USP 795 Non Sterile Compounding
HealthMay 01, 2020

USP 795: 6 key areas of focus for pharmacy nonsterile compounding 

Compounding medication can be a complicated and nuanced process, with potentially devastating results to any transgression. USP <795> Pharmaceutical Compounding – Nonsterile Preparations standards address the inherent risk in compounding pharmacy medications in a nonsterile environment. Eric Kastango, MBA, BS Pharm, FASHP from the Kastango Consulting Group, presented on USP <795>: Compliance and Best Practices, to highlight the key principals in ensuring safe compounding. Here are the general principals of practicing safe compounding:

1. Training and Documentation of Competence  

Skilled and trustworthy staff are essential to safe nonsterile compounding.  Are you providing your clinical staff the necessary training to ensure they know the key steps required to perform nonsterile compounding? Utilizing USP as the expert guidance on knowledge and skills will ensure you’re meeting the minimum requirements.  Consider other sources such as CriticalPoint for further accepted best practices. Employees must become familiar with USP <795>, and each of the procedures related to compounding. You can aid in their learning by personally demonstrating each task they must learn, as well as by watching and approving their final preparation. Additionally, are you proving and continually tracking their competence?

Expertise is not a one-and-done event; it either grows and cultivates over time or is lost without effort. By regularly reviewing and documenting your staff’s practical skills, you can ensure uninterrupted safe practice. If you’re not sure your current educational tools can instill expertise, a comprehensive web-based tool that combines the training curriculum of CriticalPoint with the competency management of Simplifi 797 can be invaluable for your team. Pharmacies must deliver closed-loop, on-demand training for sterile compounding.

2. Compounding Ingredients

Contrary to myth, pharmacists are not alchemists; we can only produce from what we put in.  When starting with inferior ingredients, you will only be able to deliver an inferior medicine. Are you reviewing and tracking the quality of your Active Pharmaceutical Ingredient (API)? An easy way to ensure you are using approved and accepted ingredients is to ensure they are a USP, NF or Food Chemical Codex (FCC) substance that was manufactured in an FDA-registered facility.  In fact, the 2019 version says this is a must. If you must purchase from a non-FDA vendor, a base standard of responsibility is to obtain a Certificate of Analysis (this is required for any API) and to avoid terms like “chemical-grade” and “not for human use.”

A compounded drug will include materials other than the API—you’ll also need to ensure the quality of your added substances (inactive ingredient, excipients and pharmaceutical ingredients), your vehicle (carrier or diluent into which your other ingredients are dissolved or suspended), and your water. Water should be purified for use in compounds, and for best results, for rinsing your equipment.  And do not forget—even high-quality ingredients can degrade over time. Follow the expiration date included on your bulk ingredients; if there is no expiration listed, the standard practice is to not exceed three years from date of receipt. Proper labeling and tracking of your ingredients are key to ensuring quality medications.  

3. Facilities 

Your ingredients and training can all be compromised if you are performing your compounding in an unsuitable environment. Foremost, you should be practicing in a space that is specifically designated for nonsterile compounding, not performing double duty for other pharmaceutical practices. Some things to consider are appropriate counter space, access to a sink with both hot and cold water, a hand and eyewash station, soap, an air-dryer (removed in the 2019 version of USP <795>), or single-use towels and a well-functioning plumbing system.

Also, the appropriate heating, cooling and venting systems should be ensured—humidity can have an impact on the quality of your process. Aesthetically, your space should be well-lit, and be clean, orderly and in good repair, with adequate, organized and temperature-controlled storage for your compounding ingredients and equipment. Ideally, following these standards should prevent opportunity for cross-contamination.   

4. Equipment

The equipment you use and wear for nonsterile compounding should be designed and/or used with specific regard to your process. This is not the time to MacGyver a solution! Do your scales measure in amounts necessary for your purposes? Can you be sure your surfaces are non-reactive, additive or sorptive? And is your garb appropriate for the level of risk being undertaken? You don’t necessarily need to wear sterile PPE, but we need to protect personnel from chemical exposure, and to protect our patients from ourselves. Barrier systems are required for compounding because we as practitioners are one of the main sources of contamination. Hair bonnets, face masks, gloves and gowns can ensure a compliant process. Once you have got the appropriate equipment, the next step is to make sure it’s being maintained according to the manufacturer’s guidance and being inspected and calibrated regularly.

If you are performing specialty compounding, including hazardous drugs or antibiotics, you should either dedicate equipment specific to that purpose, or meticulously clean them between use. Another option is disposable equipment such as spatulas, beakers, flasks, bags and more, to reduce bio-burden and cross contamination. Finally, consider the quality of your delivery system—the containers and closures your patient receives your drugs in should be of a suitable, non-reactive and clean material that is unable to alter the strength, quality or purity of your drug.  


5. Pharmacy Documentation

In a quality system, “if it wasn’t documented, it didn’t happen.” USP <795> advises on specific required documentation to ensure that your compounding processes and procedures are meeting the quality intended in the regulation. The master formulation record is the documentation of your drug compound recipes, which goes hand-in-hand with the compounding record—the steps taken to create the compounded drug. What is the difference between the two? Think of your master formulation as the foundational recipe for every drug you make. You will come back to it over and over. Your compounding record is the documentation of each instance you create a drug. It should reflect the name, strength and dose, the quantity developed, sources, lot numbers and expiration dates, and the name of the practitioners who prepared, inspected and approved the product. On the macro scale, you should create standard operating procedures (SOPs)—a guide to the processes used not only in the actual compounding, but in each facet of a compounding pharmacy.

Historically, pharmacies have developed and maintained their own SOPs, an intensive, time-consuming endeavor. Quality management systems like Simplifi 797 allow you to leverage a cache of expertly written best-practice SOPs that can be modified to your specific needs. Safety data sheets outline the characteristics and risks of each ingredient, but specifically those that can pose a hazardous threat. Your documentation and record-keeping should comply with your state board of pharmacy requirements.  Many practices traditionally used paper-based documenting, but products like Simplifi 797® can streamline the documentation and inspection process on an electronic, mobile-responsive platform.  

6. Quality Control and Error Prevention

Quality control means that you are taking every opportunity to prevent a potential problem before it happens. It is a natural progression of documentation—the more a compounder is able to reference standard operating procedures, master formulations and compounding records, the more consistent and uniform his or her output will become. Pharmacy quality assurance goes one step further in establishing control procedures to inspect and approve the final product, as well as review the performance of the procedures and equipment used in the process. Well-trained practitioners should be able to assess the final product and identify product instability using organoleptic procedures: does the product look, feel and smell right? Pay close attention to variances—an unexpected result in output is usually a sign something has gone wrong.

Any reported problems must be investigated and reconciled. Recognizing and tracking trends means that you will eventually be able to spot red flags and design safety nets. Quality control and error prevention should also be a consideration in patient counseling—ensuring they understand the proper use, storage and potential adverse effects will prevent any user error once the drug leaves your facility. USP 795 advises on best practices in patient counseling, but make sure you are also following any federal and state laws regarding the counseling process.  

These general principals are your roadmap for ensuring safety in pharmacy nonsterile compounding. While keeping track of each of these factors may seem overwhelming, a turnkey safety and compliance tool like Simplifi 797 can streamline your operations, giving you confidence that your processes are safe and compliant, and allow you the freedom to focus elsewhere in your practice. 

Simplifi 797®
Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.
Simplifi 797®

Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.

Simplifi 797 provides the latest evidence-based guidance and helps navigate the complex USP Chapters 795, 797 and 800 processes to ensure inspection confidence and keep patients and staff safe.