USP news:
〈825〉 Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging
In accordance with the Rules and Procedures of the Council of Experts, the Small Molecules Expert
Committee has revised General Chapter 〈825〉 Radiopharmaceuticals—Preparation, Compounding,
Dispensing, and Repackaging.
The purpose of this revision is to remove the text regarding #compendialapplicability, added as part of the Revision Bulletin which became official on December 1, 2020.
The text regarding compendial applicability, added as part of the Revision Bulletin which became official
on December 1, 2020, is being deleted from General Chapter 〈825〉.
General Chapter 〈825〉 is now
compendially applicable because it is referenced in both 〈795〉 and 〈797〉, which are applicable general
chapters numbered below 1000 and became official on November 1, 2023.
This means that #regulatorybodies with jurisdiction over compounded #radiopharmaceuticals may also require compliance with the
requirements in 〈825〉.
Radiopharmaceuticals, as defined in this chapter, are a subset of #radioactivematerials (#RAMs) falling under the control of the US Nuclear Regulatory Commission (#NRC) or NRC-contracted agreement state agency.
Radiopharmaceuticals are also a subset of prescription drugs falling under the control of the US #FDA for manufacturing and marketing.
Other federal regulatory authorities (e.g., Department of Transportation) have control over certain activities related to radiopharmaceuticals.
Compliance with these regulations, as applicable, must be ensured in addition to compliance with the standards described in this chapter.
This chapter is intended to provide uniform minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and nonsterile radiopharmaceuticals for humans and animals that occur as part of state-licensed activities.
These standards apply to all radiopharmaceutical processing activities, including those with radionuclides that emit a single photon, a positron, or a therapeutic particle. Furthermore, these standards apply to sterile intravascular radioactive devices
Practice settings consist of state-licensed nuclear pharmacies, federal nuclear pharmacy facilities, and other healthcare facilities, including, but not limited to: nuclear medicine departments in hospitals and clinics, nuclear cardiology clinics, and other specialty clinics.
This chapter applies to all individuals who prepare, compound, dispense, or repackage radiopharmaceuticals. Applicable individuals consist of authorized nuclear pharmacists (#ANPs) and authorized user (#AU) physicians, as well as individuals working under their supervision.
This chapter describes appropriate strategies that provide assurance of maintaining #patientsafety, while also ensuring the safety of individuals performing these activities.
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Sales Manager Canada, Cyclomedica
1moHayley Olson