Potency Explained: What It Means and Why Consistency Is Everything

When a medication is prescribed, the expectation is straightforward: it should work. But between the prescription pad and the patient, a critical variable determines whether that expectation becomes reality potency. Understanding what potency means in sterile compounding and why consistency matters helps both providers and patients make more informed decisions about their care.

Potency isn't just a technical term. It's the difference between a therapy that delivers results and one that falls short or worse, causes harm. In a compounding pharmacy, where every medication is prepared individually rather than mass-produced, potency verification carries even greater weight than in commercial manufacturing.

Cody Drug's sterile compounding standards are built around one foundational principle: every medication must contain exactly what the label claims, prepared to the same specification every single time. That commitment to precision is what separates reliable compounding partners from those who simply meet minimum requirements.

What Is Potency?

Potency refers to the concentration of active pharmaceutical ingredient (API) in a compounded preparation. It answers a deceptively simple question: does this medication contain the right amount of the right substance?

In a commercial drug, potency is validated through industrial-scale manufacturing processes with automated equipment and real-time quality controls. In compounding, every batch is prepared by hand in a controlled environment, which means precision and analytical verification become the primary safeguards.

Acceptable Range

No compounded preparation can achieve perfect potency, nor does it need to. Regulatory standards allow for a defined acceptable range, typically ±5% to ±10% of labeled concentration, depending on the compound and intended use.

What matters is that every batch consistently falls within that range. A preparation that tests at 98% potency today and 87% three months later is NOT a stable product. Patients and providers need confidence that dose one and dose thirty deliver the same therapeutic effect.

Potency vs. Sterility

It's worth distinguishing potency from sterility, because both are essential but they address different risks.

Sterility ensures a medication is free from microbial contamination bacteria, fungi, and other organisms that could cause infection. Potency ensures the active ingredient is present at the correct concentration. A medication can be perfectly sterile and still be ineffective if the API is under-concentrated, or dangerous if it's over-concentrated.

Cody Drug verifies both at every stage of the compounding process.

When Consistency Matters for Outcomes

Inconsistent potency doesn't just affect a single dose it disrupts the entire arc of a treatment plan.

For Prescriber's 

When a healthcare provider prescribes a compounded medication, they're building a treatment protocol around an expected pharmacological response. If a Semaglutide injection delivers 95% of labeled potency in the first month and 78% in the third, the prescriber is no longer working with predictable data.

Dose adjustments become guesswork. Side effect profiles shift. Therapeutic windows narrow. Providers who've experienced inconsistent potency from compounding pharmacies often describe the frustration of chasing a moving target never certain whether a patient's suboptimal response reflects the treatment itself or the compound's variability.

Consistent potency gives providers the solid ground they need to evaluate outcomes and refine protocols with confidence.

For Patient's 

For patients, potency consistency directly shapes the treatment experience. Consider someone using a compounded peptide therapy to support recovery, sleep, or metabolic health. If their injections vary in potency from batch to batch, their experience becomes equally variable, making it difficult to evaluate whether the therapy is working and how their body is responding.

Consistent potency creates a stable therapeutic foundation. Patients can track their progress meaningfully, communicate clearly with their providers, and build confidence in their treatment plan. This consistency is particularly important for long-term therapies, where subtle batch-to-batch variability compounds over months into significant outcome differences.

For Safety 

Over-potency is not simply an "extra benefit," it's a safety must-have. A medication prepared at 120% of the labeled concentration delivers a higher dose than prescribed, potentially exceeding safe thresholds or triggering adverse effects. In sterile compound therapies, this margin matters enormously.

Cody Drug's potency testing catches both under- and over-potency, ensuring every medication stays within the range that is both therapeutically effective and clinically safe.

Verification: Potency Testing Methods

Potency verification requires sophisticated analytical equipment and validated testing methods. Understanding how these processes work builds appropriate confidence in the results.

When Testing Happens

Potency testing isn't reserved for flagged batches or quality concerns it's built into the routine quality system. At Cody Drug, testing protocols are determined by:

• Compound risk category: Higher-risk preparations receive more frequent testing

• Batch size: Larger batches may require additional sampling points

• Beyond-use date: Extended dating requires stability data supporting potency through the full intended period

• Compound stability profile: Compounds known to degrade more readily receive enhanced monitoring

The result is a systematic, evidence-based approach to potency assurance rather than a reactive one.

How Time & Storage Matter

A compound that tests at correct potency on day one isn't necessarily at correct potency on day thirty. Stability the ability of a medication to maintain its potency over time is a distinct but closely related quality dimension.

Beyond-Use Dating

Every compounded preparation is assigned a beyond-use date (BUD), after which the medication should not be used. BUDs are determined based on:

• Stability studies: Real-time or accelerated testing that measures potency decline over time

• USP guidelines: Regulatory standards for different preparation categories

• Storage conditions: Temperature, light exposure, and container type all affect stability

• Compound-specific data: Some APIs are inherently more stable than others

Cody Drug assigns BUDs conservatively, based on supporting data rather than maximum allowable limits. A compound that shows potency decline beginning at day 45 won't receive a 60-day BUD, even if regulations might permit it.

Storage Conditions That Protect Potency

Stability begins with proper storage. Even a perfectly compounded preparation loses potency prematurely if stored incorrectly. Our facility maintains:

• Refrigerated storage (2-8°C) for temperature-sensitive compounds including peptides, GLP-1 agents, and certain vitamins

• Frozen storage for compounds requiring long-term preservation

• Light-protected containers and storage areas for photosensitive preparations

• Humidity control to prevent moisture-related degradation

Patients and providers also play a role in maintaining potency. Every preparation ships with clear storage instructions, and our team is available to answer questions about proper handling.

Outcomes Depend on Precision

Cody Drug offers verified potency documentation, direct pharmacist support, and comprehensive sterile compounding services for healthcare providers who demand reliable, consistent compounds.

Our team works directly with prescribers to ensure every formulation meets clinical requirements from initial order through the full treatment course. With extensive experience in potency-sensitive compounds, we help providers achieve the predictable outcomes their patients deserve.

Ready to build your practice on compounds you can count on? Contact us today.

Your Checklist:

Healthcare providers who partner with Cody Drug have access to quality documentation that supports both clinical decision-making and practice compliance.

✅ Certificates of Analysis

Every batch that undergoes potency testing receives a Certificate of Analysis (CoA) documenting the test method, results, acceptance criteria, testing laboratory, and batch identification. CoAs are available upon request and can be shared with patients who want full transparency about their medications.

✅ Licensed in your state

✅ USP compliance

✅ Sourcing from FDA-registered suppliers

✅ Batch testing and QA protocols

✅ Clear pharmacist oversight