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〈7〉 Labeling

BRIEFING

〈7〉 Labeling. This proposal is based on the version of the chapter official as of September 1, 2023. The Nomenclature and Labeling Expert Committee is proposing the following revisions:

  1. Apply a new format for epinephrine in multi-entity anesthetic drug products and remove ratio expressions of strength.

  2. Add text that includes flexible containers for Potassium Chloride for Injection Concentrate.

  3. Clarify alphanumeric expiration date formats.

  4. Update labeling for unit-dose cups.

  5. Add a new section titled "Dietary Supplements".

  6. Change the section titled "Products That Contain Vitamins" to "Products That Contain Vitamins and Minerals" and add:

    • New labeling requirements for dietary supplements containing iron.

    • New labeling requirements for dietary supplements containing potassium.

    • New labeling requirements for dietary supplements containing calcium.

  7. Add labeling for products containing oral liquid dosing tools.

  8. Add a new section addressing the labeling of radiopharmaceuticals.

  9. Other changes for clarity or to update terminology have been incorporated throughout the chapter.

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

 Please submit comments using the electronic submission form here https://usp.az1.qualtrics.com/jfe/form/SV_065GBqEph8sYNZY.

 (NL: M. Spann)

 Case ID—SUB-678

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