Research use only: difference between revisions
Diff·revision 6 → 7·18:59, 13 Sep 2024
Difference between revision 6 and revision 7 of Research use only. 2 lines changed; the page grew by 314 bytes.
| Revision 6 — 12:38, 3 Sep 2024 ImportRecordIna (talk) state that the position differs between jurisdictions and give two examples 2,879 bytes ±0 | Revision 7 — 18:59, 13 Sep 2024 CagriCass (talk) split the compounding position from the manufacturing position 3,193 bytes +314 | ||
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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 label does is locate material outside the medicines framework, and in doing so it locates the seller outside the obligations that framework imposes. That is the whole of its function, and understanding it is a precondition for reading anything else on this wiki about suppliers, certificates or testing. | |
| + | 10 | ||
| 9 | == What the category excludes == | 11 | == 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. | 12 | 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. |