BRIEFING

 〈1823〉 Positron Emission Tomography Drugs—Information. This proposal is based on the version of the chapter official as of May 1, 2017. The Small Molecules 4 Expert Committee is proposing to update this chapter with the following key changes:

1. Revise the Introduction to be consistent with current terminology and practices as well as

   • Add zirconium-89 to Table 1, which includes examples of positron emission tomography (PET) radionuclides and their associated half-lives.

   • Revise the term "[¹⁸F]Fluorinated" to "¹⁸F-Fluorinated" in the process summary to be consistent with the current convention.

   • Expand the requirements associated with finished PET drug products and biologically active PET drug products.

   • Remove the reference to compounding from the self-verification requirement within the characteristics defining PET drug products.

2. Add a Typographic Conventions for PET Radionuclides section to provide information about typographic conventions.

3. Add a Regulatory Framework for PET Drugs section to provide information about regulations related to PET drugs.

4. Add a PET Drug Substance versus PET Drug Product section to provide definitions for a PET drug substance and PET drug product.

5. Revise the Quality Assurance section to be consistent with current terminology and practices, and add a new subsection, titled Structural Characterization of the PET Drug Substance.

6. Change the Equipment for Automated Synthesis section to allow remote manipulators to be used in addition to robots.

7. Clarify that “PET drug” refers to a “PET drug product” in the Quality Control section.

8. Make the following changes to the Analytical Methodologies section:

   • Add a new subsection to provide calibration and system suitability standards for PET drugs.

   • Remove the paragraph about calibration from the High-Performance Liquid Chromatography subsection.

9. Make the following changes to the Quality Attributes section to be consistent with current terminology and practices:

   • Add a paragraph acknowledging that the section includes typical quality attributes for PET drugs and that other attributes and test methods may be appropriate beyond those described therein.

   • Add a statement about stabilizers and other additives to the Chemical Purity subsection.

   • Clarify that the total mass of the active pharmaceutical ingredient (API) includes the nonradioactive carrier in the Total Mass of the Active Pharmaceutical Ingredient and Specific Activity subsection.

   • Add a new subsection titled Potency to address the quality of biologically active PET drug products.

10. Make the following changes to the Sterility Assurance section to be consistent with current terminology and practices:

    • Add "environmental monitoring” to the Aseptic Techniques section.

    • Add a preference for commercially presterilized components, a statement about in-house sterilized components, and a reference to ISO 5 in the Presterilized Components section.

    • Add Table 2 titled ISO Classification of Particulate Matter in Area Air in the Environmental Controls section.

    • Change the title of the Media Fills subsection to Aseptic Simulations, and replace references to media fills with simulations or aseptic simulations.

11. Change the title of the Labeling section to Product Labeling, and add a container labeling requirement for investigation new drug (IND) PET drug products.

12. Update Glossary to include additional definitions, to remove the entry for Active Pharmaceutical Ingredient, and to revise the entries for PET drug substance, PET drug product, and Strength.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (SM4: G. Hsu)

 Correspondence Number—C322484