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.

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.