Standards

(1) All sterile products shall be prepared in compliance with applicable USP standards for pharmaceutical compounding. (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 sterile products, except hospital pharmacies compounding for inpatients of a hospital, shall submit to the Board of Pharmacy, on a quarterly basis, a report listing the quantity of high risk or batch sterile products, as defined by USP standards, compounded and dispensed during the previous quarterly period and any other information as required by USP standards. (a) Quarterly reports submitted pursuant to this paragraph shall be submitted by the 15th day of the month following the end of each calendar quarter. STERILE PRODUCT PREPARATION IN PHARMACY PRACTICE CHAPTER 1140-07 (b) In any calendar year where any one of the above dates fall on a weekend or official state holiday, all quarterly reports due on that date shall be submitted on the following business day. (c) The format for reports submitted pursuant to this paragraph shall be determined by the Board of Pharmacy through policy and made available to the public on the Board of Pharmacy’s website. (5) Any licensed pharmacy which compounds and dispenses sterile products shall provide at a minimum upon request of the Board of Pharmacy the following information for any sterile drug product compounded, dispensed, traded, sold, or otherwise distributed: (a) Name, strength, and dosage form; (b) Quantity compounded, dispensed, traded, sold, or otherwise distributed during the preceding quarterly period; (c) All components and an accurate statement of the weight or measure of each component; (d) The beyond-use date; (e) Storage requirements; (f) Labels and labeling with appropriate beyond-use date and instructions for storage and use. (6) Any licensed pharmacy which compounds and dispenses sterile products must ensure that the following information is on file at the practice site and readily accessible for sterile products: (a) Documentation of the name and strength of all drug products compounded over the past two (2) years; (b) The sources and lot numbers of the components used in those drug products; (c) The total number of dosage units compounded over the past two (2) years; (d) The name of the person who prepared the drug product; (e) The name of the pharmacist who approved the drug product; (f) The name of the practitioner or the name of the patient or healthcare entity who received the compounded drug product; (g) The results of any sampling, testing or other quantitative evaluation conducted for the purposes of quality control for any sterile compounded products, as defined by chapter 1140-01, compounded over the past two (2) years. (7) 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.