Section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act deems a drug misbranded unless its labeling bears adequate directions for use, which 21 CFR 201.5 defines as directions under which a layman can use the drug safely and for the purposes for which it is intended.
A product intended for use in people that has not been approved cannot meet this requirement. Publishing preparation or use information does not cure the problem: it is evidence of the intended use that makes the product a drug.
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For in vitro laboratory research only. Not for human or veterinary use. This library describes chemistry, analytical methods and published laboratory research; it gives no guidance on use in people or animals.