Tenn. Comp. R. & Regs. 1140-07-.06 - LABELING

(1) At the time of labeling the final compounded drug product, the dispensing container must bear a label which contains the following information:

(a) Patient's name or healthcare entity name;

(b) Prescriber(s) name (if for outpatient use);

(c) Pharmacy practice site name, address, and phone number (if for outpatient use);

(d) Identification of the pharmacist performing the final product verification;

(e) Name and amount of drug added. Additional labels or other written/typed documentation may be given to the patient separately if there is not enough space on the label to accommodate all active ingredient(s), their amount(s), activity(ies), or concentration(s) as applicable;

(f) The date, or hour and date, after which a compounded drug product must not be used, stored, or transported. The date is determined from the date or time the preparation is compounded ("BUD");

(g) Date of compounding;

(h) Date of dispensing;

(i) Appropriate auxiliary label(s);

(j) Assigned internal identification number; and

(k) Directions for use (if for outpatient), if applicable.

(2) At the time of labeling the anticipatory drug product, the container must bear a label which contains the following information:

(a) Identification of the pharmacist performing the final product verification;

(b) Name and amount of drug added;

(c) The date, or hour and date, after which a compounded drug product must not be used, stored, or transported. The date is determined from the date or time the preparation is compounded. ("BUD");

(d) Date of compounding;

(e) Appropriate auxiliary label(s);

(f) Assigned lot and batch; and

(g) Storage requirements, if applicable.

(3) Original medical or prescription orders for sterile products shall comply with applicable state and federal laws and regulations.

Notes

Tenn. Comp. R. & Regs. 1140-07-.06

Original chapter filed October 1, 1987; effective November 15, 1987. Amendment filed March 30, 1994; effective June 13, 1994. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rules filed January 31, 2014; effective through July 30, 2014. Emergency rules expired effective July 31, 2014, and the rules reverted to their previous statuses. Rule was previously numbered 1140-07-.05, but was renumbered to 1140-07-.06 with the addition of a new 1140-07-.02. Rule filed July 11, 2014; effective October 9, 2014. Amendments filed December 15, 2023; effective 3/14/2024.

Authority: T.C.A. §§ 63-10-216, 63-10-308, and 63-10-310.