503A Compounded
Compounded Topical Anesthetic Formulations
Formulary reviewed by Benn Bluestein-Veyra, M.Sc. Organic Chemistry · Founder, ExaVeyra Sciences
Four topical anesthetic combinations and one injectable vasoconstrictor, prepared to order for in-office procedural use by practices that run scheduled aesthetic and dermatologic appointments.
The formulations below differ in their active combination and in the percentage of each active. Because each is compounded rather than manufactured, the container label carries the beyond-use date assigned at preparation, and that date governs.
Supply and documentation
- Lead time
- 3 to 5 business days from order to delivery, covering both preparation and transit.
- Coverage
- licensed in 33+ states, with licensure confirmed for your destination before a first order ships
- Testing
- Endotoxin and sterility testing on every sterile batch
- Compounded under USP General Chapters 795, 797 and 800
- FDA-registered, GMP-compliant supplier sourcing, with no gray-market material
- Lot identification and the assigned beyond-use date on every container label
- Documentation package matched to what Tennessee Public Chapter 1016 asks of a supplier: particle counts, lot-specific sterility reporting and a Certificate of Analysis
- Certificates of Analysis are documented and lot-specific, held on file with the tissue bank and the pharmacy for your records.
- Account registration in 24 to 48 hours for licensed clinics and practitioners
- Same-day quotes
- Orders placed with the pharmacy within 24 hours of approval
- A dedicated account manager for each practice
ExaVeyra exists to simplify access to biologics, molecules and medical devices through one point of contact, so a practice runs one account rather than three.
- Every formulary page is checked by a chemist. ExaVeyra was founded by an M.Sc. organic chemist, and specification data is verified against the source catalogue rather than reproduced from a vendor sheet.
- When Tennessee became the first state to write exosome documentation into statute, it asked for particle counts, a viscosity report and a lot-specific Certificate of Analysis. That is the package we already supply against.
- One verified account covers biologics, 503A compounded formulations and devices, with a single account manager rather than a separate vendor relationship for each.
Formulary
Available Formulations
What the pharmacy can prepare. This is not a dosing recommendation, and it does not indicate suitability for any patient.
Benzocaine 20% / Lidocaine 10% / Tetracaine 10%
Topical Cream
| Strength & size | Beyond-use date | Quantity per fill |
|---|---|---|
| 60 mL Pump | 180 days | Up to 5 units |
Lidocaine 23% / Tetracaine 10%
Topical Cream
| Strength & size | Beyond-use date | Quantity per fill |
|---|---|---|
| 60 mL Pump | 180 days | Up to 5 units |
Lidocaine 23% / Tetracaine 10% / Phenylephrine 0.5%
Topical Cream
| Strength & size | Beyond-use date | Quantity per fill |
|---|---|---|
| 60 mL Pump | 180 days | Up to 5 units |
Lidocaine 23% / Tetracaine 7% / Prilocaine 2%
Topical Cream
| Strength & size | Beyond-use date | Quantity per fill |
|---|---|---|
| 60 mL Pump | 180 days | Up to 5 units |
Phenylephrine
Injectable
| Strength & size | Beyond-use date | Quantity per fill |
|---|---|---|
| 0.1% | 180 days | Max 2 vials |
Why practices source these compounded
Commercially manufactured topical anesthetics ship in fixed combinations and fixed percentages. A compounding pharmacy can prepare a combination a prescriber specifies, which is why practices running procedural volume tend to standardise on one or two compounded formulations rather than stocking several commercial products.
What you get in exchange is composition control and a full paper trail. A compounded preparation is made for a named patient under a prescription, it carries a beyond-use date rather than a manufacturer expiry, and the pharmacy holds the lot record. Practices that set their reorder cadence around that dating get the composition they specified, documented lot by lot.
What varies between the formulations
- Active combination. Three actives (benzocaine, lidocaine, tetracaine) or two, with prilocaine or phenylephrine substituted in two of the variants.
- Percentage of each active, which is fixed per formulation and stated in the product name rather than chosen at order time.
- Container format. The topical combinations are supplied in 60 mL pumps; the injectable vasoconstrictor is supplied in vials.
- Per-fill quantity, which differs between the topical pumps and the injectable and is set by pharmacy policy and pharmacist review.
The table above lists each formulation as the pharmacy can prepare it. It is a statement of what is available, not a recommendation of which to select, and it carries no direction on quantity or use. Those are prescriber decisions.
Beyond-use dating and storage
Beyond-use dates are assigned at compounding under USP General Chapter 795 for non-sterile preparations and USP General Chapter 797 for sterile ones, and are printed on each container label. The values shown here are a planning reference for ordering cadence and may vary by lot.
Store as stated on the container label. Neither the pumps nor the vials are cold chain, and the two carry their own handling requirements, so practices ordering both get storage confirmed for each at account setup.
Choosing between the four combinations
Three of the topicals are built on a lidocaine and tetracaine base at 23 percent and 7 to 10 percent respectively. The fourth substitutes a benzocaine, lidocaine and tetracaine combination at 20, 10 and 10 percent, which is the combination many practices know by its initials. Two of the lidocaine and tetracaine variants add a third active: phenylephrine at 0.5 percent, or prilocaine at 2 percent.
Those percentage differences are the whole basis for selecting one over another, and the selection belongs to the prescriber. What matters for procurement is that each is a distinct preparation with its own lot record, so a practice switching combinations is switching products rather than adjusting a setting.
Pump format and the injectable
The four topicals are supplied in 60 mL pumps, a single container size across the category, which keeps reordering arithmetic simple for a practice tracking usage per appointment. The pump also avoids the repeated jar opening that makes an in-use date harder to defend.
The phenylephrine injectable sits in this category for procedural adjacency rather than because it shares anything else with the topicals. It is a sterile preparation in vials, prepared under different chapter requirements, with its own per-fill limit. Your account manager will set it up as its own line item.
FDA has warned consumers about topical products that carry anesthetic actives at concentrations above those in approved products, noting the potential for systemic absorption when applied over large areas or under occlusion. [1]
USP General Chapter 795 sets the standards for compounding quality nonsterile preparations and became official on 1 November 2023. [2]
Ordering
Accounts are opened to NPI-verified licensed practitioners. Each preparation is dispensed against a prescription for an individual patient, so ordering runs through the pharmacy rather than as stock purchasing, and quantity per fill is bounded by the limits shown for each entry. Wholesale pricing is released once an account is verified.
The shortest limit governs
Assigned beyond-use date, product stability, in-use and puncture dating, the prescribed directions, pharmacy policy and pharmacist review all apply at once, and whichever expires first is the one that counts.
Sources
- FDA, Warning to consumers to avoid certain topical pain relief products (accessed 2026-08-09)
- USP General Chapter <795>, Pharmaceutical Compounding, Nonsterile Preparations (accessed 2026-08-09)
Verified practitioner access
Request the full formulary and pricing
The pages on this site list a representative selection. Verified practitioners receive the complete named formulary, current wholesale pricing, available strengths and formats, and the identity and credentials of the compounding pharmacy that prepares each preparation.
Access requires a valid NPI. Compounded formulations are prepared by our 503A pharmacy partner, a compounding pharmacy licensed by the Texas State Board of Pharmacy. We verify the number against the national registry before an account is opened, which is why pricing is not published openly: these are prescription preparations supplied to licensed practices rather than consumer products.
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Compounded medications are not FDA-approved finished drug products. Preparations are dispensed against a prescription for a named patient. Nothing on this page is medical advice or a recommendation for any patient.
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Frequently asked questions
- Can we specify a combination that is not listed?
- Often, yes. The formulations shown are what the pharmacy prepares routinely, and a prescriber-specified combination outside that set is a normal request. Send the specification to your account manager and we will come back with what the pharmacy can compound and document.
- Why is a beyond-use date shorter than a commercial expiry?
- A manufacturer expiry rests on stability data generated for one product in one container. A beyond-use date is assigned at compounding under USP 795 and 797 for a preparation made in smaller quantity, so the default dating is conservative by design.
- What is the regulatory status of these formulations?
- Compounded medications are not FDA-approved finished drug products. They are prepared under section 503A of the Federal Food, Drug, and Cosmetic Act against a prescription for an individual patient, which is a separate regulatory pathway rather than a lesser version of the same one.
- What documentation ships with an order?
- Lot identification on the container label, with a Certificate of Analysis available on request. Practices with their own documentation requirements should raise them at account setup so the pharmacy can confirm what it is able to supply.
- Who can open an account?
- NPI-verified licensed practitioners. Verification happens before pricing is released, and licensure is confirmed for the destination state before a first order ships.
These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. Compounded medications are not FDA-approved and are prepared by a licensed 503A compounding pharmacy per individual patient prescription. Formulations are supplied to NPI-verified licensed practitioners only. A Certificate of Analysis and lot documentation are available on request. Nothing on this page is medical advice, a dosing recommendation, or a statement that any formulation is suitable for a given patient.
Reviewed 2026-08-09 by Benn Bluestein-Veyra, M.Sc. Organic Chemistry, founder, exaveyra sciences. Specifications on this page are transcribed from the pharmacy formulary and checked line by line against the source catalogue.