Showing posts with label USP. Show all posts
Showing posts with label USP. Show all posts

Wednesday, January 15, 2014

MUST READ!! Very Important!! USP Answers Some Fequently Asked Questions

Compounding


  1. Is USP considering revisions to <797> Pharmaceutical Compounding – Sterile Preparations?

    Yes, the Compounding Expert Committee began the revision process for General Chapter <797> in July 2010. Additionally, the Expert Committee formed an Expert Panel in April 2013. When the revisions are completed, the proposed changes will be posted in the Pharmacopeial Form (PF) for public comment. PF is published every two months and is a forum for stakeholders to submit their comments on the proposed changes. The PF comment period is 90 days.
     
  2. Can the table of “Beyond-Use Date (BUD) by Type of Formulation” under the section General Guidelines for Assigning Beyond-Use Dates in <795> Pharmaceutical Compounding – Nonsterile Preparations be applied to sterile preparations?

    No, General Chapter <795> is specific for nonsterile preparations. Footnote (a) under the table indicates that the table represents the maximum Beyond-Use Date (BUD) for compounded nonsterile preparations in the absence of stability information. A Revision Bulletin for <795> was posted on November 22, 2013 (official January 1, 2014) to further clarify this. (See http://www.usp.org/usp-nf/official-text/revision-bulletins/pharmaceutical-compounding-nonsterile-preparations).
     
  3. What are the considerations for assigning a BUD for a compounded sterile preparation?

    When assigning a BUD for a compounded sterile preparation, the compounder must consider both the sterility and stability of the preparation.
     
  4. Is there a difference between testing stability with a strength (potency) or a stability-indicating method?

    Yes, a strength (potency over time) test determines the amount of active ingredient in a preparation, however, it may not be able to separate the inactive ingredient from its degradation products and impurities for quantitation depending on the analytical methods used for the test. A stability-indicating method will be able to quantitate the active ingredient and its degradation products or related impurities in the preparation by separating the inactive ingredient from its degradation products and impurities, and to show a change in the concentration of the active ingredient with increasing storage time. A stability-indicating method is used to determine stability of a drug and used to establish the BUD. (See article, “Strength and Stability Testing for Compounded Preparations.”)
     
  5. Does General Chapter <797> require me to test according to <51> Antimicrobial Effectiveness Testing when compounding a multiple-dose container that contains a preservative?

    Currently, General Chapter <797> provides minimum practice and quality standards for compounding sterile preparations, but it does not contain specific requirements for compounding multiple-dose containers, such as the need for a preservative, nor requirements for testing, labeling, and container closures for compounded multiple-dose containers.  Future revisions of <797> may contain more specific standards for compounding multiple dose containers.
     
  6. Why is General Chapter <51> Antimicrobial Effectiveness Testing mentioned in <797>?

    The reference to General Chapter <51> under the section Single-Dose and Multiple-Dose Containers in <797> is provided for informational purposes to refer to commercially manufactured sterile multiple-dose containers. The reference to <51> serves to indicate the source of the 28-day BUD after initially entering or opening (e.g., needle-punctured) a multiple-dose container, unless otherwise specified by the manufacturer.
quoted from here

Sunday, November 10, 2013

USP Notice of Intent to Revise Regarding Sterile Preparations


General Chapter <797> Pharmaceutical Compounding–Sterile Preparations

Type of Posting
Notice of Intent to Revise
Targeted Official Date
TBD
Expert Committee
Compounding
In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the Compounding Expert Committee intends to revise General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. The purpose of the revision is to reflect new science, respond to stakeholder input, and improve clarity of the General Chapter. Specifically, the Expert Committee proposes to revise the Storage and Beyond-Use Dating section in General Chapter <797> to eliminate the cross-references to General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. The revision will clarify that the beyond-use dates in General Chapter <795> are solely for nonsterile preparations and do not apply to sterile preparations.
  1. The two proposed revisions are:
  2. 1. Delete the statement “(see Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding—Nonsterile Preparations <795>)” in the section Storage and Beyond-Use Dating.
2. Delete the statement “BUDs for CSPs that lack justification from either appropriate literature sources or by direct testing evidence shall be assigned as described in Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding—Nonsterile Preparations <795>” in the subsection Determining Beyond-Use Dates
This intent to revise is posted along with the Revision Bulletin for General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. The Revision Bulletin for General Chapter <795> will remove the reference to sterile preparations in the section General Guidelines for Assigning Beyond-Use Dates to clarify that the beyond-use dates in the chapter is specific only to nonsterile preparations and do not apply to sterile preparations.
Should you have any questions, please contact Rick Schnatz, Pharm. D., Manager Compounding and Healthcare Standards (301-816-8526rxs@usp.org).
quoted from here

Friday, December 28, 2012

Revised USP Standards Guide Prescription Container Labels


Revised USP Standards Guide Prescription Container Labels


The US Pharmacopeial Convention (USP) has released standards that provide a universal approach to organizing labels for prescription containers dispensed by pharmacists. The new standards aim to eliminate the variability that currently exists between pharmacies across the US and improve patient understanding of medication instructions by giving direction for optimal format, appearance, content, and language.

The standards include detailed instructions for how to:

Emphasize instructions and information important to patients
Improve readability
Give explicit instructions
Include purpose for use
Address limited English proficiency
Address visual impairment.

The standards are contained in General Chapter <17> Prescription Container Labeling (November 2012). For more details, see USP.

Saturday, December 1, 2012

USP 2010–2015 Compounding Expert Committee


Focus Areas

  • Human Drug Compounding (Sterile and Nonsterile)
  • Veterinary Drug Compounding
  • Radiopharmaceuticals Compounding
  • Compounding Flavorings

Expert Committee Members

  • Gigi S. Davidson, R.Ph., DICVP, Chair
  • Lisa D. Ashworth, B.S.Pharm., R.Ph., Vice Chair
  • Loyd V. Allen, Ph.D.
  • Gus S. Bassani, Pharm.D.
  • Edmund J. Elder, Jr., Ph.D.
  • Maria do Carmo M. Garcez, B.S.Pharm.
  • Deborah R. Houston, Pharm.D.
  • Ken Hughes, R.Ph.
  • Eric S. Kastango, B.S.Pharm., M.B.A.
  • Patricia C. Kienle, M.P.A.
  • Keisha D. Lovoi, B.S.Pharm.
  • Linda F. McElhiney, Pharm.D.
  • William A. Mixon, M.S.
  • David W. Newton, Ph.D.
  • Alan F. Parr, Pharm.D., Ph.D.
  • Regina F. Peacock, Ph.D.
  • Robert P. Shrewsbury, Ph.D.
  • Keith St. John, M.S.

Government Liaisons

  • Ian F. Deveau, Ph.D.
  • Edisa Gozun
  • Martine Hartogenesis, DVM
  • John W. Metcalfe, Ph.D.
  • Terrance W. Ocheltree, Ph.D., R.Ph.
  • Judith McMeekin, Pharm.D.
  • Yichun Sun, Ph.D.

USP Documentary Standards Staff

  • Shawn Becker, M.S., R.N.
  • Anthony DeStefano, Ph.D.
  • Donna Goldberg, M.Ph.
  • Rick Schnatz, Pharm.D.
  • Ivonne Zuniga

Primary Points of Contact