SECTION 291.36. Pharmacies Compounding Sterile Preparations (Class A-S)

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).

Source Note: The provisions of this §291.36 adopted to be effective December 10, 2013, 38 TexReg 8835