Saturday, July 7, 2012

Virginia Pharmacy Board Statement Regarding Compliance With USP 795 and 797

From Page 4 – July 2012, of The Virginia Board of Pharmacy News found here:

Compliance with USP Standards for
Media-fill testing is required when performing low, medium,
and high-risk level compounding of compounded sterile preparations
(CSPs). USP35-NF30 states:
Media-Fill Test Procedure – This test or an equivalent
test is performed at least annually by each person
authorized to compound in a low-risk level environment
under conditions that closely simulate the most
challenging or stressful conditions encountered during
compounding of low-risk level CSPs. Once begun,
this test is completed without interruption. Quality
assurance procedures for medium-risk level CSPs
include all those for low-risk level CSPs, as well as
a more challenging media-fill test passed annually
or more frequently. In addition, a media-fill test that
represents high-risk level compounding is performed
semiannually by each person authorized to compound
high-risk level CSPs.
On June 12, 2012, the Board approved changes to Guidance
Document 110-36. The terms “annually” and “semiannually”
as used in United States Pharmacopeia (USP) Chapters 795 and
797 are defined to mean every 12 months and every six months,
respectively. Records associated with annual and semiannual
requirements shall be maintained for two years from the date
performed. Such records may be maintained in off-site storage
or as an electronic image that provides an exact image of the
document that is clearly legible provided such off-site 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. Board of Pharmacy guidance documents are available at

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