New USP Rules Could Lead to Big Changes for Pharmacies

Healthcare worker adhering to USP nonsterile compounding rules.

Healthcare facilities need to prepare for sweeping new proposed changes to United States Pharmacopeia (USP) standards. Specifically, the USP is revising General Chapters <795>, <797> and <800>, which set standards for clean rooms, compounding nonsterile drugs and sterile drugs, and the handling of hazardous drugs.

These regulatory changes are meant to better align <795> and <797> chapters with Chapter <800> (“Hazardous Drugs – Handling in Healthcare Settings”), which was published in 2016 and is expected to become official Dec. 1, 2019.

Most health systems with cleanrooms are already likely to be familiar with these chapters, since each address various rules for cleanroom design. What pharmacy and facilities managers need to be prepared for is that the proposed revisions to <795> and <797> will require careful consideration because the new guidance may have a considerable impact on facility workflow and finances.

What’s proposed for compounding

Currently, the changes outlined in Proposed Revision to GC <795> (“Pharmaceutical Compounding – Nonsterile Preparations”) are wide-ranging and may require significant changes to facility workflows and finances. The changes include new rules for:

  • The definition of what constitutes nonsterile compounding
  • Guidance for “use by” dates
  • Requirements for designated space
  • Sanitation and dedicated staff

Because these proposed changes are so substantive, it’s incumbent on pharmacists and hospital executives to review USP <795> and determine how new regulations could influence their practices if it goes into effect as currently written.

USP <797> also outlines two compounded sterile preparations (CSP) microbial risk categories – Category 1 and Category 2 – based primarily on the conditions under which they are made and the time within which they’ll be used;

What constitutes compounding may expand

The very definition of compounding itself may change if the proposed revisions go into effect. That’s because the new version of USP <795> removes the simple, moderate and complex compounding categories. This means pharmacies that do not currently consider themselves to be compounding drugs will be subject to USP <795> standards if approved by their state Board of Pharmacy.

The new description “not stored for future use” clause directly impacts the very common practice in both hospital and retail pharmacies of reconstituting a powder by adding a diluent to make a suspension.

For example, the new USP <795> means that if a pharmacist makes a simple amoxicillin suspension to be immediately dispensed to a patient, that process is not compounding. However, if the pharmacist chooses to make this suspension and place it on the shelf for future use, that now represents “nonsterile compounding” and could mean pharmacists and facilities have to operate by guidelines set for compounding pharmacies.

Definition of hazardous drugs has changed

While the compounding changes are proposed, the USP’s rules for hazardous drugs will go into effect Dec. 1, 2019. The first step for any organization reaching for USP <800> compliance is to create a comprehensive list of hazardous drugs available in the facility.

Don’t assume you already understand how USP defines hazardous drugs. Per USP <800>, a “hazardous drug” is any identified as such by the National Institute for Occupational Safety and Health (NIOSH) on the basis of 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 has released a draft of the drugs it considers hazardous and a final updated list will be issued by the end of 2018.

It’s critical to review the new list, and ensure your hospital is in compliance. Avoid existing assumptions about what constitutes a hazardous drug, since some inclusions surprise you. For one example, some hazardous drugs will now require additional mitigation strategies once manipulated.

Beyond use dates may change

Related to issues of “storing for future use,” the guidance for beyond-use dates (BUD) faces big changes. The proposed USP <795> states that: “nonaqueous dosage forms” stored at “controlled room temperature,” will have a BUD of 90 days. This compares to a previous regulation that allowed the time remaining until the earliest expiration date or up to six months of storage.

The new language means that the BUD for nonaqueous solutions has been reduced by half. This will require changes in inventory management and may cause additional waste.

The proposed USP <797> introduces a new term “in-use time” to refer to the time before which a conventionally manufactured product or compounded dilution bag must be utilized after it has been punctured.

Both of these usage rules could significantly impact current facility processes.

Manpower requirements modified

Pharmacies could take a significant hit to their staffing budget due to one new rule within USP <795>. As proposed, the regulation will require:

“The compounding facility must designate one or more individuals (i.e., the designated person) to be responsible and accountable for the performance and operation of the facility and personnel in the preparation of compounded nonsterile preparations (CNSPs).”

This means that one staff member will be uniquely responsible for training on nonsterile compounding, assuring competencies are performed and recorded, and observational studies are conducted.

For smaller hospitals in particular, this new regulation may necessitate hiring new personnel or bringing in a third party for training. Either option could weigh heavily on the budget.

More training and oversight will also be required for the USP<797> guidelines calling for an increase in staff competency with visual observation of hand hygiene and garbing, as well as more frequent environmental monitoring requirements to promote better control over the compounding area.

Budget for construction

All of these regulatory changes mean that most organizations will need to budget for capital investment.

First, the rules that cover buildings and facilities may expand upon a requirement that “compounding facilities must have a space that is specifically designated for [nonsterile] compounding” and that “the surfaces of … a compounding area must be cleanable and must be kept clean.”

Currently, this regulation is subject to interpretation, with some pharmacies designating a space, such as a counter in the corner, as “separated from areas not directly related to compounding.” The proposed changes may mandate a separate room dedicated solely to nonsterile compounding.

The new USP <800> requirements, such as HVAC improvements for proper air handling and adjustments to the facility’s footprint to comply with storage guidelines, could cost $50,000 on the low end to $500,000, or more on the high end.

In extreme cases, some hospitals may even need to relocate to a new space if their current facility cannot be altered for compliance.

Compliance deadline set for Dec. 2019

USP <800> guidelines for the handling of hazardous drugs will become enforceable on Dec. 1, 2019, so your hospital should already be working toward accommodating its new requirements.

USP suggested revisions to <795> in March 2018 and closed public comments on July 31. Final versions of new rules are usually available about 90 days after the comment period has closed, so we expect to know what <795> will look like by early November 2018. However, nothing official will be known until June 1, 2019, when the final version of GC <795> is published.

Learn more about the new USP regulations here:


By Kenneth Maxik

Kenneth Maxik is director of patient safety and compliance for CompleteRx. He has more than 20 years of pharmacy operations and management experience and works closely with health organizations across the country to help them stay ahead of current and imminent regulatory standards.    


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