22 Tex. Admin. Code § 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).
Notes
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