Texas Administrative Code › Title 22 - EXAMINING BOARDS › Part 15 - TEXAS STATE BOARD OF PHARMACY › Chapter 291 - PHARMACIES › Subchapter B - COMMUNITY PHARMACY (CLASS A) › Section 291.36 - Pharmacies Compounding Sterile Preparations (Class A-S)

Current through Reg. 49, No. 28; July 12, 2024
Licensing Requirements. A community pharmacy engaged in the
					 compounding of sterile preparations shall be designated as a Class A-S
					 pharmacy.
(1) A Class A-S pharmacy
				  shall register annually or biennially with the board on a pharmacy license
				  application provided by the board, following the procedures as specified in
				  §
										291.1
				  of this title (relating to Pharmacy License Application). A Class A-S license
				  may not be issued unless the pharmacy has been inspected by the board to ensure
				  the pharmacy meets the requirements as specified in §
										291.133
				  of this title (relating to Pharmacies Compounding Sterile
				  Preparations).
(2) A Class A-S
				  pharmacy may not renew a pharmacy license unless the pharmacy has been
				  inspected by the board within the last renewal period.
(3) A Class A-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).
(4) A Class A-S pharmacy which changes
				  location and/or name shall notify the board within ten days of the change and
				  file for an amended license as specified in §
										291.3
				  of this title.
(5) A Class A-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, following the procedures as specified in §
										291.3
				  of this title.
(6) A Class A-S
				  pharmacy shall notify the board in writing within ten days of closing,
				  following the procedures as specified in §
										291.5
				  of this title (relating to Closing a Pharmacy).
(7) A separate license is required for each
				  principal place of business and only one pharmacy license may be issued to a
				  specific location.
(8) 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.
(9) A Class A-S pharmacy
				  which would otherwise be required to be licensed under the Act, §
										560.051(a)(1)
				  concerning Community Pharmacy (Class A) is required to 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), §
										291.35
				  of this title (relating to Official Prescription Requirements), and §
										291.133
				  of this title.
(10) A Class A-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).
(11) A Class A-S
				  pharmacy engaged in the provision of remote pharmacy services, including
				  storage and dispensing of prescription drugs, shall comply with the provisions
				  of §
										291.121
				  of this title (relating to Remote Pharmacy Services).
(12) A Class A-S pharmacy engaged in
				  centralized prescription dispensing and/or prescription drug or medication
				  order processing shall comply with the provisions of §
										291.123
				  of this title (relating to Centralized Prescription Drug or Medication Order
				  Processing) and/or §
										291.125
				  of this title (relating to Centralized Prescription Dispensing).