AGREED BOARD ORDER #H1-15-001-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 letters dated June 22, 2015, and July 15, 2015, 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 562.156(a); 565.001(a)(1), (2), (12) and (13); and $65,002(ay(3) and (4) of the Texas Pharmacy Act, TEX. Occ, CODE ARN. Title 3, Subtitle J (2013); and Sections 281.7(a)(13); 291.32(6)(1)(E) and (F); 291.32(6)(2\(B); 291.33(a)(11); 291.34(g)(7); 291.36(1); and 295.3 of the Texas Pharmacy Board Rules, 22 Tex. Apmn. Cope (2014), in that allegedly: COUNTS (1) On or about May 5, 2014, a pharmacist of Stonegate Pharmacy, 2501 West William Cannon, Suite 203, Austin, Texas 78745, transcribed a telephonic prescription for patient C.T, as calling for a compounded preparation of testosterone 1%/hyaluronie acid 1% cream with directions to “apply 0.25ml (1 click) [illegible] to inner wrist TIW (three times weekly}". Duc to a delay in dispensing the prescription, patient C.T. requested that the prescription be transferred to Poople’s Pharmacy #1, 4018 North Lamar, Austin, Texas 78756, Staci Collin Kurmel, while acting as an employee (staff pharmacist) of Stonegate Pharmacy, transferred the prescription via the telephone to People's Pharmacy #1, Ms. Kurmel inaccurately communicated the prescription, in that it was recorded as testosterone 1% with directions to “apply “4 gram (I click) to inner wrist qd [every day].” (On or about May 16, 2014, a pharmacist of People’s Pharmacy # dispensed testosterone 1% cream with directions to “apply one click to inner wrist every day.” ‘The prescription ‘was assigned prescription number 1300334C, Patient C:T. applied the preparation for ‘one month and experienced adverse effects, including fatigue. (2) From on or about September 26, 2014, through January 26, 2015, Justin Timothy ‘Swanberg, while acting as an employee (pharmacist-in-charge) of Stonegate Pharmacy, 2501 West William Cannon, Suite 203, Austin, Texas 78745, allowed Stoncgate Pharmacy to unlawfully compound and dispense sterile preparations when it did not possess a Class A-S license, Stonegate Pharmacy failed to file an application for ClassAgreed Board Order #H-15-001-B Stonegate Pharmacy Page 2 ASS license with the Texas State Board of Pharmacy (Board) to continue as a pharmacy compounding sterile preparations after August 31, 2014. As evidenced by pharmacy records, Stonegate Pharmacy compounded and dispensed sterile preparations without a Class A-S license during the time period previously described. This discovered during a Board inspection on April 8, 2015, ‘On April 15, 2015, Stonegate Pharmacy became licensed with the Board as a Class A-S pharmacy. An informal conference was hel the Board's office on September 2, 2015, with Rene Faustino Garza, RPh., Owner and Chief Executive Officer of Stonegate Pharmacy, L.P., on behalf of Respondent; and Megan Hudgeons, Legal Counsel for Respondent, in attendance, The informal conference was heard by a Board panel comprised of: Jeanne D. Wagener, RPh., Board Member; Gay Dodson, R.Ph., Executive Director/Secretary; and Carol Fisher, R.Ph. MP.A., Director of Enforcement; ith Caroline Hotchkiss, Assistant General Counsel. Ginger Shuffer, Staff Attomey, was also in attendance, By appearing ut the informal conference and by signing this Order, Rene Faustino Garza and Respondent's counsel neither admit nor deny the truth of the matters previously set out in this Order, and agree that the Board has jurisdiction this matter and waive the right to notice of hearing, formal administrative hearing, and judicial review of this Order. ‘The parties acknowledge that this Order resolves the allegations set forth herein, and agree to the terms and conditions set forth in the ORDER OF THE BOARD below. ORDER OF THE BOARD ‘THEREFORE, PREMISES CONSIDERED, the Board does hereby ORDER that: (1) Respondent's license is reprimanded. 2) Respondent shall pay an administrative penalty of three thousand dollars ($3,000) due cone hundred twenty (120) days after the entry of this Order. (3) Respondent shall allow Board staff to directly contact Respondent on any matter rogarding the enforcement ofthis Order. (4) Failure to comply with any of the requirements in this Order constitutes a violation and shall be grounds for further disciplinary action, The requirements of this Order are subject to the Texas Pharmacy Act, TEX. Occ. CODE ANN., Title 3, Subtitle J (2015), and ‘Texas Pharmacy Board Rules, 22 TEX. ADMIN. CODE (2015).Agreed Board Order #11-15-001-B Stonegate Pharmacy Page 3 And il is so ORDERED. ‘THIS ORDER IS A PUBLIC RECORD. SIGNED AND ENTERED ON THIS_3rd__day of _N 2015 RP E BOARD OF PHARMACY, ATTEST: /, Gay Dodson, RPh, wh’ DirectorSecreiary SSS ‘Texas State Board of Pharnflcy APPROVED AS TO FORM AND AGREED TO: Rene Faubtixo Gafe), R-Ph., Owner and Chie For and on bchalf of Stonegate Pharmacy Megan Hudgéns, Legal Counbll for Stonegate Pharmacy Norton Rose Fulbright 98 San Jacinto Boulevard, Suite 1100 Austin, Texas 78701 ‘ecutive Officer of Stonegate Pharmacy, L.P. APPROVED AS TO FORM: Kelstit/Amold, General Counsel Texas State Board of Pharmacy |S Aone PNISO115- 1218 StoggatePhamay Stonsyte Mlnaey AD 281228 amended dos