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Regulatory status by jurisdiction (revision 1)

Old revision·09:30, 5 Nov 2024·PrimarySrcPatia

This is an old revision of this page, as it stood at 09:30, 5 Nov 2024, saved by PrimarySrcPatia with the summary start article on the regulatory position. It may differ substantially from the current revision, and any error it contains may since have been corrected.
Regulatory status by jurisdiction
Determined byRegulatory category, not chemical identity
CategoriesMedicine, research reagent, controlled substance, unregulated
ConsequenceThe same molecule differs in status between countries
Topic infobox · conventions

Regulatory status by jurisdiction describes how the legal treatment of a substance differs between countries. Status follows from the regulatory category a substance occupies in a given jurisdiction, and the same molecule may be a licensed medicine in one, an unapproved investigational compound in another, and a research reagent in a third.[1]

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.[2]

References

  1. ^ World Customs Organization, International Convention on the Simplification and Harmonization of Customs Procedures (revised Kyoto Convention).
  2. ^ United States Food and Drug Administration, Regulatory Procedures Manual, chapter 9 (coverage of personal importations).