If you've ever downloaded a formula from the PCCA database and thought, “Wow, that was easy,” you’re not wrong — but behind that single click is a mountain of work, innovation and science. In a recent episode of The Mortar & Pestle podcast, PCCA Senior Formulation Specialist & Project Manager Stacey Lemus, BS, gave us a behind-the-scenes look at the engine that drives PCCA’s formulation development.

For compounders, this isn’t just nitty gritty minutiae — it’s a reminder of the care, rigor and intelligence behind every formula you use.

The Formulation Team: Small but Mighty

PCCA’s Formulation Development team is a tight crew of eight, including four compounding pharmacists, two lab formulation specialists, a PhD scientist and the legendary Martha — an admin powerhouse who’s been with PCCA since the typewriter era. This team works across departments and alongside the Research & Development and Clinical Services teams to develop, review, test and refine more than 9,000 formulations in the database.

From Idea to Tested Formula

A formulation request can be driven by a whole host of needs — new APIs, novel dosage forms, drug shortages or general requests. Regardless of where it comes from, every request undergoes a thorough review process:

• Clinical need: Is there a therapeutic gap this formula fills?
• Feasibility: Will it compound well? Is it chemically compatible? Do we have the necessary excipients and equipment?
• Regulatory compliance: Does it meet FDA’s 503A and USP requirements?
• Stability and performance: Will it hold up for its full beyond-use date?

Some formulations are picture-perfect on the first try. Others go through 10, 15 or even 20 trials. The work doesn’t stop at “good enough” — it continues until the formula is not just viable but reproducible.

The Evolution of Bases — and What It Means for You

New bases like SuspendIt® and Anhydrous SuspendIt® have changed the game in oral suspensions. But they’ve also added complexity for the team. Creating a new base means evaluating hundreds of popular formulations to determine which should be updated, expanded or recreated using the new vehicle.

Important insight: older formulas aren’t necessarily retired — they’re often maintained to serve specific patient needs (e.g., sugar-free, soy-free or minimal excipient formulas).

The team now also develops formulations using commercially available drug products (CADPs), a nod to real-world pharmacy workflows, shortages and cost constraints.

Why Substitutions Can Be Challenging

One of the biggest member questions? “Can I sub out this base or excipient?”

Short answer: maybe — but tread carefully. Swapping a wetting agent, changing a flavor or using a different supplier's chemical could alter solubility, stability or even trigger unwanted chemical reactions — especially in anhydrous systems.

Many of PCCA’s formulas do more than provide instructions — they act as data-driven blueprints based on PCCA products. And that data isn’t cheap — FormulaPlus™ studies can cost up to $50,000 each to develop.

FormulaPlus: The Gold Standard

As of today, there are over 225 FormulaPlus formulations in the PCCA database. These extended beyond-use date formulas are tested using stability study protocols that utilize stability-indicating assays, along with USP 51 antimicrobial effectiveness and container closure testing, when applicable.

About 75 of them are bracketed, meaning they apply to a range of strengths, giving pharmacists more flexibility without compromising stability.

And this number is growing — PCCA adds approximately 20 new FormulaPlus studies each year.

Lessons from the Bench

Stacey’s personal journey — from compounding technician in a member pharmacy to developing formulation processes at PCCA — underscores one powerful message: Never stop learning.

In her early days, she didn’t understand why a cream got gritty over time or how an ointment mill worked beyond “reducing grittiness.” Now, she knows those issues stemmed from solubility limits, precipitation or particle size — and that the “why” matters just as much as the “what.”

For technicians and pharmacists alike, Stacey encourages ongoing education and a healthy respect for the science behind compounding. PCCA’s blog and training resources offer valuable insights into choosing the right wetting agents, gelling agents, preservatives and more.

Final Takeaway: It’s More Than Just a Formula

When you pull a formulation from the PCCA database, you’re benefiting from:

• Months of lab work
• Hours of research
• Decades of experience
• Cross-functional teamwork
• Real-world applicability
• Regulatory foresight
• And sometimes 20+ failed attempts before that successful one

It’s not just a number on a page — it’s an investment in your success.

PCCA members with clinical services access can explore the full formula database anytime. Curious about membership? Find out how a PCCA membership can benefit your compounding practice.