32 of 40 Mass. Compounding Pharmacies Cited in Surprise Inspections

Share:

Report gives more reason to worry about drug contamination.


You'd think compounding pharmacies in Massachusetts would have cleaned up their acts in the wake of the fatal outbreak of fungal meningitis last year, but surprise health inspections found that just 8 of 40 specialty pharmacies are fully complying with industry safety standards, officials said.

The sterile compounding facilities were inspected as part of Governor Deval Patrick's edict to strengthen oversight of the commonwealth's compounding pharmacy industry in the wake of the fungal meningitis outbreak caused by New England Compounding Center.

Of the 40 inspected pharmacies, 11 were issued cease-and-desist orders for a range of violations and another 21 were cited for "minor deficiencies that have since been corrected or are currently being addressed through corrective measures," according to the Massachusetts Department of Public Health.

Cease-and-desist-related violations uncovered by the expanded efforts included non-compliant storage of hazardous medications, non-compliant preparation and dispensing of sterile medications, non-compliant clean-room engineering controls and structure, and insufficient personnel training and environmental monitoring. One pharmacy was cited "after inspectors found evidence the pharmacy was engaged in sterile compounding despite an earlier statement that it was not."

Orders to stop operations have been issued to Apothecare South Shore in Brockton; Baystate Home Infusion, Springfield; Home Infusion Solutions, Falmouth; Lenox Village Pharmacy, Lenox; OncoMed Pharmaceuticals, Waltham; PalliMed Solutions Pharmacy, Woburn (partial); PharmaHealth Pharmacy, New Bedford; PharMerica, Brockton; Western MA Compounding Center, West Springfield; and West River Pharmacy, Marlborough. Whittier Pharmacist in Bradford was issued a full cease-and-desist on November 28. Upon inspection, board staff noted significant deficiencies in the structure and engineering of the clean room.

Eight of the 11 pharmacies have submitted corrective plans. Pharmacies must implement the corrective measures and pass re-inspection in order to begin operating again. NECC was shut in October, and its 2 sister companies, Ameridose and Alaunus, are still under temporary suspension orders. The meningitis outbreak has resulted in 46 deaths and 704 infections.

Stephanie Wasek

Related Articles