USP <800> for Community Pharmacists and Pharmacies

USP General Chapter <800> applies to all healthcare personnel who handle hazardous drug (HD) preparations and all entities that store, prepare, transport, or administer HDs (e.g., pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians’ practice facilities, or veterinarians’ offices). Personnel who may potentially be exposed to HDs include pharmacists, pharmacy technicians, and other personnel who work in a pharmacy.
Community pharmacies handle HDs in their normal course of business. Some examples of common HDs include:
• Estradiol tablets
• Methotrexate tablets
• Azathioprine tablets
• Cyclophosphamide tablets
• Cyclosporine capsules
• Risperidone tablets
• Paroxetine tablets
The risks involved in handling these drugs depend on many factors including the actual toxicity of the drug, how the drugs may enter the body (dermal, inhalation, ingestion, etc.), how they may be manipulated, how often they are handled, and availability and use of primary and secondary engineering controls and personal protective equipment. Non-compounding pharmacies often don’t think about primary and secondary engineering controls or personal protective equipment. The emergence of USP <800> forcibly changes that unawareness.
At a minimum, community pharmacies should be doing the following:
• Review USP <800> (download for free after registering at the USP website).
• Download and review a copy of the NIOSH 2016 List of Hazardous Drugs
• Create a list of NIOSH listed HDs in your inventory.
• Conduct assessments of risk for handling those HDs in you inventory.
An assessment of risk may be used only for counting and packaging HD finished dosage forms in preparation for dispensing. An assessment of risk may NOT be used to avoid the requirements of USP 800 if any manipulation (crushing, breaking, or compounding) of the finished dosage form occurs.

Pharmacies must incorporate the standards in Chapter <800> into their occupational safety plan. Components of your pharmacy’s health and safety management system must, at a minimum, include:
• A list of HDs
• Facility and engineering controls
• Competent personnel
• Safe work practices
• Proper use of appropriate personal protective equipment (PPE)
• Policies for HD waste segregation and disposal

The good news is that on September 29, 2017 USP announced its intention to postpone the effective date of these new standards that were to take effect July 1, 2018. The purpose of this postponement is to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797> Pharmaceutical Compounding — Sterile Preparations, to provide a unified approach to quality compounding. The new effective date is December 2019.
If you want further information, and assistance in developing your strategies to meet these new standards please give us a call.


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.