What the status categories mean
Approved means a regulator has reviewed a clinical dossier and authorised the product for a specific indication. That authorisation is indication-specific: a drug approved for one use has not been shown to work for another and is not approved for it.
Prescription-only means lawful supply requires a prescription. Research-only means the substance is not authorised as a medicine and is supplied for laboratory use. Unregulated means no specific framework applies, which is not the same as permitted and usually means the question has not been settled rather than settled favourably.
- •Approved: authorised for a named indication after regulatory review
- •Prescription only: lawful supply requires a prescription
- •Research only: not authorised as a medicine, supplied for laboratory use
- •Unregulated: no specific framework, which is not the same as permitted
- •Warning issued: the regulator has published a concern about the substance or its suppliers
- •Banned: prohibited in a defined context, often sport rather than commerce
Why status differs between countries
Each jurisdiction reviews independently, on its own timetable, against its own standards and on whatever dossier a sponsor chose to file there. A compound approved in one country may simply never have been submitted in another.
Scheduling frameworks differ too. Australia's poisons standard captures substances that the United States handles through the food and drug framework, so the same compound can be prescription-only in one and research-only in the other without any disagreement about its properties.
Compounding and enforcement
A separate and frequently confused question is compounded preparation. A compounded version of an approved drug is not the approved product, and regulators have taken enforcement action over compounded semaglutide and tirzepatide specifically.
Enforcement is also where the practical status of research-only compounds is set. The published warning letters record which claims and which marketing practices have drawn action, which is more informative about the boundary than the formal category alone.
Sport, which is a separate regime entirely
The World Anti-Doping Agency prohibited list operates independently of medicines regulation. A substance can be an approved medicine and still be prohibited in competition, and many peptides are covered by the list's catch-all clauses for substances with no current regulatory approval.
A compound's status under medicines law says nothing about its status in sport, and the reverse is equally true.
How the regulatory summary is compiled
Public regulatory records per compound and jurisdiction, categorised into a small set of statuses with the responsible agency named.
- Identify the responsible agency. FDA in the United States, Health Canada, MHRA in the United Kingdom, EMA and member states in the European Union, TGA in Australia.
- Determine the authorisation status. Whether the compound is approved, and for what indication. Approval is indication-specific and the indication is recorded with it.
- Note enforcement and advisories. Warning letters, import alerts and safety advisories, which describe the practical position more precisely than the formal category does.
- Categorise and date. Into the status set, with the agency named and the entry dated, since regulatory positions move.
What this method cannot tell you
- •Regulatory status changes and this is a summary, not a legal record. Verify against the primary source before relying on it.
- •Approval is indication-specific. Approved status for one use says nothing about another.
- •European Union status varies by member state where a compound is not centrally authorised.
- •It does not cover import, personal possession or sport, each of which is a separate regime.
Where the numbers come from
Peptide regulatory status: frequently asked questions
That the substance is supplied for laboratory research and is not authorised as a medicine. It is a statement about the product's qualification, not a general permission.
The specific restrictions that follow depend on the jurisdiction.
Because each regulator reviews independently, on its own timetable and on whatever dossier a sponsor filed with it.
A compound may simply never have been submitted in a given jurisdiction, which produces an absence of approval rather than a rejection.
That no specific framework applies to the substance. It is not the same as permitted, and it usually means the question has not been addressed rather than resolved favourably.
Its status varies. It is not approved as a medicine in any major jurisdiction, and the specific position ranges from research-only to prescription-only depending on the country.
The FDA has issued warning letters to companies marketing it, which describes the practical boundary more precisely than the formal category.
Sources: FDA warning letters database
Approved means a regulator authorised the product for an indication. Prescription only describes how it may be supplied.
Most approved peptide medicines are also prescription only, but the two describe different things.
No. A compounded preparation is made by a pharmacy and has not been through the approval process for that product.
Regulators have taken specific enforcement action over compounded semaglutide and tirzepatide.
That a regulator has notified a company of a violation it has identified. It is directed at that company's conduct rather than at the substance in general.
The published letters are informative about where the boundary sits in practice.
Sources: FDA warning letters database
Many are. The World Anti-Doping Agency prohibited list operates independently of medicines regulation and includes catch-all clauses covering substances with no current regulatory approval.
A compound can be an approved medicine and still be prohibited in competition.
Centralised EMA authorisation applies across the Union. Nationally authorised products apply only where they were authorised.
For compounds without central authorisation, status varies by member state.
Usually about unapproved products marketed with medical claims, or about products found to contain something other than what they claim.
Import rules are separate from supply rules and vary by jurisdiction. Some allow research imports with documentation; some do not.
This summary covers regulatory status, not import law.
It means safety and efficacy have not been established through the approval process. That is an absence of evidence rather than evidence of harm.
The two are different conclusions and only one of them is supported by the status.
Entries are dated and reviewed periodically. Regulatory status changes, so verify against the primary source before relying on it.
A prescription-only medicine under the Australian poisons standard. Supply requires a prescription from an authorised prescriber.
Scheduling under the poisons standard is separate from approval for therapeutic use, and a substance can be scheduled without being approved.
No. It is a summary of published regulatory positions for reference. Legal questions about a specific situation need a qualified professional.
Because no one has sought approval and no regulator has addressed them specifically. Most research peptides fall into this category.
An absence of status is an absence of review, not a clearance.
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