11.19.12

HELP Committee Seeks Answers from States on Compounding Pharmacies

WASHINGTON—Today, 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 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.

At a hearing last week, Senators heard a 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 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 full text of the letter is below:

Dear Sir or Madam:

The U.S. Senate Committee on Health, Education, Labor, and Pensions is investigating a public health crisis involving hundreds of cases of fungal meningitis and other types of infections.  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.

As you are probably aware, the Centers for Disease Control and Prevention (CDCP) linked the 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. 

Our ongoing investigation into this matter has revealed that NECC was previously the subject of investigations and enforcement actions as a result of complaints to state and federal regulators by various parties, including from other state pharmacy oversight agencies.  These complaints and other enforcement actions should have drawn attention to concerns regarding the quality and sterility of products produced by NECC, which were documented as far back as thirteen years ago, as well as to the fact that NECC was operating what appears to be a large scale drug manufacturing operation.  In light of these facts, it is unclear why the company was allowed to continue producing large quantities of standardized drugs with insufficient quality protections, in the absence of individual prescriptions, and with little or no ongoing oversight by state or federal regulators.

NECC was licensed in the vast majority of states and was required to comply with legal requirements where it was licensed.  In fact, in response to the outbreak, many states have begun proceedings to suspend NECC’s licenses and/or NECC has surrendered its licenses.

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, we would appreciate if you could provide information responsive to the requests below to the Committee no later than December 7, 2012:

1)   Did your state file a complaint or otherwise report problems, violations or adverse events regarding NECC products in the last 12 years to the Food and Drug Administration or the Massachusetts Board of Registration in Pharmacy?  Did you take any disciplinary actions against NECC in your state for violations prior to the current meningitis outbreak?

2)   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?

3)  Does your state require that pharmacies engaged in sterile compounding comply with USP <797> and if so what is your procedure for ensuring compliance with the standard?

4)   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?   If there is a prescription requirement, please provide a description of the process used in your state to determine if a compounding pharmacy is in compliance with the requirement.

5)   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):

a)      engage in sterile compounding;

b)      holdlicenses in other states; and

                        c)  engage in compounding as opposed to dispensing.

6)   How do you handle complaints about out of state compounding pharmacies?  Do you have any protocols on communications with other states’ pharmacy oversight boards?

7)   What actions, if any, have you taken to address the issues raised by the meningitis outbreak?

8)   Does your state define compounding, in the context of the practice of pharmacy, and if it does, please provide that definition?

9)   Does your state allow physicians to compound medicines, and if yes, how is that practice regulated?

Please contact Committee staff Beth Stein and Nick Geale if you have questions. 

                                                            Sincerely,

                     Tom Harkin                                                Michael B. Enzi

                       Chairman                                                Ranking Member

###