The short version
Grade Bio makes material and the documents that prove what it is. A licensed practitioner writes a prescription for a named patient. The licensed pharmacy of record dispenses it.
Those are three separate roles held by three separate parties, and the separation is the model rather than a formality inside it. Grade Bio never holds the prescription, never dispenses, and never ships to a patient.
What Grade Bio does, and does not do
| Grade Bio does | Grade Bio does not |
|---|---|
| Manufacture and fill the material. | Dispense to a patient. |
| Test it against a published specification and release it against a signature. | Ship to a patient, at any address, for any reason. |
| Hold the lot genealogy, retained samples and the full document set. | Hold or receive a prescription. |
| Supply material against a valid prescription for an individually identified patient. | Supply on a standing order, a stock order or an anticipatory basis. |
| Verify that a requesting practitioner is who they say they are. | Verify that a practitioner is clinically correct. That is not verifiable and we do not pretend to it. |
| Answer questions about identity, methods, lots and documents. | Answer a question about a dose, a schedule, a route or a protocol. Not once, not informally. |
The route, end to end
The practitioner requests access
Identity, license and NPI are submitted on sheet G‑10, along with six attestations that are read and affirmed one at a time. Nothing is auto approved; a submission opens a pending record.
Six attestations
Typed signature
The account is verified by a person
The license is checked against the issuing state board and the NPI against the national registry. An NPI proves enumeration, not licensure, so both checks are run and neither substitutes for the other.
NPPES lookup
Reviewed by a person
The practitioner prescribes
For an individually identified patient, in the course of their own practice. Grade Bio has no part in this step and no view into it beyond the fact that it happened.
Named patient
Own practice
The pharmacy of record dispenses
The prescription is filled by the licensed pharmacy named on the account. The pharmacy is the dispensing party and the license on the label is theirs.
Their license
Their dispensing act
The documents follow the lot
Certificate, identity package and genealogy are available against the lot number to the account and to the dispensing pharmacy, for the full retention period.
Account and pharmacy
24 months
Compounding, in plain terms
A pharmacy compounding under section 503A prepares a preparation for an individually identified patient, against a prescription, in the quantity that prescription calls for. It is not registered with FDA as an outsourcing facility and it does not produce office stock.
This is the route the model on this sheet runs through, and it is why the prescription has to come first rather than follow an order.
An outsourcing facility registers with FDA under section 503B, may produce without a patient specific prescription, and is subject to current good manufacturing practice requirements and FDA inspection.
Grade Bio is not a registered outsourcing facility and does not describe itself as one. Nothing on this site should be read as a 503B claim.
Why two entries are held
Both sit in the group an FDA advisory committee discussed for the 503A bulk drug substances list in July 2026. A committee recommendation is advisory. For a substance to become eligible, a proposed rule and then a final rule would have to issue, and neither has.
So neither compound is compoundable today. Both are marked on revision on sheet G‑02, neither is available, and no date is stated or implied for either. If that changes, it changes as a numbered revision to the register with the authority cited, not as a quiet edit.
The two label classes
| Class | Printed on the vial and carton | Applies to |
|---|---|---|
| P | FOR PHYSICIAN USE ONLY Rx ONLY and the license number of the dispensing pharmacy of record. | Ten of the twelve entries. Requires a named licensed pharmacy partner, which is why the license line renders as a placeholder today. |
| M | No human use language of any kind appears on the label. | The two entries held on revision. Neither is available. |
Grade Bio is a brand of Mountain Brands LLC. Entity formation is pending and no registration has been filed. Correspondence to jv@gradebio.com or sw@gradebio.com.
Pre‑launch document Entity pending