Controlled Substances Schedule
Definition
The classification placing a substance under legal control according to accepted medical use and potential for abuse, with different lists in each country. Most research peptides sit outside these schedules entirely, which is a separate question from whether they are approved.
What this means for research sourcing
Regulatory status varies by jurisdiction and applies to research supply, not human use. Volta sells to researchers only.
Related Terms in Regulatory
GRAS
Generally Recognized As Safe, a United States designation for food substances supported by expert consensus or long use. It concerns use in food and carries no implication for any other context.
Research Use Only (RUO)
A label stating that material is supplied for laboratory work and not for human or veterinary use. It is a category of supply rather than a certification of quality: on its own it carries no requirement that the contents be sterile, pure or correctly identified, which is why the certificate matters separately.
FDA Approval
A finding by the US Food and Drug Administration that a drug's benefits outweigh its risks for a specific labelled use. Approval is always for named indications and never for a substance in general, so a molecule can be approved for one use and investigational for every other.
Indication
The condition and population a medicine is approved to be used in, as written in its labelling. It is the boundary that makes the difference between approved use and off-label use.
Investigational Drug
A substance under study that no regulator has approved for sale. In the United States it may be given to people only under an Investigational New Drug application. Most compounds supplied as research peptides are investigational or have never entered human study at all.
IND (Investigational New Drug)
The FDA application that allows an unapproved substance to be given to humans in a clinical trial. Most research peptides have no IND behind them, which is precisely why they cannot be marketed for human use.
Accelerated Approval
An FDA pathway permitting earlier approval for serious conditions with unmet need, based on a surrogate endpoint believed to predict clinical benefit. Confirmatory trials are still required and the agency can withdraw the approval if benefit is not confirmed.
Prescribing Information
The approved label for a medicine, carrying its indications, administration schedule, contraindications and warnings. It is the authoritative statement of what a drug is approved to do, and it is public.