AGREED BOARD ORDER #H-16-041-B RE: INTHE MATTER OF BEFORE THE TEXAS STATE, STONEGATE PHARMACY BOARD OF PHARMACY (PHARMACY LICENSE #24369) On this day came on to be considered by the Texas State Board of Pharmacy (Board) the matter of pharmacy license number 24369 issued to Stonegate Pharmacy (Respondent), 2501 West William Cannon, Suite 203, Austin, Texas 78745. By letter dated October 27, 2017, the Board gave preliminary notice to Respondent of its intent to take disciplinary action. This action was taken as a result of an investigation which produced evidence indicating that Respondent may have violated: Sections 565.001(a)(1), (2), (8), (9A), (12), (13) and (20); and 565.002(a)(3), (6), (8), (9) and (12) of the Texas Pharmacy Act, TEX. Occ, Cope ANN, Subtitle J (2015); Sections 281.2(8); 281.7(a)(6), (12), (13) and (23)(A); 281.8(a)(2) and (b)(4)(A)s 291.17{a\(1) and (3); 291.17(6(1) and GY; 291.31(1), (15), (16) and (17); fa AVE), and (Hs ai 291.32(6)(1)(E) and (F); 291.32(6)(2)(D);_ 291.33(b)(2)(A);_ 291.34(@)(1); 291.34()(6); 291.131(0)3); 291.131(6)2(B)_ and (C); 291.131@)3)(C); 291.131(d)(8)(E); 291.131(€)(9)(B); 291.131(€)(2)(B); and 295.3 of the Texas Pharmacy Board Rules, 22 Tex. ADMIN. CoDE (2016); Sections 431,002(25); and 431.114 of the Texas Food, Drug, and Cosmetic Act, ‘TeX. HEALTH & SAFETY CODE ANN, (2015); ns 321(p)(1); 331(d); and 355(a) of the FEDERAL FOOD, DRUG, AND MIC ACT (TITLE 21 U.S.C.) (2015); Section 481.067(a), (b) and (c) of the Texas Controlled Substances Act, TEX. Heavti & Sarery CopE ANN. (2015); and Sections 13.182(a); 13.202(e); and 13.222 of the Texas Controlled Substances, Rules, 37 Tex. ADMIN. CODE ANN. Part 1 (2016), in that allegedly: PREVIOUS HISTORY On or about November 3, 2015, the Texas State Board of Pharmacy entered Agreed Board Order #H-15-001-B in the matter of Stonegate Pharmacy. ‘The Order was based on allegations that a prescription was telephonically transferred to another pharmacy with incorrect directions for use resulting in a dispensing error, and the pharmacy compounded and dispensedAgreed Board Order #H-16-041-B Stonegate Pharmacy Page 2 sterile preparations without a class A-S license, The Order imposed a reprimand and a $3,000 penalty. ou! (1) On or about December 27, 2014, through on or about July 24, 2016, Stonegate Pharmacy, 2501 West William Cannon, Suite 203, Austin, Texas 78745, failed to keep and maintain complete and accurate records of purchases and disposals of 72,768 hydrocodone/APAP 10/325 mg tablets (-30.81%), a controlled substance listed in the ‘Texas Controlled Substances Act: Hydrocodone. 2) The audit shortages described in Count (1) reflects that Stonegate Pharmacy, 2501 West William Cannon, Suite 203, Austin, Texas 78745, failed to establish and maint effective controls against diversion or loss of a controlled substance. (3) Onor about December 27, 2014, Justin Timothy Swanberg, while acting as an employee (pharmacist-in-charge) of Stonegate Pharmacy, 2501 West William Cannon, Suite 203, Austin, Texas 78745, failed to keep and maintain inventory records, in that the annual inventory was not notarized. nk (staff_pharmacist) of Stonegate Pharmacy, 2501 West Wil : ‘Austin, Texas 78745, adjusted the purity percentage calculation in the pharmacy’ formula for the T4 ingredient without reviewing the certificate of analysis for the T4 powder or the actual ingredient. (5) On an unknown date in 2016, a staff pharmacist of Stonegate Pharmacy, 2501 West William Cannon, Suite 203, Austin, Texas 78745, failed to verify or incorrectly verified the accuracy of master formula worksheets prepared for T4 preparations, in that the pharmacist adjusted purity percentage calculations in the formula without reviewing the certificate of analysis for the T4 powder or the actual ingredient. The pharmacy’s formulas for T4 3 preparations called for a preparation utilizing T4 and 3 at a dilution. of 1:1000 (0.01%). However, the pharmacy’s compounding records failed to have the calculations used to prepare the raw ingredient of T4 and 73 at this dilution, resulting in preparations of T4 and T3 that were of greater potency than prescribed. Subsequently, the pharmacy dispensed the prescriptions described below and in Counts (6) and (7), respectively, pursuant to three batches assigned the following lot numbers 02122016:04@32; 03032016:72@16; and 03032016:75@9. On or about February 26, 2016, Kyle Ryan Grimslid, while acting as an employee (pharmacist-in-charge) of Stonegate Pharmacy, 2501 West William Cannon, Suite 203, Austin, Texas 78745, dispensed a compounded preparation from lot number 02122016:04@32. consisting of 30 capsules T4 T3 to patient L.L.-G. on a prescription for T4 T3 70 meg/10 meg. The prescription was labeled with directions to take 1 capsule by mouth daily. Patient L.L.-G. took the prescription, and was hospitalized forAgreed Board Order ¥H-16-041-B Stonegate Pharmacy Page 3 6) a approximately two weeks for thyroto: number 6138518, ‘osis, ‘The prescription was assigned prescription On or about April 12, 2016, samples of the compounded preparation of lot number 02122016:04@32 were analyzed for Stonegate Pharmacy. The results of the analysis indicated that the potency of T4 was approximately 38,191 meg, which is more than 54,000% greater than 70 meg, and the potency of T3 was 33 meg, more than 300% greater than 10 meg. ‘On or about March 3, 2016, Kyle Ryan Grimslid, while acting as an employee (pharmacist-in-charge) of Stonegate Pharmacy, 2501 West William Cannon, Suite 203, Austin, ‘Texas 78745, dispensed a compounded preparation from lot number 03032016:72@16 consisting of 30 capsules T4 T3 to patient S.L. on a prescription for ‘T4°T3 111 mog/27.7 meg. ‘The prescription vial was labeled “T4/T3 111/27.7 meg” with directions to “take one capsule by mouth every day.” Patient S.L. took the prescription for three days, and was hospitalized for approximately two weeks for thyrotox ‘The prescription was assigned prescription number 6140679. On or about September 11, 2017, samples of the compounded preparation of lot number the analysis indicated that the potency of T4 was approximately 109,484 meg, which is more than 98,000% greater than 111 meg, and the potency of T3 was approximately 99 meg, which is more than 350% greater than 27.7 meg. On or about March 3, 2016, Kyle Ryan Grimslid, while acting as an employee (pharmacist-in-charge) of Stonegate Pharmacy, 2501 West William Cannon, Suite 203, Austin, Texas 78745, dispensed a compounded preparation from lot number 03032016:75@9 consisting of 90 capsules T4 T3 to patient J.R. on a prescription for T4 ‘T3 75 meg/10 meg, Patient J.R, took two doses of the prescription, sought immediate medical treatment after having being notified of a possible error by the pharmacy, and was hospitalized for approximately two days and experienced adverse effects over several weeks, including fever, rapid heart rate, and anxiety. ‘The prescription was assigned prescription number 6138171 An informal conference was held in the Board’s office on January 11, 2018, with Andres David Ruiz, Corporate President, Stonegate Pharmacy LP, Andrecor Management, LLC, G.P.s Rene Faustino Garza, Chief Executive Officer, Stonegate Pharmacy LP, Andrecor Management, LLC, G.P., on behalf of Respondent; and Robert L. Seibert, Legal Counsel for Respondent, in attendance. informal conference was heard by a Board panel comprised of: Dennis F. Wiesner, R.Ph., Board Member; Jenny Downing Yoakum, R.Ph. Board Member; and Allison Vordenbaumen Benz, R.Ph., M.S., Executive Director/Secretary; with Kerstin Amold, General Counsel, Megan Holloway, Assistant General Counsel, was also in attendance,