Texas Administrative Code › Title 22 - EXAMINING BOARDS › Part 15 - TEXAS STATE BOARD OF PHARMACY › Chapter 291 - PHARMACIES › Subchapter D - INSTITUTIONAL PHARMACY (CLASS C) › Section 291.77 - Pharmacies Compounding Sterile Preparations (Class C-S)

Current through Reg. 49, No. 28; July 12, 2024
Licensing requirements. An institutional or ASC pharmacy
					 engaged in the compounding of sterile preparations shall be designated as a
					 Class C-S pharmacy.
(1) A Class C-S
				  pharmacy shall register annually or biennially 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). A Class C-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 C-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 C-S pharmacy which changes
				  ownership shall notify the board within 10 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 C-S pharmacy which changes
				  location and/or name shall notify the board within 10 days of the change and
				  file for an amended license as specified in §
										291.3
				  of this title.
(5) A Class C-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 10 days of the change following the procedures in §
										291.3
				  of this title.
(6) A Class C-S
				  pharmacy shall notify the board in writing within 10 days of closing, following
				  the procedures in §
										291.5
				  of this title (relating to Closing a Pharmacy).
(7) 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.
(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 Class C-S pharmacy, licensed under the
				  Act, §560.051(a)(3), which also operates another type of pharmacy which
				  would otherwise be required to be licensed under the Act, §560.051(a)(1)
				  (Community Pharmacy (Class A)) or the Act, §560.051(a)(2) (Nuclear
				  Pharmacy (Class B)), is not required to secure a license for the such other
				  type of pharmacy; provided, however, such licensee 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), and §
										291.35
				  of this title (relating to Official Prescription Requirements), contained in
				  Community Pharmacy (Class A), or §
										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.
(10) A Class C-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 C-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 C-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 Central Prescription Drug or Medication Order
				  Processing) and/or §
										291.125
				  of this title (relating to Centralized Prescription Dispensing).
(13) A Class C-S pharmacy with an ongoing
				  clinical pharmacy program that proposes to allow a pharmacy technician to
				  verify the accuracy of work performed by another pharmacy technician relating
				  to the filling of floor stock and unit dose distribution systems for a patient
				  admitted to the hospital if the patient's orders have previously been reviewed
				  and approved by a pharmacist shall make application to the board as follows.
(A) The pharmacist-in-charge must submit an
				  application on a form provided by the board, containing the following
				  information:
(i) name, address, and pharmacy
				  license number;
(ii) name and
				  license number of the pharmacist-in-charge;
(iii) name and registration numbers of the
				  pharmacy technicians;
(iv)
				  anticipated date the pharmacy plans to begin allowing a pharmacy technician to
				  verify the accuracy of work performed by another pharmacy technician;
(v) documentation that the pharmacy has an
				  ongoing clinical pharmacy program; and
(vi) any other information specified on the
				  application.