Millions of sterile compounds are manufactured each year in the United States to meet the unique needs of patients. Understanding the risks inherent in sterile preparations and incorporating established standards is essential for patient safety.
The United States Pharmacopeia (USP) develops standards for the preparation of sterile compounded medications to ensure patient benefit and reduce risks such as contamination, infection, or incorrect dosage. Although not a governing body, USP standards and guidelines are often adopted and enforced by state boards of pharmacy.
The chapter <797> of the USP, first promulgated in 2008, sets standards for sterile preparations. USP <797> aims to reduce negative outcomes associated with compounded medications.
Following a multi-year effort dating back to 2019, the long-awaited revision of the USP <797> was published on November 1, 2022 and will become official on November 1, 2023. This “official date” is the date by which compounds are expected to meet the requirements of the new standards. However, ensuring compliance with the requirements of these standards is the responsibility of the applicable regulatory jurisdiction. Regulatory agencies, including state boards of pharmacy, may have different accommodations, so pharmacists should be sure to check with their local board of pharmacy; USP has no role in enforcement.
The updated version of the USP <797> includes several modifications. These revisions relate to expiration dates (BUDS) and reflect advances in science and clinical practice. Additionally, revisions aim to clarify topics that have not been systematically understood. The updated version of the USP <797> also incorporates stakeholder input and more than 1,400 comments received during the public comment period from September 2021 to March 2022. This official document is accessible by subscribing to the USP Compounding Compendium.
Some of these USP updates <797> have been in the works for over 3 years, and many institutions and state boards of pharmacy have preemptively adopted some of the standards. For example, some facilities have already spent millions of dollars on clean rooms to meet the updated standards. The cleanroom design must take into account all essential processes, procedures and personnel. All furniture and materials entering the area must be waterproof, lint-free, cleanable and resistant to disinfectants. Ceilings, walls, floors, shelves, fixtures, cabinets, passageways and counters must also permit cleaning, not crumble and remain free of cracks and crevices that impede sanitation. The cleanroom must have epoxy paint, cleanroom grade ceiling tiles (smooth and seamless), and clear grooved vinyl flooring. In addition, the primary technical control (or hood) must be an ISO class 5 environment or better. The positive pressure buffer zone must be an ISO Class 7 environment or better, and the positive pressure inlet chambers must be an ISO Class 8 environment or better.
Although many updates have already been adopted, several changes cannot be implemented before the official release date of the chapter. Let’s briefly discuss some of the major changes.
As indicated in the Paintingthe revised chapter changed the categorization of compounded sterile preparations (CSPs) from microbial contamination risk levels (i.e. low, medium and high risk levels) to Category 1 and Category 2 CSPs .Category 3 CSPs have been added to describe the requirements that a compounding facility must meet at all times to award BUDs up to a maximum of 180 days.
Painting. Comparison of BUD between <797> previous and revised. Source: USP Composition Standards and Use-by Dates Fact Sheet.
Personnel making up Category 1 and 2 CSPs will be required to conduct visual observation of hand and clothing hygiene, gloved fingertip sampling, and media fill testing every 6 months; and every 3 months for Category 3 CSPs. Support roles who supervise composition staff but do not do composition will be required to demonstrate their skills every 12 months.
Viable air sampling is required every 6 months for categories 1 and 2, and is now required monthly for category 3 tanks. Surface sampling is now required monthly for category 1 and 2 CSPs, and weekly for category 3 CSPs.
The revised chapter clarifies that docking, a proprietary system of bags and vials for immediate use, is not is considered a composition, while docking for future use is considered a composition and must comply with all standards. The BUD on immediate use compounds has now been extended from 1 to 4 hours if there are fewer than 3 ingredients.
These are just a few of the major changes, and there is no doubt that many chapter revisions will result in many changes to our practices. Nonetheless, we will increase patient safety and have the option to extend BUDs – a win-win in my opinion!
This article was originally published on pharmacytechnician.org and was republished through a partnership between Drug Topics and the National Pharmacy Technician Association.
