Section 291.106 - Pharmacies Compounding Sterile Preparations (Class E-S)Licensing requirements. A non-resident pharmacy engaged in the compounding of sterile preparations shall be licensed as a Class E-S pharmacy.
(1) A Class E-S pharmacy shall register with the board on a pharmacy license application provided by the board, following the procedures specified in § 291.1 of this title (relating to Pharmacy License Application).(2) A Class E-S license may not be issued unless the pharmacy has been inspected by the board or its designee to ensure the pharmacy meets the requirements as specified in § 291.133 of this title (relating to Pharmacies Compounding Sterile Preparations). A Class E-S pharmacy shall reimburse the board for all expenses, including travel, related to the inspection of the Class E-S pharmacy.(3) On initial application, the pharmacy shall follow the procedures specified in § 291.1 of this title and then provide the following additional information specified in §560.052(c) and (f) of the Act (relating to Qualifications): (A) evidence that the applicant holds a pharmacy license, registration, or permit issued by the state in which the pharmacy is located;(B) the name of the owner and pharmacist-in-charge of the pharmacy for service of process;(C) evidence of the applicant's ability to provide to the board a record of a prescription drug order dispensed by the applicant to a resident of this state not later than 72 hours after the time the board requests the record;(D) an affidavit by the pharmacist-in-charge which states that the pharmacist has read and understands the laws and rules relating to a Class E pharmacy; and(E) proof of creditworthiness.(4) A Class E-S pharmacy may not renew a pharmacy license unless the pharmacy has been inspected by the board or its designee within the last renewal period.(5) A Class E-S pharmacy which changes ownership shall notify the board within ten days of the change of ownership and apply for a new and separate license as specified in § 291.3 of this title (relating to Required Notifications).(6) A Class E-S pharmacy which changes location and/or name shall notify the board as specified in § 291.3 of this title.(7) A Class E-S pharmacy owned by a partnership or corporation which changes managing officers shall notify the board in writing of the names of the new managing officers within ten days of the change, as specified in § 291.3 of this title.(8) A Class E-S pharmacy shall notify the board in writing within ten days of closing.(9) A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.(10) A fee as specified in § 291.6 of this title (relating to Pharmacy License Fees) will be charged for the issuance and renewal of a license and the issuance of an amended license.(11) The board may grant an exemption from the licensing requirements of this Act on the application of a pharmacy located in a state of the United States other than this state that restricts its dispensing of prescription drugs or devices to residents of this state to isolated transactions.(12) A Class E-S pharmacy engaged in the centralized dispensing of prescription drug or medication orders shall comply with the provisions of § 291.125 of this title (relating to Centralized Prescription Dispensing).(13) A Class E-S pharmacy engaged in central processing of prescription drug or medication orders shall comply with the provisions of § 291.123 of this title (relating to Central Prescription or Medication Order Processing).(14) A Class E-S pharmacy engaged in the compounding of non-sterile preparations shall comply with the provisions of § 291.131 of this title (relating to Pharmacies Compounding Non-Sterile Preparations).(15) A Class E-S pharmacy engaged in the compounding of sterile preparations shall comply with the provisions of § 291.133 of this title.(16) A Class E-S pharmacy which would otherwise be required to be licensed under the Act, §560.051(a)(5) concerning Non-Resident Pharmacy (Class E) is required to comply with the provisions of § 291.101 of this title (relating to Purpose), § 291.102 of this title (relating to Definitions), § 291.103 of this title (relating to Personnel), § 291.104 of this title (relating to Operational Standards) and § 291.105 of this title (relating to Records).22 Tex. Admin. Code § 291.106
The provisions of this §291.106 adopted to be effective December 10, 2013, 38 TexReg 8866; Amended by Texas Register, Volume 40, Number 24, June 12, 2015, TexReg 3646, eff. 6/11/2015; Amended by Texas Register, Volume 42, Number 10, March 10, 2017, TexReg 1127, eff. 3/19/2017