Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule establishes guidelines for
temporary pharmacy operations during an emergency or declared
disaster.
(1) Definitions.
(A) "Disaster Area" - A specified
geographical area within the state that has been designated by the governor or
federal authorities as an area that has been adversely affected by a natural or
man-made disaster and that requires extraordinary measures to provide adequate,
safe, and effective health care for the affected population.
(B) "Emergency Situation" - An emergency
caused by a natural or man-made disaster that substantially prevents a Missouri
licensed pharmacy from providing pharmacy services at the pharmacy's permitted
location.
(C) "Home Pharmacy"-A
Missouri licensed pharmacy that operates or applies for an emergency temporary
pharmacy permit pursuant to this rule.
(D) "Emergency Declaration" - A state or
federally declared emergency or disaster that impacts Missouri
patients.
(2) Emergency
Situations. A pharmacy that is substantially unable to provide pharmacy
services at their permitted location due to an emergency situation may file a
change of location application with the board to provide pharmacy services at a
temporary site. No application fee shall apply. The location change must be
approved by the board prior to changing locations and the designated location
must successfully pass a board inspection.
(A)
Approval of a temporary change of location under this rule will be based on the
need, type, and scope of the emergency situation, as well as the ability of the
pharmacy to ensure proper security and comply with state and federal drug
laws.
(B) Unless otherwise approved
by the board for good cause, temporary pharmacy permits shall be valid for up
to six (6) months, if requested. A change of location application is required
if the pharmacy will be operating at a temporary location for more than the
allowed six (6) months or desires to permanently remain at the temporary
site.
(C) The board may waive
designated facility or pharmacy operational requirements at a temporary
location to prevent the interruption of pharmacy services. Waiver requests must
be submitted in writing and must demonstrate how the permit holder will
maintain patient safety and ensure adequate security.
(D) A change of location application must be
filed with the board when the home pharmacy is ready to return to their
original permitted location. No fee will apply. The permitted location must
pass a board inspection prior to resuming pharmacy services at the original
location.
(E) Records must be
maintained as required by Chapter 338, RSMo, and the rules of the
board.
(F) Approval of a temporary
location change does not interfere with any rights or privileges of a pharmacy
permit holder at the original pharmacy location, or prevent a permit holder
from applying for a change of location as outlined in the board's
rules.
(3) Emergency
Declarations/Disaster Areas. A Missouri licensed pharmacy located in Missouri
may apply for an emergency temporary pharmacy permit to provide pharmacy
services to Missouri patients impacted by an emergency declaration or located
in a disaster area. Applications for an emergency temporary pharmacy permit
must be submitted on a form provided by the board with the applicable fee, and
must demonstrate that the temporary pharmacy is needed to ensure adequate
pharmacy services are reasonably available for impacted patients. The following
additional requirements apply, unless otherwise approved by the board:
(A) The temporary pharmacy permit shall be
considered part of the home pharmacy's permit and not a separate pharmacy
permit. The home pharmacy and the temporary pharmacy must have the same
pharmacist-in-charge. The home pharmacy is responsible for ensuring compliance
with all applicable state and federal law at a temporary pharmacy licensed
under this rule;
(B) Unless
otherwise approved by the board, temporary pharmacy permits will only be
approved for a designated location and for the pharmacy classifications
authorized on the home pharmacy's permit prior to the declared disaster or
emergency declaration;
(C) Approval
of an emergency temporary pharmacy permit will be based on the need, type, and
scope of emergency or disaster, as well as the pharmacy's ability to maintain
proper security and comply with applicable state and federal law, including,
section
338.240,
RSMo;
(D) The temporary location
must successfully pass a board inspection before a temporary pharmacy permit is
issued. Additionally, temporary pharmacies must be available for inspection, as
requested by the board or the board's authorized designee;
(E) The board may waive designated facility
or pharmacy operational requirements to prevent the interruption of pharmacy
services at an emergency temporary pharmacy. Waiver requests must be submitted
in writing and must demonstrate how the permit holder will maintain patient
safety and adequate pharmacy security, if approved. Controlled substances must
be handled and dispensed in accordance with state and federal law;
(F) Temporary pharmacy permits issued under
this section are valid for thirty (30) days but may be renewed at the
discretion of the board. To renew, the home pharmacy must file a written
request with the board and demonstrate that renewal of the temporary pharmacy
permit is needed to protect the public health and ensure access to pharmacy
services;
(G) Temporary pharmacies
approved under this section must terminate services on the expiration date
approved by the board or within five (5) days after the disaster area
designation or emergency declaration is withdrawn or terminated, whichever is
earlier; and
(H) Records must be
maintained as required by Chapter 338, RSMo, and the rules of the board.
Required records must be maintained at the home pharmacy after the temporary
pharmacy permit closes, and must be available for inspection or copying by the
board or the board's authorized designee.
*Original authority: 338.210 , RSMo 1951 and 338.280, RSMo
1951, amended 1971, 1981.
