| (a) Change of Location.
(1) When a pharmacy changes location, the following
is applicable:
(A) A new completed pharmacy application containing
the information outlined in §291.1 of this title (relating to
Pharmacy License Application) must be filed with the board not later
than 30 days before the date of the change of location of the pharmacy;
(B) An amended license reflecting the new location
of the pharmacy will be issued by the board; and
(C) A fee as specified in §291.6 of this title
(relating to Pharmacy License Fees) will be charged for processing
the application for change of location.
(2) At least 14 days prior to the change of location
of a pharmacy that dispenses prescription drug orders, the pharmacist-in-charge
shall post a sign in a conspicuous place indicating that the pharmacy
is changing locations. Such sign shall be in the front of the prescription
department and at all public entrance doors to the pharmacy and shall
indicate the date the pharmacy is changing locations.
(3) Disasters, accidents, and emergencies which require
the pharmacy to change location shall be immediately reported to the
board. If a pharmacy changes location suddenly due to disasters, accidents,
or other emergency circumstances and the pharmacist-in-charge cannot
provide notification 14 days prior to the change of location, the
pharmacist-in-charge shall comply with the provisions of paragraph
(2) of this subsection as far in advance of the change of location
as allowed by the circumstances.
(4) When a Class A-S, C-S, or E-S pharmacy changes
location, the pharmacy's classification will revert to a Class A,
Class C, or Class E unless or until the board or its designee has
inspected the new location to ensure the pharmacy meets the requirements
as specified in §291.133 of this title (relating to Pharmacies
Compounding Sterile Preparations).
(5) When a Class B pharmacy changes location, the board
shall inspect the pharmacy at the new location to ensure the pharmacy
meets the requirements as specified in subchapter C of this title
(relating to Nuclear Pharmacy (Class B)) prior to the pharmacy becoming
operational.
(b) Change of Name. When a pharmacy changes its name,
the following is applicable:
(1) A new completed pharmacy application containing
the information outlined in §291.1 of this title (relating to
Pharmacy License Application) must be filed with the board within
10 days of the change of name of the pharmacy;
(2) An amended license reflecting the new name of the
pharmacy will be issued by the board; and
(3) A fee as specified in §291.6 of this title
(relating to Pharmacy License Fees) will be charged for processing
the application for change of name.
(c) Change of Managing Officers.
(1) The owner of a pharmacy shall notify the board
in writing within 10 days of a change of any managing officer of a
partnership or corporation which owns a pharmacy. The written notification
shall include the effective date of such change, an updated sworn
disclosure statement as required by §560.052(b) of the Act and
as specified in §291.4 of this title (relating to Sworn Disclosure
Statement), and the following information for all managing officers:
(A) name and title;
(B) home address and telephone number;
(C) date of birth;
(D) a copy of social security card or other official
document showing the social security number as approved by the board;
and
(E) a copy of current driver's license, state issued
photo identification card, or passport.
(2) For purposes of this subsection, managing officers
are defined as the top four executive officers, including the corporate
officer in charge of pharmacy operations, who are designated by the
partnership or corporation to be jointly responsible for the legal
operation of the pharmacy.
(d) Change of Ownership.
(1) When a pharmacy changes ownership, a new pharmacy
application must be filed with the board following the procedures
as specified in §291.1 of this title (relating to Pharmacy License
Application), including, as required by §560.052(b) of the Act,
the submission of a sworn disclosure statement as specified in §291.4
of this title (relating to Sworn Disclosure Statement). In addition,
a copy of the purchase contract or mutual agreement between the buyer
and seller must be submitted.
(2) A fee as specified in §291.6 of this title
will be charged for issuance of a new license.
(e) Change of Pharmacist Employment.
(1) Change of pharmacist employed in a pharmacy. When
a change in pharmacist employment occurs, the pharmacist shall report
such change in writing to the board within 10 days.
(2) Change of pharmacist-in-charge of a pharmacy. The
incoming pharmacist-in-charge shall be responsible for notifying the
board within 10 days in writing on a form provided by the board that
a change of pharmacist-in-charge has occurred. The notification shall
include the following:
(A) the name and license number of the departing pharmacist-in-charge;
(B) the name and license number of the incoming pharmacist-in-charge;
(C) the date the incoming pharmacist-in-charge became
the pharmacist-in-charge; and
(D) a statement signed by the incoming pharmacist-in-charge
attesting that:
(i) an inventory, as specified in §291.17 of this
title (relating to Inventory Requirements), has been conducted by
the departing and incoming pharmacists-in-charge; if the inventory
was not taken by both pharmacists, the statement shall provide an
explanation; and
(ii) the incoming pharmacist-in-charge has read and
understands the laws and rules relating to this class of pharmacy.
(f) Notification of Theft or Loss of a Controlled Substance
or a Dangerous Drug.
(1) Controlled substances. For the purposes of the
Act, §562.106, the theft or significant loss of any controlled
substance by a pharmacy shall be reported in writing to the board
immediately on discovery of such theft or loss. A pharmacy shall be
in compliance with this subsection by submitting to the board a copy
of the Drug Enforcement Administration (DEA) report of theft or loss
of controlled substances, DEA Form 106, or by submitting a list of
all controlled substances stolen or lost.
(2) Dangerous drugs. A pharmacy shall report in writing
to the board immediately on discovery the theft or significant loss
of any dangerous drug by submitting a list of the name and quantity
of all dangerous drugs stolen or lost.
(g) Fire or Other Disaster. If a pharmacy experiences
a fire or other disaster, the following requirements are applicable.
(1) Responsibilities of the pharmacist-in-charge.
(A) The pharmacist-in-charge shall be responsible for
reporting the date of the fire or other disaster which may affect
the strength, purity, or labeling of drugs, medications, devices,
or other materials used in the diagnosis or the treatment of injury,
illness, and disease; such notification shall be reported to the board,
within 10 days from the date of the disaster.
(B) The pharmacist-in-charge or designated agent shall
comply with the following procedures.
(i) If controlled substances, dangerous drugs, or Drug
Enforcement Administration (DEA) order forms are lost or destroyed
in the disaster, the pharmacy shall:
(I) notify the DEA and the board of the loss of the
controlled substances or order forms immediately upon discovery; and
(II) notify the board in writing of the loss of the
dangerous drugs by submitting a list of the dangerous drugs lost.
(ii) If the extent of the loss of controlled substances
or dangerous drugs is not able to be determined, the pharmacy shall:
(I) take a new, complete inventory of all remaining
drugs specified in §291.17(c) of this title (relating to Inventory
Requirements);
(II) submit to the DEA a statement attesting that the
loss of controlled substances is indeterminable and that a new, complete
inventory of all remaining controlled substances was conducted and
state the date of such inventory; and
(III) submit to the board a statement attesting that
the loss of controlled substances and dangerous drugs is indeterminable
and that a new, complete inventory of the drugs specified in §291.17(c)
of this title was conducted and state the date of such inventory.
(C) If the pharmacy changes to a new, permanent location,
the pharmacist-in-charge shall comply with subsection (a) of this
section.
Cont'd... |
