Tenn. Comp. R. & Regs. 1140-07-.02 - STANDARDS

(1) The preparation, labeling, and dispensing of all compounded drug products shall comply with the standards established by United States Pharmacopeia ("USP") chapters 795, 797, 800, and/or 825, pursuant to the compounding pharmacy's site practice, including all USP chapters and standards incorporated into chapters by reference and including all subsequent amendments and editions of the same, governing both the compounded drug products and the physical and environmental conditions under which compounded drug products are prepared, labeled, and dispensed.

(2) The Board of Pharmacy, upon a showing of good cause and in the best interest of the public health, safety and welfare, may waive the requirements of any applicable portion of USP standards.

(a) All waiver requests submitted pursuant to this part shall be submitted in writing.

(b) The Board of Pharmacy may authorize the Executive Director to exercise some, or all, of its waiver authority under this part.

(3) Noncompliance by a licensee with applicable standards and guidelines, or any other violation of the provisions of this rule shall be considered unprofessional conduct within the meaning of T.C.A. § 63-10-305 and a violation of a duly promulgated rule of the Board of Pharmacy.

(4) Any licensed pharmacy which compounds and dispenses drug products shall provide at a minimum upon request of the Board of Pharmacy the following information for any drug product compounded, dispensed, traded, sold, or otherwise distributed within the past two (2) years:

(a) Name, strength, and dosage form;

(b) Quantity compounded, dispensed, traded, sold, or otherwise distributed during the preceding period;

(c) The source, lot number, expiration date and an accurate statement of the weight or measure of each component;

(d) The Beyond Use Date which is 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");

(e) Storage requirements;

(f) Labels and labeling with appropriate BUD and instructions for storage and use;

(g) The names of all personnel who prepared the compounded drug product;

(h) The name of the pharmacist who approved the compounded drug product;

(i) The name of the patient, practitioner or healthcare entity who received the compounded drug product; and

(j) The results of any sampling, testing or other quantitative evaluation conducted for the purposes of quality control for any compounded drug products, compounded over the past two (2) years.

(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. 1140-07-.02

Original rule filed July 11, 2014; effective October 9, 2014. Amendments filed November 22, 2016; effective February 20, 2017. Amendments filed December 15, 2023; effective 3/14/2024.

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