The pharmacy
Prepared for one. Named on every label.
A US state-licensed 503A compounding pharmacy prepares and labels your prescription in your name, after your clinician decides, and ships it sealed and cold.
Prescription required. A licensed provider decides whether treatment is appropriate.
The route
From a decision to a preparation.
Nothing is prepared until a licensed clinician has decided it should be. Then one pharmacy makes one prescription, for one name.
- 01
Your clinician decides
A prescription exists only after a licensed clinician has reviewed you by video and decided that treatment is appropriate. Sometimes the answer is no, and then nothing is prepared.
- 02
The pharmacy receives it
Your name, your clinician, the compound, the strength, the directions. The pharmacy prepares exactly that, and nothing it was not asked for.
- 03
Prepared for you
Made to order for one patient, never from stock, and checked before it is released. The label is printed with your name on it.
- 04
Sealed, labelled, shipped cold
Into your container, into the Mitoss pouch with an ice pack, at 2–8 °C all the way. Your directions travel with it, and a check-in is already booked.
The label
What is on the label.
Every container leaves the pharmacy with the pharmacy’s name and licence, your name, your clinician’s, and exactly what was prepared. Nothing anonymous, nothing generic.
Sample layout. Exact label content follows state board requirements.
The rules
503A, plainly.
The part of US law that lets a pharmacy prepare a medication for one patient, and what it does and does not mean.
What 503A means
A pharmacy licensed by its state, preparing a medication for one named patient on a prescription from a licensed clinician. It answers to its state board of pharmacy and works to USP standards. Section 503A is the part of US federal law that allows it.
What it is not
Not an FDA-approved drug: the FDA does not review or approve compounded preparations. Not a manufacturer: nothing is made in bulk or kept on a shelf. No stock, no “one size”. Every preparation starts with a name.
Who checks
The state board of pharmacy licenses and inspects the pharmacy. Sterile and non-sterile preparation follow USP <797> and <795>. Testing records are available on request.
Specifics appear here once the pharmacy partner is confirmed.
Compounded medications are prepared by US state-licensed 503A pharmacies for individual patients on a prescription; they are not FDA-approved. Availability varies by state.
Cold chain
Cold, all the way.
Some preparations keep only while they stay cold. Yours leaves the pharmacy sealed, against an ice pack, inside the insulated Mitoss pouch, and travels at 2–8 °C to your door.
Insulated pouch and ice pack
Packed and sealed at the pharmacy, your container against an ice pack. The pouch is made to be kept, and it is yours.
2–8 °C in transit, tracked
Cold from the bench to your door. A tracking number the moment it ships; the delivery day before you confirm.
When it arrives
Into the fridge, check the seal, read the card. Your directions and a line back to your clinician are inside.
Room and product images are illustrations.
Our pharmacy partner
One pharmacy, named here.
Mitoss works with one US state-licensed 503A compounding pharmacy. It is named on every label, and it is named here.
[Pharmacy partner]
US state-licensed 503A (to confirm)
Name, state licence and inspection history appear here once counsel confirms them.
Questions
Asked often.
Anything about your own health is answered by a licensed clinician on a visit, not here.
Is a compounded medication FDA-approved?
No. The FDA approves drugs that manufacturers make for the general market. A compounded preparation is made by a state-licensed pharmacy for one patient on a prescription, and the FDA does not review or approve it. The pharmacy is licensed and inspected by its state board, and we say all of this everywhere, including on the label.
Who is the pharmacy?
A US state-licensed 503A compounding pharmacy. Its name, state and licence number are on every label, and they appear on this page once counsel confirms them.
Can I choose a different pharmacy?
Your prescription is yours. If you would rather have it filled elsewhere, ask your clinician at the visit and they will tell you how. The Mitoss kit and cold shipping come with our partner pharmacy.
How is it shipped and how long does it take?
Sealed, at 2–8 °C in the Mitoss pouch with an ice pack, and tracked to your door. Usually within days of your clinician’s decision; you see the date before you confirm.
What if something arrives damaged or warm?
Don’t use it. Message your clinician from your account, with a photo if you can, and it is replaced. Keep the package until you hear back.
Modern medicine, made personal.
Prescription required. A licensed provider decides whether treatment is appropriate.