By Celeste Zizzamia, PharmD, BCSCP, PCCA Clinical Compounding Pharmacist

For years, sterile compounding formulas in the PCCA database were primarily built for nonsterile-to-sterile preparations, using bulk powder as the source of the active pharmaceutical ingredient (API). But as the needs of health system pharmacies have evolved, so has our approach. To better support hospital teams focused on medication safety and efficiency, PCCA has expanded our formulation database to include sterile-to-sterile formulas that use a Commercially Available Drug Product (CADP) as the API source.

This shift is more than a technical update. It represents a larger commitment to standardization — one that aligns with the American Society of Health-System Pharmacists (ASHP) Standardize 4 Safety (S4S) initiative and its goal of reducing IV medication errors nationwide.

How the new formulas came together

The PCCA Formulation Development Team and Clinical Compounding Pharmacists began by referencing ASHP’s S4S lists for both pediatric and adult continuous infusion standards. These lists identify standardized concentrations and dosing units for IV and oral medications — a framework first developed in 2008 to prevent patient harm and supported by an FDA grant beginning in 2015.

Using these lists, we evaluated which APIs and concentrations to include in our database. Each selection was guided by two questions: Is there clear, referenced data supporting this concentration? And will this formula help health systems adopt S4S standards more efficiently?

From there, our team compared the S4S information to each drug’s CADP package insert. If the insert already included directions for diluent type, resultant strength, container-closure system and storage time, pharmacists could follow those instructions directly — in which case the preparation would not be considered compounding.

However, when published research presented an alternative stability-indicating study that deviated from the package insert, that preparation became a Compounded Sterile Preparation (CSP) under USP <797> guidelines. Those instances required additional data review and verification to ensure compliance and clarity for users.

What each formula includes

Each sterile-to-sterile formula begins with the CADP information and integrates any relevant literature findings. The result is a practical, pharmacist-ready resource that outlines:

• The recommended diluent (e.g., 0.9% Sodium Chloride Injection or 5% Dextrose Injection), with additional compatible options noted when supported by data.
• Calculations showing how to determine the correct CADP volume based on the desired concentration.
• Referenced stability data when available, prioritized from studies using stability-indicating assays.
• Detailed notes covering concentration, diluent, container closure, storage temperature, light exposure and beyond-use dates (BUDs), as applicable.

This structure enables compounders to quickly assess whether a commercially available premade product is available at the same concentration before proceeding — and, when compounding is necessary, to do so with confidence in the data behind every step.

Why this matters for health systems

For hospital and health system pharmacies, sterile-to-sterile formulas can remove some of the most time-consuming barriers to standardization. Each formula in this growing library includes the research and references pharmacists need to make evidence-based decisions while staying focused on patient safety and workflow efficiency.

Every formulation includes literature citations that link directly to the studies informing our guidance. When no stability-indicating data is available, we provide a summary chart of USP <797> beyond-use-date limits by CSP category, giving pharmacists a clear framework to assign appropriate BUDs in line with regulatory expectations.

In practice, that means less time spent combing through primary literature or reconciling package inserts, and more time applying validated concentrations already aligned with S4S standards. It’s a small but significant way to help teams meet national benchmarks for medication safety without adding complexity to their compounding processes.

Continuing the work of standardization

The expansion of PCCA’s sterile-to-sterile database is an ongoing effort. As ASHP’s S4S lists evolve, so will our formulations. Upcoming additions will include ophthalmic preparations such as intravitreal, subconjunctival and topical dosage forms — areas where standardized concentrations can further improve safety and consistency.

Each update reflects the same guiding principle: that the right data, clearly presented, can help health systems strengthen both safety and efficiency. By combining referenced stability research with practical compounding guidance, we aim to make standardization not just an aspiration, but a daily reality for hospital pharmacies everywhere.