Compliance With USP-NF Standards for
Compounding
At the June 18, 2013 full Board meeting, the Board
adopted revisions to Guidance Document 110-36, Compliance With USP Standards for Compounding. Guidance Document 110-36 addresses deficiencies that are frequently cited
during inspections as well as commonly asked questions
about sterile and nonsterile compounding. The following is
a continuation of frequently asked questions from the May
2013 Board electronic Newsletter. Pharmacists are encouraged to review Guidance Document 110-36 in its entirety.
1. How may a hospital pharmacy “batch producing” a
limited quantity of compounded sterile preparations
(CSPs) for in-house use extend the beyond-use date
(BUD) past the default dating in United States Pharmacopeia (USP) Chapter <797>?
Each batch must undergo sterility testing in accordance
with USP Chapter <71> in order to extend the BUD past
the default dating in Chapter <797>, and the appropriate
documentation to support an extended BUD must be kept
on file for presentation upon inspection.
2. Do batches less than 25 require sterility testing to be
performed?
No, however, the batches may not be assigned a BUD that
exceeds the default BUDs in USP Chapter <797>. The
chapter requires sterility testing according to USP Chapter <71> before CSPs are dispensed or administered for:
♦ high-risk level CSPs that are prepared in groups of
more than 25 identical individual single-dose packages (eg, ampuls, bags, syringes, vials),
♦ multiple-dose vials for administration to multiple
patients, or
♦ CSPs that are exposed longer than 12 hours at 2°C
to 8°C and longer than six hours at warmer than 8°C
before they are sterilized.
3. Must compounding personnel who work in multiple
pharmacies, to include pharmacy interns on rotations,
pass a media-fill test at each pharmacy where they
will prepare CSPs?
Yes, all compounding personnel working in multiple
pharmacies, to include pharmacy interns on rotations,
must pass a media-fill test at each pharmacy prior to
performing sterile compounding.
4. Because batches less than 25 do not require sterility
testing to be performed, may the CSP, which may
have been autoclaved, be assigned an extended BUD
based on stability data?
Yes, sterility tests for autoclaved CSPs are not required
unless they are prepared in batches of more than 25 units.
The Board would expect to see that biological indicators
are used with each autoclave batch and that the cycle time
and temperature were recorded on a log or printer tape
directly from the autoclave.
5. Does the United States Pharmacopeia–National Formulary (USP-NF) address how long a CSP may hang
for infusion?
No, USP-NF does not address how long a CSP may hang
for infusion. Refer to facility policy on this issue. USPNF, however, does require the administration of CSPs to
begin prior to the assigned BUD.
6. May a pharmacist repackage Avastin®
for office
administration not pursuant to a patient-specific
prescription?
No. While pharmacists may repackage a drug product
when dispensing a drug pursuant to a patient-specific
prescription, a pharmacist may not repackage a drug for
another entity. The Board has historically interpreted
the repackaging of a drug for distribution purposes as
an act restricted to a manufacturer, defined in Virginia
Code §54.1-3401. This interpretation appears consistent
with recent warning letters from the US FDA. The allowance in Virginia Code §54.1-3401 for a pharmacist
to provide compounded drugs to a physician for office
administration does not apply. Repackaging Avastin does not constitute compounding as it does not involve the
mixing of two or more substances.
7. May a pharmacist repackage Avastin pursuant to a
patient-specific prescription?
Yes, a pharmacist may repackage a drug as part of the
dispensing process pursuant to a patient-specific prescription.
quoted from
Virginia Board of Pharmacy August 2013 Newsletter