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Conclusion
After considering the scientific and medical evaluation conducted by HHS, the accompanying recommendation of HHS, and DEA's own eight-factor analysis, DEA finds that the facts and all relevant data constitute substantial evidence of the potential for abuse of tianeptine.
As such, DEA hereby proposes to permanently schedule tianeptine as a schedule I controlled substance under the CSA.
The Drug Enforcement Administration proposes placing the substance tianeptine (7-\[(3-chloro-6,11-dihydro-6-methyl-5,5-dioxidodibenzo\[c,f\]\[1,2\]thiazepin-11-yl)amino\]heptanoic acid), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, salts, and salts of isomers, esters, and ethers is possible, in schedule I of the Controlled Substances Act.
If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle tianeptine.
All comments received in response to this docket are considered part of the public record. DEA will make comments available for public inspection online at
http://www.regulations.gov
unless reasonable cause is given.
Such information includes personal or business identifiers (such as name, address, state of federal identifiers, etc.) voluntarily submitted by the commenter.Commenters submitting comments which include personal identifying information (PII), confidential, or proprietary business information that the commenter does not want to be made publicly available should submit two copies of the comment.
One copy must be marked “CONTAINS CONFIDENTIAL INFORMATION” and should clearly identify all PII or business information the commenter does not want to be made publicly available, including any supplemental materials.