The compounded drug complies with all other Section 503A requirements
According to these criteria, the following data were excluded: within the SMA voxel, GABA in 1 healthy and 1 OCD subjects, and Gln in 2 participants with OCD, within the OCC voxel, 2 Glu and Gln in 2 healthy subjects, and 1 GABA in a healthy subject, and 3 GABA in patients
With our whey products, the biologically active components have been evaluated by an independent lab that performs SDS PAGE Gel Method testing
FDA routinely conducts similar, web-based inspections, which are well suited to reveal a products intended use often the determining factor in whether a product is a drug. See 21 CFR 201.128 (intended use can be derived from a broad array of objective factors, including labeling claims, advertising matter, or oral or written statements.) See also 21 USC 321(g) (defining drug based on, inter alia, its intended use)