Position summary
Element MD sells reagent-grade research peptides in the United States under the research-use-only (RUO) framework. We do not sell drugs, supplements, cosmetics, or food. The chemistry on our shelves is intended for in-vitro and pre-clinical work by qualified patients & providers — nothing else. This page describes the laws that make that distinction real and how we keep our operations inside it.
Three things that follow from that posture, written here so they don't have to be hunted for:
— We will not
Make any claim that any compound here is safe or effective for human use; recommend a dose for a person; reference a "patient" anywhere in our copy.
— We will
Verify every patient account; ship only to U.S. addresses we can match to an institution, sole proprietorship, or accepted-use research declaration; refuse orders we can't.
— We commit to
Posting changes to this stance within 5 business days of a final agency action, and notifying any account that has ordered a re-classified compound in the last 12 months.
What you are buying
Every vial we ship is an active pharmaceutical ingredient (API) manufactured at a cGMP-audited synthesis facility, repackaged at our analytical lab in Phoenix, and tested by an ISO/IEC 17025-accredited contract lab on every batch.
That is not equivalent to a finished drug product, and the difference is doing real legal work:
- A finished drug product is approved (or denied) by the FDA for a specific indication, dose, and route of administration in a specific population. It carries a label written by the agency.
- An API for research use is a chemical reagent. It has a Certificate of Analysis describing identity, purity, and impurity profile — not a drug label. It is intended to be consumed inside a research workflow.
You can verify the cGMP origin and the COA for any vial we sell on the batch lookup page. Authenticity protocols and tamper checks are documented at Anti-counterfeit & authenticity.
FDA framework
The FDA does not have a single, standalone "research peptide" rule. The framework is built from several places in the Federal Food, Drug, and Cosmetic Act and FDA guidance — we sit inside the seams. The relevant pieces:
What about semaglutide and tirzepatide specifically?
Both compounds are approved as finished drug products under brand names — Ozempic, Wegovy, Mounjaro, Zepbound. Their approved use is for adults with specific indications, dispensed by pharmacies under prescription. Our identical-molecule API is not those drugs. It is research material that happens to contain the same compound, in a different dosage form, under a different label, sold to a different customer, for a different purpose. We are explicit about that boundary and we do not ride the brand.
If a patient is studying these molecules — receptor binding kinetics, formulation stability, comparative pharmacology in a pre-clinical model — they have a legitimate need for high-purity API. That is who we sell to.
State overlay
State law adds a second layer on top of the federal framework. Three categories of state action have actually moved supply in the past 18 months:
- Pharmacy-board declarations. A handful of states have asked their boards of pharmacy to take a position on whether non-pharmacist-compounded peptides may be sold within their borders. These positions vary and they evolve.
- Wholesaler / distributor licensing. Some states require an out-of-state seller of "drug-like" materials to register as a wholesaler regardless of how the product is labeled. We hold the relevant licenses; the list is on Lab accreditations.
- Consumer-protection enforcement. A state attorney general can argue that marketing a research material with intent to be used as a drug is an unfair or deceptive practice. We treat this as the operating constraint that shapes our copy.
The current state-level shipping restrictions, including any restrictions added since the last review of this document, are listed on State restrictions & shipping compliance. That page is the source of truth for "can you ship to me" questions; this document explains the framework behind it.
Scheduling & controls
None of the peptides we sell are controlled substances under the U.S. Controlled Substances Act. They are not scheduled, and we do not require DEA registration to receive them.
Two adjacent points:
- Anti-doping. Many of the molecules on our shelves are listed on the WADA Prohibited List for athletic competition. Selling research material to a non-athlete patient is fully lawful; using it in competitive sport is, separately, against WADA rules. We do not advertise to athletes and do not coach around testing.
- State scheduling drift. A state can schedule a compound that is not federally scheduled. We monitor for this. None of our current compounds are state-scheduled in any jurisdiction we ship to as of the effective date of this document.
Customs & export
We synthesize and finish all product domestically. We do not currently ship outside the United States. The reasons are practical, not legal: international shipping of API into a customer-research context introduces customs documentation we are not able to support at the standard a patient should expect.
If you are an institutional patient outside the U.S. who needs API for an in-licensed program, contact institutional@elementmd.com and we will route through our distributor network.
Labeling regime
Identity
INN or sequence designator. No brand-name reference.
Quantity
Mg per vial, ±2% spec.
Lot & date
Lot number, fill date, retest date. Tied to the COA.
Use statement
"Telehealth · Prescription required. Not for human or veterinary use." On every vial, every time.
What we will not put on a label: dose-per-injection figures, administration route, indication, brand-style imagery, marketing claims of any kind. The dosing calculator exists to support pre-clinical method development by qualified patients & providers; it is not a label component.
How we talk about products
The single most enforceable line in this entire framework is the line between describing a research material and marketing a drug. Internal copy review covers:
When the rules change
Regulation moves. Our commitment is operational, not aspirational:
- Within 5 business days of a final agency or court action that changes the legal status of any compound on our shelves: a notice on the affected product page, a banner on the storefront, and a regulatory update on this page.
- Within 30 days: a personal email to every account that has purchased the affected compound in the previous 12 months, with the change summarized and our recommended action (continue, pause, return for credit).
- Within the next quarterly review: a counsel-signed update to this document with the new state of the framework.
Past regulatory updates are available in the site index. Subscribe to the regulatory feed via your account to receive these notices automatically.
Contacts
Compliance & counsel: compliance@elementmd.com · 1-800-ELEMENT MD-LAB ext. 4
Adverse-event reports: Adverse Event Reporting →
State / institutional inquiries: institutional@elementmd.com
FDA correspondence of record: Element MD, Inc., 1212 N 24th Pl, Phoenix, AZ 85008, USA. Attn: Regulatory Affairs.
This statement is not legal advice. It describes our position as it stands on the effective date above. Patients operating in regulated institutions should consult their own counsel and IRB. If our position changes, that will be reflected here, on this URL, with a new effective date — not in a press release that disappears.