On June 1, 2019, the United States Pharmacopeia (“USP”) published the final revisions to its pharmaceutical sterile compounding standards (“chapter <797>”). Chapter <797> sets forth standards for the preparation of compounded sterile medications to help ensure products are safe and effective and reduce risks such as contamination or incorrect dosing. The most recent revisions implement new standards and revise existing ones based on recent scientific and technological developments. The chapter <797> revisions also incorporate stakeholder input raised during the July 2018 to November 2018 public comment period, much of which concerned allergens, beyond-use dating, and the general ambiguity throughout the chapter.
The USP’s most recent revisions to chapter <797> are extensive and those who prepare compounded sterile products (“CSPs”) are advised to familiarize themselves with the new standards. Significant changes include:
- Scope of chapter <797>: USP has changed the scope of the chapter by excluding the administration of medication and moving sterile radiopharmaceuticals to chapter <825>. The revised chapter instead focuses on standards aimed at ensuring the integrity of CSPs. With this modified scope, the June 1st revisions set forth stringent controls on the compounding environment in which compounding activities occur.
- Simplified Risk Levels: The revised chapter simplifies the microbial risk levels of CSPs from four categories (low, medium, high, and low with a 12-hour beyond-use date) to two — Category 1 and Category 2. Category 1 CSPs generally have a shorter beyond-use date and can be prepared in an unclassified segregated compounding area. In contrast, Category 2 CSPs generally have a longer beyond-use date and must be prepared in a cleanroom suite. This important and constructive change will likely reclassify most hospitals from medium-risk compounders to category 2 compounders. As a result, hospitals that prepare Category 2 CSPs will find themselves subjected to a heightened standard that may require the facility build or renovate a compounding suite.
- Conventionally Manufactured Products: USP provided further guidance on the use and storage of conventionally manufactured products. In doing so, the revised guidelines define single-dose containers, multiple-dose containers, bulk packages, and make clear their respective uses and beyond-use dates.
- Investigations and Corrective Actions: The USP expanded the category of scenarios that mandate investigations or corrective actions. These scenarios include personnel qualification failure, facility certification failure, quality control check failure, media fill failure, complaints on quality of CSPs, out-of-specification results in laboratory tests, and other potentially adverse events.
- Allergenic Extract Prescription Sets: Chapter <797> now requires that the compounding of allergen extracts must occur in an ISO Class 5 PEC or a dedicated allergenic extract compounding area (“AECA”). The chapter sets forth the conditions that must be met for AECAs, including that the AECA have a visible perimeter.
The revised chapter will go into effect on December 1, 2019.
In light of the new standards, pharmacies should evaluate the physical capabilities of their compounding facilities to ensure they can meet the demands of the revised requirements. With states increasingly requiring that licensees adhere to the USP standards, state Boards of Pharmacy are likely to adopt these or similar changes in the near future. In addition, providers may need to train employees to work within a controlled environment that conforms to the new USP standards. Due to the difficulties in developing and handling process and testing documentation and determining which tests are appropriate for the environments and materials being manipulated, challenges may arise as facility managers take steps to ensure that their operations meet the requirements of chapter <797>.
If you or anyone at your organization has questions regarding the revised USP chapter <797> or other pharmacy compliance matters, please contact one of Husch Blackwell’s healthcare attorneys.