Hospitals Facing More Rapidly Changing Regulations

In 2018, several regulatory changes were announced that have an impact on the practice of pharmacy. The first was a continuation by the United States Pharmacopeia (USP) to revise general chapters <795> and <797>, which cover the topics of compounding nonsterile and sterile preparations. The goal was to better align these two chapters with USP <800> (“Hazardous Drugs – Handling in Healthcare Settings”), which was published in 2016. All three of these chapters are scheduled to go into effect on December 1, 2019.

The USP proposed revision to <795> was released on March 30, 2018, with a public comment period that ended on July 31, 2018. The proposed revision for <797> followed on July 27, 2018, with a public comment period that closed on November 30, 2018. Facilities that perform nonsterile or sterile compounding must understand the proposed changes and determine the potential impact.  

Below are the revisions that will require attention. 

Requirement for dedicated staff

The global requirement for all three revised chapters states that any compounding facility must provide a dedicated staff member who is uniquely responsible for training on compounding, record keeping and assuring competencies among other duties. This does not need to be the same individual for all three chapters but the organization will be required to designate someone to oversee each of the areas. 

Requirement for dedicated space

Specific change requirements from USP<795> “compounding facilities must have a space that is specifically designated for compounding.” This section clearly addresses that compounding nonsterile preparation in the center of the pharmacy or on the same counter that you conduct your daily work is no longer permitted. Facilities will be required to provide a designated space that is “separated from areas not directly related to compounding.” This revision mandates a separate room dedicated solely to nonsterile compounding, and depending on the type of compounding conducted, a containment device such as a powder containment hood. This could necessitate new and expensive construction beyond what was planned for in USP<800>.

This USP<797> also brings fundamental change to the medication compounding model. The previous version of <797> outlined three categories of compounded sterile products: low, medium and high risk. The proposed revision to <797> consolidates that into two: categories 1 and 2. This shift is likely to have the greatest impact on facilities that were formerly classified as low-risk compounders, which describes many smaller hospitals in the United States. Many of these facilities will now find themselves stretched to meet the requirements of category 2, and required to build a clean room suite.

The USP revision has changed the frequency of the auditing process in areas such as glove fingertip testing and media fill testing, which were done annually, but <797> will now mandate that these be performed semi-annually. Those responsible for this quality assurance will now effectively have their workload doubled.  Similarly, the requirement for surface sampling is mandated to be done monthly in the new version of <797>. The previous version required that this testing need only be done “periodically,” with that term being loosely defined. 

For those facilities that previously were compounding at the low risk category the Beyond Use Date (BUD) will change, and products that previously could be given a 14 day BUD, will now be eligible for a 9 day BUD. This could increase the amount of medication being wasted at the facility.

While it appears that the changes USP has put into place were done to improve employee and patient safety, it will also have the consequences of additional expense to facilities in terms of construction, personnel and equipment.

Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075

This final rule was signed on December 11, 2018, which is stated to enact cost savings and streamline standards, while maintaining protection of human health and environment. The revision adds a new part 266 subpart P for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. This revision removes FDA-approved as an over-the-counter nicotine replacement therapy from the list of hazardous waste, and provides a conditional exemption to Drug Enforcement Administration (DEA) controlled substances.

The revision also prohibits all facilities from sewering hazardous pharmaceutical waste.

This rule will become effective in June 2019.  States that have their own Resource Conservation and Recovery Act (RCRA) requirements will also need to make changes to align with these revisions.

Kenneth Maxik has worked with interdisciplinary hospital teams for more than 20 years on quality, patient safety and compliance. In his role as director of patient safety at CompleteRx—a hospital pharmacy management and patient care company—he develops and annually updates a proprietary 250-point patient safety checklist for clients, including medical error measures, leveraging the data he collects to recommend protocols that improve patient safety at client facilities.

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