Regulatory status
Read FDA's 503A bulk-substance categories, the withdrawn-nomination table and the July 2026 advisory meeting without turning a status label into an approval or a safety verdict.
7 min read · Research guide
Regulatory status
Verify approval status from FDA databases instead of a seller's wording, and record why a molecule name, registration or NDC number is not proof that a specific product is approved.
7 min read · Research guide
Regulatory status
See how FDA's 2026 warning letters weighed website claims, dosing tools and accessory products against "Research Use Only" labels, and what that means for supplier due diligence.
7 min read · Research guide
Regulatory status
Understand the S0 non-approved substances class, USADA's statements on BPC-157 and the 2027 change that names peptides generally, before relying on a seller's "not prohibited" claim.
6 min read · Research guide
Regulatory status
A sourced explanation of how FDA distinguishes approved GLP-1 products from compounded, salt-form and research-labeled versions, including the adverse-event figures FDA publishes.
7 min read · Research guide
Regulatory status
What CGMP and ICH Q7 require of a manufacturer, what records GMP implies, and why "research grade" carries no defined standard, with a comparison table and questions to ask about any GMP claim.
7 min read · Research guide
Regulatory status
The stages of FDA import review from entry to release or refusal, what a Notice of FDA Action means at each stage, the records FDA may request, response windows, and how to search refusal data.
8 min read · Research guide
Regulatory status
How the Human Medicines Regulations 2012 define a medicinal product, how MHRA decides borderline cases from presentation and function, what import licences cover, and what a UK lab should document when buying from EU or US suppliers.
8 min read · Research guide
Regulatory status
How Directive 2001/83/EC defines a medicinal product, what its research exclusion covers, how presentation and function decide status, and what an EU lab buyer should document about a supplier's research-only claims.
8 min read · Research guide
Regulatory status
What Omni Peptides, Evolve Peptides and Peptides EU ask a buyer to agree to at checkout: research-use wording, minimum age, liability caps, indemnity, governing law and dispute venue, compared clause by clause from their terms pages.
8 min read · Research guide
Regulatory status
What CBP and the White House actually changed: the dates of the de minimis suspension and its statutory repeal, formal versus informal entry, the new postal informal entry process, who pays under DAP and DDP, and the paperwork and budget lines a lab should expect.
10 min read · Research guide
Regulatory status
What US GLP rules and the OECD GLP principles require for a test article's identity, strength, purity, composition, stability and reserve samples, where a typical research-use certificate falls short, and a checklist of documents to obtain or generate.
9 min read · Research guide
Regulatory status
Plain definitions of the regulatory labels and acronyms that appear on peptide listings and in FDA warning letters, each tied to its legal source, with what the label does not mean.
9 min read · Research guide
Regulatory status
What Health Canada published about unauthorized peptide products between 2025 and 2026, how the Food and Drugs Act defines a drug, how CBSA detains and refers health products at the border, and what a Canadian laboratory should keep on file.
9 min read · Research guide
Regulatory status
Why a US customs broker asks for a TSCA positive or negative certification on a chemical import, what each statement says, how TSCA excludes FD&C Act drugs, and what the research and development exemption in 40 CFR 720.36 requires.
8 min read · Research guide