| (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.
(H) An FEMCF pharmacy, which also operates another
type of pharmacy which would otherwise be required to be licensed
under the Act, §560.051(a)(1), concerning community pharmacy
(Class A), is not required to secure a license for the other type
of pharmacy; provided, however, such license is required to 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), to the extent such sections are applicable
to the operation of the pharmacy.
(I) An FEMCF pharmacy engaged in the compounding of
non-sterile preparations shall comply with the provisions of §291.131
of this title.
(2) Environment.
(A) General requirements.
(i) Each FEMCF shall have a designated work area separate
from patient areas, and which shall have space adequate for the size
and scope of pharmaceutical services and shall have adequate space
and security for the storage of drugs.
(ii) The FEMCF pharmacy shall be arranged in an orderly
fashion and shall be kept clean. All required equipment shall be clean
and in good operating condition.
(B) Special requirements.
(i) The FEMCF pharmacy shall have locked storage for
Schedule II controlled substances and other controlled drugs requiring
additional security.
(ii) The FEMCF pharmacy shall have a designated area
for the storage of poisons and externals separate from drug storage
areas.
(C) Security.
(i) The pharmacy and storage areas for prescription
drugs and/or devices shall be enclosed and capable of being locked
by key, combination, or other mechanical or electronic means, so as
to prohibit access by unauthorized individuals. Only individuals authorized
by the pharmacist-in-charge may enter the pharmacy or have access
to storage areas for prescription drugs and/or devices.
(ii) The pharmacist-in-charge shall consult with FEMCF
personnel with respect to security of the drug storage areas, including
provisions for adequate safeguards against theft or diversion of dangerous
drugs, controlled substances, and records for such drugs.
(iii) The pharmacy shall have locked storage for Schedule
II controlled substances and other drugs requiring additional security.
(3) Equipment and supplies. FEMCFs supplying drugs
for outpatient use shall have the following equipment and supplies:
(A) data processing system including a printer or comparable
equipment;
(B) adequate supply of child-resistant, moisture-proof,
and light-proof containers; and
(C) adequate supply of prescription labels and other
applicable identification labels.
(4) Library. A reference library shall be maintained
that includes the following in hard copy or electronic format and
that pharmacy personnel shall be capable of accessing at all times:
(A) current copies of the following:
(i) Texas Pharmacy Act and rules;
(ii) Texas Dangerous Drug Act and rules;
(iii) Texas Controlled Substances Act and rules; and
(iv) Federal Controlled Substances Act and rules or
official publication describing the requirements of the Federal Controlled
Substances Act and rules;
(B) at least one current or updated general drug information
reference which is required to contain drug interaction information
including information needed to determine severity or significance
of the interaction and appropriate recommendations or actions to be
taken; and
(C) basic antidote information and the telephone number
of the nearest regional poison control center.
(5) Drugs.
(A) Procurement, preparation, and storage.
(i) The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from
other appropriate staff of the facility, relative to such responsibility.
(ii) The pharmacist-in-charge shall have the responsibility
for determining specifications of all drugs procured by the facility.
Cont'd... |
