USP Notice of Intent to Revise Regarding Sterile Preparations

General Chapter <797> Pharmaceutical Compounding–Sterile Preparations

Type of Posting

Notice of Intent to Revise

Posting Date

22–Nov–2013

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 (301-816-8526, rxs@usp.org).

quoted from here

Outline of Recent Revisions to FDA Regulatory Procedures Manual

From the FDA website found here.

2012 Revisions and Updates

• 08/16/2012: Chapter 9 of the Regulatory Procedures Manual¹ (RPM) was revised and updated, as detailed below.
  • Chapter 9 - Import Operations and Actions
    • Section 9-1, subsection "Scope and Purpose," was revised to include the following Tobacco Acts - Federal Cigarette Labeling and Advertising Act and Comprehensive Smoking Tobacco Health and Education Act of 1986. Section 9-6, "Recommendation Based on Multiple Samples," was revised to include the amount "at least 25%" in paragraphs 1(b), 2(b), and 3(b), and to also include the following language, "FDA may consider additional information in conjunction with sample analysis when considering whether to recommend products from a manufacturer, shipper, geographic area, or country for detention without physical examination, such as the results of foreign inspections and other types of information discussed in this subchapter." Section 9-15, subsection "Background," was revised to clarify section 801(d)(3)(B) of the Act.
    • Section 9-21, Exhibits - Exhibit 9-1 was deleted so please refer to Exhibit 9-6 instead. Exhibit 9-2 was updated with the current version. Exhibit 9-3 was revised to omit "tobacco products" from the following sentence, "These laws are designed to protect you from, among other things, unsafe or misrepresented foods, drugs, biologics, cosmetics, devices, and other articles." The title of Exhibit 9-11 had the words "for Special Events" added. Exhibit 9-12 was deleted as a duplication of Exhibit 9-6. Exhibit 9-13 was removed.