Call us
"Pharmacy Law" Category

How USP 800 Affects Compounding Pharmacies

Published on March 23rd, 2017

The new USP General Chapter 800 became effective January 1, 2017 and marked the completion of revisions that were initiated in 2014 by the California Board of Pharmacy. However, official implementation of the new regulation is delayed until July 1, 2018. Prior to the birth of this chapter, no portion of the USP specifically addressed hazardous drugs in the compounding setting. Chapter 800 attempts to rectify the oversight.

USP 800 is essentially a revision that combines or expands certain requirements of USP General Chapters 795 and 797. The basis for both chapters is the furtherance of safety for patients and pharmacy workers. Chapter 795 describes set standards for nonsterile preparations including the compounding process, equipment, personnel training and beyond-use dates.

Chapter 797 details requirements for sterile substances such as no pollutants and consistency in prescription criteria. It also covers personnel training, plus testing measures and storage of finished compounds. Additionally, this chapter describes the protective attire staff should don as an impediment to potential contamination.

More comprehensive, USP 800 aims to clarify any grey areas clouding the dispensary and handling of explicitly hazardous drugs in compound facilities. The regulation’s foundation is that no level of exposure to substances in said class is deemed acceptable. The chapter lists specific safeguards to be implemented for pertinent personnel as well as for the dispensing environment itself.

Chapter 800 Outtakes:

  • Employs the definition of a hazardous drug cited by the National Institute for Occupational Safety and Health which is based upon at least one of six criteria in humans or animals: “carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity and new drugs that mimic existing hazardous drugs in structure or toxicity.”
  • Considers all possible handling of hazardous drugs i.e., receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, altering, counting, crushing or pouring.
  • Delayed implementation date of July 1, 2018 may accommodate those providers that will need to institute structural refinements to their premises.
  • Prioritizes utilization of personal protection equipment and engineering controls.
  • Describes deactivation, decontamination, cleaning procedures and proper ventilation.
  • Presents in-depth explanations of segregated room types for both sterile and nonsterile compounding including requirements for each.

If your pharmacy is not able to meet your prescription needs due to this regulation change, we at Fusion Rx are ready and able to do so.

  • It is rare to find health professionals who are so willing to educate the patient on what they need to know.

    Clair C. | West Hollywood, CA