For Pharma, Biotech & Specialty Startups
A 503A Drug Development Partner That Moves at Your Speed
Batch minimums, long lead times, and a change order for every formulation tweak slow early programs to a crawl. We iterate on your preparation at patient-specific scale, so prescribers can individualize therapy for their patients while your regulatory work continues on its own track.
The CMO bottleneck
Contract manufacturing is built for scale and repeatability. That is exactly the wrong shape for a formulation that is still changing.
Minimum order quantities
Contract manufacturers typically require large batch minimums. Early programs rarely need that much material — and paying for it locks you into a formulation before you've learned much about it.
Lead times
Scheduling, qualification, and queueing at a CMO are often measured in months rather than days. Every iteration you want to test waits behind that queue.
The cost of reformulating
Change the excipient base, the strength, or the release profile and you're usually looking at a change order, requalification, and another full run.
No real-world feedback loop
Large-batch commitments happen before prescribers and patients have used the preparation. You learn about tolerability, palatability, and adherence after you've already committed.
What we actually do
Hands-on formulation work in a PCAB/ACHC-accredited 503A lab, run by pharmacists who compound every day.
Formulation development & prototyping
Iterative bench work on a candidate preparation, with adjustments turned around at patient-specific scale instead of full production runs.
Dosage form selection
Capsules, troches, oral suspensions, topicals and transdermals, and other forms — chosen around the route, the population, and the practical realities of adherence.
Excipient & allergen work
Dye-free, preservative-free, gluten-free, and other restricted-excipient bases for populations that can't tolerate a conventional vehicle.
Strength & release adjustments
Strength laddering and release-profile changes so a prescriber can individualize therapy for the patient in front of them.
Stability & beyond-use dating
Beyond-use dating assigned in accordance with USP <795> and <797> standards, with stability testing arranged where a program calls for it.
Scale-up readiness
Formulations documented in a way that translates when your program is ready to move to a manufacturing partner.
Documentation you can hand off
Formulation records, ingredient sourcing and CoAs, and compounding procedures organized so a CMO or a regulatory consultant can pick them up later.
How a 503A fits your regulatory path
ProCompounding is a 503A compounding pharmacy. That means one thing above all: we prepare and dispense medications only pursuant to a patient-specific prescription written by a licensed prescriber for an identified patient. That prescription is the only mechanism by which a compounded preparation reaches a patient.
What a 503A relationship can do is compress the formulation-learning loop. While your regulatory path runs on its own timeline, prescribers who choose to individualize therapy for their own patients generate practical, real-world observations — tolerability, palatability, dosing practicality, adherence — and those observations can inform the formulation you eventually carry into a manufacturing and approval process.
We compound in accordance with USP <795> and USP <800> standards and within the limits of Section 503A, including the constraint that we do not compound copies of commercially available drug products. Where a program has questions about its own regulatory strategy, that belongs with your regulatory counsel — we will work within whatever framework you and they establish.
Why ProCompounding
- PCAB/ACHC accredited — an accreditation held by a small fraction of compounding pharmacies
- Compounding since 1936, independently owned
- Licensed in 49 states plus the District of Columbia
- Pharmacist-led quality oversight on every preparation
- USP <795> and USP <800> compliant compounding operations
- Non-sterile and specialty dosage form capability in-house
Related pages
503A vs CMO
A side-by-side comparison of a 503A pharmacy and a contract manufacturer for early-stage development.
Telehealth platform fulfillment
Already running a platform with prescribers and patients? This is the fulfillment side of our partner work.
For prescribers
Individual clinicians writing compounded prescriptions can start here.
Get Started
Book a Formulation Consult
Tell us what you're trying to make. A pharmacist will review your request and set up a call to talk through dosage form, excipients, and what a 503A workflow can and cannot do for your program.
Disclaimer — Compounded preparations are not FDA-approved and are not evaluated by the FDA for safety or efficacy. ProCompounding is a 503A compounding pharmacy that prepares and dispenses medications only pursuant to a patient-specific prescription written by a licensed prescriber. We do not manufacture, sell, or commercially distribute drug products on behalf of any company. Nothing on this page is a promise or prediction of any regulatory outcome, approval, or timeline.