| (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.
|
| Source Note: The provisions of this §291.54 adopted to be effective March 19, 1998, 23 TexReg 2815; amended to be effective June 1, 2002, 27 TexReg 1781; amended to be effective June 23, 2003, 28 TexReg 4638; amended to be effective June 6, 2004, 29 TexReg 5362; amended to be effective September 14, 2010, 35 TexReg 8357; amended to be effective September 14, 2015, 40 TexReg 6110 |
