December 13, 2012
On November 19th, Chairman Tom Harkin (D-IA), Ranking Member Mike Enzi (R-WY) and members of the Senate Health, Education, Labor and Pensions Committee sent letters to all fifty state boards of pharmacy, the entities responsible for maintaining registries of pharmacies operating within their state. The HELP Committee is investigating the New England Compounding Center (NECC) for its production of tainted drugs that caused the recent outbreak of fungal meningitis, which has resulted in 33 deaths and more than 480 illnesses.
The letters were sent as a follow up to a hearing on November 15th in which Senators heard a very troubling account of NECC’s oversight record, which highlighted the gaps and grey areas that complicate the law establishing regulatory authority over such companies. In the course of the investigation, committee staff found that compounding pharmacies like NECC are required to register with their state of residence, and not with the U.S. Food and Drug Administration. This inquiry will help lawmakers to assess the scope of these companies nationwide. Today’s letters will also assist the committee as it determines what changes need to be made to ensure that compounded drugs are safe and available for patients and hospitals who need them.
“The outbreak raises serious questions about the level of oversight that a large-scale compounding pharmacy was subject to, both by state and federal regulators, and what if any additional steps need to be taken to prevent such a tragedy in the future. Therefore, as part of our investigation, we write to request information regarding general oversight of compounding pharmacies in your state and what actions you have taken to address this meningitis outbreak,” the Senators wrote.
Key Points Made in the Inquiry
As foundation for its request for information, HELP noted that the Centers for Disease Control and Prevention (CDCP) linked the recent meningitis outbreak to three lots of preservative-free methylprednisolone acetate produced by the New England Compounding Center (NECC) — a compounding pharmacy in Massachusetts. According to the CDCP, the three lots consisted of 17,676 products distributed to 23 states, exposing approximately 14,000 patients since May 21, 2012. As of November 16, 2012, at least 480 patients have become ill throughout the country, of which 33 have died as a result of the contamination.
In order to better understand how states address the potential issue of compounding pharmacies distributing large quantities of drugs throughout the country and whether additional federal oversight may be necessary, HELP requested that each state’s board of pharmacy provide information responsive to its requests as noted below:
- Does your agency require compounding pharmacies to identify if they produce large volumes of drugs, if they compound sterile injectable products and/or ship their products across state lines? Do your inspection procedures vary based upon the production of sterile drugs, or large quantities of drugs, or drugs shipped across state lines?
- Does your state require that pharmacies engaged in sterile compounding comply with USP and if so what is your procedure for ensuring compliance with the standard?Are compounding pharmacies in your state required to have a patient-specific prescription prior to producing a compounded drug or are they able to produce batches of products without a prescription?
- Please provide the name and address of all pharmacies in your state that hold licenses or waivers or other exceptions that permit the pharmacy to operate in the absence of providing a full service retail pharmacy and meet all of the following three criteria (to the extent that you have information that allows you to identify pharmacies this way):
- engage in sterile compounding;
- hold licenses in other states; and
- engage in compounding as opposed to dispensing.
Assuming the states responded, information should have been available no later than Friday, December 7, 2012. Unfortunately, no responses have been published at this point, but it will be interesting to see how each state views its responsibilities to oversee compounding pharmacies at the state level.