Recalls since DQSA was passed as of March 2015

Recalls • Nearly 20 firms have recalled compounded drugs in the last year, many due to conditions and practices resulting in a lack of drug sterility assurance • Some recalls overseen by FDA, others overseen by the state • 2 letters formally asking firms to recall compounded drugs after they refused informal requests • Voluntary Cessation of Operations • Over 10 firms have temporarily or permanently ceased sterile operations in the last year 4

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