What the software has to do now
A peptide program needs software that makes it hard to sell anything outside the HHS policy. Since October 28, 2026, HHS has said it does not intend to take enforcement action against 503A compounding of BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon when ten conditions are met, among them a single active ingredient, routes limited per peptide, MedWatch and state reporting of serious adverse events, the label "This is a compounded drug product. Not for resale.", and a 510(k)-cleared syringe as the only device. The notice calls it a draft and an interim policy, comments run two weeks from the October 30 Federal Register publication, and law firms disagree on whether to call it in effect. Our checklist post maps all ten conditions to the brand, the prescriber and the pharmacy.
This post is the software half. This is not legal advice.
Seven requirements, and who really carries them
| Requirement | What the software must do | Who is accountable |
|---|---|---|
| 1. Single-ingredient formulary | Every product is one peptide, one route, one form; no blend or "stack" SKU can be published | Brand and prescriber |
| 2. Route lock | Semax only intranasal, KPV only topical or oral, TB-500 and MOTS-c only injectable, and so on | Prescriber, enforced in the catalog |
| 3. Intake and contraindication screens per product | Separate screening for an injectable, an oral, a topical; history, medications, pregnancy, red flags; clinician sees structured answers | Prescriber and medical director |
| 4. Clinician chooses, patient does not | Dose, route and product are set in the prescription, not picked at checkout | Prescriber |
| 5. Lot and COA traceability | Each shipment links to a pharmacy lot; COA and supplier file available on request | Pharmacy, with the brand storing references |
| 6. Adverse-event capture and reporting | Patient can report from the portal; event reaches the clinician and the pharmacy; serious events filed with MedWatch and the states | Pharmacy files; clinician documents |
| 7. Label, consent and claims language | Consent says compounded and not FDA-approved; nothing on the storefront implies approval | Brand |
Requirement 4 comes from outside the peptide policy. A September 18, 2026 FDA warning letter to a compounder questioned prescriptions generated through "preselected options on third-party telehealth platforms," according to Holland & Knight. A checkout where the patient picks "BPC-157 500 mcg, 30 days" before anyone clinical has looked is exactly that pattern. The patient can request a goal; the clinician picks the product.
The parts people get wrong
Formulary control is a catalog problem
Most peptide sites built before October sell bundles: recovery stacks, BPC-157 with TB-500 in one vial, pens for convenience. Under the policy a blend is out, and LegitScript reads the single-API condition as excluding any combination. The safest software makes those products impossible to configure: one product equals one peptide, one route, one dosage form. If a vendor demo opens on a stack template, ask how you would remove it and prove it never ships.
Epitalon has its own wrinkle. The policy permits it in intermittent courses, so the subscription logic has to allow a course with an end date and a gap, not an open-ended monthly refill. A billing engine that only knows "every 30 days until cancelled" will create the wrong order.
Lot and COA tracking lives at the pharmacy
The policy puts sourcing on the compounder: API from an FDA-registered facility, a valid certificate of analysis, the original manufacturer named on it. Your software should not pretend to hold that. What it should hold is the link: which order went to which pharmacy, the lot or batch the pharmacy reports back, and the date. When a patient calls about a reaction, or a pharmacy issues a recall, you need to find every patient on that lot in minutes. Ask the pharmacy in writing whether it returns lot numbers per shipment and will send COAs on request; our pharmacy selection guide covers the rest of that diligence.
Adverse events need a path, not a form
Two summaries of the policy (McDermott and BakerHostetler) say serious adverse events and quality issues go to FDA's MedWatch and the relevant state authorities; McDermott adds that patient labeling explains how to report. The pharmacy files. Your program's job is to get the report to the clinician and the pharmacy fast, and document it. The workflow we described in the side-effect triage post applies directly: a portal report, a severity rule, an escalation clock, and a record that survives an audit.
Consent and claims
The consent form should say the product is compounded, is not FDA-approved, and that HHS's position is an enforcement policy that can change. LegitScript's November 2 guidance tells merchants to keep labels, marketing and patient messages from implying approval. Our consent forms post has the structure; the peptide-specific lines are a job for your counsel.
Metabolic and Longevity
The group most adjacent to existing GLP-1 programs. Natural cross-sell candidates for an established metabolic patient base.
Often called 'exercise in a vial.' Research interest around metabolism, insulin sensitivity, and obesity-adjacent indications.
Most discussed in the longevity context, including telomere-related research and sleep regulation.
Three ways to get the software
| Build on an EHR | All-in-one DTC platform | Pharmacy-provided storefront | |
|---|---|---|---|
| What you get | Charting, forms, scheduling; you add storefront, billing, pharmacy links | Storefront, intake, provider routing, billing, pharmacy routing, portal in one system | A ready shop tied to one pharmacy's catalog |
| Formulary control | Yours to build | Configured per product; check blends cannot be published | The pharmacy's catalog; check what it lists |
| Prescriber | You bring them | Varies; some include a provider network | Varies; ask whose clinical entity prescribes |
| Pharmacy choice | Any, with integration work | Network or bring your own | That pharmacy |
| Lot and AE linkage | Custom | Depends on the pharmacy integration | Usually native for that pharmacy |
| Main risk | Months of integration; parallel systems | Vendor dependence | Pharmacy owns the patient relationship; no second source |
EHR. Healthie is the common pick for DTC programs that want a real chart. Per its pricing page and our Healthie comparison, plans run from $19 to $149+ a month, e-prescribing is a DoseSpot add-on at $40 per clinician per month, payments are 2.9% plus $0.30, and intake forms can feed chart notes. It has no storefront or pharmacy routing as a core job, so a peptide program on an EHR is the EHR plus three or four other tools you connect yourself.
All-in-one. The platforms that sell the whole flow differ mostly on who prescribes, who owns the merchant account, and pricing. Fuse Health publishes tiers (DIY at $499 a month once live with a 3% merchant fee; Growth at $5,600 upfront then $699 a month with 2%) and lists a fitness peptides case study; we have not checked how its catalog handles blends. Several small peptide-specific products (PepEasy, Pepture, Ratatui) rank for "peptide clinic software" on pages that predate October 28. We have not evaluated them, and nothing we found says whether they changed for the policy.
Pharmacy storefront. Some 503A pharmacies offer clinics a branded shop on top of their own catalog. Lot and COA linkage can be simplest here, because there is one pharmacy. The cost is the one we described in our pharmacy front-end post: the routing decision, and often the patient relationship, sit with the pharmacy, and there is no second source if that pharmacy has a quality problem.
Our view: for a brand, the EHR build is the slowest and the pharmacy storefront is the riskiest if the policy changes for one peptide or one supplier. The all-in-one is the default, if it passes the questions below.
Demo questions that separate ready from marketed
- Show me how I would try to create a BPC-157 plus TB-500 product, and what stops me.
- Can a product be locked to one route, and can intake differ by route?
- Where does the clinician set dose and product, and can the patient change either at checkout?
- Does the pharmacy return a lot number per order, and where do I see it?
- A patient reports a reaction in the portal at 11 p.m. Who is notified, and what is recorded?
- Can an Epitalon order run as a fixed course with an end date?
- If my pharmacy loses its supplier, how long to route that peptide to a second qualified 503A?
- Who owns the merchant account, and can I export patients and order history if I leave?
Pricing the program
The software sets the floor, not the price. Peptide programs we have written about run on a membership, typically $150 to $300 a month for review, dosing changes and messaging, with the compounded product billed at the pharmacy's price (the September peptide clinic guide has the full model). One policy-driven detail: price each single-ingredient product separately, never as a stack.
Where Turbopills fits
Turbopills runs storefront, conditional intake, state-aware routing to licensed providers, billing that starts after clinical approval, pharmacy routing with live status, a branded portal and mobile app as one system. Products are configured one at a time, so a single-ingredient, single-route catalog is the natural shape. Our treatments directory lists sermorelin, NAD+ and PT-141 today; adding one of the six peptides is a catalog, intake and pharmacy change. Ask us in a demo to walk through questions 1 to 7 on a real configuration, and ask which network pharmacies compound under the policy, because we would rather you see it than read it here. You bring the medical director, protocols, pharmacy approval and LegitScript application. We are in private beta, with hands-on onboarding and limited capacity, and quote per program.
FAQ
What is the best software for a peptide clinic? For a DTC brand, the one that enforces single-ingredient products, route limits and clinician-chosen dosing, links orders to pharmacy lots, and routes adverse-event reports. For a practice with staff clinicians, an EHR plus a storefront can work.
Does peptide clinic software need to report adverse events to the FDA? The policy puts MedWatch and state reporting on the compounder. The software's job is getting the patient's report to the clinician and pharmacy quickly and recording it.
Can I sell peptide stacks on my telehealth storefront? Not under the HHS policy. Each covered peptide must be compounded as a single active ingredient, so stacks and blends fall outside it.
Can a telehealth platform let patients choose their peptide dose at checkout? We would not. FDA questioned prescriptions generated through preselected platform options in a September 2026 warning letter. The clinician should set product, route and dose.