Developing a Proprietary Formulation for Your Telehealth Program: How It Works

A signature product starts before the first prescription

Many telehealth and clinic programs want something of their own: a base their patients tolerate well, a combination their prescribers use often, or a presentation that fits their brand. That is a formulation question, and the best time to answer it is before launch, while there is still room to test ideas and adjust them.

Here is how we approach formulation development with a new program, and what your team can do to make it go smoothly.

Step 1: Schedule the planning meetings

Formulation development starts with scheduled meetings between your team and our formulation development team, ahead of launch. Bring your prescribers' protocols, the patient population you serve, the dosage forms you have in mind, and any sensitivities you already know you need to design around.

If the concept is proprietary, we can put an NDA in place before those details are shared.

Step 2: Research and development

Our formulation development team then researches and develops the preparation against your protocols: the base, the dosage form, how it will be packaged and how it will be dispensed to each patient. This is also where practical questions get settled, such as whether a hypoallergenic base or a dye-free, lactose-free or filler-free option makes sense for your patients.

Step 3: Testing before release

Proposed products are tested by the formulation development team before they are rolled out. A formulation is only released to your program once that development work is complete.

Step 4: Staff briefing and rollout

Before the first prescriptions arrive, your team is briefed on the finished formulation: what to write on the prescription, how orders reach us, and what your patients will receive. Prescriptions can come in by direct API connection, e-prescribing or our provider portal. Our pharmacy integrations page explains the API side.

The rules that shape what can be developed

A 503A compounding pharmacy prepares medications for individual patients, so even a signature formulation is compounded one prescription at a time, for the patient named on it, at the strength the prescriber writes. Federal 503A rules also limit which active ingredients a pharmacy can compound with, and a compounded preparation cannot be essentially a copy of a commercially available drug. Our development team checks each proposal against those rules early, so the program is built on something that can be filled for the long term. Our explainer on what a 503A pharmacy is covers the framework in more detail.

What to bring to the first meeting

• The protocols your prescribers use, and the patients they treat
• The dosage forms you have in mind, and any your patients find hard to use
• Known sensitivities to design around, such as dyes, lactose or fillers
• The states your patients live in
• How you want prescriptions to reach the pharmacy
• Your packaging and branding plans

Our telehealth launch kit turns this into a checklist your clinical, operations and technical teams can work through together.

Where ProCompounding fits

ProCompounding is a PCAB-accredited 503A compounding pharmacy in Johnson City, Tennessee, licensed in all 50 states and the District of Columbia. We compound non-sterile preparations with a 48-hour compounding time on most preparations; shipping time is additional. Custom formulas are developed on request, including for hormone therapy programs and practices led by nurse practitioners and physician assistants.

When your team is ready, start clinic onboarding and tell us about the formulation you have in mind.

Compounded preparations are not reviewed or approved by the FDA for safety or efficacy. This article is general information for clinics and is not legal or medical advice.