Tenn. Comp. R. & Regs. 1140-03-.08 - REPACKAGING

(1) Any repackaging of prescription drugs and devices and related materials must be supervised and controlled by a pharmacist with in-process and end-process verification and documentation.

(2) Prescription drugs and devices and related materials which are repackaged by an institutional pharmacy practice site for subsequent dispensing and use within the institution shall be labeled to include:

(a) The name, strength, and quantity of prescription drug or device or related material, if larger than one (1), in the container;

(b) The manufacturer's name, and lot or control number;

(c) The expiration date of the prescription drug or device or related material being repackaged; and

(d) Cautionary notations (e.g., refrigerate, shake well, not for injection), if applicable.

(3) A batch number assigned by the pharmacy practice site may be placed on the label in lieu of the manufacturer's name and lot number, provided that the pharmacy practice site maintains a readily retrievable record which identifies, by batch number, the manufacturer and lot number of the prescription drug or device or related material.

(4) The pharmacy practice site shall have proper facilities, qualified personnel, effectual operational practices, suitable packaging material, and adequate control procedures to assure that the purity, integrity, safety, and effectiveness of the prescription drug or device or related material are not affected by such repackaging. All repackaging must be performed by a pharmacist or by a pharmacy intern or pharmacy technician under the supervision of a pharmacist.

(5) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board's authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.

Notes

Tenn. Comp. R. & Regs. 1140-03-.08

Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendments filed November 22, 2016; effective 2/20/2017.

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(8), (14), (26), and (28), and 63-10-504(b)(1) and (2).