Mass. Governor Proposes Compounding Laws

The Massachusetts Board of Pharmacy would be able to assess fines against compounding pharmacies that violate state law under legislation introduced late Friday by Gov. Deval Patrick (D).

The broad set of reforms, which include requiring special licensure for compounders producing sterile drugs, came in reaction to the multi-state fungal meningitis outbreak linked to more than 600 cases and 40 deaths from steroids made at the troubled New England Compounding Center (NECC).

The legislation is one of a number of proposed reforms at the state and federal level to ensure greater oversight of the safety of drugs produced at compounding pharmacies like Framingham, Mass.-based NECC, which seemed to escape much regulation. State boards of pharmacies oversee compounding pharmacies, while the FDA regulates manufacturers.

NECC produced sterile compounds in the presence of visible mold and bacteria in rooms not kept to standards normal for sterile production, according to inspection reports.

“This legislation makes patient safety paramount and will help fill the gaps in compounding pharmacy monitoring that allowed NECC to operate in the shadows,” Patrick said in a release. “Together these changes can ensure that the tragic events of last fall never happen again.”

Specifically, Patrick’s legislation would:

• Require a special license for sterile compounding
• Authorize the state Board of Pharmacy to assess fines against pharmacies that violate state policy, regulations, or laws
• Establish whistle-blower protections for pharmacists and pharmacy staff
• Require licensure for out-of-state pharmacies that deliver and dispense medications in Massachusetts
• Reorganize the composition of the state Board of Pharmacy by including more members who are not practicing pharmacists

The last point comes after questions arose in congressional and state investigations about the cozy relationship between NECC and state Board of Pharmacy. Under Patrick’s proposal, the 11-member board would comprise four pharmacists, one nurse, one physician, one pharmacy technician, one quality-improvement expert, and three public members.

Patrick also directed on Friday that the state Department of Public Health increase inspection staff and require inspectors be pharmacists with at least 5 years of clinical experience with expertise in sterile compounding if they work in that area.

Massachusetts has already issued regulations to improve the safety of compounding pharmacies, including requiring sterile compounders in the state to report volume and distribution to the state for the first time. Lawmakers in Washington questioned why the FDA didn’t take action against NECC since it appeared to be operating like a small manufacturer, producing more than 17,000 vials of the tainted methylprednisolone acetate and shipping it to 23 states.

Patrick’s proposals drew praise from a number of state lawmakers who must still pass the bill.

The governor’s release also quotes Rep. Ed Markey (D-Mass.), whose congressional district includes Framingham and the NECC’s headquarters. “I will work closely with Gov. Patrick and anyone in Congress to turn lessons we have learned from this tragedy into law,” Markey said.

The FDA is pushing its own reforms that would need passage by Congress. The agency proposed classifying compounding pharmacies as “traditional” and “nontraditional.”

Traditional compounders, who generally operate under the one-prescription-one-drug paradigm, will still be under the oversight of state boards of pharmacies. Nontraditional compounders would register with the FDA and adhere to other requirements typically mandated for manufacturers.

The clarification is needed, the FDA says, to differentiate what is under the purview of the FDA and what is under purview of the states.

Meanwhile, NECC wrote the Wilmington, Mass.-based cleaning company UniFirst last week asking that it take legal responsibility for the outbreak and “indemnify NECC regarding claims made against NECC.” UniFirst provided once-monthly cleaning services of portions of NECC clean rooms.

UniFirst announced the letter in its quarterly filing with the Securities and Exchange Commission. “Based on its preliminary review of this matter, the Company believes that NECC’s claims are without merit,” the filing read.

Meanwhile, federal investigators continue to pursue criminal charges against the NECC and its management.

Source: http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/36746?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&xid=NL_DHE_2013-01-08&eun=g514381d0r&userid=514381&[email protected]&mu_id