| (xii) meeting all inspection and other requirements
of the Texas Pharmacy Act and this section; and
(xiii) maintaining records in a data processing system
such that the data processing system is in compliance with the requirements
for an FEMCF; and
(xiv) ensuring that a pharmacist visits the FEMCF at
least once each calendar week that the facility is open.
(2) Consultant pharmacist.
(A) The consultant pharmacist may be the pharmacist-in-charge.
(B) A written contract shall exist between the FEMCF
and any consultant pharmacist, and a copy of the written contract
shall be made available to the board upon request.
(3) Pharmacists.
(A) General.
(i) The pharmacist-in-charge shall be assisted by a
sufficient number of additional licensed pharmacists as may be required
to operate the FEMCF pharmacy competently, safely, and adequately
to meet the needs of the patients of the facility.
(ii) All pharmacists shall assist the pharmacist-in-charge
in meeting the responsibilities as outlined in paragraph (1)(B) of
this subsection and in ordering, administering, and accounting for
pharmaceutical materials.
(iii) All pharmacists shall be responsible for any
delegated act performed by pharmacy technicians or pharmacy technician
trainees under his or her supervision.
(iv) All pharmacists while on duty shall be responsible
for complying with all state and federal laws or rules governing the
practice of pharmacy.
(B) Duties. Duties of the pharmacist-in-charge and
all other pharmacists shall include, but need not be limited to, the
following:
(i) receiving and interpreting prescription drug orders
and oral medication orders and reducing these orders to writing either
manually or electronically;
(ii) selecting prescription drugs and/or devices and/or
suppliers; and
(iii) interpreting patient profiles.
(C) Special requirements for compounding non-sterile
preparations. All pharmacists engaged in compounding non-sterile preparations
shall meet the training requirements specified in §291.131 of
this title (relating to Pharmacies Compounding Non-Sterile Preparations).
(4) Pharmacy technicians and pharmacy technician trainees.
(A) General. All pharmacy technicians and pharmacy
technician trainees shall meet the training requirements specified
in §297.6 of this title (relating to Pharmacy Technician and
Pharmacy Technician Trainee Training).
(B) Duties. Pharmacy technicians and pharmacy technician
trainees may not perform any of the duties listed in paragraph (3)(B)
of this subsection. Duties may include, but need not be limited to,
the following functions, under the direct supervision of a pharmacist:
(i) prepacking and labeling unit and multiple dose
packages, provided a pharmacist supervises and conducts a final check
and affixes his or her name, initials, or electronic signature to
the appropriate quality control records prior to distribution;
(ii) preparing, packaging, compounding, or labeling
prescription drugs pursuant to medication orders, provided a pharmacist
supervises and checks the preparation;
(iii) compounding non-sterile preparations pursuant
to medication orders provided the pharmacy technicians or pharmacy
technician trainees have completed the training specified in §291.131
of this title;
(iv) bulk compounding, provided a pharmacist supervises
and conducts in-process and final checks and affixes his or her name,
initials, or electronic signature to the appropriate quality control
records prior to distribution;
(v) distributing routine orders for stock supplies
to patient care areas;
(vi) entering medication order and drug distribution
information into a data processing system, provided judgmental decisions
are not required and a pharmacist checks the accuracy of the information
entered into the system prior to releasing the order or in compliance
with the absence of pharmacist requirements contained in subsection
(d)(6)(D) and (E) of this section;
(vii) maintaining inventories of drug supplies;
(viii) maintaining pharmacy records; and
(ix) loading drugs into an automated medication supply
system. For the purpose of this clause, direct supervision may be
accomplished by physically present supervision or electronic monitoring
by a pharmacist.
(C) Procedures.
(i) Pharmacy technicians and pharmacy technician trainees
shall handle medication orders in accordance with standard written
procedures and guidelines.
(ii) Pharmacy technicians and pharmacy technician trainees
shall handle prescription drug orders in the same manner as pharmacy
technicians or pharmacy technician trainees working in a Class A pharmacy.
(D) Special requirements for compounding non-sterile
preparations. All pharmacy technicians and pharmacy technician trainees
engaged in compounding non-sterile preparations shall meet the training
requirements specified in §291.131 of this title.
(5) Owner. The owner of an FEMCF pharmacy shall have
responsibility for all administrative and operational functions of
the pharmacy. The pharmacist-in-charge may advise the owner on administrative
and operational concerns. The owner shall have responsibility for,
at a minimum, the following, and if the owner is not a Texas licensed
pharmacist, the owner shall consult with the pharmacist-in-charge
or another Texas licensed pharmacist:
(A) establishing policies for procurement of prescription
drugs and devices and other products dispensed from the FEMCF pharmacy;
(B) establishing and maintaining effective controls
against the theft or diversion of prescription drugs;
(C) if the pharmacy uses an automated medication supply
system, reviewing and approving all policies and procedures for system
operation, safety, security, accuracy and access, patient confidentiality,
prevention of unauthorized access, and malfunction;
(D) providing the pharmacy with the necessary equipment
and resources commensurate with its level and type of practice; and
(E) establishing policies and procedures regarding
maintenance, storage, and retrieval of records in a data processing
system such that the system is in compliance with state and federal
requirements.
(6) Identification of pharmacy personnel. All pharmacy
personnel shall be identified as follows:
(A) Pharmacy technicians. All pharmacy technicians
shall wear an identification tag or badge that bears the person's
name and identifies him or her as a pharmacy technician.
(B) Pharmacy technician trainees. All pharmacy technician
trainees shall wear an identification tag or badge that bears the
person's name and identifies him or her as a pharmacy technician trainee.
(C) Pharmacist interns. All pharmacist interns shall
wear an identification tag or badge that bears the person's name and
identifies him or her as a pharmacist intern.
(D) Pharmacists. All pharmacists shall wear an identification
tag or badge that bears the person's name and identifies him or her
as a pharmacist.
(d) Operational standards.
(1) Licensing requirements.
(A) An FEMCF pharmacy shall register annually or biennially
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).
(B) An FEMCF pharmacy which changes ownership shall
notify the board within 10 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).
(C) An FEMCF pharmacy which changes location and/or
name shall notify the board of the change within 10 days and file
for an amended license as specified in §291.3 of this title.
(D) A 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 10 days of the change,
following the procedures in §291.3 of this title.
(E) An FEMCF pharmacy shall notify the board in writing
within 10 days of closing, following the procedures in §291.5
of this title (relating to Closing a Pharmacy).
(F) A fee as specified in §291.6 of this title
(relating to Pharmacy License Fees) will be charged for issuance and
renewal of a license and the issuance of an amended license.
(G) A separate license is required for each principal
place of business and only one pharmacy license may be issued to a
specific location.
Cont'd... |
