Congress Will Consider Greater Oversight of Compounding Pharmacies

From the meningitis outbreak, something good may come out of something bad. Earlier this month, U.S. Rep. Edward J. Markey of Massachusetts introduced a bill in Congress to boost the federal government’s authority to regulate compounding pharmacies.

As we’ve been reporting in the last several weeks (most recently last week), compounding pharmacies have been able to operate in often sketchy ways without the kind of oversight necessary to protect patients from harm. As reported on FDA Law Blog, Markey’s bill, the Verifying Authority and Legality in Drug Compounding Act of 2012 (VALID):

  • Ensures that compounding pharmacies operating as drug manufacturers are regulated by the FDA as drug manufacturers (they do not currently fall under FDA scrutiny).
  • Preserves state regulatory authority for traditional small compounding pharmacy activities and the requirement that drugs are compounded per each patient’s prescription. The FDA may waive this requirement in the event of a drug shortage or to protect the public health or well-being, but not for longer than one year unless the Secretary of Health and Human Services deems an extension necessary.
  • Increases transparency to the public by requiring compounded drugs to include this statement: “This drug has not been tested for safety and effectiveness and is not approved by the FDA. Serious adverse reactions to this drug should be reported to the pharmacy where it was received and the FDA at _____” (phone number and a website).
     
A “Do Not Compound” list of unsafe or ineffective drugs must be published within one year of enactment. State agencies responsible for regulating compounding pharmacies will receive the list, and it will be available on the FDA’s website.

Pharmacists and pharmacies compounding a drug product are required to report to the Secretary of Health and Human Services (HHS) any adverse event associated with the use of it within 10 days after becoming aware of it. If a pharmacist or pharmacy knows of any kind of contamination, chemical or physical change or deterioration of a drug that has been distributed and “could cause serious injury or death,” the pharmacist has five days to report it to the Secretary.

Some compounding operations are excused from some of the Act’s provisions, but not pharmacies required to be registered as drug manufacturers. Pharmacies or pharmacists might be waived if they: work within a hospital system compounding drug products exclusively for its patients; compound sterile drug products; compound drug products in limited quantities before receiving a valid prescription for an individual patient in their state.

As noted on FDA Law Blog, Markey, whose district is home to the New England Compounding Center (NECC) that distributed the contaminated steroid medicine that caused meningitis, said the VALID Compounding Act would close the “regulatory black hole.”

Additional developments in the NECC case were reported last week by the Boston Globe.

First, Massachusetts regulators ordered all the pharmacists and technicians employed by the NECC to stop working in the drug-compounding industry. That indicates, the paper said, that state regulators are concerned that the workers failed to follow proper procedures.

Duh. A letter from the Massachusetts Board of Registration in Pharmacy obtained by The Globe said that pharmacy staff “may present an immediate or serious threat to the public health, safety, and welfare and should immediately cease.”

The state board had already decided to seek surrender of NECC’s license. And the outfit shut down last month and recalled all of its products.

Later in the week, The Globe reported that the director of the state pharmacy board was fired and the board’s attorney placed on administrative leave for allegedly ignoring a complaint in the summer that NECC was distributing bulk shipments of drugs to hospitals in Colorado. That violates its state license.

NECC has long been a problem. As the Globe noted, The Colorado Board of Pharmacy issued a cease and desist order to the pharmacy in April 2011 after discovering its “unlawful distribution of prescription drugs.” This summer, when a Colorado hospital discovered a bulk shipment of a drug from NECC, Colorado authorities notified their Massachusetts counterparts.

They blew it off.

The House of Representatives’ Energy and Commerce Committee is convening public hearings Nov. 14 about the problems at NECC.

 

Published In: Administrative Agency Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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