Regulatory status by jurisdiction: difference between revisions
Diff·revision 1 → 2·21:29, 8 Nov 2024
Difference between revision 1 and revision 2 of Regulatory status by jurisdiction. 12 lines changed; the page grew by 824 bytes.
| Revision 1 — 09:30, 5 Nov 2024 PrimarySrcPatia (talk) start article on the regulatory position 1,315 bytes +1,315 | Revision 2 — 21:29, 8 Nov 2024 StateBoardStace (talk) add the note that a certificate of analysis has no regulatory standing 2,139 bytes +824 | ||
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| 10 | Category is not a property of the chemistry. It follows from whether a marketing authorisation exists, what the substance is presented for, and whether it appears on any scheduling list.{{r|fda_pip}} | 10 | Category is not a property of the chemistry. It follows from whether a marketing authorisation exists, what the substance is presented for, and whether it appears on any scheduling list.{{r|fda_pip}} |
| 11 | 11 | ||
| + | 12 | == The categories == | |
| + | 13 | | Category | Typical consequence | | |
| + | 14 | |---|---| | |
| + | 15 | | Authorised medicine | Prescription and distribution rules apply | | |
| + | 16 | | Unapproved investigational compound | Not lawfully supplied as a medicine | | |
| + | 17 | | Research reagent | Supplied for laboratory use; not for administration | | |
| + | 18 | | Controlled substance | Scheduling rules; possession may be an offence | | |
| + | 19 | | Unregulated | Ordinary commercial law only | | |
| + | 20 | ||
| + | 21 | Most peptides discussed on this wiki sit in the second or third category in most jurisdictions. The [[Research use only]] designation is a statement of the third and is a presentation as much as a status: the same material presented as a medicine is a medicine.{{r|usp1503}} | |
| + | 22 | ||
| 12 | == References == | 23 | == References == |
| 13 | {{reflist}} | 24 | {{reflist}} |
| 14 | <ref name="wco">World Customs Organization, ''International Convention on the Simplification and Harmonization of Customs Procedures'' (revised Kyoto Convention).</ref> | 25 | <ref name="wco">World Customs Organization, ''International Convention on the Simplification and Harmonization of Customs Procedures'' (revised Kyoto Convention).</ref> |
| 15 | <ref name="fda_pip">United States Food and Drug Administration, ''Regulatory Procedures Manual'', chapter 9 (coverage of personal importations).</ref> | 26 | <ref name="fda_pip">United States Food and Drug Administration, ''Regulatory Procedures Manual'', chapter 9 (coverage of personal importations).</ref> |
| + | 27 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 16 | 28 | ||
| 17 | {{DEFAULTSORT:Regulatory status by jurisdiction}} | 29 | {{DEFAULTSORT:Regulatory status by jurisdiction}} |