Regulatory Framework
Our Regulatory Framework
From a 100% women-owned company, compliance in the research materials space is not a checkbox — it is the operational foundation of every lot we release. Here is a precise account of what we do and why it matters.
The RUO Framework
Research Use Only (RUO) is an FDA-recognized classification established under 21 CFR Part 801 and clarified in FDA guidance for laboratory reagents. It permits the manufacture and sale of chemical and biological materials for in vitro and preclinical research without the full pre-market approval required of drugs or diagnostics — provided materials are correctly labeled and sold only to qualified research buyers.
We apply this framework without exception. Product labels, invoices, packing slips, and every page of this site carry explicit RUO language. We require verified age confirmation (21+) and a signed research-use acknowledgment at account creation and at every checkout. Buyer screening records are maintained and available for regulatory audit.
What RUO does not mean
RUO is not a loophole. It does not exempt materials from quality standards — it describes the intended use context. Misrepresenting the end use of RUO materials is a federal offense. Our buyer agreements make this explicit, and we cooperate fully with any regulatory inquiry.
Our Testing and COA Process
Every lot received from our manufacturing partners undergoes independent third-party testing before it is offered for sale. We do not test in-house — in-house testing creates a conflict of interest that undermines the integrity of the result. Our testing partners are ISO 17025-accredited analytical laboratories with no commercial relationship to our suppliers.
Lot-Matching at Shipment
Every order ships from the active lot associated with that product at the time of fulfillment. The lot number appears on the package label, the packing slip, and the physical COA insert in every shipment. The same lot number can be verified independently via our public Batch Lookup tool — no account required.
Research reproducibility depends on knowing precisely which compound — from which batch — was used in a given experiment. Lot-matched documentation is not a premium offering. It is the minimum we consider acceptable.
CAS Number and SDS Policy
Every shipment from AGERE includes two additional documents beyond the COA:
CAS Registry Number
The Chemical Abstracts Service registry number uniquely identifies the compound. We include it on the label and on a separate card in every package. Researchers can cross-reference the CAS number against the NIST Chemistry WebBook, PubChem, or their institution's chemical inventory system to confirm compound identity independently of our documentation.
Abbreviated Safety Data Sheet (SDS)
We include a printed abbreviated SDS with every shipment covering the compound's physical properties, handling precautions, storage requirements, and disposal guidance per OSHA Hazard Communication Standard (29 CFR 1910.1200). A full SDS is available for download in your account for each purchased compound.
Compliance Inquiries
We are transparent about our processes and welcome questions from researchers, institutions, and regulators. Write to us at compliance@agerepeps.com — we will give you a direct, substantive answer.
