Research use only: difference between revisions
Diff·revision 3 → 4·11:10, 13 Aug 2024
Difference between revision 3 and revision 4 of Research use only. 11 lines changed; the page grew by 1,223 bytes.
| Revision 3 — 12:30, 6 Aug 2024 StubExpanderSven (talk) add the cross-link to the legal-status-by-jurisdiction list 1,656 bytes ±0 | Revision 4 — 11:10, 13 Aug 2024 GMP_Gita (talk) British spelling per PP:MOS 2,879 bytes +1,223 | ||
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| 7 | The label is a '''commercial and regulatory category, not an approval'''. Material carrying it has not been assessed by any medicines regulator, is not manufactured under the obligations that apply to medicines, and is '''not approved for human use''' in any major jurisdiction. Its identity, purity, sterility and [[Bacterial endotoxin test|endotoxin]] content are not assured by anybody outside the supply chain that produced it.{{r|gmp,usp1503}} | 7 | The label is a '''commercial and regulatory category, not an approval'''. Material carrying it has not been assessed by any medicines regulator, is not manufactured under the obligations that apply to medicines, and is '''not approved for human use''' in any major jurisdiction. Its identity, purity, sterility and [[Bacterial endotoxin test|endotoxin]] content are not assured by anybody outside the supply chain that produced it.{{r|gmp,usp1503}} |
| 8 | 8 | ||
| + | 9 | == What the category excludes == | |
| + | 10 | The obligations that attach to a medicine and do not attach to research-use-only material are extensive. The following are the ones that bear directly on what a purchaser can and cannot infer. | |
| + | 11 | ||
| + | 12 | * '''No marketing authorisation.''' No regulator has assessed the material for quality, safety or efficacy for any use. | |
| + | 13 | * '''No manufacturing authorisation.''' Production need not take place under [[Good manufacturing practice|good manufacturing practice]], and no inspectorate has visited the site.{{r|gmp}} | |
| + | 14 | * '''No pharmacopoeial compliance requirement.''' Compendial monographs and general chapters describe what a determination should look like; nothing requires unregulated material to meet them.{{r|usp1503}} | |
| + | 15 | * '''No sterility or endotoxin requirement.''' A lyophilised powder is not sterile unless it is stated to be, and an absence of statement is not a statement of absence. | |
| + | 16 | * '''No pharmacovigilance.''' There is no adverse-event reporting route, so no signal accumulates anywhere. | |
| + | 17 | * '''No labelling standard.''' Strength, fill convention and storage statements follow no prescribed form; see the discussion of nominal fill at [[Peptide content]]. | |
| + | 18 | ||
| 9 | == References == | 19 | == References == |
| 10 | {{reflist}} | 20 | {{reflist}} |
| ⋮ | ⋮ | ||
| 16 | [[Category:Drug regulation]] | 26 | [[Category:Drug regulation]] |
| 17 | [[Category:Legal status by jurisdiction]] | 27 | [[Category:Legal status by jurisdiction]] |
| + | 28 | [[Category:Importation and customs]] | |
| 18 | 29 |