Minnesota News: Adoption of Rules Package

October 1, 2007 12:33 PM Topics: Compounding

Reprinted from the October 2007 Minnesota Board of Pharmacy Newsletter.

On May 14, 2007, a notice of “Adopted Permanent Rules Relating to Pharmacy Regulations” was published in the Minnesota
State Register. This was the final step in the adoption of a package of rule changes that the Board had worked on
for over two years. The rule changes officially went into effect on May 21, 2007. Several documents relating to the rule
changes are available on the Board’s Web site, including an unofficial version of the changed rules.
 

The Board began highlighting information about specific rule changes in the last edition of this Newsletter. Information
about rule changes concerning nonsterile and sterile compounding follows.

Nonsterile compounding

The Board replaced several rules concerning the equipment and record-keeping requirements for nonsterile compounding
with a requirement that all “licensed Minnesota pharmacies that compound nonsterile drug preparations must follow United
States Pharmacopeia (USP), Chapter 795, standards.” USP Chapter 795 contains standards for facilities and equipment, stability
and beyond-use dating, ingredient selection, the compounding process, record keeping and documentation, and quality control.
Thirteen steps are given that, if followed, help to minimize error and maximize the benefit of the product for the patient.

A complete discussion of USP Chapter 795 is beyond the scope of this Newsletter. USP Chapter 795 is available in the
Pharmacists’ Pharmacopeia, a publication of the USP that is a comprehensive reference for a number of areas of pharmacy
practice.

Sterile compounding

The Board now also requires that any “licensed Minnesota pharmacy compounding a sterile product must follow the United
States Pharmacopeia, Chapter 797, standards.” USP Chapter 797 sets standards that apply to all settings in which sterile preparations are compounded and to all professionals who are engaged in such compounding. USP Chapter 797 is also available in the Pharmacists’ Pharmacopeia. First adopted as an enforceable standard in 2004, USP Chapter 797 is in the process of being
revised. Information concerning the proposed revisions of the chapter can be obtained on the USP Web site at www.usp.org/
USPNF/pf/generalChapter797.html.