Regulatory status by jurisdiction: difference between revisions
Diff·revision 14 → 15·08:42, 17 Jun 2025
Difference between revision 14 and revision 15 of Regulatory status by jurisdiction. 6 lines changed; the page grew by 568 bytes.
| Revision 14 — 11:44, 23 May 2025 StubSorterBot (talk) bot: update parent category chain 3,662 bytes ±0 | Revision 15 — 08:42, 17 Jun 2025 FiveOhThreeB (talk) ce 4,230 bytes +568 | ||
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| 34 | Sub-national variation exists in federal systems, particularly for compounding and dispensing, which is why [[503A compounding pharmacy|compounding]] rules cannot be summarised at national level alone.{{r|ich_q7}} | 34 | Sub-national variation exists in federal systems, particularly for compounding and dispensing, which is why [[503A compounding pharmacy|compounding]] rules cannot be summarised at national level alone.{{r|ich_q7}} |
| 35 | 35 | ||
| + | 36 | == What this means practically == | |
| + | 37 | A statement that a substance is "legal" is incomplete without a jurisdiction, a category and a purpose. The same three questions apply to any claim encountered in supplier material.{{r|reports}} | |
| + | 38 | ||
| + | 39 | Border treatment follows from status but is not identical to it, since enforcement discretion and declaration also operate. See [[Customs seizure]] and [[Personal importation policy]].{{r|fda_pip}} | |
| + | 40 | ||
| 36 | == References == | 41 | == References == |
| 37 | {{reflist}} | 42 | {{reflist}} |
| ⋮ | ⋮ | ||
| 40 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 45 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 41 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 46 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 47 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | |
| 42 | 48 | ||
| 43 | == See also == | 49 | == See also == |