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Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans. The agency has classified the product as 503A, a vague category for non-mass-produced compounded products

New York, Raven Press, p 427

[DOI] [PMC free article] [PubMed] [Google Scholar] 103.Lscher C, Malenka RC

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Stringent regulations pertaining to production and approvals 3.4

Mol Neurobiol 61:42404258