| (a) Licensing requirements.
(1) A Class C 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).
(2) A Class C 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).
(3) A Class C pharmacy which changes location and/or
name shall notify the board of the change as specified in §291.3
of this title.
(4) A Class C 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.
(5) A Class C 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).
(6) 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.
(7) A separate license is required for each principal
place of business and only one pharmacy license may be issued to a
specific location.
(8) A Class C pharmacy, licensed under the Act, §560.051(a)(3),
which also operates another type of pharmacy which would otherwise
be required to be licensed under the Act, §560.051(a)(1) (Community
Pharmacy (Class A)) or the Act, §560.051(a)(2) (Nuclear Pharmacy
(Class B)), is not required to secure a license for the such other
type of pharmacy; provided, however, such licensee 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 Records), contained in Community Pharmacy
(Class A), or §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.
(9) A Class C 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).
(10) Class C pharmacy personnel shall not compound
sterile preparations unless the pharmacy has applied for and obtained
a Class C-S pharmacy.
(11) A Class C pharmacy engaged in the provision of
remote pharmacy services, including storage and dispensing of prescription
drugs, shall comply with the provisions of §291.121 of this title
(relating to Remote Pharmacy Services).
(12) A Class C pharmacy engaged in centralized prescription
dispensing and/or prescription drug or medication order processing
shall comply with the provisions of §291.123 of this title (relating
to Central Prescription Drug or Medication Order Processing) and/or §291.125
of this title (relating to Centralized Prescription Dispensing).
(13) A Class C pharmacy with an ongoing clinical pharmacy
program that proposes to allow a pharmacy technician to verify the
accuracy of work performed by another pharmacy technician relating
to the filling of floor stock and unit dose distribution systems for
a patient admitted to the hospital if the patient's orders have previously
been reviewed and approved by a pharmacist shall make application
to the board and submit any information specified on the application.
(14) A rural hospital that wishes to allow a pharmacy
technician to perform the duties specified in §291.73(e)(2)(D)
of this title (relating to Personnel), shall make application to the
board and submit any information specified on the application.
(A) A rural hospital may not allow a pharmacy technician
to perform the duties specified in §291.73(e)(2)(D) of this title
until the board has reviewed and approved the application and issued
an amended license to the pharmacy.
(B) Every two years, in conjunction with the application
for renewal of the pharmacy license, the pharmacist-in-charge shall
update the application for pharmacy technicians to perform the duties
specified in §291.73(e)(2)(D) of this title and shall attest
as required on the application.
(b) Environment.
(1) General requirements.
(A) The institutional pharmacy shall have adequate
space necessary for the storage, compounding, labeling, dispensing,
and sterile preparation of drugs prepared in the pharmacy, and additional
space, depending on the size and scope of pharmaceutical services.
(B) The institutional pharmacy shall be arranged in
an orderly fashion and shall be kept clean. All required equipment
shall be clean and in good operating condition.
(C) A sink with hot and cold running water exclusive
of restroom facilities shall be available to all pharmacy personnel
and shall be maintained in a sanitary condition at all times.
(D) The institutional pharmacy shall be properly lighted
and ventilated.
(E) The temperature of the institutional pharmacy shall
be maintained within a range compatible with the proper storage of
drugs. The temperature of the refrigerator and/or freezer shall be
maintained within a range compatible with the proper storage of drugs.
(F) If the institutional pharmacy has flammable materials,
the pharmacy shall have a designated area for the storage of flammable
materials. Such area shall meet the requirements set by local and
state fire laws.
(G) The institutional pharmacy shall store antiseptics,
other drugs for external use, and disinfectants separately from internal
and injectable medications.
(2) Security requirements.
(A) The institutional pharmacy 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 shall enter
the pharmacy.
(B) Each pharmacist on duty shall be responsible for
the security of the institutional pharmacy, including provisions for
adequate safeguards against theft or diversion of dangerous drugs,
controlled substances, and records for such drugs.
(C) The institutional pharmacy shall have locked storage
for Schedule II controlled substances and other drugs requiring additional
security.
(c) Equipment and supplies. Institutional pharmacies
distributing medication orders shall have the following equipment:
(1) data processing system including a printer or comparable
equipment; and
(2) refrigerator and/or freezer and a system or device
(e.g., thermometer) to monitor the temperature to ensure that proper
storage requirements are met.
(d) 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:
(1) current copies of the following:
(A) Texas Pharmacy Act and rules;
(B) Texas Dangerous Drug Act and rules;
(C) Texas Controlled Substances Act and regulations;
and
(D) Federal Controlled Substances Act and regulations
(or official publication describing the requirements of the Federal
Controlled Substances Act and regulations);
(2) at least one current or updated reference from
each of the following categories:
(A) drug interactions. A reference text on drug interactions,
such as Drug Interaction Facts. A separate reference is not required
if other references maintained by the pharmacy contain drug interaction
information including information needed to determine severity or
significance of the interaction and appropriate recommendations or
actions to be taken;
(B) a general information reference text;
(3) a current or updated reference on injectable drug
products;
(4) basic antidote information and the telephone number
of the nearest regional poison control center;
(5) metric-apothecary weight and measure conversion
charts.
(e) Absence of a pharmacist.
(1) Medication orders.
(A) In facilities with a full-time pharmacist, if a
practitioner orders a drug for administration to a bona fide patient
of the facility when the pharmacy is closed, the following is applicable:
Cont'd... |
