Why are my compounded prescriptions changing?

New standards for compounding pharmacies went into effect in many states recently, which may have resulted in some changes to the compounded medications you receive: 

• Your medication/prescription may have been changed to be made in an “anhydrous” compounding base, which simply means no water activity.  
• Your medication/prescription may have a shorter expiration date.  
• Your medication/prescription may go up in cost, as pharmacies are required to implement new regulations that increase the cost of making your medication/prescription.  
• Your compounding pharmacist may say they can no longer make your medication/prescription that they have made for years.

Why all the CHANGE?  

The United States Pharmacopeia, or USP, creates standards for pharmacy compounders to follow to make sure compounded medications are high quality and prepared in appropriate environments. Recently, USP updated three of its standard chapters for compounding — 795 (covering non-sterile compounded medications), 797 (covering sterile compounded medications), and 800 (covering hazardous medications). 

Those updates were made to try to reflect the latest scientific advancements, stakeholder input, and a more practical and risk-based approach to assigning beyond-use dates (similar to expiration dates). The updates were also designed to improve sterility assurance and reduce risks in preparing sterile medications. USP 800 is a new standard intended to minimize the risk of exposure to hazardous drugs to healthcare personnel, patients, and the environment. Updates to all three chapters went into effect on November 1, 2023. 

2023? Why am I just now seeing changes?

While USP sets the standards, it doesn't have the authority to enforce them. That responsibility belongs to the individual state boards of pharmacy. Many state boards of pharmacy decided to delay enforcement of the updated standards for a year — until November 1, 2024 — to give compounding pharmacies more time to prepare and comply with the changes. 

So how do these updates actually impact me? 

While this doesn't cover all the updates to the USP compounding standards, here are some of the major ones and how those updates may impact your compounded medications/prescriptions:

USP 800 (Hazardous Drug Standards)

Several commonly compounded medications are newly classified as hazardous drugs, including hormones, antifungals, immune-suppressants, and topical medications used in dermatology. All handling of and compounding with hazardous drugs must be done in a separate, specialized laboratory space and must include additional personal protective equipment. Hazardous drugs also require specific procedures and documentation, including receiving the active pharmaceutical ingredient, compounding, packaging, and storage. For almost all compounding pharmacies, this required substantial and costly reconstruction of their compounding laboratories. Because of these changes, you may see an increase in price, or your compounding pharmacy may not be able to make certain medications anymore. 

USP 797 (Sterile Compounding Standards)  

The updated standard includes stricter air and surface testing in compounding environments to prevent contamination. It also requires compounding staff to undergo detailed training and regular evaluations to make sure they are highly skilled in sterile techniques, contamination prevention, and equipment use. Better training reduces the risk of errors or contamination, giving you more confidence that your medication is prepared by qualified professionals in controlled environments. These changes also increase the costs to the compounding pharmacy to make your medication, so you may see an increase in price. 

USP 795 (Non-Sterile Compounding Standards) 

Beyond-use dates, similar to expiration dates, indicate how long a compounded medication is okay to use. Compounding formulas that have any “water activity” must now have shorter beyond-use dates, unless extensive and expensive testing is done on each formula. Many pharmacies are changing their formulas to now use anhydrous compounding bases without any water activity, so you may notice a change in your compounded medication. This mainly affects topical creams, such as hormone replacement therapies and topical pain creams. 

What do I do now? 

While all of these changes may seem complex and can be frustrating, don’t fret. Talk to your compounding pharmacist about your concerns, and they will tailor a solution for you. 

By Ashley Berthelot, Vice President, Marketing and Administration, Professional Arts Pharmacy and Emily Durham, Vice President of Business Development, Revelation Pharma Corporation