In the wake of the tragic and deadly fungal meningitis outbreak, emergency regulations were implemented in Massachusetts and Florida; an emergency rule was adopted in Louisiana; rules were changed in Mississippi; and draft legislation was introduced in New Jersey.
Many hearings at the state level are scheduled, and many boards have scheduled meetings and begun discussions as a result of the outbreak linked to the New England Compounding Center (NECC) facility, according to Rebecca P. Snead, Executive Vice President & CEO, National Alliance of State Pharmacy Associations.
Meanwhile, the International Academy of Compounding Pharmacists (IACP) developed recommendations for states, the National Association of Boards of Pharmacy issued a four-part action plan, and FDA is talking with pharmacy and the states about federal and state roles in regulating compounding pharmacy.
The practice of pharmacy, and therefore compounding, is regulated at the state level, Snead told Pharmacy Today. “It is critical that state regulators are proactive in their review of their rules and regulations to ensure they have addressed any areas that may be improved,” she said. “In addition, they must remain diligent in their enforcement of their regulations.
Approved November 1, 2012, by the Massachusetts state board of pharmacy, the emergency regulations in that state—home to the now-closed NECC—add additional enforcement language, according to Snead.
These regulations require pharmacies that do sterile compounding to provide reports to the state board, including the number of prescriptions dispensed, states where the prescriptions were distributed, and the status of nonresident licenses and certifications. According to the regs (which refer to pharmacy broadly and not specifically to who at the pharmacy), all reports shall be accompanied by an affidavit attesting compliance with all laws and regulations pertinent to sterile compounding, and that the registrant/licensee only prepares and dispenses pursuant to a valid prescription for a single patient, regardless of whether the medication is prepared for a Massachusetts or out-of-state patient. Pharmacies are required to report all adverse events to the board of pharmacy within 7 business days.
Florida has emergency regulations for immediate notification to its board of pharmacy of a compounding pharmacy’s activities, effective November 27, 2012, and expiring February 24, 2013, according to Snead.
On December 13, 2012, the Louisiana Board of Pharmacy adopted a declaration of emergency and emergency rule to repeal certain parts of its rules allowing pharmacists to compound medications intended for administration by practitioners without a patient-specific prescription. “The business entity that wishes to continue the preparation of such products will be able to apply for a manufacturer’s registration from FDA,” according to the declaration of emergency.
Mississippi adopted rule changes to its Good Compounding Guidelines/Good Compounding Practices in the areas of compounding guidelines (page 266) and wholesaler/manufacturer permits (page 270), effective January 1, 2013.
The New Jersey draft legislation, introduced October 15, 2012, requires compounding pharmacies to be accredited by the Pharmacy Compounding Accreditation Board (PCAB), of which APhA is a member. A companion bill related to compounding certification has been prefiled.
IACP recently recommended changes in state pharmacy practice acts to ensure that states have set in regulation the highest standards—United States Pharmacopeia (USP) <795> and USP <797>—and to eliminate the gray area and loopholes that can be exploited by a compounder seeking to manufacture without a license, according to IACP spokesperson David Ball.
IACP formally announced the state-level recommendations during a national town hall–style teleconference for IACP members, state pharmacy associations, and state boards of pharmacy on December 7. USP <797> is a national standard for any compounded sterile preparations, and USP <795> provides similar guidance for nonsterile preparations compounded in health care settings.
Developed by the IACP Board of Directors, the principles of the recommendations “focus on assuring inspection authority by and adequate funding of all state Boards of Pharmacy, individual practices’ compliance with state laws and regulations, and mandatory compliance with quality standards for all practitioners engaged in compounding,” according to a statement on the IACP website.
The National Association of Boards of Pharmacy (NABP) is “implementing a four-part action plan centered around inspection of nonresident compounding pharmacies and creating an information-sharing network of regulatory details on such pharmacies,” according to a December 12 NABP news release.
The first part of the action plan involved NABP sharing a list of nonresident compounding pharmacies provided by the Iowa Board of Pharmacy with other NABP member boards of pharmacy, and beginning to coordinate the collection of information on these pharmacies. With this data, NABP identified initial pharmacies to inspect.
The second part of the action plan is to implement inspections that currently are under way. The third part includes NABP collecting and maintaining data on the compounding pharmacies identified by the Iowa board as well as by other state boards. Initial data will be stored in an NABP pharmacy e-profile; ultimately, states will be able to submit inspection reports and related information to NABP for pharmacies’ e-profiles.
In the fourth part, NABP plans to schedule training of board of pharmacy inspectors and compliance officers via webinar and field training opportunities.
On December 14, 2012, 11 pharmacy organizations, including APhA, met with FDA regarding compounding pharmacies and the best way to provide oversight of that industry; the agency is working with Congress to consider new authorities over nontraditional compounding pharmacies.
As APhA’s representative at the meeting, Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA, shared the perspective that pharmacy is committed to doing everything possible to enhance patient safety while maintaining access to pharmacy compounding services. The pharmacy groups promoted greater recognition of PCAB standards and a PCAB draft decision tree that may be used to help differentiate compounding from manufacturing.
Five days later, FDA held a closed intergovernmental meeting on a Framework for Pharmacy Compounding: State and Federal Roles for representatives from all 50 states, as well as FDA staff—more than 100 people in all. The last 2 hours of the meeting were public, with the webcast viewed by 500 people, according to FDA.
In opening remarks, FDA Commissioner Margaret A. Hamburg, MD, noted that the agency had spoken with more than 50 different organizations, including pharmacy groups, leading up to the December 19 meeting. “Today was the states’ turn,” Hamburg said, to discuss four questions that get to the heart of federal and state roles. What FDA heard underscores the need for new legislation, she added.
During the public discussion of the questions, state representatives zeroed in on the need for clear definitions of pharmacy compounding versus manufacturing, and better communication among states and between FDA and states. Cody Wiberg, PharmD, MS, Executive Director of the Minnesota Board of Pharmacy, said at the meeting that most states have the authority and resources to handle traditional compounding, but fewer states may have the resources to handle nontraditional compounding in facilities like NECC. “I think the consensus in our group was in the latter case, with NECC, there is a role for FDA to be involved,” Wiberg said.
Hamburg responded minutes later that defining the terms—compounder, manufacturer—and how that then aligns with regulatory actions is “just so, so fundamental.” She suggested a working group to address the issue.
Comments on the questions—outlined in the November 28 Federal Register meeting notice—are due January 18, 2013.
This profile of Sen. Jerry Moran (R-KS) is part of an occasional series in Pharmacy Today on Members of Congress who are champions of pharmacy. Moran founded the Congressional Community Pharmacy Caucus in 2007, created the U.S. Senate Community Pharmacy Caucus in 2011, and is a member of the Senate Appropriations health subcommittee that has jurisdiction over the U.S. Department of Health & Human Services.
Moran supported construction of the new University of Kansas (KU) School of Pharmacy building to help address a shortage of pharmacists in Kansas. On August 7, 2012, he toured the KU School of Pharmacy with CMS Acting Administrator Marilyn Tavenner, RN, BSN, MHA, and spoke with members of the Kansas Pharmacists Association and other medical societies.
Following are his responses from a recent e-mail interview:
I was raised in Plainville, KS, a town with a population of around 2,000. My dad, who is 97, still lives in Plainville and has been able to remain in his home due to the love and care of family, friends, and neighbors.
We have a great hospital, but Dad does not like to visit the doctor because he thinks they are going to tell him bad news. But I never worry about my dad’s health being monitored because he has his morning coffee with our town’s local pharmacist. Our pharmacist will ask Dad how he is feeling, listen to him, slip the blood pressure cuff on him regularly, and counsel Dad on when he should go see the doctor.
This sense of community is what I love about my hometown and other towns across Kansas. I also think this is a great example of the important role pharmacists play in caring for patients by helping them manage the safe use of medications, administering immunizations, and working collaboratively with doctors and other providers to improve care.
I believe that pharmacists play a very important role in the delivery of health care in our communities. This is especially true in rural states like my home state of Kansas, where the local pharmacist is often the most accessible health care provider in a community. Additionally, these pharmacies are quintessential Main Street community small businesses and face a variety of regulatory challenges that are both health- and business-related.
I helped found [the House and Senate community pharmacy] caucuses to advocate for community pharmacy issues and to serve as a forum for ideas and information about the role of community pharmacists as health care providers. I want to help inform my colleagues in Congress about the different ways pharmacists serve their communities and the challenges they face.
Access to affordable, quality health care determines whether Kansans can remain in the communities they call home and whether their children can return to raise families of their own. To ensure towns survive and flourish across Kansas, our medical workforce shortages must be addressed to preserve and strengthen patients’ access to health care services.
A primary way to address this challenge is to educate and train providers from in and around our state. The University of Kansas School of Pharmacy is our state’s sole educational provider of pharmacy graduates.
KU’s pharmacy program ranks among the top public university programs and is fourth among all pharmacy schools for utilizing National Institutes of Health research funding. The quality of this program allows Kansas students unique opportunities to stay home and strengthen their communities.
Many of these pharmacists go on to serve the health care needs of Kansans, open their own businesses, and become part of the foundation of their communities.
I invited CMS Acting Administrator Tavenner to Kansas to tour health care facilities in my state and to meet with a variety of health care providers. I have had the opportunity to host CMS administrators from previous administrations in Kansas as well. These federal officials are directly responsible for administering Medicare and Medicaid, so I think it is very important for them to see for themselves the unique challenges facing providers and patients in Kansas and other rural states.
I am very proud of our state’s sole pharmacy school—the University of Kansas School of Pharmacy—and I wanted to show Ms. Tavenner this state-of-the-art facility and explain how the school benefits Kansans. Additionally, it was important for her to meet with a group of Kansas pharmacists, many of whom are KU School of Pharmacy graduates, to learn more about how they provide medication, counsel, and care to Kansans across the state.
Federal officials need to include pharmacists in the dialogue about Medicare and Medicaid policies and how they are applied daily in the real world.