cold chain company you work with should be carefully documenting the conditions your products are in to ensure they’re compliant with this regulation.

21 CFR 203.36

As mentioned previously, one of the best things you can do when it comes to compliance with FDA regulations is documentation. 21 CFR 203.36, or “fulfillment houses, shipping, and mailing services, co-marketing agreements, and third-party recordkeeping,” is specifically dedicated to documentation.

Manufacturers of pharmaceuticals must create and maintain forms, reports, and records detailing their compliance, even if they use another company to ship to distributors or consumers. This section also notes that you should produce those documents if requested by the FDA or another enforcement official within two days.

21 CFR 211.150

211.150 of Title 21 refers to “distribution procedures” of pharmaceuticals. Companies should have written procedures for distributing their drugs that also account for potential problems within the cold chain or supply chain. Pharmaceutical companies should focus on distributing their oldest approved stock first and have a program in place that allows for easy recall of products if necessary.

The FDA is only one regulatory bodies that pharmaceutical companies need to follow regarding the sale and distribution of their drugs. Companies may also have to adhere to ICH, CDC, WHO, and other federal and worldwide agencies. However, understanding these four FDA regulations will help you craft a solid cold chain strategy for your products.

We understand the importance of FDA regulations and other requirements for the shipment of your pharmaceuticals. We’re here to help you develop a cold chain plan that takes documentation, compliance, and safety into account to help protect your business. Please visit our website For inquiries and questions, contact us at [email protected].

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