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FDA inspections find unsafe practices in compounding pharmacies

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2414 (Published 16 April 2013) Cite this as: BMJ 2013;346:f2414
  1. Michael McCarthy
  1. 1Seattle

Inspections of 31 compounding pharmacies have found numerous safety violations, the US Food and Drug Administration reports.1

Compounding firms are licensed to combine, mix, and otherwise alter drug ingredients to create prescription drugs tailored to the needs of an individual patient.2 The inspections were conducted in response to an outbreak of fungal meningitis and abscesses in 2012 that were linked to methylprednisolone acetate products used for spinal and paraspinal injections prepared by New England Compounding Center, a Massachusetts compounding firm.3

By 8 April this year, a total of 733 cases (including 53 deaths) linked to the injections had been reported in 20 states.

Although the FDA has some authority over compounding pharmacies, the firms are licenced by state pharmacy …

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