In short. Look up licences yourself instead of taking a logo’s word for it. Know whether you are dealing with a 503A pharmacy or a registered 503B facility. Ask what standard it compounds to and how it tests. Then hold the platform to the same bar: what it checks, what it shows you before you pay, and what it keeps.
The pharmacy: what you can look up yourself
Licences, in its state and in your patients’ states
Every pharmacy is licensed by the board of pharmacy in the state where it operates. One that ships to patients in other states usually needs a non-resident licence in each of those states as well. Search the board’s public licence lookup for the pharmacy’s name and address, and note any disciplinary action. NABP keeps the contact list for every state board.
503A or 503B
A 503A pharmacy compounds for individual patients on prescriptions. A 503B outsourcing facility registers with FDA and works to manufacturing standards. If a supplier says it is a 503B, find it on FDA’s list of registered outsourcing facilities, which shows its last FDA inspection and whether a Form FDA 483 of observations was issued. A 483 is not a verdict, but it is worth asking what was found and what changed. The 503A vs 503B article explains what each may supply.
Accreditation
Accreditation is voluntary. PCAB accreditation for compounding pharmacies is administered by ACHC; if a pharmacy cites it, ask for the current certificate and whether it covers the kind of compounding you are buying, such as sterile preparations.
The pharmacy: what to ask
- Which standard it compounds to. For a 503A, the USP compounding chapters as your state applies them: chapter 795 for non-sterile and chapter 797 for sterile preparations, whose revisions became official on November 1, 2023. For a 503B, current good manufacturing practice.
- How it tests. What it tests each batch for, whether testing is done by an independent laboratory, and whether you can see the results.
- Where its active ingredients come from. Ask for the source and the exact ingredient. For semaglutide, FDA says the sodium and acetate salt forms are different active ingredients from those in the approved drugs, with no lawful basis it knows of for compounding.
- What it will and will not fill. A pharmacy that compounds on prescriptions for identified patients, and turns away an order it should not fill, is doing its job.
The ordering platform: what to ask
Many clinics order through software that sits between the prescriber and the pharmacy. It handles your prescriptions, your money and your audit trail, so it deserves the same scrutiny.
- Does it prescribe? It should not. The prescription, its product, quantity and directions should be the prescriber’s, signed under their own licence.
- What does it check before a card is charged? At least the prescriber’s licence in the patient’s state, whether the product can be sent for that patient, and controlled substances.
- Do you see the price before you commit? Your account’s price on every item, and each order itemized: product, fees and shipping on their own lines, with the total shown before signature.
- Who on your team can do what? Separate roles for prescribing, ordering and paying, and, for a group, one view across locations.
- Can the record change after the fact? A signed prescription should be frozen as signed, and status, payment and shipment history should be append-only.
- Is office stock kept apart? Office-use supply should be its own purchase order to an outsourcing facility, never prescriptions written to fill a cabinet.
How TrueRoute answers those questions
TrueRoute is software: it does not dispense and does not practice medicine. Orders are filled by licensed pharmacies in our network, each holding its own state licensure. The prescriber writes and signs the prescription; TrueRoute checks the prescriber’s licence in the patient’s ship-to state as attested, refuses controlled substances, and says in words when a product cannot be sent for a patient, all before anything is charged. Prescribers are NPI-validated and clinic-attested. You see your account’s price on every item and each order’s itemized total before you commit. Billing has its own role that can pay without being able to prescribe. The signed prescription is frozen at signature, and orders, payments and configuration changes are kept as append-only records. Office-use purchasing is a separate purchase order, available once your account’s program is set up.
Security and compliance · How pricing works · The pharmacy network
