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Cool Chain Drugs | What are Cool Chain Drugs?


In the pharmaceutical world, there are certain medicine products that needs certain specific temperature in order to maintain its efficiency, structure and safety. These materials require formulators or individuals to have complete and thorough knowledge about its handling procedure, temperature control, cool environment , precise carton usage as well as how to deliver and ship these products from one location to another while observing the SOPS and guidelines that are published by health authorities such as the FDA and other regulatory organization. The temperature guideline includes products that are chemicals, biological, and pharmaceutical as well as lab samples.

USA Regulations Concerning Cool Chain Drugs

Under US FDA in Code of Federal Regulation (CFR) title 21, section 211.94 (b), the section explains the container type that should be used to maintain and control the temperature within the standard limit.

Cool Chain – Controlled Room Temperature

Experts in the industry suggest that the cool chain products should be given another name such as “controlled room temperature or CRT” near health agencies and the FDA.

What would happen if the temperature is not controlled?

The US FDA requires that all cool chain product should be maintained according to the limit of the temperature. If there is an imbalance or no control, the drugs may become adulterated resulting to poor quality of the product. This is also published and explained in Section 501 (a) (2) (B) of the Federal Food, Drug and Cosmetic Act.

It is believed that should the temperature of the surrounding area is not controlled especially concerning cool chain products, there are therapeutic effects to the drugs. If there are changes in the temperature and the product is provided the right temperature limit, the FDA will take legal action. An example would be drugs or vaccines that are given for diabetic patients. Uncontrolled temperature may result to the vaccines causing harmful side effects to the patient.

Temperature Limit

The temperature limit as set by the US FDA for cool chain product range from 2 centigrade to 8 centigrade (2-8 C).


With regards to the shipping process, according to the SOP guidelines, cool chain drugs should be shipped and transported using special containers such as thermos pole cartons. Polythene sheets are placed in the container first and then the container is aligned with ice packs to control the temperature and reach the required temperature limit.

Should drugs be kept in refrigerator, the thermostat should be between 2 to 8 centigrade. A backup generator should be kept inside in case there is an emergency. The generator would help stabilize and maintain the temperature level. Using a thermometer, such as a digital one, is also required to check the temperature of the package. A recording sheet for documentation is also required and temperature taken should be recorded after each specific interval.