Press Release from MA Board of Pharmacy with List of Pharmacies

For Immediate Release - February 05, 2013

Department Of Public Health Announces Update on Unannounced Pharmacy Inspections

Governor’s budget provides additional resources for enhanced pharmacy inspections and oversight

BOSTON — The Massachusetts Department of Public Health (DPH) today provided an update on the unannounced inspections of 40 sterile compounding pharmacies across Massachusetts as part of a broad range of actions put forth by Governor Deval Patrick to strengthen oversight of the compounding pharmacy industry.

DPH began unannounced inspections of compounding pharmacies last fall, following the fungal meningitis outbreak caused by the New England Compounding Center in Framingham. Over the course of the unannounced inspections, partial or complete cease and desist orders were issued to 11 pharmacies for a range of violations. DPH cited another 21 pharmacies for minor deficiencies that have since been corrected or are currently being addressed through corrective measures.

“While these results are troubling, this process has led to significant corrective measures and increased compliance among sterile compounders in Massachusetts,” said DPH interim Commissioner Dr. Lauren Smith. “These findings underscore the need for additional budget resources and legislation the Governor has proposed to further strengthen our monitoring of this industry.”

The Patrick-Murray Administration launched a series of aggressive initiatives to ensure that the significant harms resulting from substandard sterile compounding are never allowed to happen again.

At the Governor’s direction, the Board of Pharmacy issued new regulations that require sterile compounding pharmacies in Massachusetts to report volume and distribution to the state for the first time.

A $1 million investment in the Governor’s FY14 budget will enable the Board to hire additional inspectors to continue the unannounced pharmacy inspections. The Governor is also directing DPH to strengthen inspector training requirements toensure that all inspectors are pharmacists with at least five years of clinical experience.

The Governor’s budget supports more than 30 new full time positions across DPH to enhance the department’s capacity to protect public health and safety and meet its regulatory responsibilities.

Building on recommendations released by the Commission on Pharmacy Compounding, Governor Patrick filed legislation earlier last month that would require a special license for sterile compounding, create monetary fines for violations of law and regulations, institute whistleblower protections, require licensing of out-of-state pharmacies that do business in Massachusetts, and reorganize the Board of Pharmacy’s structure to include more members who are not practicing in the industry they are responsible for regulating.

Eleven pharmacies have been subject to partial or complete cease and desist orders as part of the unannounced inspections since October. Eight of the 11 pharmacies have submitted corrective plans.

Pharmacies that receive a notice of deficiency or cease and desist must submit a written plan of correction to the Board of Pharmacy. They must then implement the corrective measures and perform renovations, if necessary, and then pass re-inspection to ensure compliance with USP 795 and 797. Cease and desist orders will remain in place until this process is complete.

• Apothecare South Shore in Brockton was ordered on December 20 to cease and desist all sterile and non-sterile compounding and quarantine all prepared sterile compounds in its possession. The pharmacy was found to be non-compliant with required standards for facility design and controls, storage of hazardous medications, and the preparation and dispensing of sterile medications. Apothecare South Shore has submitted a plan of correction.
• Baystate Home Infusion in Springfield was ordered on December 12 to cease and desist all sterile compounding. The pharmacy was found to be non-compliant with required standards for the preparation of sterile medications. Baystate Home Infusion has submitted a plan of correction.
• Home Infusion Solutions in Falmouth was ordered on December 27 to cease and desist all sterile compounding. The pharmacy was found to be non-compliant with regard to its facility design and controls, and the preparation of sterile medications. Home Infusion Solutions has submitted a plan of correction.
• Lenox Village Pharmacy in Lenox was ordered on December 12 to cease and desist all sterile compounding and quarantine all prepared sterile compounds in its possession. The pharmacy was found to be non-compliant with required standards with regard to its preparation of sterile medications.
• OncoMed Pharmaceuticals in Waltham was issued a cease and desist notice on November 21 due to issues with the storage of chemotherapy drugs. OncoMed Pharmaceuticals has submitted a plan of correction.
• PalliMed Solutions Pharmacy in Woburn was issued a partial cease and desist notice on November 27 to halt the production of sildenafil citrate. Inspectors found that the pharmacy had prepared and distributed sildenafil citrate using improper components. PalliMed Solutions Pharmacy has submitted a plan of correction.
• PharmaHealth Pharmacy in New Bedford was issued a cease and desist order for all sterile compounding on February 1 after inspectors found evidence the pharmacy was engaged in sterile compounding despite an earlier statement that it was not sterile compounding. The pharmacy was cited with having non-compliant clean room engineering controls and sterile compounding practices, and insufficient personnel training and environmental monitoring.
• PharMerica in Brockton was ordered on December 27 to cease and desist all sterile compounding. The pharmacy was found to be non-compliant with facility design and controls, and its preparation of sterile medications. PharMerica also has locations in Rhode Island and New Hampshire. As a result of the investigation of the Massachusetts facility, the Rhode Island and New Hampshire boards of pharmacy were notified. PharMerica in Brockton has submitted a plan of correction.
• Western MA Compounding Center in West Springfield was ordered on December 6 to cease and desist all sterile compounding, and quarantine all prepared sterile compounds and sterile medications in its possession. The pharmacy was found to be non-compliant with required standards for preparation and dispensing sterile medications, and the storage and handling of hazardous medications. Western MA Compounding Center has submitted a plan of correction.
• West River Pharmacy in Marlborough was ordered on December 20 to cease and desist all sterile compounding, and quarantine all prepared sterile compounds in its possession. The pharmacy was found to be non-compliant with required standards with regard to facility design and control. West River Pharmacy submitted a plan of correction last month.
• 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.

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