As a standard of minimums, USP <797> lays a solid foundation for preserving patient safety and the efficacy of compounded sterile preparations. The expectation is that pharmacies will conduct further risk assessments to establish more detailed SOPs that address specific areas of their business. Not content to leave it up to their members, some state pharmaceutical boards take USP <797> a step further by creating legal requirements that are more prescriptive.
California’s new rules for compounding pharmacies went into effect on October 1, 2025. In this post, I’ll review some of the revisions that impact compounding pharmacies in California. I will also make a case for why compounding pharmacies across the country might want to model California’s new rules in their own standard operating procedures (SOPs).
A Couple of Caveats
In the next section, the copy in italics is taken directly from the final text of the standard, but for brevity’s sake, I left out large blocks of text. As always, consult the final order and your state pharmacy board requirements when making critical compliance decisions.
In addition, the final order covers more than just USP <797>. We’ll be focusing on Article 4.6 Sterile Compounding in this post, but other sections may also apply to your organization, including Article 4.5 Nonsterile Compounding (USP <795), Article 4.7 Hazardous Drugs (USP <800>), and Article 4.8 Radiopharmaceuticals (USP <825).
With those caveats out of the way, let’s get into a few details.
California Pharmacy Board Goes Beyond USP <797>
As I mentioned in my introduction, USP <797> is a standard of minimums, and like many other states, the California State Pharmacy Board’s requirements build on that baseline. Below are some examples that jump out at me as I review California’s requirements.
1736.2 Personnel Training and Evaluation
(b) Initial and ongoing aseptic manipulation training and competency documentation shall include the Primary Engineering Control (PEC) type and PEC unique identifier used during the evaluation. Aseptic manipulation competency evaluation and requalification shall be performed using the same procedures, type of equipment, and materials used in aseptic compounding...
(c) Aseptic manipulation ongoing training and competency shall occur each time and for each staff member involved in an occurrence where the quality assurance program required by the SOPs yields an unacceptable result, as defined in the SOPs, that may indicate microbial contamination of CSPs due to poor practices. Aseptic manipulation ongoing training and competency procedures shall be defined in the facility’s SOPs.
(d) Compounding personnel or persons with direct supervision and control of compounding personnel who fail any aspect of the aseptic manipulation ongoing training and competency evaluation shall not be involved in compounding of a CSP until after successfully passing training and competency in the deficient area(s) as detailed in the facility’s SOPs. A person with only direct supervision and control of personnel who fails any aspect of the aseptic manipulation ongoing training and competency evaluation may continue to provide only direct supervision and control of personnel for no more than 30 days after a failure of any aspect while applicable aseptic manipulation ongoing training and competency evaluation results are pending.
Relevance
Clause 2(b) contains language that is particularly important for larger enterprises with multiple laboratories or pharmacies that use a training center. Under the revised California standard, evaluations must be done in an environment identical to the one the individual will be working in. If personal work in multiple sites with even slightly different SOPs, equipment, or materials, they must be re-evaluated in that environment.
Also, under USP <797>, compounding pharmacies need to define an SOP for addressing unacceptable results, but the standard does explicitly call for retraining. California’s revised standard is more explicit in 2(c), requiring competency training and testing for each person involved in the exceedance. Furthermore, the standard defines how quickly the training and re-evaluation needs to happen and what these individuals are authorized to do in the meantime. If nothing else, the need to go through training again may be enough to make sure processes are followed correctly the first time.
1736.3 Personnel Hygiene and Garbing
(c) With the exception of sterile gloves, garb shall be donned in an anteroom or immediately outside the segregated compounding area (SCA). Sterile gloves shall be donned in a classified room or SCA. Donning and doffing garb shall not occur in the anteroom at the same time unless the facility’s SOPs define specific processes that must be followed to prevent contamination.
Relevance
In some healthcare facilities, air changes aren’t high enough to compensate for shedding when removing garb. In addition, these areas are often quite small, which can compound the issue. These garbing best-practices are highly recommended, especially in hospital settings.
(e) Any garbing accommodations provided by a designated person shall be documented and the documentation shall include the name of the individual granted the accommodation, date granted and description of the reasons for granting the accommodation. The record shall be retained in accordance with Business and Professions Code section 4081.
Relevance
USP <797> allows designated person(s) to grant garbing accommodations and lays out a few examples in section 3.1. Note that these are only examples. Many of the compounding pharmacies I work with are more explicit in their SOPs, banning things such as nail polish, fake nails, facial hair, and so on from their cleanroom environments.
California’s rule goes beyond USP <797> by requiring any accommodations to the garbing rules to be documented, including why the accommodation was granted and by whom. A documented audit trail is always a best practice, whether you’re complying with USP <797> or any other standard or regulation. I also like this clause because garbing accommodations can too easily become tradition, e.g., always allowing people to wear their wedding rings in the cleanroom. Anything that may compromise patient safety should be carefully considered on a case-by-case basis and documented.
Since I often get asked how long records need to be retained, I also like that California specifies that these records must be retained in accordance with Business and Professions Code section 4081. This is California law pertaining to record keeping and retention for facilities dealing with pharmaceuticals or medical devices.
Article 1736.4 Facilities and Engineering Controls
(c)(1) Designated compounding area(s) shall typically be maintained at a temperature of 20° Celsius or cooler.
(2) The temperature shall be monitored in each room of the designated compounding area each day that compounding is performed, either manually or by a continuous recording device.
Relevance
A similar clause is included in USP <797>, but it is a “should” instead of a “shall.” Arguably, “shall” means “must,” but the California State Pharmacy Board added “typically” for reasons unknown to me. Feel free to email me if you have more insight into why they added “typically” to this clause.
Although 20° Celsius (68° Fahrenheit) is on the cool side of comfortable, if you’ve ever tried to work in full compounding garb, you know how quickly things can heat up, literally to the point of sweating through your garb. This can increase shedding and the potential for contamination. While both California and USP <797> allow for either continuous monitoring or a once-a-day temperature check, my experience suggests that continuous monitoring may be the more prudent approach.
Why California’s Rules Deserve a Closer Look
As I noted at the beginning of this post, USP <797> is a standard of minimums, and it’s up to each compounding pharmacy to perform its own risk assessments and develop SOPs that address those patient risks. Even if your business doesn’t operate in California, reviewing its more explicit requirements can uncover valuable practices worth integrating into your own procedures.
Furthermore, with the growing prevalence of mail order pharmaceuticals, pharmacies may need to align with California’s rules—and those of other states—to continue serving a nationwide market. These mandates can not only help ensure compliance but also drive improvements in quality and safety across your operations.
While this is a brief review of specific areas of a complex topic, if you have questions or want to discuss how these standards might impact your pharmacy, please reach out. We’re here to help you navigate the regulatory landscape and keep patient safety front and center.