1. Application; Fees
An application for licensure as an extended hospital
pharmacy must be filed by the hospital in which the extended hospital pharmacy
is located on forms provided by the board. The application must be accompanied
by the license fee required by Chapter 10, Section
5(27) of the rules
of the Department of Professional and Financial Regulation, Office of
Professional and Occupational Regulation, entitled "Establishment of License
Fees." Incomplete applications will not be accepted and will be returned to the
applicant. The applicant shall provide the following information:
A. The name, address, telephone number and
email address of the person responsible for submission of the
application;
B. The name, physical
address, contact address, telephone number, email address and world wide web
address of the hospital;
C. All
trade or business names used or to be used by the extended hospital pharmacy or
the hospital in which it is located;
D. The names of the owner of the hospital,
including:
(1) If a partnership, the name,
contact address, telephone number and employer identification number of the
partnership, and the name and contact address of each partner;
(2) If a business corporation, the name,
contact address, telephone number and employer identification number of the
corporation; the name of the parent company, if any; the name, contact address
and title of each corporate officer and director; the name and contact address
of each shareholder owning 10% or more of the voting stock of the corporation,
including over-the-counter stock, unless the company is traded on a major stock
exchange and not over-the-counter; a certificate of existence from the
corporation's state of organization and, for corporations not organized under
Maine law, a certificate of authority from the Maine Secretary of
State;
(3) If a nonprofit
corporation, the name, contact address, telephone number and employer
identification number of the corporation; the name of the parent company, if
any; the name, contact address and title of each corporate officer and
director; the name and contact address of each voting member; a certificate of
existence from the corporation's state of organization and, for corporations
not organized under Maine law, a certificate of authority from the Maine
Secretary of State;
(4) If a
limited liability company, the name, contact address, employer identification
number, telephone number, fax number and email address of the limited liability
company; the names and mailing addresses of each member and manager; a
certificate of existence from the Maine Secretary of State or, for limited
liability companies not organized under Maine law, a certificate of authority
or certificate of qualification from the Maine Secretary of State; and the name
of the member or manager who will be representing the applicant in matters
before the board.
(5) If a sole
proprietorship, the name, contact address, telephone number and social security
number of the sole proprietor and the name of the business entity;
E. The hours of operation of the
extended hospital pharmacy during which a pharmacist will be on duty;
F. The DEA number of the hospital
pharmacy;
G. The name and license
number of the pharmacist in charge of the hospital pharmacy;
H. The name and license number of the
pharmacist in charge of the extended hospital pharmacy (if different than the
above);
I. A copy of the hospital's
current license from DHHS;
J.
Survey or Inspection Report-
(1) If the
hospital is accredited by an accrediting organization recognized by the Centers
for Medicare and Medicaid Services, the portion of the most recent survey
conducted by the accrediting organization that relates to pharmacy
services;
(2) If the hospital is
not accredited by an accrediting organization recognized by the Centers for
Medicare and Medicaid Services, the portion of the most recent report of an
inspection of the hospital conducted by DHHS that relates to pharmacy
services;
(3) All adverse findings,
responses, remediation plans, and follow-up surveys or follow-up inspection
reports related to the survey or inspection report provided pursuant to
subparagraph 1 or 2 above;
K. Suspension, revocation or other
disciplinary action taken by a federal, state or local governmental body with
respect to any type of pharmacy license currently or previously held by the
applicant;
L. Issuance of a
citation, warning letter or untitled letter to the applicant by the FDA, or
similar action taken by another governmental body;
M. A text summary of any complaints filed or
generated against the hospital relating to pharmacy services during the ten
years preceding application that includes, for each such complaint, the
allegations of the complaint, the complaint investigation, and the findings,
resolution, and any remediation or penalties ordered against or agreed to by
the hospital; and
N. Such other
information as the board may require.
2. Processing of Application
A. The board shall review the application for
compliance with the pharmacy law and rules and shall issue a license upon a
determination that operation of the extended hospital pharmacy will be in the
best interest of the public health and welfare.
B. Following review of the application the
board may approve the application, preliminarily deny the application, approve
the application with conditions, direct the applicant to resubmit the
application with specific modifications, request further information from the
applicant, or investigate any of the information contained in the application.
A denial shall identify the specific deficiencies in the application that
resulted in the denial.
3. Response by Applicant to Adverse Board
Action
No later than 30 days following receipt of written notice
from the board, or within such longer or shorter time as the board may specify,
an applicant may, as the case may be-
A. Submit an application with modifications
requested by the board;
B. Furnish
additional information requested by the board;
C. Make site modifications requested by the
board;
D. Request a hearing to
contest a preliminary denial; or
E.
Request a hearing to contest a condition imposed by the board.
F. Failure of the applicant to act within the
applicable time period shall result in the automatic denial of the application
without need of further action by the board or, in the case of applications
conditionally approved, finality of the conditions.
4. License Term; Renewal
All extended hospital pharmacy licenses expire annually on
December 31. A licensee may renew the license by completing the renewal
application form provided by the board and remitting the license fee required
by Chapter 10, Section
5(27) of the rules
of the Department of Professional and Financial Regulation, Office of
Professional and Occupational Regulation, entitled "Establishment of License
Fees."
5. Change of
Ownership, Location or Application Information
Upon a change of ownership, the hospital in which the
extended hospital pharmacy is located shall file a new application with the
board no less than 7 days prior to the change. Upon a change of location, the
hospital in which the extended hospital pharmacy is located shall file a new
application with the board no less than 7 days prior to the change. The
licensee shall notify the board of any other change in the information provided
on its application within 10 days after the change.
6.
Notice of Termination of Employment
of Pharmacist For Drug-Related Reasons or Theft
An extended hospital pharmacy shall notify the board of the
termination of employment of a pharmacist for drug-related reasons or theft as
required by Chapter 30, Section
1(26) of the board's
rules.
