Since the new United States Pharmacopeia (USP) guidelines went into effect on November 1, 2023, I have been receiving many inquiries regarding their impact on compounders. Because the changes are fairly recent, compounders want to know how and when they must be fully compliant, what enforcement vehicles are in the government arsenals, and what types of resources they must have to comply with the new requirements. This post answers some of these questions by summarizing major changes and discussing some of the pitfalls on the way to compliance. On the other hand, this post does not go into any of the technicalities of the USP requirements, nor does it detail the requirements of each new rule. For the full text of USP chapters, please visit the USP’s website , which contains many resources and training materials.  And if you have a specific question regarding your or your client’s practice, you can reach USP directly at

Does USP guidelines apply to your or your client’s practice?

If you do not compound on a regular basis or do not run into the USP chapters often, you might be wondering if the new USP requirements apply to your practice. The USP chapters mostly apply to hospitals and compounding pharmacies. But they also apply to healthcare facilities where compounding takes place, such as hospitals, 503A and 503B compounders, vet compounding, and pharmacy schools. The USP provides a comprehensive framework for compounding sterile, non-sterile, and hazardous drugs, including training, cleaning and maintenance of work areas in such compounding facilities. Most state board of pharmacies ensure that their compounding regulations match the USP guidelines.

Summary of the 2023 USP Changes:

The latest update went into effect on November 1, 2023 and still causes many questions, such as when compliance is due. Full compliance was due back on November 1, 2023. The USP clarified that it would no longer give any extensions for full compliance.

BUD assignments: Most of this year changes pertain to the beyond-use date (BUD) assignment. For example:

  • the USP has clarified how BUD is computed for water containing products. Due to water’s susceptibility to microbial contamination and hydrolytic degradation, the revised chapter clarifies what actually constitutes a “water-containing” product and how BUD should be assigned to such products.
  • It also provided instructions on BUD assignability when compounders add flavors to commercially manufactured nonsterile products.
  • The USP made changes to BUD assignment to compounding products under Category 2 and 3 (which are medium and high risk products in terms of susceptibility to microbial contamination). To facilitate patient access, the BUD for aseptically prepared Category 2 preparations is extended if only sterile ingredients at room temperature were used. In addition, for Category 3 sterile compounding, the USP provided more stringent standards for personnel training, garbing, and environmental monitoring frequency.
  • BUD is extended up to a maximum of 180 days when sterility and stability tests have been performed.

Personnel training: The USP increased requirements for compounding staff training, such as additional training, testing, documentation, and practical evaluations on the job. The supervising pharmacist now must also be trained to demonstrate competency in aseptic manipulation, core compounding skills, and garbing every year. Compounding staff now must undergo regular competency evaluations on the job to ensure they are capable of performing sterile compounding procedures safely.

Garbing: garbing requirements now apply to anyone involved in compounding. No exposed skin is allowed in the buffer room. Garbs must be sterile, low-lint, re-sterilized each time after washing. Gloved fingertip and thumb sampling must be taken to assess microbial contamination and garbing competency evaluations. It must contain zero colony-forming units on the gloved fingertips. The USP set specific timeframes when such tests must be performed (depending on the products being compounded).

Aseptic manipulations and environmental monitoring: to reduce microbial contamination, the USP now requires that compounding staff obtains a work surface sample with a maximum of 3 colony-forming units (CFUs) before compounding and then repeat every 6 months. For Category 3 compounding, compounders must test hood surface weekly at the end of each batch and perform monthly air sampling.

Cleaning: for non-sterile compounding, cleaning and sanitization must be performed at the beginning and end of every compounding activity/shift. For sterile compounding, on the other hand, only daily surface cleaning is required.

USP 800 changes (compounding hazardous drugs): unlike, Chapters 795 and 797, Chapter 800  protects not only the consumers but compounders, environment, staff, and the patients. While an image of very dangerous drugs comes to mind when we talk about hazardous drugs, these drugs could be simple hormonal creams. What dictates whether a drug is hazardous or not is determined by the National Institutes for Occupational Safety and Health (NIOSH), which is a branch of the CDC. They create and publish a list of hazardous drugs. The USP provides standards on how these drugs should be handled. Some of the changes pertain to training, cleaning, receiving, labeling, packaging, transport and disposal of hazardous drugs, as well as spill control and decontamination.

What does it all mean to your or your client’s practice?

Hospitals and compounding pharmacies now must update or develop policies addressing the USP changes. Some of the changes are extensive, such as the above mentioned BUD reevaluation, cleaning, staff training and garbing. This means that smaller compounders may be struggling to find additional resources to comply. Compounding providers must reevaluate facilities, equipment, processes , and staffing capacity, which could potentially cost compounders – according to the USP’s representatives – millions of dollars. Here is a link to the USP’s team analysis of the changes, published by Pharmacy Times.

For example, let’s take training: your facility now needs to evaluate whether there is enough staff to perform training, evaluations, and observations on the job. Plus, you will need additional compounding supplies for training for practice, tests, and evaluations.  Failure of any portion of the evaluation requires repeating the entire competency hands-on training.

Or air sampling: because this is required for Category 3 compounding involving more complex processes, most providers now need to hire a third party company or invest in expensive instruments to monitor air quality.

I anticipate that FDA’s oversight will increase and we will see more compliance audits from the FDA and state boards. Thus, hiring consultants and performing mock inspections could be a helpful preventative measure. In response, many online resources sprouted offering assistance with the USP compliance by providing policies, competency evaluation templates, and other guidance.

If state boards increase their number of inspections to ensure compliance with the new requirements, many smaller independent compounders could be exposed to enforcement actions. For example, following the New England Compounding Center’s meningitis outbreak, the California State Board of Pharmacy  increased its scrutiny and toughened its compounding regulations (as most state boards did). This effectively eliminated the majority of sterile compounders in the state. Will the number of sterile and non-sterile compounders further decrease with the new USP requirements? Time will show.