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Understanding Cold Chain Shipping

By:

Tammy Blady RPh, HDDP, Corporate Pharmacy Surveyor 

Karen Spano RPh, HDDP, ACHCU Pharmacy Educator 

Posted: September 25, 2025

ACHC Pharmacy Surveyors visit all types of pharmacies every day. We see independent pharmacies, hospital pharmacies, and large corporate pharmacies. Regardless of a pharmacy’s size and location, we’ve noticed a recurring issue—pharmacies are challenged by cold chain shipping.  

Why do pharmacies have difficulty meeting this requirement? Over the past three years, we’ve catalogued several potential causes: 

  • Limited understanding of third-party cold chain data.
  • Lack of knowledge regarding when and how to conduct independent validations.
  • Failure to ensure the data covers what/where your pharmacy transports (utilizing pack-outs specific to your data, including geographical areas and temperature profiles).
  • Insufficient training and competencies for staff who will prepare products for transport.
  • Not checking manufacturer requirements and/or payor requirements.

What is cold chain shipping? 

Cold chain shipping refers to the transportation of temperature-sensitive medications. The appropriate temperature must be maintained for safety, quality, and efficacy of the medication. Transportation methods include local delivery (by courier or by the nurse who will be administering the medication) and shipping via UPS or FedEx. 

Requirements for cold chain shipping are outlined in several USP general chapters, including <659>, <1079>, and <1079.2>.  

Consider these factors  

1. Should you use in-house or third-party vendor validation testing?

  • ACHC Standards do not require you to use a third-party vendor for your shipping and validation program.
  • Third-party vendors can be helpful in developing your own testing program. However, they may only provide limited validation data based on specific pack-outs and environmental conditions, which may vary from your needs.
  • You still need to test your internal process based on the unique requirements of your pharmacy, unless you have enlisted a third-party vendor to validate for you.

2. What’s the temperature profile of the transportation route?

  • Are you shipping from Miami to Anchorage? How will the temperature differential impact your packaging requirements?
  • Consider summer vs. winter shipments and define the temperature ranges in degrees Celsius or Fahrenheit.

3. Examine the potential for delays within the delivery cycle time.

  • How many hours do you want to validate?
  • What is the worst-case scenario to get the medications where they need to go? How will you take care of the patient if shipment is delayed or lost?
  • Do you have a payor requirement or product requirement?

4. How do the materials used in your pack-out affect the temperature?

  • Does staff understand the validation data?
  • Are you allowing ice packs to condition before packaging?
  • Is there consistency among staff? Are you using the same materials in your daily workflow that you used to collect validation data?

5. Maintain detailed, consistent patient communication.

  • Ensure the patient/caregiver is aware of the expected delivery timeframe.
  • Ask about living arrangements. Is it an apartment or a gated community? Will someone be home to accept the delivery? Will the package be sitting out in extreme temperatures for hours?
  • Is the patient on vacation? Has a different delivery address been requested? Do you have proper licenses to ship into other states, and do you have cold chain testing to that geographical area, etc.?

Define your process

Develop your pack-outs based on the specific requirements of your business. Your process should always reflect both your needs and the needs of your patients. Otherwise, you’re setting yourself up for noncompliance.  

  • As tempting as it may be, do not get creative, or use the random “good box” in your warehouse! Use the same materials packaged in the same order as your validation testing, every time.
  • Ensure that your patients’ medications for transportation are packaged only by staff for whom you have documentation of training and competency. Create visual guides for staff to ensure consistency.
  • Remember: if it isn’t documented, it didn’t happen! Document all aspects of your program. Monitor regulatory changes; audit and update as needed.

We’ve developed a reference guide with additional tips for compliance with USP requirements related to cold chain shipping. Click below and get the guide delivered straight to your inbox. 

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