IND (Investigational New Drug)
Definition
An FDA application that allows an experimental drug or peptide to be used in clinical trials on humans. Most research peptides have not filed an IND and therefore cannot legally be marketed for human use.
Related Terms in Regulatory
503A Pharmacy
A compounding pharmacy that prepares medications based on individual prescriptions. Subject to state board of pharmacy oversight.
503B Outsourcing Facility
A compounding facility registered with the FDA that can produce compounded medications in larger quantities without individual prescriptions, subject to FDA inspection.
Compounded Medication
A medication prepared by a licensed compounding pharmacy to meet an individual patient's specific needs. Subject to different regulations than manufactured drugs.
Research Use Only (RUO)
A regulatory designation indicating a product is intended solely for laboratory research and is not approved for human consumption or therapeutic use.
WADA (World Anti-Doping Agency)
The international organization responsible for promoting, coordinating, and monitoring anti-doping in sports. Many research peptides are on the WADA prohibited list.
FDA Category 2
Under FDA compounding rules, a substance placed on the Category 2 list is nominated for evaluation but has not yet been approved for use in compounding by 503A or 503B pharmacies. BPC-157 has been placed on this list.
FDA Category 1
Under FDA compounding rules, substances on the Category 1 list have been evaluated and approved as bulk drug substances eligible for compounding by 503A and 503B pharmacies.
Class II Recall
An FDA product recall classification indicating a situation where use of or exposure to the product may cause temporary or medically reversible adverse health consequences. All peptide-related FDA recalls to date have been Class II.