Research Use Policy.

What these materials are for, who may buy them, and how they must be handled.

FDA

Why this says “Not FDA Approved”

Every compound sold by Codex Research is an unapproved new drug under United States law. That is not marketing language or a disclaimer we invented — it is a legal status defined by the Federal Food, Drug, and Cosmetic Act, and it is the reason these materials may never be administered to a human or an animal. The passages below are quoted directly from the U.S. Food and Drug Administration and the Code of Federal Regulations, with links to the original sources so you can read them in full.

“Unapproved prescription drugs pose significant risks to patients because they have not been reviewed by FDA for safety, effectiveness or quality.”

U.S. Food & Drug Administration — Unapproved Drugs

“Without FDA review, there is no way to know if these drugs are safe and effective for their intended use, whether they are manufactured in a way that ensures consistent drug quality or whether their label is complete and accurate.”

U.S. Food & Drug Administration — Unapproved Drugs

“CAUTION: Contains a new drug for investigational use only in laboratory research animals, or for tests in vitro. Not for use in humans.”

The label statement required by 21 CFR § 312.160 — Drugs for investigational use in laboratory research animals or in vitro tests

What that means for every order placed here

  • These materials are supplied strictly as laboratory reference compounds for in vitro work and for use in laboratory research animals under an appropriate institutional protocol.
  • They are not drugs, dietary supplements, cosmetics, food, or medical devices, and they are not intended to diagnose, treat, cure, or prevent anything in any species.
  • No compound listed on this site has been reviewed by FDA for safety, effectiveness, or quality, and none is approved for human or veterinary administration in the United States.
  • Codex Research publishes no dosing schedules, no administration routes, no reconstitution-for-injection guidance, and no human outcome claims, and our staff will not supply them on request.
  • Purchasing requires that you are a qualified researcher, laboratory, or institution and that you accept full responsibility for lawful handling, containment, and disposal in your jurisdiction.

“Research use only” is a standard, not a loophole

FDA has been explicit that a research-use label does not change a product’s legal status when the seller’s own words show the product is meant for people. Under section 201(g)(1) of the Act, whether something is a “drug” turns on its intended use — and intended use is established by how it is described, marketed, and sold. In enforcement actions against peptide sellers, FDA has found that despite research-use and not-for-human-consumption statements, the evidence on a company’s own website established that its products were intended as drugs for human use, making them unapproved new drugs under section 505(a).

We treat that as a hard operating rule rather than a risk to be managed. Our catalog describes mechanism and research context only; we do not publish therapeutic claims, weight or body-composition outcomes, before-and-after imagery, testimonials, protocol advice, or any content that implies personal use. If a customer asks us for that information, the answer is no. It is the reason our pages read like a reagent catalog instead of a pharmacy, and it is the standard we hold our suppliers and our staff to.

Primary sources

Codex Research is not affiliated with, endorsed by, or acting on behalf of the U.S. Food and Drug Administration. Quotations above are reproduced from public U.S. government sources for reference. Nothing on this page is legal or medical advice.

01

Scope

This policy applies to every product listed on codexresearch.shop and to every order placed through it. It sits alongside our Terms and Conditions, and by placing an order you accept both. Where the two documents overlap, the stricter reading applies.

02

Research Use Only

All materials sold by Codex Research are supplied strictly for in-vitro laboratory research and development. They are not for human or veterinary consumption. They are not drugs, foods, dietary supplements, cosmetics or medical devices, and they are not intended for medical, diagnostic, therapeutic or clinical use of any kind. Nothing we publish is intended to diagnose, treat, cure or prevent any disease or condition, and no statement on this site has been evaluated by the U.S. Food and Drug Administration.

03

Who May Purchase

You must be 21 years of age or older to browse or buy from this site. By ordering you affirm that you are a qualified researcher, or are purchasing on behalf of a research institution, laboratory or comparable organisation, and that the materials will be handled only by people competent to do so. We may ask for proof of age or of institutional affiliation before releasing an order, and we may decline any order at our discretion.

04

Handling, Storage and Disposal

You are responsible for handling every product in line with standard laboratory safety practice: appropriate personal protective equipment, a controlled work area, correct cold storage, and containment of any reconstituted material. Lyophilised material should be stored as stated on the product page and on the vial. Unused material, containers and sharps must be disposed of in accordance with the rules that apply in your state and locality. Codex Research accepts no liability for injury, loss or damage arising from handling that departs from these practices.

05

No Dosing, Protocol or Medical Guidance

We do not publish dosing information, administration routes, cycles or research protocols, and our team cannot supply them on request. Any such information you encounter elsewhere — on forums, social media or third-party sites — is not endorsed by us, is not part of what we sell, and should not be treated as guidance from Codex Research. If you have a question about your health, speak to a licensed clinician.

06

Certificates of Analysis

Every batch is tested by an independent third-party laboratory and the certificate is published against the batch. A certificate of analysis reports what the laboratory measured on the sample it received — identity, purity by HPLC and the other assays listed on the certificate. It is a statement of analytical result and nothing more. It is not a safety assessment, not a clearance for any use in humans or animals, and not a claim of biological effect.

07

Regulatory Status and Your Jurisdiction

Our products are research chemicals and are not approved by the FDA for any use. Rules on the possession, purchase and use of research materials vary by state and locality, and they change. You are responsible for satisfying yourself that your purchase and your intended research use are lawful where you are before you order.

08

Resale, Export and Redistribution

We ship within the United States only and do not export. You may not re-ship, export or otherwise send our products abroad, sell them on for human or veterinary use, repackage or relabel them for consumer sale, or represent them as anything other than research materials. Orders placed through freight forwarders will be cancelled.

09

Enforcement

We may refuse, cancel or refund any order, and close any account, where we reasonably believe this policy is being breached — including where an order appears to be intended for human use, where a customer asks for dosing or administration guidance, or where the buyer will not confirm their research purpose. Where the law requires it, we will cooperate with the appropriate authorities.

10

Questions

If anything in this policy is unclear, email info@codexresearch.shop before you order and we will answer. We answer enquiries Monday through Friday and aim to respond within one business day.