Item 2262 – Continuing Update on Pharmacy
Compounding Matters
Item 2252 of the January 2013 Newsletter and Item 2259 of
the April 2013 Newsletter updated pharmacists on compounding
regulation matters. The North Carolina Board of Pharmacy’s Compounding Working Group reported its initial recommendations to
the Board in April. That report may be found here: www.ncbop.org/
PDF/CompoundingWorkGroupRecommendationsApril2013.pdf.
Many of the Compounding Working Group’s data collection
and training recommendations have already been implemented by
Board staff or are in the process of implementation. Other recommendations for rule amendments are presently under consideration
by the Board.
Legislative activity concerning pharmacy compounding continues apace at the federal level. S 959, the Pharmaceutical Compounding Quality and Accountability Act, was introduced in the
United States Senate on May 15, 2013. The bill may be found here:
http://thomas.loc.gov/cgi-bin/query/z?c113:S.959. The bill’s chief
proposal is to categorize “compounding manufacturers,” which
would be regulated primarily and exclusively by Food and Drug
Administration (FDA). A compounding manufacturer is defined
as a facility that either:
(1) compounds any sterile drug product without receiving a
prescription order for such sterile drug product prior to beginning compounding and distributes or offers to sell such
compounded product in interstate commerce; or
(2) repackages any preservative-free sterile product or pools any
such sterile drug products (with some exceptions).
Observers expect the US House of Representatives to introduce
its own legislation concerning pharmacy compounding, but no bill
had been introduced at the time of this writing.
In late May, reports again surfaced of potentially contaminated preservative-free methylprednisolone acetate injections,
this time from the Main Street Family Pharmacy in Newbern, TN.
Board staff sought and obtained a surrender of Main Street Family Pharmacy’s out-of-state pharmacy permit, and worked with
the North Carolina Department of Health and Human Services
to identify and contact clinics and patients who had received the
potentially contaminated products. Main Street Family Pharmacy
initiated a voluntary recall of all compounded sterile products. At
the time of this writing, several adverse event reports have been
collected from a handful of states. State and federal authorities are
cooperating in the investigation, and twice-weekly updates may
be found here: www.cdc.gov/hai/outbreaks/tn-pharmacy/index
.html?mobile=nocontent.
In April, the Board issued a partial summary suspension of the
pharmacy permit held by Stewart Pharmaceuticals in Fayetteville,
NC, stemming from concerns over sterility control measures.
Stewart Pharmaceuticals subsequently issued a voluntary recall of
all sterile products. More information on the recall may be found
here: www.ncbop.org/PDF/StewartRecallNotice041213.pdf.
quoted from North Carolina Board of Pharmacy July 2013 Newsletter