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).
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Source Note: The provisions of this §291.106 adopted to be effective December 10, 2013, 38 TexReg 8866; amended to be effective June 11, 2015, 40 TexReg 3646; amended to be effective March 19, 2017, 42 TexReg 1127 |