Texas Administrative Code › Title 22 - EXAMINING BOARDS › Part 15 - TEXAS STATE BOARD OF PHARMACY › Chapter 291 - PHARMACIES › Subchapter F - NON-RESIDENT PHARMACY (CLASS E) › Section 291.104 - Operational Standards

Current through Reg. 49, No. 28; July 12, 2024
(a) Licensing
				  requirements.
(1) A Class E 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)
				  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;
(E)
				  proof of creditworthiness; and
(F)
				  an inspection report issued not more than two years before the date the license
				  application is received and conducted by the pharmacy licensing board in the
				  state of the pharmacy's physical location.
(i) A Class E pharmacy may submit an
				  inspection report issued by an entity other than the pharmacy licensing board
				  of the state in which the pharmacy is physically located if the state's
				  licensing board does not conduct inspections as follows:
(I) an individual approved by the board who
				  is not employed by the pharmacy but acting as a consultant to inspect the
				  pharmacy;
(II) an agent of the
				  National Association of Boards of Pharmacy;
(III) an agent of another State Board of
				  Pharmacy; or
(IV) an agent of an
				  accrediting body, such as the Joint Commission on Accreditation of Healthcare
				  Organizations.
(ii) The
				  inspection must be substantively equivalent to an inspection conducted by the
				  board.
(3) On
				  renewal of a license, the pharmacy shall complete the renewal application
				  provided by the board and, as specified in §561.0031 of the Act, provide
				  an inspection report issued not more than three years before the date the
				  renewal application is received and conducted by the pharmacy licensing board
				  in the state of the pharmacy's physical location.
(A) A Class E pharmacy may submit an
				  inspection report issued by an entity other than the pharmacy licensing board
				  of the state in which the pharmacy is physically located if the state's
				  licensing board does not conduct inspections as follows:
(i) an individual approved by the board who
				  is not employed by the pharmacy but acting as a consultant to inspect the
				  pharmacy;
(ii) an agent of the
				  National Association of Boards of Pharmacy;
(iii) an agent of another State Board of
				  Pharmacy; or
(iv) an agent of an
				  accrediting body, such as the Joint Commission on Accreditation of Healthcare
				  Organizations.
(B) The
				  inspection must be substantively equivalent to an inspection conducted by the
				  board.
(4) A Class E
				  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).
(5) A
				  Class E pharmacy which changes location and/or name shall notify the board of
				  the change as specified in §
											291.3 of this title.
(6) A Class E 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, following the procedures in §
											291.3 of this title.
(7) A Class E pharmacy shall notify the board
				  in writing within ten days of closing.
(8) A separate license is required for each
				  principal place of business and only one pharmacy license may be issued to a
				  specific location.
(9) 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.
(10) 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.
(11) A Class
				  E pharmacy engaged in the centralized dispensing of prescription drug or
				  medication orders or outsourcing of prescription drug order dispensing to a
				  central fill pharmacy shall comply with the provisions of §
											291.125 of this title (relating to
				  Centralized Prescription Dispensing).
(12) A Class E 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).
(13) A Class E 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).
(14) Class E pharmacy personnel shall not
				  compound sterile preparations unless the pharmacy has applied for and obtained
				  a Class E-S pharmacy license.
(15)
				  A Class E pharmacy, which operates as a community type of pharmacy which would
				  otherwise be required to be licensed under the Act §560.051(a)(1)
				  (Community Pharmacy (Class A)), shall comply with the provisions of §
											291.31 of this title (relating to
				  Definitions), §
											291.32 of this title (relating to
				  Personnel), §
											291.33 of this title (relating to
				  Operational Standards), §
											291.34 of this title (relating to
				  Records), and §
											291.35 of this title (relating to
				  Official Prescription Requirements), contained in Community Pharmacy (Class A);
				  or which operates as a nuclear type of pharmacy which would otherwise be
				  required to be licensed under the Act §560.051(a)(2) (Nuclear Pharmacy
				  (Class B)), shall comply with the provisions of §
											291.51 of this title (relating to
				  Purpose), §
											291.52 of this title (relating to
				  Definitions), §
											291.53 of this title (relating to
				  Personnel), §
											291.54 of this title (relating to
				  Operational Standards), and §
											291.55 of this title (relating to
				  Records), contained in Nuclear Pharmacy (Class B), to the extent such sections
				  are applicable to the operation of the pharmacy.