| (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;
Cont'd... |
