Footnote in FTC order address compounded medications used in racehorses-has to be compliant with Animal Medicinal Drug Use Clarification Act (AMDUCA) and the FDA Guidance for Industry (GFI) #256

Anti-Doping and Medication Control (ADMC) Program became effective March 27, 2023.

https://www.federalregister.gov/documents/2023/01/26/2023-00957/hisa-anti-doping-and-medication-control-rule

8 Proposed Rule 4111 (“S0 Non-approved Substances”) states: “Any pharmacological substance that (i) is not addressed by Rules 4112 through 4117 [other categories of banned substances], (ii) has no current approval by any governmental regulatory health authority for veterinary or human use, and (iii) is not universally recognized by veterinary regulatory authorities as a valid veterinary use, is prohibited at all times. For the avoidance of doubt, compounded products compliant with the Animal Medicinal Drug Use Clarification Act (AMDUCA) and the FDA Guidance for Industry (GFI) #256 (also known as Compounding Animal Drugs from Bulk Drug Substances) are not prohibited under this section S0.” Notice, 88 Fed. Reg. at 5122