<905> Uniformity of Dosage Units

Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 30–Sep–2022
Official Date: 01–Aug–2023
Expert Committee: General Chapters—Dosage Forms
Coordinating Pharmacopeia: USP

Note: The changes as noted below was signed off by PDG in November 4, 2015 and was inadvertently not updated in USP-NF. This update in USP-NF is to correct for this inconsistency and align with the current PDG text.

The harmonized standard for Uniformity of Dosage Units has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 4 of the PDG process, the General Chapter - Uniformity of Dosage Units has been formally approved by the USP General Chapters—Dosage Forms Expert Committee in accordance with the Rules and Procedures of the 2020–2025 Council of Experts.

Changes from the existing USP-NF General Chapter include:

  • Modified the text according to the PDG sign-off document as underlined:        
    • “The uniformity of dosage units specification is not intended to apply to solutions, suspensions, emulsions, or gels in unit-dose containers intended for local action following external, cutaneous administration."
  • Clarification of “Others” in Table 1: Dosage forms not addressed by the other categories in this table including but not limited to suppositories, transdermal systems (patches) and semisolid preparations applied cutaneously and intended for systematic distribution of the drug substance.

The General Chapter <905> Uniformity of Dosage Units will be incorporated into and became official on August 1, 2023 into USP 2023 – Issue 2.

Should you have any questions about this General Chapter, please contact Margareth Marques (301-816-8106 or mrm@usp.org). For any questions about the PDG and its processes, please contact Richard Lew at (240-221-2060 or rll@usp.org).

The previous PDG sign-off Cover pages and Stage 4 postings are included as below: