usp 825 summary what you need to know
USP General Chapter <825> Impact on Nuclear Medicine Technology Do
Abstract
U.S. Pharmacopeia (USP) general chapter <825>, "Radiopharmaceuticals: Grooming, Compounding, Dispensing, and Repackaging," is a new standard proposed to provide minimum requirements for the preparation, compounding, dispensing, and repackaging of sterile and nonsterile radiopharmaceuticals. This new standard represents endeavors on the part of the USP to reply to appeals by nuclear medicine professionals to move beyond a minimal supplement to USP <797> and provide policies specific to radiopharmaceuticals. USP <825> provides nuclear pharmacies and nuclear medicine departments in hospitals and clinics with the benchmarks to appraise current practice activities and integrate needed changes to come across regulatory and accreditation audit reviews. This continuing education article focuses on components of USP <825> specific to the nuclear medicine technologist for a ameliorate understanding of obligations when preparing sterile radiopharmaceuticals for clinical use.
- USP <825>
- radiopharmaceutical compounding
- sterile radiopharmaceutical
- USP standards
Radiopharmaceuticals, or radioactive drugs, are controlled by international, federal, country, and even local agencies. The Nuclear Regulatory Commission or contracted agreement-state agencies regulate radiopharmaceuticals to ensure the prophylactic use of radioactive materials. The Department of Transportation and the Environmental Protection Agency control the shipment and disposal of radioactive drugs. Radiopharmaceuticals are included in the category of prescription drugs, with the Nutrient and Drug Assistants (FDA) responsible for manufacturing and ultimate patient safe. State medical and pharmacy boards require compliance with standards to ensure that providing prescription drugs to patients produces the best outcomes.
Wellness-care professionals involved in the use of radiopharmaceuticals must conform with a myriad of regulations, guidelines, and standards in a variety of practice settings to aid ensure patient safety and protect the general population and the surround. Compliance is often secured through the publication and expected ascertainment of practise standards, policies, procedures, and rules.
U.S. PHARMACOPEIA (USP)
Founded in 1820, the USP is a nongovernment arrangement that provides standards of identity, forcefulness, quality, purity, and labeling for medications, pharmaceutical excipients or additives, and dietary supplements. Originally formed to confirm the safe use of drugs through the publication of formulas, quality tests, and identity tests, the USP evolved over time and, through interactions with the FDA, began to develop and publish standards that describe storage, dispensing, packaging, preparation, and specifications for weather and practices for pharmaceutical compounding. USP publications, called general capacity, include both advisory and enforceable standards. The USP has no authorization to behave inspections. Country chemist's shop board inspectors and institutional accreditation agency surveyors ofttimes use USP standards for practice evaluation. USP standards are often cited in regulatory and reference publications.
THE USP AND RADIOPHARMACEUTICALS
In 1995, the USP provided information and recommendations for compounding sterile drug products in general chapter <1206>. Voluntary compliance with guidelines in USP <1206> proved inadequate, with big numbers of patients reportedly having infections caused by contaminated compounded drug products. In 2004, the USP published general chapter <797>, "Pharmaceutical Compounding: Sterile Preparations," which specifies that sterile compounding applies to all preadministration manipulations (preparation, storage, and transport) of compounded sterile preparations, including radiopharmaceuticals (1). Although this publication was generally ignored, nuclear medicine professionals were provided standards describing the preparation of sterile drugs, including radiopharmaceuticals, for patient use. Although radiopharmaceuticals were not explicitly mentioned in the original publication, the intent was that USP <797> would apply to all sterile compounding activities. The first revision of USP <797>, in 2008, included a department on radiopharmaceuticals as compounded sterile preparations; this revision contained standards for radiopharmaceuticals and nonradioactive drugs (one). Nearly hospitals and clinics outsource the compounding of radioactive drugs to commercial nuclear pharmacies. However, the preparation of radiopharmaceutical dosages for emergency procedures and other on-site manipulations involving radioactive drugs has been nether the guidance of the USP since 1995. The Joint Committee and other accreditation bodies, state boards of pharmacy, and the Centers for Medicare and Medicaid Services volition act to enforce the standards. Sterile compounding standards in USP full general chapters utilize to all places and all wellness-intendance personnel involved in the grooming, storage, manipulation, and transportation of compounded sterile preparations. With regard to radiopharmaceuticals, nuclear medicine technologists and nuclear medicine facilities are included among the health-care personnel to whom these standards apply. Forth with post-obit the regulations and accreditation standards, nuclear medicine technologists are directed to comply with USP standards on the preparation of sterile radiopharmaceuticals. USP standards are cited in published do and performance standards (ii) for the cleansing and garbing protocols to be used before staff enters make clean areas, as well as for protocols for aseptic technique in vial puncture procedures, for establishing beyond-use dates (BUDs) or beyond-apply times, and for proper storage of radiopharmaceutical kits, radionuclide generators, and prepared radiopharmaceuticals.
COMPLIANCE PROBLEMS WITH USP <797> AND RADIOPHARMACEUTICALS As COMPOUNDED STERILE DRUGS
Nuclear medicine professionals directed to follow USP <797> standards were faced with challenges unique to the grooming of radiopharmaceuticals. The primary consequence involved merging radiation condom standards with the aseptic handling scenarios described in USP <797>. Established radiation condom practices requiring lining of workspace surfaces with absorbent paper, utilize of syringe and vial shields, positioning of lead-drinking glass L-shields in front of laminar flow workstations, and placement of radiation-measuring instrumentation (dose calibrators) in the same environment where sterile compounding takes identify largely contradicted USP guidance for the creation of a sterile workspace. Lack of specific guidance on sterile compounding of radioactive drugs led to defoliation amid nuclear medicine professionals on how to interpret the standards, likewise as confusion amid inspectors who were using the USP <797> standards for guidance. Guidance for sterile compounding of radioactive drugs in USP <797> was largely ignored past nuclear medicine professionals until a failed inspection left the facility with a listing of required modifications to practice. Nuclear medicine professionals, every bit well as regulators and inspectors, recognized the need for radiopharmaceutical specific standards (three).
USP <825> SCOPE, GOALS, AND OBJECTIVES
During the 2016 revision of USP <797>, nuclear medicine professionals submitted over one,500 comments, with about including examples of the failure of USP <797> to run across the requirements of radiations safety while attempting to conform with the standards associated with sterile compounding of radioactive drugs. A Gild of Nuclear Medicine and Molecular Imaging publication identified practices in the preparation of radiopharmaceuticals that are different from the mutual sterile compounding activities associated with nonradioactive drugs and ended with a list of recommendations that establish criteria for preparation of radiopharmaceuticals that follow aseptic guidelines while meeting as-low-as-reasonably-doable (ALARA) principles (three). Somewhen, the USP standards committee was convinced that a distinct set of specifications for radiopharmaceuticals was needed. This conclusion led to the establishment of an practiced console on radiopharmaceuticals to develop the model that would provide guidance for the activities associated with the sterile compounding of radiopharmaceuticals. USP general affiliate <825>, "Radiopharmaceuticals: Grooming, Compounding, Dispensing, and Repackaging," provides standards for the preparation, compounding, dispensing, and repackaging of sterile and nonsterile radiopharmaceuticals included in the exercise of pharmacy and medicine (4). Information technology applies to all practise settings where these activities involving radiopharmaceuticals occur, including nuclear pharmacies, nuclear cardiology imaging clinics, and nuclear medicine departments of hospitals. It applies to sterile and nonsterile radiopharmaceuticals and to direct infusion radionuclide generators and devices. It applies to all individuals involved in the grooming, compounding, dispensing, and repackaging of radiopharmaceuticals, including pharmacists and physicians who hold authorized user regulatory condition and those working under their supervision, such equally chemist's technicians, nuclear medicine technologists, residents, and students or trainees. USP general chapter <823>, "Radiopharmaceuticals for PET: Compounding," supersedes USP <797> and <825> for guidance involving PET radiopharmaceuticals. On release of a PET radiopharmaceutical as a finished drug production from the commercial manufacturing facility, further treatment, manipulation of unit doses from a vial, and use of the product are considered compounding activities and subject to standards in USP <797> and <825>. Nuclear medicine departments and nuclear cardiology imaging clinics involved in administering to patients unit-dose radiopharmaceuticals received from a nuclear pharmacy, with no additional manipulation later on commitment, are non subject to USP standards other than to ensure that the nuclear chemist's shop outsourcing facility is compliant (4).
USP <825> models USP <797> with needed modifications. USP <825> includes content to provide minimum standards for the training, compounding, dispensing, and repackaging of sterile and nonsterile radiopharmaceuticals. The USP <825> standards describing facilities and applied science controls, personnel qualifications, preparation and hygiene, cleaning and disinfecting, and air and surface monitoring by and large parallel those found in USP <797> (iv). In the sterile compounding, preparation, dispensing, and repackaging of radiopharmaceuticals in a nuclear chemist's setting, USP <825> standards for those activities more often than not stand for to those in USP <797>.
USP <825> RADIOPHARMACEUTICAL-SPECIFIC STANDARDS
The differences found in USP <825> reflect the unique properties of radioactive drugs and emphasize the importance of following good radiation safety practices while being attentive to the fourth dimension element for the clinical apply of radiopharmaceuticals and balancing with hygienic handling practices. USP <825> addresses the failure of USP <797> to include radiation rubber considerations. Placement of absorptive pads in hoods, handling of sharps during radiopharmaceutical compounding, and positioning within hoods the radiation-measuring instrumentation needed during compounding activities were specifically adopted in the new standard (4).
RADIOPHARMACEUTICAL PREPARATION OR COMPOUNDING
USP <825> clearly differentiates radiopharmaceutical preparation from compounding. Preparation is the customary radiolabeling procedure in which the radionuclide is combined with the chemical carrier designed to deliver the radioactivity to the organ of interest or the target. A collection of actions, including mixing, combining, diluting, or reconstituting, can be used to gear up the nonsterile or sterile radiopharmaceutical. Except for minor deviations, preparation must be done according to directions establish in the FDA-approved labeling for the conventionally manufactured radiopharmaceutical kit and radionuclide. Unless intended for immediate use, sterile radiopharmaceutical grooming must exist completed in an International Organization for Standardization (ISO)–classified area or device to ensure that the minimum environmental standard is met (Table i). The required primary engineering command (PEC), secondary applied science command, and manipulations involved in the radiopharmaceutical preparation are used to determine the BUD for the final preparation (4). Along with ecology controls, aseptic treatment practices to maintain sterility must be followed by personnel, including prior aseptic procedure training or qualification, paw hygiene, and garbing. The final preparation must be assessed to ensure that it will meet the quality and purity specifications throughout the assigned BUD. Depending on the radiopharmaceutical, this assessment may include testing for radionuclide purity, radiochemical purity, and chemical purity, besides as physical backdrop (4).
Tabular array i
ISO Classification of Particulate Matter in Air and PEC or Secondary Engineering Controls
Compounding is recognized every bit a major alteration to the FDA-approved directions for preparation or radioactive drug formulation from bulk drug substances and radionuclides. Established written procedures for compounding radiopharmaceuticals must exist in place, with records of the materials used and the testing results for each finished production. Sterile compounding must follow aseptic procedures and be completed in an ISO class five PEC (Tabular array 1). USP <825> prohibits the compounding of conventionally marketed, FDA-approved radiopharmaceuticals except for clinically relevant changes requested for a specific patient past a licensed doctor. Compounding radiopharmaceuticals removed from commercial distribution can keep only every bit part of an investigational written report approved by the establishment'south review board (4). When nonsterile components or bulk drug substances for sterile compounding are used, a final sterilization procedure with testing for sterility and liberty from pyrogens must exist completed. Additional tests for purity, identity, quality, chemical stability, radiochemical stability, and pH, as well equally changes to whatsoever of these parameters, must exist established for consignment of the BUD to the final production.
Grooming WITH MINOR DEVIATIONS
On occasion, circumstances not addressed in FDA-approved labeling require variation from the manufacturer's preparation instructions. Patient-care requisites, or variations in the availability or chemic or physical properties of radiolabeling components, may require a minor deviation from the routine radiopharmaceutical preparation. Variations may involve differences in the specific action of the concluding preparation or proportions of the components of the radiopharmaceutical kit used in the formulation. Examples include a alter in the FDA-canonical step-by-step labeling instructions, a variation in the quantity of radioactive decay, or a variation in the concluding volume of the preparation. Such variations are common when the nuclear medicine technologist prepares a 99mTc-aggregated albumin vial to meet a doc's asking for fewer particles for a specific patient. Pocket-size deviations may involve the utilize of alternative devices or equipment (different sizes of needle or syringe, different shielding materials, employ of a heating block instead of a h2o bath), use of quality control testing other than that described in the prescribing information, and filtration of 99mTc sulfur colloid for lymphatic mapping procedures. All the same, alterations from the manufacturer's instructions must maintain the same ingredients and must not include the improver of actress components (four).
RADIOPHARMACEUTICAL PROCESSING ENVIRONMENT
The USP <825> standards model those in USP <797> for design and layout and the required engineering controls for the sterile radiopharmaceutical processing. With the understanding that most microbial contaminants are carried through the air on particulates, following the guidelines of USP <825> ensures that the sterile radiopharmaceutical grooming and compounding procedures are completed in areas and under engineering controls that run into air quality standards for the activities to be completed, thereby reducing the likelihood of contagion. Forth with control of temperature and humidity, the use of nonshedding edifice materials on the surfaces of walls, floors, and ceilings; planning of personnel traffic; full general cleaning; and manipulation of the air currents from the heating, ventilation, and air-conditioning organisation or opened doors, selection and placement of PEC is critical for institution of an environment favorable for sterile radiopharmaceutical processing. A PEC is a laminar flow hood using a unidirectional, high-efficiency particulate air–filtered airflow to create an ISO class 5 or better workspace. When used for training, for preparation with minor deviations, for dispensing, or for repackaging of sterile radiopharmaceuticals, the ISO-class PEC may be located in an unclassified segregated radiopharmaceutical processing area with low traffic and away from air currents that may disrupt the laminar airflow inside the hood. The segregated radiopharmaceutical processing expanse does not require filtered air along with air monitoring. If used in the compounding of sterile radiopharmaceuticals, the PEC must be located inside an ISO class 7 or ameliorate buffer area, forth with an ISO class 8 or improve anteroom (four).
Preparation AND QUALIFICATION OF PERSONNEL
Sterile compounding or grooming activities outside immediate-use practice require prior completion of training on policies and standard operating procedures established by the authorized nuclear chemist or authorized user physician. In addition, training on aseptic handling and claret-borne pathogens, if appropriate, is required. Before conducting hygienic techniques involved with radiopharmaceutical compounding across firsthand utilize or radiolabeled blood component preparation, personnel must prove competency. Successful completion of the job functions listed in Table 2 nether the observation of a designated person is required for initial qualification and at 12-mo intervals, depending on sterile compounding responsibilities (iv).
TABLE 2
Hygienic Qualifications
HIGHLIGHTS OF USP <825> FOR NUCLEAR MEDICINE TECHNOLOGISTS
Compliance with USP <825> standards is adamant by the practise activities of the nuclear medicine technologist. Near USP <825> standards volition not apply to a nuclear medicine practice that outsources the grooming of radiopharmaceuticals and receives patient dosages fix for assistants. For nuclear medicine departments using radionuclide generators or bulk radionuclide material and radiopharmaceutical kits for the grooming of multidose vials, USP <825> provides benchmarks for those activities that are bailiwick to audit or inspection. For facilities involved in radiopharmaceutical preparations simply under the firsthand-utilize criteria, less rigorous area and personnel standards are applied for final preparations, with more than ascetic requirements for storage and assistants, as seen in Tabular array iii. Immediate-apply provisions allow for benchtop grooming but require that a unmarried dose exist prepared for a single patient within i h after the formulation begins, as well as requiring that any remaining material be discarded, since the radioactive drug was completed in a nonsterile surround.
TABLE three
Radiopharmaceutical Grooming Requirements
INTERVENTIONAL AGENTS AND Offshoot MEDICATIONS
USP <797> placed limitations on the preparation of nonradioactive drugs for use equally interventional agents in diagnostic and therapeutic studies conducted in nuclear medicine. USP <825> does not utilize to nonradioactive drugs such every bit amino acid preparations, morphine, sincalide, furosemide, and regadenoson. Linguistic communication in USP <825> specifically references adherence to standards in USP <797> when nonradioactive drugs are prepared for patient use. USP <797> standards for immediate use must be followed, including aseptic-technique grooming, unmarried-patient employ, a fourth dimension limit for patient administration, and labeling requirements (4).
Post-obit ALARA PRINCIPLES
USP <797> did not accost issues of radiation safety and the ALARA benchmarks. Observance of the established radiation safety practices of time, distance, shielding, and contagion control while maintaining USP <797> specifications during radiopharmaceutical sterile compounding procedures was not possible. USP <825> addresses considerations for radiation prophylactic, including observation of ALARA practices, noting the demand for multiple hand movements into and out of the hood during aseptic handling procedures to limit the fourth dimension of exposure; use of remote treatment tools to increase the distance from vials and syringes, use of vial and syringe shielding and an Fifty-cake in the front of the hood to reduce exposure during radioactive drug grooming; and lining of the surface of the hood with absorbent pads to limit spill contamination. The requirement for within-the-hood placement of the dose calibrator, disposable abrupt container, and other instrumentation required during the radioactive drug preparation and dispensing functions was an effort to balance the hygienic handling process with established radiation safety practices. Addressing the primary reason for failure to comply with USP <797> requirements was a focused objective of USP <825>.
Before USP <825>, sterile compounding guidelines for immediate use limiting the number of needle entries through the vial septum to no more than than 2 were non compatible with 99mTc-labeled ruby blood prison cell preparation, which requires 5 needle punctures (five). USP <825> includes a section entitled, "Preparation of Radiolabeled Carmine Blood Cells for Immediate Employ," containing a description of defended space and equipment for the red blood cell radiolabeling procedure, cleaning and disinfecting procedures for the space and equipment, besides as paw hygiene and garbing requirements. Although immediate utilize lists a BUD of 1 h, in that location are no restrictions on the number of needle punctures during the radiolabeling process (4). Following standards established in USP <825>, the nuclear medicine technologist tin can prepare 99mTc-labeled red blood cells for a patient on a lab demote in a hot lab using recognized ALARA principles and aseptic technique.
THE NUCLEAR MEDICINE HOT LAB
Recognized as an area for manipulations of radioactive materials, including sterile preparation of radiopharmaceuticals for immediate apply, the nuclear medicine hot lab is defined in USP <825> equally an unclassified (ambient or unfiltered air) radiopharmaceutical processing area located inside a infirmary or clinical site that is advisable simply for immediate-use radiopharmaceuticals. USP <825> recognizes the need for radioactive drugs to be prepared exterior the sterile surround created in a hood within a clean room with loftier-efficiency particulate air–filtered air. The nuclear medicine technologist is responsible for observing hot lab restrictions, include limiting traffic in the area during radiopharmaceutical training equally well every bit separating the infinite from patient care and nonsterile activities such every bit radiolabeling meals for gastric elimination studies. Before sterile radiopharmaceutical preparation in a hot lab, the nuclear medicine technologist must follow strict aseptic technique, including hand hygiene and garbing every bit well as cleaning and disinfecting of the expanse (lab bench) where the drug preparation volition occur (4). The hot lab must be clean, and all clinical activities involving patient intendance must be stopped during the sterile radiopharmaceutical training.
PREPARATION OF RADIOPHARMACEUTICALS FOR Firsthand USE
Although USP <797> provided strategies for the training of radiopharmaceutical doses for immediate apply, the criterion included restrictions that were field of study to interpretation and often not amenable to radioactive drug preparation and dispensing. USP <825> includes a clarification of the preparation and dispensing of sterile radiopharmaceuticals for firsthand apply in a patient intendance setting (iv). Preparation components must be sterile FDA-approved kits, the finished product must be limited to use for a single patient, and the finished product must be administered within ane h of the kickoff vial puncture that started the radiolabeling procedure. Along with radiopharmaceutical kit preparation, manipulations of unit doses (needle changes, adjustments of the radioactivity dose or volume), dispensing of a single dose from a prepared vial, dose pooling (combining doses to meet a single-patient demand), and add-on of a nonradioactive pharmaceutical to a unit dose (e.g., adding lidocaine to a 99mTc-radiopharmaceutical for lymphatic mapping or sentinel lymph node imaging) are allowed under firsthand-employ provisions. Manipulation of a unmarried dose to see the needs of multiple patients (dose splitting) may not be done under immediate-use standards (4). Missing from the immediate-use provisions of USP <797> are guidelines—provided in USP <825>—for the qualifications for personnel who prepare these sterile drugs; USP <825> incorporates guidance on completing a sterile radiopharmaceutical preparation, including directions for mitt hygiene, gloving, garbing, and the required aseptic technique, likewise as claret borne pathogen training (iv). Table 4 summarizes the weather condition that must be met for sterile training of radiopharmaceuticals for firsthand use.
Tabular array 4
USP <825> Immediate-Use Sterile-Radiopharmaceutical Preparation Requirements
QUALITY Command OF RADIOPHARMACEUTICALS
Completion of a quality assessment, including the concrete advent, radiochemical purity, and radionuclidic purity of radiopharmaceuticals prepared or compounded on site, is no longer optional. Decision of the quality and purity of prepared radiopharmaceuticals, as appropriate, is mentioned in the training and documentation sections of USP <825>. Applicable quality testing—the need for which is specifically mentioned for radiopharmaceuticals that are prepared with minor deviations from the manufactured kit directions—is mandatory for validating the radiochemical purity of the final product through to the BUD (4). The nuclear medicine technologist is responsible for complying with this standard, equally is supported by published practice standards likewise (half dozen).
RADIOLABELING OF BLOOD COMPONENTS
USP <797> contained no sterile compounding guidance for the radiolabeling of blood components, including leukocytes, platelets, and stem cells. To provide direction for this important area of radioactive materials preparation, USP <825> includes guidelines for the preparation of radiolabeled blood components (four). There are strict requirements for the location and procedure to prevent microbiologic contamination of the claret product or of the surface area, equipment, or instruments used during the radiolabeling procedure. Radiolabeling of blood components other than red blood cells is not included in the firsthand-employ category of USP <825> and requires strict measures for the creation of a sterile training area. Standards include instructions for complete separation of areas where blood components are handled and the apply of an ISO grade 5 hood in an ISO class 7 buffer area to maintain the air quality of the radiolabeling space. Also, cleaning or disinfecting procedures for hoods, equipment, and instruments and instructions for manus hygiene, garbing, and prior aseptic training or qualification of staff are addressed. Directives for labeling of tubes, syringes, and other supplies with patient identifiers and a time limit of 6 h after blood collection for administration of the finished radiolabeled product are contained in the specifications. Claret components from a single patient only are allowed in the PEC during the radiolabeling process. Cleaning and disinfection of the hood and reusable equipment, including the dose calibrator liner and dipper, must be completed earlier use for another radiolabeling process (4).
Grooming OF NONSTERILE RADIOACTIVE PRODUCTS
Hospitals and clinics that rely on commercial nuclear pharmacies for the preparation and commitment of unit-dose radiopharmaceuticals for most of their patient needs oftentimes become involved in the preparation of nonsterile radioactive products, commonly to meet a specific need for a single patient. Compounding of nonsterile radiopharmaceuticals is described in USP <825> equally the combining, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug to create a nonsterile radiopharmaceutical (4). Included in this category is changing from a sterile intravenous dosage form to an oral dosage class, changing from an oral capsule to a liquid, preparation of an oral sheathing from a liquid, and radiolabeling of a nutrient substance for oral administration. A description of the area designated for nonsterile compounding and of the required records and materials used for nonsterile radiopharmaceutical compounding is included in the USP <825> standards. Separation of the expanse and activities involved in compounding nonsterile radiopharmaceuticals from those used in the training of sterile radiopharmaceuticals is addressed in the standard. The surface area designated for nonsterile compounding must exist clean, uncluttered, free of patient care activities, and carve up from the area designated for sterile radiopharmaceutical preparations.
BUD Assignment
USP <825> provides information on establishing the assigned fourth dimension beyond which the compounded radiopharmaceutical must not be administered. Closely associated with the take a chance level of the prepared radioactive drug, the BUD is dependent on the preparation weather condition, the known or measured quality and purity parameters, and the storage environments. BUD is determined with consideration of the manipulations involved in the radiopharmaceutical preparation, maintenance of sterility, radiochemical and radionuclide purity, the age of the radionuclide generator eluate used in the radiopharmaceutical preparation, the specific activity, and the grooming conditions. The established BUDs are half-dozen h for radiolabeled blood components, i h for 99mTc-labeled red blood cells for immediate use, 1 h for sterile radiopharmaceuticals for immediate use, x h for direct infusion systems, and 24 h for preparing and dispensing radiopharmaceuticals prepared under classic sterile conditions (4).
DIRECT INFUSION SYSTEMS
USP <825> provides guidance on maintaining the sterility of directly infusion systems using aseptic technique during clinical utilise. Multiple patient infusions from direct infusion systems, such as the portable PET patient infusion device and 82Rb generators, are completed in ambient air environments with potential for contamination. Following specific device labeling for fix-up, clinical utilize, storage, and disposal is a requirement. Guidance in USP <825> includes instructions for setting upward the infusion system; cleaning and disinfecting vials, eluent pocketbook, and infusion device; as well as observing a BUD of 10 h for aseptic handling in an ambient air environment (four). Only 1 puncture of the sterile container is allowed. If there is a problem with the infusion device, the sterile container, along with its contents, must exist discarded.
USP <825> IMPLEMENTATION TIMELINE
USP full general chapter <825> was published on June ane, 2019, with the goal of being implemented six mo afterwards on Dec one, 2019. After publication of the new standard, the USP received two appeals, which delayed its implementation. The first appeal questioned the standards requiring compounding using sterile substances, consignment of BUDs, and compounding of radiopharmaceuticals bachelor in an FDA-approved format and was denied after consideration by the responsible USP expert commission (7). The second appeal, which requested deviations from the proposed framework and BUD provisions of USP <825>, was granted an official USP appeals hearing on January 21, 2020, and was denied. The USP will publish a new official approval date, followed by another vi-mo flow for implementation (viii). Until and then, the nuclear medicine community continues to compound, prepare, and manipulate sterile radiopharmaceuticals under the guidance of the 2008 revision of USP <797> (ix).
CONCLUSION
Since 2004, nuclear medicine technologists' activities associated with the sterile preparation and clinical use of radiopharmaceuticals have been discipline to inspection by the Joint Commission, the Centers for Medicare and Medicaid Services, and other regulatory bodies under USP <797> standards. USP <825> was adult to provide clear and effective standards that see patient and practitioner requirements specifically for compounded sterile and nonsterile radiopharmaceuticals. The primary objective for the development of USP <825> is an improved understanding of the expectations related to sterile preparation of radioactive drugs. Regarding the traditional practise of compounding sterile radiopharmaceuticals using radionuclide generators, radiopharmaceutical manufacturer's kits, bulk chemicals, and radionuclide supplies, the requirements of USP <825> are not different from those of the USP <797> standards. There were only minor changes in USP <825> to personnel qualifications, preparation, hand hygiene, garbing, facilities and engineering controls, cleaning and disinfecting, microbiologic air and surface monitoring, and records maintenance to accommodate the required observation of radiations safety practices. USP <825> includes significant changes to accommodate the preparation and dispensing of sterile radiopharmaceuticals typically completed by nuclear medicine technologists to meet individual patient needs.
DISCLOSURE
No potential disharmonize of involvement relevant to this article was reported.
Footnotes
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CE credit: For CE credit, you can access the examination for this commodity, as well as additional JNMT CE tests, online at https://www.snmmilearningcenter.org. Complete the test online no later than June 2023. Your online test will exist scored immediately. You may make 3 attempts to laissez passer the test and must reply 80% of the questions correctly to receive ane.0 CEH (Standing Education 60 minutes) credit. SNMMI members volition have their CEH credit added to their Vocalisation transcript automatically; nonmembers will exist able to print out a CE certificate upon successfully completing the test. The online examination is free to SNMMI members; nonmembers must pay $15.00 by credit card when logging onto the website to take the test.
REFERENCES
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- Received for publication February 25, 2020.
- Accustomed for publication April 22, 2020.
Source: https://tech.snmjournals.org/content/48/2/106
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