BPC-157 is not FDA approved for human use and is classified as an unapproved drug.[1][4] It cannot be legally prescribed or sold over the counter because it is not recognized as a dietary supplement.[1][4] The FDA placed it in Category 2 due to potential safety risks and limited safety data.[1][7] It does not qualify for exemptions such as expanded access or right to trial.[1] Nevertheless, it has gained popularity for its reported effects, such as accelerated healing of wounds, muscles, tendons, and nerves, according to animal studies.[2][3] It has anti-inflammatory properties and can help with digestive disorders, such as healing ulcers.[2][3] Large-scale controlled clinical trials in humans are lacking, preventing confirmation of safety and efficacy.[2][3][4] It is banned on the WADA list and the DoD list of banned ingredients in supplements.[4]