Therapeutic Use Exemptions: Educational Overview

Why it comes up with peptides

Some approved peptide medicines are on the List. WADA notes, for instance, that insulin for diabetes is one of the common medications on it. [1] The List also covers many growth-hormone-related peptides; see Sports Anti-Doping Rules for Peptides. Approved medicines are the normal subject of TUEs. Experimental compounds are a different matter, as below.

Who grants a TUE

Athletes do not apply to WADA. [1] National-level athletes apply to their National Anti-Doping Organization, and international-level athletes to their International Federation. [1] Each ADO defines what national-level and international-level mean, so athletes should check. A TUE can be submitted to one ADO only. In the United States, USADA notes that not all International Federations recognize a TUE decision issued by USADA. [2]

The four criteria (WADA)

WADA says four criteria must be met: [1]

1. The substance or method is needed to treat a diagnosed medical condition supported by relevant clinical evidence.
2. Its therapeutic use will not, on the balance of probabilities, produce extra performance enhancement beyond a return to normal health.
3. It is an indicated treatment for the condition, with no reasonable permitted therapeutic alternative.
4. The need is not a consequence, wholly or in part, of earlier use without a TUE of a substance that was prohibited at the time.

Process and timing

• The physician is responsible for completing the TUE form and providing the supporting information. [1]
• ADOs must decide within 21 days of receiving a complete application. [1]
• For a substance prohibited in-competition only, WADA advises applying at least 30 days before competition. [1]
• USADA says TUEs are not guaranteed to be approved regardless of the reason or condition. [2]

Retroactive TUEs

A retroactive TUE is applied for after use. WADA lists conditions such as the athlete needing emergency or urgent treatment of a medical condition. [1] Meeting a condition does not mean a TUE will be granted. [1] Because the circumstances matter, athletes with questions should contact their ADO directly.

Experimental peptides and TUEs

A TUE depends on a diagnosed condition, clinical evidence and the absence of a permitted alternative. USADA says it is unlikely that a TUE for BPC-157 would be approved because there are permitted alternatives, though USADA considers each case individually. [3] USADA also states there are no human clinical trials establishing BPC-157's efficacy for any diagnosis or treatment, and it has not been approved by FDA or any other health authority. [3] For other experimental peptides, Proper evidence not found: I did not locate TUE statements on them.

Related guides

• Sports Anti-Doping Rules for Peptides
• Approved, Investigational and Unapproved Peptides
• Prescription Requirements for Peptide Medicines