22 Tex. Admin. Code § 291.106 - Pharmacies Compounding Sterile Preparations (Class E-S)
Licensing requirements. A non-resident pharmacy engaged in the compounding of sterile preparations shall be licensed as a Class E-S pharmacy.
(1) A Class E-S 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)
A Class E-S license may not be issued unless the pharmacy has been inspected by
the board or its designee to ensure the pharmacy meets the requirements as
specified in §
291.133 of this title (relating to
Pharmacies Compounding Sterile Preparations). A Class E-S pharmacy shall
reimburse the board for all expenses, including travel, related to the
inspection of the Class E-S pharmacy.
(3) 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; and
(E) proof of creditworthiness.
(4) A Class E-S pharmacy may not
renew a pharmacy license unless the pharmacy has been inspected by the board or
its designee within the last renewal period.
(5) A Class E-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).
(6) A
Class E-S pharmacy which changes location and/or name shall notify the board as
specified in §
291.3 of this title.
(7) A Class E-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, as specified in §
291.3 of this title.
(8) A Class E-S pharmacy shall notify the
board in writing within ten days of closing.
(9) A separate license is required for each
principal place of business and only one pharmacy license may be issued to a
specific location.
(10) 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.
(11) 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.
(12) A Class
E-S pharmacy engaged in the centralized dispensing of prescription drug or
medication orders shall comply with the provisions of §
291.125 of this title (relating to
Centralized Prescription Dispensing).
(13) A Class E-S 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).
(14) A Class E-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).
(15) A Class E-S pharmacy engaged in the
compounding of sterile preparations shall comply with the provisions of §
291.133 of this title.
(16) A Class E-S pharmacy which would
otherwise be required to be licensed under the Act, § 560.051(a)(5)
concerning Non-Resident Pharmacy (Class E) is required to comply with the
provisions of §
291.101 of this title (relating to
Purpose), §
291.102 of this title (relating to
Definitions), §
291.103 of this title (relating to
Personnel), §
291.104 of this title (relating to
Operational Standards) and §
291.105 of this title (relating to
Records).
Notes
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