Friday, July 13, 2012

Virginia Board of Pharmacy Revisions to Compliance Requirements of 797

In June 12, 2012, th e Virginia Board of Pharmacy revised its police on compliance requirements of USP Chapter 797 for facilities engaged in sterile compounding.  Those revisions can be found here and state as follows:

Guidance Document: 110-36  Revised:  June 12, 2012
June 8, 2004
Revised: June 7, 2005, June 5, 2006, June 4, 2008, June 12 2012
Virginia Board of Pharmacy
§54.1-3410.2 requires pharmacies performing sterile or non-sterile compounding to comply with USP
Standards.  USP standards for sterile and non-sterile compounding may be found in the current editions
of the USP-NF.  In accordance with 18VAC110-20-170, the Board requires a pharmacy to maintain
references consistent with the pharmacy’s scope of practice and with public safety.  
USP Chapter 795 lists the requirements for non-sterile compounding including information about the
compounding environment, equipment, stability criteria and beyond-use dating and records. USP
Chapter 797 lists requirements for policies and procedures, training and evaluation of personnel
performing sterile compounding, determining risk levels and the physical standards for the sterile
compounding area. The Board expects that the requirements of Chapters 795 and 797 will be found in
compliance at time of inspection.
The terms “annually” and “semiannually” as used in USP Chapters 795 and 797 are defined to mean
every 12 months and every 6 months, respectively.  Records associated with annual and semiannual
requirements shall be maintained for 2 years from the date performed.  Such records may be
maintained in offsite storage or as an electronic image that provides an exact image of the document
that is clearly legible provided such offsite or electronic storage is retrievable and made available for
inspection or audit within 48 hours of a request by the Board or an authorized agent.

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