(a) Licensing requirements.
(1) A Class E pharmacy shall register with the board
on a pharmacy license application provided by the board, following
the procedures specified in §291.1 of this title (relating to
Pharmacy License Application).
(2) On initial application, the pharmacy shall follow
the procedures specified in §291.1 of this title and then provide
the following additional information specified in §560.052(c)
and (f) of the Act (relating to Qualifications):
(A) evidence that the applicant holds a pharmacy license,
registration, or permit issued by the state in which the pharmacy
is located;
(B) the name of the owner and pharmacist-in-charge
of the pharmacy for service of process;
(C) evidence of the applicant's ability to provide
to the board a record of a prescription drug order dispensed by the
applicant to a resident of this state not later than 72 hours after
the time the board requests the record;
(D) an affidavit by the pharmacist-in-charge which
states that the pharmacist has read and understands the laws and rules
relating to a Class E pharmacy;
(E) proof of creditworthiness; and
(F) an inspection report issued not more than two years
before the date the license application is received and conducted
by the pharmacy licensing board in the state of the pharmacy's physical
location.
(i) A Class E pharmacy may submit an inspection report
issued by an entity other than the pharmacy licensing board of the
state in which the pharmacy is physically located if the state's licensing
board does not conduct inspections as follows:
(I) an individual approved by the board who is not
employed by the pharmacy but acting as a consultant to inspect the
pharmacy;
(II) an agent of the National Association of Boards
of Pharmacy;
(III) an agent of another State Board of Pharmacy;
or
(IV) an agent of an accrediting body, such as the Joint
Commission on Accreditation of Healthcare Organizations.
(ii) The inspection must be substantively equivalent
to an inspection conducted by the board.
(3) On renewal of a license, the pharmacy shall complete
the renewal application provided by the board and, as specified in §561.0031
of the Act, provide an inspection report issued not more than three
years before the date the renewal application is received and conducted
by the pharmacy licensing board in the state of the pharmacy's physical
location.
(A) A Class E pharmacy may submit an inspection report
issued by an entity other than the pharmacy licensing board of the
state in which the pharmacy is physically located if the state's licensing
board does not conduct inspections as follows:
(i) an individual approved by the board who is not
employed by the pharmacy but acting as a consultant to inspect the
pharmacy;
(ii) an agent of the National Association of Boards
of Pharmacy;
(iii) an agent of another State Board of Pharmacy;
or
(iv) an agent of an accrediting body, such as the Joint
Commission on Accreditation of Healthcare Organizations.
(B) The inspection must be substantively equivalent
to an inspection conducted by the board.
(4) A Class E pharmacy which changes ownership shall
notify the board within ten days of the change of ownership and apply
for a new and separate license as specified in §291.3 of this
title (relating to Required Notifications).
(5) A Class E pharmacy which changes location and/or
name shall notify the board of the change as specified in §291.3
of this title.
(6) A Class E pharmacy owned by a partnership or corporation
which changes managing officers shall notify the board in writing
of the names of the new managing officers within ten days of the change,
following the procedures in §291.3 of this title.
(7) A Class E pharmacy shall notify the board in writing
within ten days of closing.
(8) A separate license is required for each principal
place of business and only one pharmacy license may be issued to a
specific location.
(9) A fee as specified in §291.6 of this title
(relating to Pharmacy License Fees) will be charged for the issuance
and renewal of a license and the issuance of an amended license.
(10) The board may grant an exemption from the licensing
requirements of this Act on the application of a pharmacy located
in a state of the United States other than this state that restricts
its dispensing of prescription drugs or devices to residents of this
state to isolated transactions.
(11) A Class E pharmacy engaged in the centralized
dispensing of prescription drug or medication orders or outsourcing
of prescription drug order dispensing to a central fill pharmacy shall
comply with the provisions of §291.125 of this title (relating
to Centralized Prescription Dispensing).
(12) A Class E pharmacy engaged in central processing
of prescription drug or medication orders shall comply with the provisions
of §291.123 of this title (relating to Central Prescription or
Medication Order Processing).
(13) A Class E pharmacy engaged in the compounding
of non-sterile preparations shall comply with the provisions of §291.131
of this title (relating to Pharmacies Compounding Non-Sterile Preparations).
(14) Class E pharmacy personnel shall not compound
sterile preparations unless the pharmacy has applied for and obtained
a Class E-S pharmacy license.
(15) A Class E pharmacy, which operates as a community
type of pharmacy which would otherwise be required to be licensed
under the Act §560.051(a)(1) (Community Pharmacy (Class A)),
shall comply with the provisions of §291.31 of this title (relating
to Definitions), §291.32 of this title (relating to Personnel), §291.33
of this title (relating to Operational Standards), §291.34 of
this title (relating to Records), and §291.35 of this title (relating
to Official Prescription Requirements), contained in Community Pharmacy
(Class A); or which operates as a nuclear type of pharmacy which would
otherwise be required to be licensed under the Act §560.051(a)(2)
(Nuclear Pharmacy (Class B)), shall comply with the provisions of §291.51
of this title (relating to Purpose), §291.52 of this title (relating
to Definitions), §291.53 of this title (relating to Personnel), §291.54
of this title (relating to Operational Standards), and §291.55
of this title (relating to Records), contained in Nuclear Pharmacy
(Class B), to the extent such sections are applicable to the operation
of the pharmacy.
(b) Prescription dispensing and delivery.
(1) General.
(A) All prescription drugs and/or devices shall be
dispensed and delivered safely and accurately as prescribed.
(B) The pharmacy shall maintain adequate storage or
shipment containers and use shipping processes to ensure drug stability
and potency. Such shipping processes shall include the use of packaging
material and devices to ensure that the drug is maintained at an appropriate
temperature range to maintain the integrity of the medication throughout
the delivery process.
(C) The pharmacy shall utilize a delivery system which
is designed to assure that the drugs are delivered to the appropriate
patient.
(D) All pharmacists shall exercise sound professional
judgment with respect to the accuracy and authenticity of any prescription
drug order they dispense. If the pharmacist questions the accuracy
or authenticity of a prescription drug order, he/she shall verify
the order with the practitioner prior to dispensing.
(E) Prior to dispensing a prescription, pharmacists
shall determine, in the exercise of sound professional judgment, that
the prescription is a valid prescription. A pharmacist may not dispense
a prescription drug if the pharmacist knows or should have known that
the prescription was issued on the basis of an Internet-based or telephonic
consultation without a valid patient-practitioner relationship.
(F) Subparagraph (E) of this paragraph does not prohibit
a pharmacist from dispensing a prescription when a valid patient-practitioner
relationship is not present in an emergency situation (e.g. a practitioner
taking calls for the patient's regular practitioner).
(2) Drug regimen review.
(A) For the purpose of promoting therapeutic appropriateness,
a pharmacist shall, prior to or at the time of dispensing a prescription
drug order, review the patient's medication record. Such review shall
at a minimum identify clinically significant:
(i) inappropriate drug utilization;
(ii) therapeutic duplication;
(iii) drug-disease contraindications;
(iv) drug-drug interactions;
(v) incorrect drug dosage or duration of drug treatment;
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