What Do Regulatory Authorities Say About Maintaining the Cold Chain?

Regulatory agencies recommend continuous temperature tracking with digital devices over traditional analog models.

Regulatory agencies recommend continuous temperature tracking with digital devices over traditional analog models.

Cold chain management is an important factor in ensuring patients obtain high-quality treatments for their specific conditions.

Researchers Ronald Ziance, RPh, Chris Chandler, PharmD, and Rafik H. Bishara, PhD reviewed the important requirements of various organizations that regulate the maintenance of appropriate handling for pharmaceuticals throughout the supply chain. Researchers examined PubMed for sources published between 1950 and 2007 on drug stability throughout the medication distribution system, with a particular emphasis on the regulatory requirements involved in product storage and stability across the supply chain.

Although the supply chain is often assumed to supply medications that have been stored at an appropriate temperature throughout the process, the management of product stability across the supply chain is actually very complex. Medications are often shipped over land, sea, and air, with storage managed by diverse parties such as manufacturers, distributors, wholesalers, and pharmacists before finally arriving in the patient's medicine cabinet.

As a result, the role of regulatory authorities is very important to ensuring that products are stored in appropriate conditions.

Three major authorities are involved in setting standards related to the cold chain:

  • The FDA creates and enforces good manufacturing practice regulations that base recommendations for storage on stability studies. The FDA also regulates documentation of product storage and handling by licensed distributors of medications, such as wholesalers through the Prescription Drug Marketing Act of 1987.
  • The United States Pharmacopeia—National Formulary (USP-NF) maintains a set of standards for temperature, ventilation, humidity, and lighting in medication storage facilities.
  • The Healthcare Distribution Management Association (HDMA) publishes guidelines for appropriate handling and storage of prescription drugs sold and transferred to and from wholesalers.

An estimated 80% of US prescription drugs are distributed by members of HDMA, which unequivocally recommends that pharmacists use technology that tracks temperature and storage conditions throughout the supply chain. USP regulations are in agreement with the HDMA rules. In addition, according to USP-NF <1118> regulations on monitoring devices for time, temperature, and humidity, digital models of temperature recording are more accurate than traditional thermometers.

Because the FDA oversees and regulates the cold chain, it is important to be aware of the proper regulatory authorities to contact with questions or concerns about product stability. The FDA may be consulted during regular business hours if there are concerns or questions about the storage of a product. For drug products, the business-hours FDA phone number is 301-796-3400, and for biologic products, 800-835-4709. An after-hours emergency hotline is available for pharmacists at 301-443-1240.

It is critically important for pharmacists to take steps that ensure patients have access to quality medications that have been stored in a proper temperature-controlled environment. By being aware of the recommendations of several important regulatory boards and authorities in the management of the cold chain, pharmacists are better equipped to answer patients’ questions, address concerns, and ensure that their patients are receiving medications that have been properly stored for maximum potency.

Reference

Ziance R, Chandler C, Bishara RH. Integration of temperature-controlled requirements into pharmacy practice. J Am Pharm Assoc. 2009;49(3):e61-e67.