Tenn. Comp. R. & Regs. 1140-11-.05 - MINIMUM REPORTING REQUIREMENTS FOR WHOLESALERS AND MANUFACTURERS

(1) Wholesalers and manufacturers, as defined in T.C.A. § 63-10-204, shall submit a report of all wholesales and distributions of controlled substances at least once every month and no later than 45 days after the earliest transaction being reported.

(a) Any report submitted pursuant to this rule shall be in the ARCOS format, as specified in the most current version of the "Instructions for Reporting Wholesale Transactions" document, which will be made freely available on the Board of Pharmacy's website or the Controlled Substance Monitoring Database's website.

(b) Any report submitted pursuant to this rule shall be sent to the database or email address specified in the "Instructions for Reporting Wholesale Transactions" document.

(c) Any entity exempt from reporting to the Drug Enforcement Administration pursuant to 21 C.F.R. § 1304.33 shall not be required to submit reports of wholesales and distributions of controlled substances pursuant to this rule.

Notes

Tenn. Comp. R. & Regs. 1140-11-.05

New rule filed November 22, 2016; effective February 20, 2017. Rule was previously numbered 1140-11-.08 but was renumbered 1140-11-.05 with the deletion of rules 1140-11-.05 through 1140-11-.07 filed October 28, 2021; effective 1/26/2022.

Authority: T.C.A. § 53-10-312.