Understanding Refrigeration According to USP <800>

There are in excess of 200 substances identified as hazardous drugs (HDs), and they pose a serious concern to human health with both acute and long-term consequences. Inadvertent exposure to these medications is known to affect or damage DNA, cause cancer, contribute to infertility or adversely affect embryo development, or cause organ damage. In the United States, more than 8 million healthcare workers are exposed to hazardous drugs each year.

Exposure to HDs can happen in many ways if precautions are not taken. Mishandling of these substances can occur during shipping, storing, dispensing, or administering. Healthcare practitioners and technicians are at risk, but so are cleaning people, delivery personnel, other staff members, and patients who may encounter these substances. A new guideline from the United States Pharmacopeia – USP <800> – has been released, providing standards for the safe handling of hazardous drugs with mandatory compliance by December 1, 2019.

Who Is at Risk For HD Exposure?

  • Pharmacists
  • Pharmacy technicians
  • Nurses
  • Surgeons
  • Physicians
  • Physician assistants
  • Respiratory therapists
  • Home health aides
  • Nurses’ aides
  • Housekeeping personnel
  • Janitorial services personnel
  • Environmental services personnel
  • Veterinarians
  • Veterinarian technicians
  • Veterinarian assistants

Many HDs require refrigeration. The USP <800> documentation stipulates that antineoplastic HDs must be stored in a dedicated refrigerator in a negative-pressure area with at least 12 air changes per hour (ACPH). It is important to note that USP <800> does not recommend any specific type of refrigeration system, and so-called “solid state” or compressorless refrigerators are not a requirement for storing of HDs.

Follett Fits the Bill

All Follett medical-grade refrigerators and freezers are suitable for use in a USP <800> negative pressure containment-segregated compounding area (C-SCA). Our compact refrigerators were recently tested in a pharmaceutical clean-room environment by a third-party lab, and the results demonstrated that these Follett refrigerators had no adverse effect on either particulate levels or temperatures within the C-SCA. Incidental temperature changes were found to be related to ambient outdoor temperature (temperatures in the C-SCA are not automatically controlled), and any small influence on particulates was determined to be well within the ISO Class 7 limits.

The bottom line is that pharmaceutical and other healthcare personnel can continue to rely on Follett refrigeration for safe and compliant storage of HDs now and beyond USP <800> implementation.