Pharmacy Compounding Update
In an effort to keep you in the loop regarding the
national tragedy that has unfolded as a result of contaminated products compounded by New England
Compounding Center (NECC) and concerns about their
sister company (Ameridose), the Nevada State Board of
Pharmacy offers the following:
♦ Both pharmacies were licensed in Nevada as “outof-state pharmacies,” however, the Board did not
renew either license in October 2012.
♦ In conjunction with the Nevada Department of
Health and Human Services, all pharmacies, surgery centers, hospitals, and clinics were notified
of the NECC recall of all of their products, and a
notification was sent to all consulting pharmacists.
NECC was contacted to obtain a list of buyers in
Nevada as a double check. A small number of NECC
compounded products were indeed found in a Las
Vegas, NV, surgery center; however, none were
used, thankfully, and those vials were confiscated.
♦ The Board then pulled all of its investigative and
inspection staff members off their regular duties
and conducted inspections of all Nevada pharmacies
that compound sterile products.
◊ These inspections included sterility and strength
testing of randomly selected products from each
pharmacy.
◊ Board staff accompanied Food and Drug Administration (FDA) inspectors (out of the San
Francisco Bay-area regional office) and Nevada
Department of Health and Human Services inspectors in conducting one Nevada pharmacy
inspection.
♦ Note: The Board enacted comprehensive compounding regulations in 2008; has trained its entire inspecting and investigatory staff in sterile compounding;
and inspects, at least annually, according to those
regulations.
♦ Committees in both the United States Senate and
the US House of Representatives have held hearings
to analyze the NECC issue and to consider regulatory changes to pharmacy compounding to ensure
prevention of another such incident.
♦ Board Executive Secretary Larry Pinson attended
a meeting called by FDA on December 19, 2012,
at FDA Headquarters in Maryland, to explore compounding pharmacy and its oversight.
♦ The National Association of Boards of Pharmacy®
has developed a Compounding Action Plan in a
national effort for better oversight of compounding
pharmacies.
The Board reminds all pharmacists that pharmacies
are licensed by boards of pharmacy to fill prescriptions,
not to manufacture drugs. FDA licenses manufacturers
to manufacture drugs. Purchases of drugs should only be
made from Nevada-licensed, FDA-approved manufacturers or wholesalers. NECC was not licensed or overseen
by FDA, yet they were clearly manufacturing, and the
results are obvious and tragic.
quoted from Nevada Board of Pharmacy July 2013 Newsletter