More detail on the company, how we test and release, how prescribers and brands work with us, and the API. It's all on this page; use the contents to jump to a section.
Why we started, what the name means, our facility, our team and the rules we work by.
Telehealth brands, hormone clinics and prescription skincare companies send their prescriptions to 503A compounding pharmacies, because their patients need doses or combinations that no approved product comes in.
Brands we've talked to describe ten-day turnarounds, mislabeled prescriptions, and pharmacies whose quality drops as volume grows. Most compounding is still mixed by hand and documented on paper or old desktop software.
Machines handle dispensing, filling and inspection, and each step writes to the batch record as it runs. A pharmacist reviews and signs every release.
In metrology, a standard is the reference a measurement is checked against, such as the kilogram or the USP reference material used in a potency assay. Our logo is a datum line with an index mark at zero, which is what a reading looks like when it matches its reference.
We chose a name you can hold us to. Each preparation has a written target, a tolerance and a recorded result, and partners can see those results on every order. Brand guidelines →
Most quality problems in compounding come from variation in manual work, and manual work is also what limits how many prescriptions a pharmacy can fill. Automating it helps with both.
A licensed pharmacist reviews and signs every release.
The sterile suite is built to USP <797>, with an ISO Class 5 hood inside an ISO 7 buffer room, entered through an ISO 8 ante-room. Non-sterile compounding happens in a separate room. Air and surfaces are monitored continuously.
Nothing is compounded without a written specification covering target, tolerance, container and the basis for its beyond-use date.
Anything that affects the dose is measured on every unit rather than on a sample.
Units outside tolerance are quarantined automatically and a pharmacist investigates.
Partners can pull the batch record and COA for any order themselves.
Sample data is marked as sample data, and targets are marked as targets.
Every account has a named person responsible for it, plus a named backup.
How tolerances are set, what each release panel tests, how beyond-use dates are set, and the records on every order.
The solid line is the target and the dashed lines are the tolerance limits. Each dot is one unit, weighed after filling. The tolerance is set by how accurate the dose needs to be for that formula.
Weight only tells you the dose if the mixture is uniform, so the release panel also tests potency and content uniformity against the label claim.
Tolerances vary by preparation and are set in each formula's SOP. ±0.5% is shown as an example.
Defined since 2019 by fixing the Planck constant.
Realized by a national metrology institute such as NIST.
An ISO/IEC 17025-accredited lab calibrates our masses.
Certified mass standards, recalibrated on schedule.
Qualified to USP <41> and verified before each run.
Weighed against its target and recorded, unit by unit.
| Because we do this | You get this | And the evidence is |
|---|---|---|
| Gravimetric check on every unit | Fill-weight consistency, supported by potency testing | Per-unit weight record + potency assay |
| Torque-controlled sealing | A closure that holds its microbial barrier for the dated shelf life | Container closure integrity, USP <1207> |
| Closed-system aseptic processing | Reduced operator contact with the critical zone | Sterility <71>, endotoxin <85>, media fills, continuous EM |
| Logged thermal & mixing profiles | Controlled conditions, tested for degradation | Stability-indicating assay of intact drug |
| Labels generated from the order | Drug, strength and patient match the order | Barcode verification at pick and pack + photo record |
| One qualified container per product | Characterized adsorption and leachables | E&L + adsorption in the stability protocol |
This assay separates the intact drug from its breakdown products. It's validated with forced-degradation studies following ICH Q1A(R2) and USP <1225>. A simple potency test can read 100% while the drug is breaking down.
For preserved and multi-dose preparations, we test that the preservative keeps microbial growth down for the whole in-use period.
Vacuum decay and other deterministic methods confirm the vial, stopper and crimp stay sealed through the dated shelf life. A product that's sterile at release can still be contaminated later if the seal fails.
Each timepoint also checks pH, appearance, subvisible particles <788> and osmolality. Sensitive molecules also get aggregation by SEC and container adsorption. Studies run in real time and accelerated.
| Record | What's in it | Available | Endpoint |
|---|---|---|---|
| Batch record | Ingredients and lots, target and actual weights, equipment IDs, process parameters, operator and system events | At release | /v1/orders/:id/batch_record |
| Certificate of analysis | Every release test, its method, specification and result, with signatures | At release | /v1/orders/:id/coa |
| Unit weights | Per-unit gravimetric results against target and tolerance | At release | /v1/orders/:id/unit_weights |
| Stability protocol | Formula, container, conditions, timepoints and methods supporting the BUD | Any time | /v1/formulas/:id/stability |
| Pick & pack photo | Barcode verification result and a photo of the packed order | At shipment | /v1/orders/:id/pack_record |
| Cold-chain log | Temperature trace and any excursion for sterile shipments | On delivery | /v1/shipments/:id/temperature |
Each complaint is investigated and documented, with a root cause and a corrective action. We send you the findings.
A unit or batch outside specification is set aside automatically. A pharmacist investigates, and the deviation goes into the batch record.
Once the facility is open, partners can visit and meet the pharmacist-in-charge.
Send a prescription the way you already do. We compound it to a written specification, check every unit against it, and give you a named pharmacist to call.
Send from your EHR as you would to any pharmacy; search for StandardRx in your e-prescribing directory. Put compound details in the sig and notes fields. If anything is unclear, we'll call.
Use our compounding order form. It lists standard strengths, bases and quantities, which cuts down on handwriting errors. A pharmacist confirms receipt and follows up on questions by phone or secure message.
Build prescriptions from the formulary, save your protocols as templates, and track each order from verification to delivery. Batch records and COAs are attached to every order.
estradiol 0.5 mg / estriol 2 mg per 1 gShip target after clearance for anything in the formulary, at a listed or adjusted strength.
Formula development, a compatibility review and conservative USP default dating. After that it ships on the normal two-day target.
We flag a delayed order to you and the patient with the reason and a new date. Every miss is logged and reviewed.
Patients get a price before we compound, text updates as the order moves, a readable label and a pharmacist they can call. That should mean fewer calls to your front desk.
Bi-Est and Tri-Est creams, progesterone capsules, testosterone and DHEA, vaginal preparations, thyroid SR. Metered applicators and the same base every refill.
Testosterone cypionate and enanthate vials, creams and troches, enclomiphene, anastrozole. Custom oil vehicles for patients sensitive to one.
Tri-Mix and Bi-Mix at custom ratios, assayed per batch, plus sildenafil–tadalafil troches and ODTs.
Scalp solutions with up to seven actives, oral minoxidil, spironolactone, tretinoin and hydroquinone blends, rosacea and acne gels.
LDN, custom-dose metformin, B12 as cyanocobalamin or hydroxocobalamin, lipotropic injections, with fine titration increments.
Build-your-own 1–6 active creams in high-load bases, neuropathic formulas, iontophoresis solutions.
We're cash-pay only, so there's no insurance, PBM or prior authorization. Every formulary item has a set price you can quote to a patient during the visit.
| Example preparation | Quantity | Patient price |
|---|---|---|
| Bi-Est 80/20 cream, 1.0 mg/g | 30 g, metered | In portal |
| Progesterone SR capsule, 100 mg | 30 caps | In portal |
| Testosterone cypionate 200 mg/mL | 10 mL MDV | In portal |
| Minoxidil 5% / finasteride 0.1% solution | 60 mL | In portal |
Prices are shared at onboarding and listed in the portal. We can bill the patient or bill your clinic.
Each account has a named pharmacist, plus a backup, for formulation questions, dose clarifications and adverse-event reports.
Shared at onboarding. We aim to answer clinical questions the same business day, and there's an after-hours line for urgent issues.
We verify your license, set up e-prescribing and the portal, and go through the formulary with you and a pharmacist.
We compound in your packaging, connect to your systems through an API, and agree service levels with you in writing, each with a target and a way to measure it.
Orders ship in your cartons with your inserts and patient-facing labels, printed from artwork your team approves. We send you samples before the first patient order. Our 3PL partner handles next-day options and validated 2–8 °C cold chain.
Each commitment has a target, a way it's measured and a remedy if we miss. Your dashboard shows performance daily, and every exception has a reason code.
Batch records, COAs, release panels and the stability protocol behind each beyond-use date are available on every order. Your clinical team sets acceptance criteria, and we report results against them.
Orders take idempotency keys, webhooks are signed, and you can check state coverage before checkout. Sandbox keys are issued the day of your scoping call.
| Measure | Proposed pilot target | How it's measured | If we miss |
|---|---|---|---|
| Ship time, catalog formulas | ≤ 2 business days | Rx clearance to carrier scan, per order | Proactive notice + reason code; service credit per agreement |
| New formulation | 2–4 weeks to first release | Signed formula spec to first released batch | Revised plan with the pharmacist within 2 days |
| Order exceptions | Flagged within 1 business hour | Exception event timestamp vs. detection | Root-cause review in the monthly report |
| Quality complaints | Remake or refund same day | Complaint logged to resolution | Documented investigation and corrective action (CAPA) |
| Records availability | At release, every order | BR + COA retrievable via API/dashboard | Escalation to your named contact |
| Clinical questions | Same business day | Ticket open to pharmacist response | Escalation to pharmacist-in-charge |
You should be able to promise patients a delivery date without checking with us. During scoping we show you our capacity and how much is already committed, and your launch volume is reserved in the agreement before the pilot starts.
30 minutes with a pharmacist and an engineer on your formulary, volumes, states and packaging.
A written answer on each formulation: spec, BUD basis, price, and the states we can serve.
Prescriber licensing verified, data terms and a BAA executed, service levels agreed.
Sandbox orders end to end, webhooks live, packaging proofed and samples shipped to you.
Part of your real volume, reviewed together against the targets before the rest moves over.
Early partners help shape our workflows and formulary, and their formulations and packaging are reviewed first. We limit how many partners we take on at once so each one gets onboarded properly.
The dashboard on the overview page and the API show the same data: each order's status, the specification it was made to, its measured results and its records.
# Create an order (sandbox) curl https://sandbox.api.standardrx.com/v1/orders \ -H "Authorization: Bearer $SRX_SANDBOX_KEY" \ -H "Idempotency-Key: 2f6c1b0e-order-10482" \ -H "Content-Type: application/json" \ -d '{ "formula": "srx-spec-0142", "quantity": 1, "patient": { "ref": "pt_8fd21a", "state": "CA" }, "prescriber": { "npi": "1234567893" }, "ship_to": { "zip": "94110", "service": "2day" }, "packaging_profile": "yourbrand-v3" }' # 201 Created { "id": "ord_2611_0482", "status": "verifying", "spec": { "id": "SRX-SPEC-0142", "rev": "C", "target_g": 8.920, "tolerance_pct": 0.5 }, "ship_target": "2026-11-19" }
// Node 18+, no SDK required const res = await fetch("https://sandbox.api.standardrx.com/v1/orders", { method: "POST", headers: { Authorization: `Bearer ${process.env.SRX_SANDBOX_KEY}`, "Idempotency-Key": crypto.randomUUID(), "Content-Type": "application/json", }, body: JSON.stringify({ formula: "srx-spec-0142", quantity: 1, patient: { ref: "pt_8fd21a", state: "CA" }, prescriber: { npi: "1234567893" }, ship_to: { zip: "94110", service: "2day" }, packaging_profile: "yourbrand-v3", }), }); const order = await res.json(); console.log(order.id, order.spec.tolerance_pct, order.ship_target);
import os, uuid, requests r = requests.post( "https://sandbox.api.standardrx.com/v1/orders", headers={ "Authorization": f"Bearer {os.environ['SRX_SANDBOX_KEY']}", "Idempotency-Key": str(uuid.uuid4()), }, json={ "formula": "srx-spec-0142", "quantity": 1, "patient": {"ref": "pt_8fd21a", "state": "CA"}, "prescriber": {"npi": "1234567893"}, "ship_to": {"zip": "94110", "service": "2day"}, "packaging_profile": "yourbrand-v3", }, timeout=10, ) r.raise_for_status() order = r.json() print(order["id"], order["spec"]["id"], order["ship_target"])
// Verify and handle a StandardRx webhook (Express) import crypto from "node:crypto"; app.post("/webhooks/standardrx", express.raw({ type: "application/json" }), (req, res) => { const [t, sig] = req.get("SRX-Signature").split(",").map((p) => p.split("=")[1]); const expected = crypto.createHmac("sha256", process.env.SRX_WEBHOOK_SECRET) .update(`${t}.${req.body}`).digest("hex"); if (!crypto.timingSafeEqual(Buffer.from(sig), Buffer.from(expected))) return res.sendStatus(400); const evt = JSON.parse(req.body); switch (evt.type) { case "order.released": // COA + batch record now available saveRecords(evt.data.order_id, evt.data.records); break; case "order.exception": // e.g. rx_clarification, out_of_tolerance notifyOps(evt.data.order_id, evt.data.reason_code); break; case "shipment.delivered": markDelivered(evt.data.order_id); break; } res.sendStatus(200); });
| Event | Fires when | Payload highlights |
|---|---|---|
| order.created | Order accepted by the API | spec, ship_target |
| order.verified | Rx, prescriber and patient verified | pharmacist_id |
| order.payment_required | Patient price confirmed, awaiting payment | amount, pay_link |
| order.compounding | Batch started | lot, batch_id |
| order.measured | Unit weighed and inspected | measured_g, deviation_pct, in_tolerance |
| order.released | Pharmacist signs release | records[coa, batch_record] |
| order.exception | Anything that threatens the ship target | reason_code, owner, new_target |
| order.cancelled | Cancelled by you, the patient or the pharmacist | reason_code |
| shipment.created | Label printed and pack verified | carrier, tracking, pack_photo |
| shipment.in_transit | First carrier scan | eta |
| shipment.temperature_excursion | Cold-chain logger outside 2–8 °C | duration_min, max_c |
| shipment.delivered | Carrier confirms delivery | delivered_at |
We agree the formulas and states you'll test.
Issued the same day, scoped to your org.
Force any event: out_of_tolerance, rx_clarification, excursions.
We review your handling of each event with you.
Issued after the BAA and service levels are signed.
TLS 1.2+ in transit, encryption at rest, scoped keys, and an audit log of every PHI access.
Resending a request with the same idempotency key won't create a duplicate order.
If you're not ready to integrate, start with e-prescribing or CSV upload. You get the same records either way.
Answers to the questions prescribers and partners ask us most.
Usually, yes. A pharmacist reviews anything outside the formulary's listed range for stability, compatibility and clinical fit, and will call you if it needs discussion.
From a stability study on that formula in that container, when we have one. Otherwise we use conservative dating under USP <795> or <797> defaults. The protocol behind the date is available on every order.
We remake or refund the same day, open a documented investigation, and send you the root cause and corrective action.
Yes, and many pilots start that way. Send us a set of formulations or states, compare turnaround and records side by side, then decide.
You do. We contact patients only when dispensing or safety requires it, using your branding and templates you've approved, unless you ask us to use ours.
We sign a BAA with every partner. PHI stays in our systems and yours, API traffic is encrypted in transit, and access is logged. We share our security overview during scoping.
Per-unit pricing with volume tiers, quoted for each formulation in the feasibility response. We bill you or the patient, whichever you prefer. Insurance, PBMs and prior authorization aren't involved.