#regulation
11 pieces tagged regulation.
- Where the line isWhat FDA reads on a website before it calls a research product a drugThe 'research use only' label is not what FDA reads. Its 2024 to 2026 warning letters spell out what is: claims, calculators, diluents sold alongside vials, and customer reviews. Here is the rule and the letters in their own words.
- Where the line isWhere research peptides sit on the WADA Prohibited ListFDA status and WADA status are different questions with different answers. Where BPC-157, TB-500, the GHRPs, the GHRH analogues, ipamorelin and Melanotan II sit on the 2026 Prohibited List, and what strict liability means.
- Where the line isRetatrutide is investigational: what that status meansRetatrutide (LY3437943) is Eli Lilly's single-peptide agonist of the GIP, GLP-1 and glucagon receptors, with no FDA-approved product as of September 2026. What 'investigational' means, and why a research vial is not the trial drug.
- Reading the paperworkA peptide paperwork glossaryThirty-six entries for the terms that appear on peptide certificates, labels and regulatory pages, each defined in one to three sentences from a primary source and linked to the piece that explains it.
- Sourcing and provenanceImport Alert 66-41: why overseas peptide orders get detainedWhat an FDA import alert is, what 'detention without physical examination' means, what Import Alert 66-41 actually covers, what the notices say, and the 5,000-shipment Cincinnati case, from FDA's and CBP's own records.
- Where the line isWhat ended for compounded semaglutide and tirzepatide, and whenCompounded tirzepatide and semaglutide were allowed only while the approved products were in shortage. The shortages and grace periods ended in 2024 and 2025. What is still open, and why a research vial is no substitute.
- Where the line isCategory 1, Category 2 and the 503A bulks list in 2026Twelve peptides left FDA's Category 2 in April, GHK-Cu went back into Category 1 in May, and an advisory committee voted in July. None of it put a peptide on the 503A bulks list. A dated tracker.
- Where the line isBPC-157 in 2026: not banned, not approved, not compoundableThree separate questions get asked as one. BPC-157 is not a controlled substance, is not an FDA-approved drug, and has no lawful 503A compounding pathway. What the molecule is and where each answer comes from, dated.
- Where the line isAre peptides steroids? The chemistry and the law behind the questionNo. A peptide is a chain of amino acids joined by amide bonds; a steroid is a lipid built on a four-ring carbon skeleton. Why the two are made, regulated and listed differently, with a comparison table.
- Where the line isAre peptides legal in the United States? A dated answer"Legal" hides seven different questions: controlled-substance status, who the law regulates, sale as research material, approval, compounding, import and sport. Each has a different answer and a different regulator. Here they are, dated.
- Where the line isCompounding pharmacy, outsourcing facility or research supplierA 503A pharmacy, a 503B outsourcing facility and a research supplier operate under three different sets of rules. What each one is, why a pharmacy cannot compound BPC-157 today, and why a research vial has no place in the other two chains.
Nothing here is medical advice. Everything on this site is supplied for laboratory research use only.