(a) Prior to closing. At least 14 days prior to the
closing of a pharmacy that dispenses prescription drug orders the
pharmacist-in-charge shall:
(1) post a closing notice sign in a conspicuous place
in the front of the prescription department and at all public entrance
doors to the pharmacy. Such closing notice sign shall contain the
following information:
(A) the date of closing; and
(B) the name, address, and telephone number of the
pharmacy acquiring the prescription drug orders, including refill
information and patient medication records of the pharmacy.
(2) notify DEA of any controlled substances being transferred
to another registrant as specified in 21 CFR 1301.52(d).
(b) Closing day. On the date of closing, the pharmacist-in-charge
shall comply with the following:
(1) take an inventory as specified in §291.17
of this title (relating to Inventory Requirements);
(2) remove all prescription drugs from the pharmacy
by one or a combination of the following methods:
(A) return prescription drugs to manufacturer or supplier
(for credit/disposal);
(B) transfer (sell or give away) prescription drugs
to a person who is legally entitled to possess drugs, such as a hospital,
or another pharmacy; and
(C) destroy the prescription drugs following procedures
specified in §303.2 of this title (relating to Disposal of Stock
Prescription Drugs); and
(3) if the pharmacy dispenses prescription drug orders:
(A) transfer the prescription drug order files, including
refill information, and patient medication records to a licensed pharmacy;
and
(B) remove all signs or notify the landlord or owner
of the property that it is unlawful to use the word "pharmacy" either
in English or any other language, or any other word or combination
of words of the same or similar meaning, or any graphic representation
that would mislead or tend to mislead the public that a pharmacy is
located at the address.
(c) After closing.
(1) Within ten days after the closing of the pharmacy,
the pharmacist-in-charge shall forward to the board a written notice
of the closing which includes the following information:
(A) the actual date of closing;
(B) the license issued to the pharmacy;
(C) a statement attesting:
(i) that an inventory as specified in §291.17
of this title; and
(ii) the manner by which the dangerous drugs and controlled
substances possessed by the pharmacy were transferred or disposed;
and
(D) if the pharmacy dispenses prescription drug orders,
the name and address of the pharmacy to which the prescription drug
orders, including refill information, and patient medication records
were transferred.
(2) If the pharmacy is registered to possess controlled
substances, send notification to the appropriate DEA divisional office
explaining that the pharmacy has closed and include the following
items:
(A) DEA registration certificate; and
(B) all unused DEA order forms (222) with the word
VOID written on the face of each order form.
(3) Once the pharmacy has notified the board that the
pharmacy is closed, the license may not be renewed. The pharmacy may
apply for a new license as specified in §291.1 of this title
(relating to Pharmacy License Application).
(d) Emergency or temporary closing.
(1) If pharmacy is closed suddenly due to fire, destruction,
natural disaster, death, property seizure, eviction, bankruptcy, or
other emergency circumstances and the pharmacist-in-charge cannot
provide notification 14 days prior to the closing, the pharmacist-in-charge
shall comply with the provisions of subsection (a) of this section
as far in advance of the closing as allowed by the circumstances.
(2) A pharmacy may temporarily close for lack of a
pharmacist-in-charge for no more than 30 days. If a pharmacy temporarily
closes for lack of a pharmacist-in-charge, the pharmacy shall:
(A) only allow access to the prescription department
if a pharmacist is present;
(B) send notification to the board as specified in §291.3(k)
of this title (relating to Required Notifications); and
(C) either:
(i) reopen within 48 hours under the supervision of
a new pharmacist-in-charge who has been reported to the board as specified
in §291.3(e)(2) of this title; or
(ii) comply with the provisions of subsection (a) of
this section as far in advance of the closing as allowed by the circumstances.
(e) Joint responsibility. If the pharmacist-in-charge
is not available to comply with the requirements of this section,
the owner shall be responsible for compliance with the provisions
of this section.
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Source Note: The provisions of this §291.5 adopted to be effective June 17, 1986, 11 TexReg 2553; amended to be effective July 29, 1987, 12 TexReg 2337; amended to be effective September 30, 1993, 18 TexReg 6459; amended to be effective June 20, 1995, 20 TexReg 4121; amended to be effective March 25, 2007, 32 TexReg 1510; amended to be effective June 12, 2016, 41 TexReg 4257; amended to be effective January 4, 2018, 42 TexReg 7691; amended to be effective December 4, 2023, 48 TexReg 7048 |