20 CSR 2220-2.020 - Pharmacy Permits
(1) All permits for the operation of a
pharmacy shall expire on the date specified by the director of the Division of
Professional Registration pursuant to
20 CSR
2231-2.010.
(2) A pharmacy permit may be issued on the
application of the owners. If the owner is a corporation, an officer of the
corporation must sign the application as the applicant. If the owner is a
partnership, a partner must sign the application as the applicant. If the owner
is a limited liability partnership, a general partner must sign the application
as the applicant. If the owner is a limited liability company, a member must
sign the application as the applicant. In the case where a pharmacy is owned
and operated by a person(s) who is a licensed pharmacist and in active charge
of the pharmacy, the application for permit can be made by either party.
Alternatively, a pharmacy permit application may be signed by an attorney or
other person lawfully granted power of attorney to sign the application on the
applicant's behalf. In such case, a representative of the applicant shall
review the application for truth and accuracy prior to submitting the
application to the board. Proof of a power of attorney designation shall be
submitted with the application.
(A) An
application for a pharmacy permit will become null and void if the applicant
fails to complete the process for licensure within six (6) months of receipt of
the application by the board.
(3) When a pharmacy changes ownership, the
original permit becomes void on the effective date of the change of ownership.
Before any new business entity resulting from the change opens a pharmacy for
business, it must obtain a new permit from the board. A temporary license shall
be issued once a completed application and fee have been received by the board.
The effective date of the temporary license may be the date the change of
ownership is listed as effective on the application. Such license shall remain
in effect until a permanent license is issued or denied by the board.
(A) A change of ownership of a pharmacy owned
by a sole proprietor is deemed to have occurred when-
1. The business is sold and the sale becomes
final;
2. The proprietor enters into
a partnership with another individual or business entity; or
3. The proprietor dies; provided, however,
that the proprietor's estate may continue to operate the pharmacy under the
licensed pharmacist in good standing in this state, but in no case for a period
of more than one (1) year and only so long as appropriate pharmacy permit fees
are paid.
(B) If a
corporation owns a pharmacy, it is not necessary to obtain a new license if the
owners of the stock change. If a limited liability partnership or a limited
liability company owns a pharmacy, it is not necessary to obtain a new license
if the partners or members of the company change, as long as the partnership or
company is not dissolved by that change. It is necessary to file written notice
with the State Board of Pharmacy within ten (10) days after a change occurs in
partners in a limited liability partnership, or in members in a limited
liability company. This notification must be in writing and certified. However,
when a corporation, limited liability partnership, or limited liability company
begins ownership of a pharmacy or transfers ownership of a pharmacy, a new
license must be obtained regardless of the relationship between the previous
and subsequent owners.
(C) All
individuals or business entities owning twenty-five percent (25%) or more of
the ownership of any entity owning a pharmacy must notify the board within
thirty (30) days of acquiring the percentage.
(4) If an individual or business entity
operating a pharmacy changes the location of the pharmacy to a new facility
(structure), the pharmacy shall not open for business at the new location until
the board or its duly authorized agent has inspected the premises of the new
location and approved it and the pharmacy as being in compliance with section
338.240, RSMo and all other
provisions of the law. Upon the approval and receipt of a change of location
fee, the board shall issue a permit authorizing operation of a pharmacy at the
new location, and the permit shall bear the same number as the previous
pharmacy permit. However, the permit remains valid if the pharmacy address
changes, but not the location, and an amended permit will be issued without
charge under these circumstances.
(A)
Remodeling of a licensed pharmacy within an existing structure shall be deemed
to have occurred when any change in the storage conditions of the Schedule II
controlled substances is made or new connections to water/sewer resources are
made or any changes in the overall physical security of drugs stored in the
pharmacy as defined in
20 CSR
2220-2.010(1)(H) are made. Remodeling
as defined within this section will not require the initiation of any change of
location procedures. Satisfactory evidence of plans for any remodeling of a
pharmacy must be provided to the board office thirty (30) days in advance of
commencing such changes along with an affidavit showing any changes to the
pharmacy physical plant and the projected completion date for any
remodeling.
(5) Permits,
when issued, will bear an original number. Permits must be posted in a
conspicuous place in the pharmacy to which it is issued.
(6) No pharmacy permit will be issued unless
the pharmacy area is under the direct supervision of a licensed pharmacist in
good standing with the Missouri State Board of Pharmacy who is designated as
the pharmacist-in-charge and meets the requirements of
20 CSR
2220-2.090.
(7) If the owner/applicant is not the
licensed pharmacistin-charge, then the pharmacist-in-charge must meet the
requirements of 20 CSR 2220-2.090 and complete
the pharmacistin-charge affidavit of the permit application.
(8) The names of all pharmacists regularly
working in a pharmacy shall be clearly displayed on the premises of every
establishment having a pharmacy permit.
(9) The following classes of pharmacy permits
or licenses are hereby established for entities providing services as defined
in section 338.010, RSMo:
(A) Class A: Community/Ambulatory. A pharmacy
that provides services as defined in section
338.010, RSMo to the general
public;
(B) Class B: Hospital
Pharmacy. A pharmacy owned, managed, or operated by a hospital as defined by
section 197.020, RSMo, or a clinic or
facility under common control, management, or ownership of the same hospital or
hospital system. This section shall not be construed to require a Class B
hospital pharmacy permit or license for hospitals solely providing services
within the practice of pharmacy under the jurisdiction of, and the licensure
granted by, the Department of Health and Senior Services under and pursuant to
Chapter 197, RSMo;
(C) Class C:
Long-Term Care. A pharmacy that provides services as defined in section
338.010, RSMo by the dispensing
of drugs and devices to patients residing within long-term care facilities. A
long-term care facility means a nursing home, retirement care, mental care or
other facility or institution which provides extended health care to resident
patients;
(D) Class D: Non-Sterile
Compounding. A pharmacy that provides services as defined in section
338.010, RSMo and provides a
non-sterile compounded product as defined in
20 CSR
2220-2.400(1) and meets the following
criteria:
1. Any product made from any bulk
active ingredient in a batch quantity as defined in
20 CSR
2220-2.400(3);
(E) Class E: Radiopharmaceutical. A pharmacy
that is not open to the general public and provides services as defined in
section 338.010, RSMo that prepares and
dispenses radioactive drugs as defined by the Food and Drug Administration
(FDA) and drugs related to the use of radioactive drugs to health care
providers for use in the treatment or diagnosis of disease and that maintains a
qualified nuclear pharmacist as the pharmacist-in-charge;
(F) Class F: Renal Dialysis. A pharmacy that
is not open to the general public that provides services as defined in section
338.010, RSMo limited to the
dispensing of renal dialysis solutions and other drugs and devices associated
with dialysis care;
(G) Class G:
Medical Gas. A pharmacy that provides services as defined in section
338.010, RSMo through the
provision of oxygen and other prescription gases for therapeutic
uses;
(H) Class H: Sterile Product
Compounding. A pharmacy that provides services as defined in section
338.010, RSMo, and provides a
sterile pharmaceutical as defined in 20 CSR 22202.200;
(I) Class I: Consultant. A location where any
activity defined in section
338.010, RSMo is conducted, but
which does not include the procurement, storage, possession or ownership of any
drugs from the location;
(J) Class
J: Shared Service. A pharmacy engaged in the processing of a request from
another pharmacy to fill or refill a prescription drug order, or that performs
or assists in the performance of functions associated with the dispensing
process, drug utilization review (DUR), claims adjudication, refill
authorizations, and therapeutic interventions;
(K) Class K: Internet. A pharmacy that
provides services as defined in section
338.010, RSMo, and is involved
in the receipt, review, preparation, compounding, dispensing, or offering for
sale any drugs, chemicals, medicines, or poisons for any new prescriptions
originating from the Internet for greater than ninety percent (90%) of the
total new prescription volume on any day;
(L) Class L: Veterinary. A pharmacy engaged
in the sale, dispensing, or filling of a legend drug for use in animals that
must only be dispensed by prescription under state or federal law, provided
that an additional Class L pharmacy permit shall not be required for pharmacies
holding a Class A pharmacy permit that are also engaged in the sale,
dispensing, or filling of a legend drug for animal use;
(M) Class M: Specialty (bleeding disorder). A
pharmacy that provides blood-clotting products and ancillary infusion equipment
or supplies to patients with bleeding disorders, as defined by
20 CSR
2220-6.100;
(N) Class N: Automated dispensing system
(health care facility). An automated dispensing system as defined in
20 CSR
2220-2.900 that is located in a facility where medical
services are provided to patients on the premises of or at the same physical
location as such facility;
(O) Class
O: Automated dispensing system (ambulatory care). An automated dispensing
system as defined in 20 CSR 22202.900 that is not located in a healthcare
facility identified in subsection (9)(N) of this rule; and
(P) Class P: Practitioner office/clinic. A
pharmacy that is located in or on the premises of an office or clinic of a
healthcare practitioner licensed in the United States who is authorized to
prescribe medication by law and that provides pharmacy services as defined in
section 338.010, RSMo, solely for
patients of such practitioner or practitioners.
(10) Pharmacy applications for initial
licensure or renewals of a license shall accurately note each class of pharmacy
that is practiced at the location noted on the application or renewal thereof.
The permit (license) issued by the board shall list each class of licensure
that the pharmacy is approved to engage in. A Pharmacy Change of Classification
Application shall be filed with the board prior to adding or deleting any
pharmacy classes with the applicable fee.
(11) Prescriptions processed by any
classification of licensed pharmacy must be provided by a practitioner licensed
in the United States, authorized by law to prescribe drugs, and who has
performed a medical evaluation of the patient as required by law. A pharmacist
shall not dispense a prescription drug if the pharmacist has knowledge, or
reasonably should know under the circumstances, that the prescription order for
such drug was issued on the basis of an Internet-based questionnaire or without
a valid pre-existing patient-practitioner relationship.
Notes
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