22 Tex. Admin. Code § 291.54 - Operational Standards
(a) Licensing
requirements.
(1) It is unlawful for a person
to provide radioactive drug services unless such provision is performed by a
person licensed to act as an authorized nuclear pharmacist, as defined by the
board, or is a person acting under the direct supervision of an authorized
nuclear pharmacist acting in accordance with the Act and its rules, and the
regulations of the Texas Department of State Health Services, Radiation Control
Program. Subsection (a) of this section does not apply to:
(A) a licensed practitioner or his or her
designated agent for administration to his or her patient, provided no person
may receive, possess, use, transfer, own, acquire, or dispose of
radiopharmaceuticals except as authorized in a specific or a general license as
provided in accordance with the requirements of the Texas Department of State
Health Services, Radiation Control Program, Texas Administrative Code, Title
25, Part 1, Subchapter F, §289.252 relating to Licensing of Radioactive
Material, or the Act;
(B)
institutions and/or facilities with nuclear medicine services operated by
practitioners and who are licensed by the Texas Department of State Health
Services, Radiation Control Program, to prescribe, administer, and dispense
radioactive materials (drugs and/or devices).
(2) An applicant for a Class B pharmacy shall
provide evidence to the board of the possession of a Texas Department of State
Health Services radioactive material license or proof of application for a
radioactive material license.
(3) A
Class B 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).
(4)
A Class B 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 B pharmacy which changes location and/or name shall notify the board
within ten days of the change and file for an amended license as specified in
§
291.3 of this title.
(6) A Class B 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 B pharmacy shall notify the board
in writing within ten days of closing, following the procedures in §
291.5 of this title (relating to
Closing a Pharmacy).
(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) A Class B pharmacy, licensed under the
provisions of the Act, § 560.051(a)(2), 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 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 Requirements), to the extent such rules are applicable to
the operation of the pharmacy.
(11)
A Class B pharmacy engaged in the compounding of non-sterile preparations,
including radioactive preparations, shall comply with the provisions of §
291.131 of this title (relating to
Pharmacies Compounding Non-Sterile Preparations).
(12) A Class B pharmacy engaged in the
compounding of sterile preparations, including radioactive preparations, shall
comply with the provisions of §
291.133 of this title (relating to
Pharmacies Compounding Sterile Preparations) using only radiopharmaceuticals
from FDA-approved drug products.
(13) Effective June 1, 2016, a Class B
pharmacy may not renew a pharmacy license unless the pharmacy has been
inspected by the board within the last renewal period.
(b) Environment.
(1) General requirements.
(A) The pharmacy shall be arranged in an
orderly fashion and kept clean. All required equipment shall be clean and in
good operating condition.
(B) The
pharmacy shall have a sink with hot and cold running water within the pharmacy,
exclusive of restroom facilities, available to all pharmacy personnel and
maintained in a sanitary condition.
(C) The pharmacy shall be properly lighted
and ventilated.
(D) The temperature
of the pharmacy shall be maintained within a range compatible with the proper
storage of drugs. The temperature of the refrigerator shall be maintained
within a range compatible with the proper storage of drugs requiring
refrigeration.
(E) If the 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.
(2) Security requirements.
(A) All areas occupied by a pharmacy shall be
capable of being locked by key, combination or other mechanical or electronic
means to prohibit unauthorized access, when a pharmacist is not on-site except
as provided in subparagraph (B) of this paragraph.
(B) The pharmacy may authorize personnel to
gain access to that area of the pharmacy containing dispensed
radiopharmaceuticals, in the absence of the pharmacist, for the purpose of
retrieving the radiopharmaceuticals to be delivered patients. If the pharmacy
allows such after-hours access, the area containing the dispensed
radiopharmaceuticals shall be an enclosed and lockable area separate from the
area containing undispensed prescription drugs. A list of the authorized
personnel having such access shall be in the pharmacy's policy and procedure
manual.
(C) Each pharmacist while
on duty shall be responsible for the security of the prescription department,
including provisions for effective control against theft or diversion of
prescription drugs, and records for such drugs
(c) Prescription dispensing and delivery.
(1) Generic Substitution. A pharmacist may
substitute on a prescription drug order issued for a brand name product
provided the substitution is authorized and performed in compliance with
Chapter 309 of this title (relating to Substitution of Drug
Products).
(2) Prescription
containers (immediate inner containers).
(A) A
drug dispensed pursuant to a radioactive prescription drug order shall be
dispensed in an appropriate immediate inner container as follows.
(i) If a drug is susceptible to light, the
drug shall be dispensed in a light-resistant container.
(ii) If a drug is susceptible to moisture,
the drug shall be dispensed in a tight container.
(iii) The container should not interact
physically or chemically with the drug product placed in it so as to alter the
strength, quality, or purity of the drug beyond the official
requirements.
(B)
Immediate inner prescription containers or closures shall not be
re-used.
(3) Delivery
containers (outer containers).
(A)
Prescription containers may be placed in suitable containers for delivery which
will transport the radiopharmaceutical safely in compliance with all applicable
laws and regulations.
(B) Delivery
containers may be re-used provided they are maintained in a manner to prevent
cross contamination.
(4)
Labeling.
(A) The immediate inner container
of a radiopharmaceutical shall be labeled with:
(i) standard radiation symbol;
(ii) the words "caution-radioactive material"
or "danger, radioactive material";
(iii) the name of the radiopharmaceutical or
its abbreviation; and
(iv) the
unique identification number of the prescription.
(B) The outer container of a
radiopharmaceutical shall be labeled with:
(i) the name, address, and phone number of
the pharmacy;
(ii) the date
dispensed;
(iii) the directions for
use, if applicable;
(iv) the unique
identification number of the prescription;
(v) the name of the patient if known, or the
statement, "for physician use" if the patient is unknown;
(vi) the standard radiation symbol;
(vii) the words "caution-radioactive
material" or "danger, radioactive material";
(viii) the name of the radiopharmaceutical or
its abbreviation;
(ix) the amount
of radioactive material contained in millicuries (mCi), microcuries (uCi), or
bequerels (Bq) and the corresponding time that applies to this activity, if
different from the requested calibration date and time;
(x) the initials or identification codes of
the person preparing the product and the authorized nuclear pharmacist who
checked and released the final product unless recorded in the pharmacy's data
processing system. The record of the identity of these individuals shall not be
altered in the pharmacy's data processing system.
(xi) if a liquid, the volume in
milliliters;
(xii) the requested
calibration date and time; and
(xiii) the expiration date and/or
time.
(C) The amount of
radioactivity shall be determined by radiometric methods for each individual
preparation immediately at the time of dispensing and calculations shall be
made to determine the amount of activity that will be present at the requested
calibration date and time, due to radioactive decay in the intervening period,
and this activity and time shall be placed on the label per requirements set
out in paragraph (4) of this subsection.
(d) Equipment. The following minimum
equipment is required in a nuclear pharmacy:
(1) vertical laminar flow hood;
(2) dose calibrator;
(3) a calibrated system or device (i.e.,
thermometer) to monitor the temperature to ensure that proper storage
requirements are met, if preparations are stored in the refrigerator;
(4) if applicable, a Class A prescription
balance, or analytical balance and weights. Such balance shall be properly
maintained and subject to periodic inspection by the board.
(5) scintillation analyzer;
(6) microscope and hemocytometer;
(7) equipment and utensils necessary for the
proper compounding of prescription drug or medication orders. Such equipment
and utensils used in the compounding process shall be:
(A) of appropriate design, appropriate
capacity, and be operated within designed operational limits;
(B) of suitable composition so that surfaces
that contact components, in-process material, or drug products shall not be
reactive, additive, or absorptive so as to alter the safety, identity,
strength, quality, or purity of the drug product beyond acceptable
standards;
(C) cleaned and
sanitized immediately prior to each use; and
(D) routinely inspected, calibrated (if
necessary), or checked to ensure proper performance;
(8) appropriate disposal containers for used
needles, syringes, etc., and if applicable, cytotoxic waste from the
preparation of chemotherapeutic agents, and/or biohazardous waste;
(9) all necessary supplies, including:
(A) disposable needles, syringes, and other
aseptic mixing;
(B) disinfectant
cleaning solutions;
(C) hand
washing agents with bactericidal action;
(D) disposable, lint free towels or
wipes;
(E) appropriate filters and
filtration equipment;
(F)
radioactive spill kits, if applicable; and
(G) masks, caps, coveralls or gowns with
tight cuffs, shoe covers, and gloves, as applicable.
(10) adequate glassware, utensils, gloves,
syringe shields and remote handling devices, and adequate equipment for product
quality control;
(11) adequate
shielding material;
(12) data
processing system including a printer or comparable equipment;
(13) radiation dosimeters for visitors and
personnel and log entry book;
(14)
exhaust/fume hood with monitor, for storage and handling of all volatile
radioactive drugs if applicable, to be determined by the Texas Department of
State Health Services, Radiation Control Program; and
(15) adequate radiation monitor(s).
(e) Library. A nuclear pharmacy
shall maintain a reference library which shall include the following in hard
copy or electronic format current or updated copies of the following:
(1) Texas Pharmacy Act and rules;
(2) Texas Dangerous Drug Act and
rules;
(3) Texas Controlled
Substances Act and rules; and
(4)
Federal Controlled Substances Act and rules (or official publication describing
the requirements of the Federal Controlled Substances Act and rules);
and
(5) a minimum of one text
dealing with nuclear medicine science.
(f) Radiopharmaceuticals and/or radioactive
materials.
(1) General requirements.
(A) Radiopharmaceuticals may only be
dispensed pursuant to a radioactive prescription drug order.
(B) An authorized nuclear pharmacist may
distribute radiopharmaceuticals to authorized users for patient use. A nuclear
pharmacy may furnish radiopharmaceuticals for departmental or physicians' use
if such authorized users maintain a Texas radioactive materials
license.
(C) An authorized nuclear
pharmacist may transfer to authorized users radioactive materials not intended
for drug use in accordance with the requirements of the Texas Department of
State Health Services, Radiation Control Program, Texas Administrative Code,
Title 25, Part 1, Subchapter F, §289.252 relating to Licensing of
Radioactive Material.
(D) The
transportation of radioactive materials from the nuclear pharmacy must be in
accordance with current state and federal transportation regulations.
(2) Procurement and storage.
(A) The pharmacist-in-charge shall have the
responsibility for the procurement and storage of drugs, but may receive input
from other appropriate staff relative to such responsibility.
(B) Prescription drugs and devices shall be
stored within the prescription department or a locked storage area.
(C) All drugs shall be stored at the proper
temperature, as defined in the USP/NF and §
291.15 of this title (relating to
Storage of Drugs).
(D) The
pharmacy's generator(s) shall be stored and eluted in an ISO Class 7 or ISO
Class 8 environment as specified in §`291.133 of this title.
(3) Out-of-date and other unusable
drugs or devices.
(A) Any drug or device
bearing an expiration date shall not be dispensed beyond the expiration date of
the drug or device.
(B) Outdated
and other unusable drugs or devices shall be removed from dispensing stock and
shall be quarantined together until such drugs or devices are disposed of
properly.
Notes
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