to stop producing
some or all drugs,
according to the
Senate Committee
on Health. At least
48 pharmacies were
found by FDA or
state regulators to
be producing drugs
that were contami-
nated or were creat-
ed in unsafe condi-
tions.
Since DQSA, many 503Bs have had quality problems:
• A Vermont pharmacy was found to be packing sterile compounds in
unsanitary conditions, according to a November 2015 FDA warning let-
ter. The firm also was failing to test quality, strength and purity.
• Multiple locations inside the aseptic processing area at a Montana
facility tested positive for bacteria and mold. The facility, FDA said in
a December 2015 warning letter, "was not adequately designed for
sterile drug production." The letter also noted the unusual practice of
the co-owner of bringing her dogs to the facility. A pet bed was locat-
ed right outside the clean room door.
• A Tennessee compounding pharmacy had not validated its
processes for autoclaving glass vials, for filtering drugs or for depyro-
genating glassware used to mix drugs. Inspectors observed workers
compounding lidocaine 2% gel for intrathecal use in a room without
HEPA filtration.
• An inspection of a New York pharmacy found workers preparing
injectable drug products with exposed facial skin and wearing non-sterile
J U L Y 2 0 1 6 • O U T PA T I E N TS U R G E R Y. N E T • 1 6 7
• WIDOWED Joyce Lovelace, who lost her husband, 78-year-old Eddie Lovelace (photo at right) to fungal meningitis, is
accompanied by Rep. Edward Whitfield, R-Ky., during testimony before the House Energy Subcommittee on Oversight and
Investigations hearing on the fungal meningitis outbreak.
AP
Photo/Susan
Walsh
