USP 800: The Need-to-Know for Pharmacies

pharmacist working in a clean room

With the holidays behind us, this year is revving up to be a high-impact year for independent pharmacies across the nation. Nowhere is this more apparent than with the upcoming full adoption of the newly aligned USP General Chapters <795>,<797>, and <800> on December 1st, 2019.

According to the USP site, the new standard makes significant changes to the way hazardous drugs are handled by “providing a unified approach to quality compounding, which includes. . . the receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preparations.” These changes, while upping the ante when it comes to protecting pharmacy staff from the harmful effects of these drugs, may represent a significant cost to comply with. Now is the time to begin making the changes that safeguard your business for the future of drug safety.

What is USP 800?

This new standard, which has been in the works since 2016, is designed to provide more rigorous protections for patients and pharmacists when it comes to hazardous medications. Although some believe it to be a replacement for <795> and <797>, this standard actually builds on the previous standards and is poised to become a state-mandated regulation in many parts of the country.

According to Patricia Kienle, a member of the USP Compounding Expert Committee, the basic goals of USP <800> are to:

  • More clearly define hazardous drugs
  • Create safer facilities and practices when containing/compounding/handling hazardous drugs
  • Identify the drugs and dosage forms eligible for an Assessment of Risk
  • Require a personalized Assessment of Risk process for every facility with hazardous drugs
  • Require designated monitors to ensure compliance with these systems and processes.

The Good

The foremost benefit of the new standard is the expected increase in the safety of you and your workers. According to the Oncology Nursing Society, American Society of Clinical Oncology, and Hematology-Oncology Pharmacy Association, the greatest risk of danger from HDs to pharmacists and their employees is due to mishandling. USP 800 was designed specifically to “increase patient safety, worker safety, and environmental protection,” through requiring protective equipment while compounding such as:

  • Gloves
  • Gowns
  • Head and hair covers
  • Shoe covers
  • Double gloves
  • Respirators

In addition, the elevated standard requires a more defined risk assessment strategy when dealing with any of the listed drugs. This means that pharmacists and techs must have a well-thought-out plan when it comes to even small doses of HD, and that the entire staff recognizes the increased importance of dealing with these drugs in a safe and effective way.

Some changes allow for a bit of convenience where there was little. For example, sterile and non-sterile HD’s may be stored or refrigerated together, allowing for a more compact work environment.

Finally, USP 800 raises the bar on professional development among pharmacy staff. This additional requirement is expected to result in a more educated pharmacological industry when it comes to HDs and limit the numbers of adverse drug reactions from mismanagement and mishandling. Pharmacists and technicians will also be more current and flexible with other HD updates as they arise.

The Expensive

Although most pharmacists recognize that USP 800 will increase the general safety of those working with HDs, there are a few drawbacks to the new standard.

Ventilation Systems:

Previous standards for managing HDs required negative pressure ventilation in compounding areas. In <800>, this standard is increased so that air from the compounding room must be vented externally. Low and medium-risk HDs may be compounded in a “containment-segregated are” with at least 12 air changes per hour.

Although the additional restrictions on ventilation is clearly a much better choice for the health of the pharmacist staff, it can represent a large cost. For the most part, before <800>, many small pharmacies managed HDs with personal protective equipment and biosafety cabinets (BSC). For some, the new regulations will mean major changes to the HVAC and ventilation units or custom-built solutions in order to comply.

Dedicated Machinery and Compounding Areas:

In the new standard, HD compounding equipment is never allowed to be used for non-HD equipment. This includes automatic counting and packaging machines. Although this seems like a no-brainer for many physicians who produce large quantities of both types of medication, for small independents, this can pose a financial and logistic setback for pharmacies that previously had a low-volume exemption which is not allowed under <800>.

Because low-volume exemptions are no longer acceptable, specialized unpacking, manipulation, and compounding areas are required for even the smallest pharmacies. Unpacking must be done in neutral or negative pressure areas, and Anitneoplastics that require manipulation must be stored in negative pressure areas.

Education and Management:

Finally, USP <800> emphasizes increased team awareness and human management of HDs. Each hazardous drug must have a written Assessment of Risk that identifies how it should be handled and the best risk mitigation strategy in your office. You must also have a dedicated Compounding Team including a supervisor to manage these HDs and ensure compliance within your organization. Although there is no specified training outlined in the standard, it is expected that professional training be provided for at least the supervisor, if not the whole team.

These management tasks can feel overwhelming to an already busy independent pharmacy, and the requirement for additional training can seem almost impossible. The time and money required to train and audit the tasks associated with HDs can be a strain on your organization if you are not proactive and prepared.

Overwhelmed? You can do this.

Despite the pressures the USP <800> possibly poses for small pharmacies, it is a vital change that will increase the safety of your business and employees. With the right preparation now, you’ll be compliant far in advance of the December 1st, 2019 effective date, giving your team a safer, more sustainable workplace and giving you peace of mind.