Is USP <800> Going to Kill Compounding?

July 2018 is rapidly approaching! This is the deadline that USP has set for the implementation of General Chapter <800> Hazardous Drugs-Handling in Healthcare Settings. All compounders of Hazardous Drugs (HDs) are expected to be fully compliant with the standards of USP Chapter <800> as it applies to all personnel who are engaged in handling HDs, including, but not limited to pharmacists, healthcare practitioners and staff, safety specialists, and human resources.

General Chapter <800> addresses:

  • Standards that apply to all personnel who compound HD preparations and all places where HDs are prepared, stored, transported, and administered;
  • Receiving, storing, compounding, dispensing, administering, and disposing of both sterile and nonsterile products and preparations;
  • Altering, counting, crushing and pouring HDs.

Do you know for sure if you are currently handling HDs?  The National Institute for Occupational Safety and Health (NIOSH) maintains the most complete list of anti-neoplastic and other HDs used in healthcare. You must be knowledgeable of these drugs and be prepared to handle and compound preparations according to USP <800> standards. These preparations will no longer be allowed to be prepared in areas that do not meet the standards as prescribed in USP <800>. Compounders must ask themselves if the volume of HD compounding that they perform warrants the associated investments and associated on-going costs.

Are You Ready???
There are many factors to be considered and difficult decisions when contemplating to continue, or even initiate, compounding of preparations that contain hazardous ingredients.  Compounders of HDs will have to completely re-engineer their operations, redesign their compounding labs, invest in new technologies as well as invest in containment, ventilation, HVAC, and personnel protective equipment. Compounders will also be required to develop and implement a comprehensive document of policies and procedures that address all aspects of compounding HDs. Compliance will take substantial investments of financial, spatial and human resources.

In addition to the necessary investments of financial, spatial and human resources, compounders must be prepared to face the challenges that regulatory agencies will present with regards to compliance. USP <800> will be enforceable by federal and state regulatory bodies. Regulatory agencies will inspect HD compounding operations to ensure complete compliance with all of the standards for handling, compounding, storage, delivery, record keeping, documentation, environmental controls, equipment, training, cleaning, safety and disposal of HDs.

No, USP <800> won’t kill compounding. But if you intend to compound HDs you need to analyze where you are in the process. Reach out to us. We are prepared to guide, advise and offer assistance.

USP 800 – A Primer on What You Need to Know

The clock is now running for entities to implement the new USP Chapter <800> Hazardous Drug Handling in Health Care Facilities. General Chapter <800> was published February 1, 2016 and becomes official July 1, 2018. All USP Chapters below <1000> are enforceable by regulatory oversight agencies such as boards of pharmacy, so pharmacies will need to integrate USP <800> requirements into their existing operating practices, and provide mandatory training for employees based on their job functions by July 1, 2018. The chapter applies to all healthcare personnel who handle hazardous drug preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians). ‘Handling’ includes the receiving, storing, compounding, dispensing, administering, and disposal of hazardous drugs. A hazardous drug is any drug identified as hazardous or potentially hazardous by the National Institute for Occupational Safety and Health (NIOSH) on the basis of at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity. NIOSH maintains a list of antineoplastic and other hazardous drugs used in healthcare settings.
Non-compliance with USP <800> will not only leave workers unprotected, but could also potentially harm your pharmacy’s fiscal performance. Penalties, fines, potential legal actions and, ultimately, suspension or termination of license are all potential outcomes of non-compliance.
Your plan of action to fall within compliance should include a thorough study of the chapter, a gap analysis of your current facility’s operations, including equipment, workflow processes, personnel awareness and training; and development of an implementation budget and timeline. For starters, USP is offering a home study course on their education website. With the implementation of <800>, combined with the pending revisions to <797> Pharmaceutical Compounding – Sterile Preparations weighing in the balance, engaging the assistance of experts should be seriously considered. The proposed changes to <797> reflect new science and evidence based on updated guidance documents, best practices, and new learnings from investigations. USP received over 8,750 comments from over 2,500 individuals when the comment period for the <797> revisions closed January 31, 2016.
PMC can assist you with both <797> and <800> from preemptively examining your operation to developing corrective action plans should you get an inspection. We encourage you to address these changes proactively, and engage the assistance of informed experts early rather than having to reactively address cited deficiencies.