Archive for the 'Compounding Legislation' Category

New Compounding Law H.R. 3204: One Pharmacist’s Perspective

Sacramento state house

Sacramento state house

A little over a year ago, an outbreak of meningitis cases caused by injectable steroid medications made by a compounding pharmacy in Massachussetts cast a national spotlight on the compounding profession. As a result of this tragedy, new legislation was signed into law in November, 2013. This new legislation, called “H.R. 3204,”” strives to create legal distinctions between traditional compounding pharmacies and a newly designated category of pharmacy called an “outsourcing facility.”

A traditional compounding pharmacy is defined as one that mostly dispenses customized medications on a case-by-case, patient specific basis. Outsourcing facilities, on the other hand, will more closely resemble drug manufacturers in that they make large quantities of medications that are not patient-specific and that can be shipped regularly across state lines.

Although outsourcing facilities are now being encouraged to officially register with the Food and Drug Administration (FDA), traditional compounding pharmacies (such as Koshland Pharm) will continue to be regulated by their individual state boards of pharmacy. The FDA has always had and will continue to have the authority to inspect any facility or business that stores medications, which means that it can inspect a traditional compounding pharmacy at any time. However, H.R. 3204 puts the FDA’s greatest attention on outsourcing facilities, and it clarifies state boards’ of pharmacy responsibility to regulate traditional compounding pharmacies in their jurisdiction.

There are many aspects of the new legislation that will only become clear once it begins to be enforced in the coming year. One question that remains is how the FDA will carry out its power to create a “do not compound” list for both traditional compounding pharmacies and outsourcing facilities alike. In the past, the FDA has written statements expressing concerns about certain kinds of commonly compounded medications, such as the hormone estriol, but without citing specific research that led them to have these concerns (see my past blog post on the FDA and estriol for further information). Up until now, the FDA has not prohibited compounding pharmacies from making estriol, even though it has had the power to do so. Although the FDA has not taken this action in the past, it could potentially do so in the future at their discretion.

Stay tuned for on-going updates about this recent law and how it is impacting the field of customized medications. Feel free to post questions here for a dialogue about this important topic for the future of customized medications.

~Peter Koshland, PharmD

www.koshlandpharm.com

An Open Letter to Our Senators Opposing Proposed Compounding Legislation

Koshland PharmThe regulation of compounding pharmacies is currently being debated in the Senate due to the understandable concern that followed the meningitis outbreak tied to a compounding facility in Massachusetts in October of 2012.  As the founders of a compounding pharmacy in San Francisco, we are supportive of efforts to tighten the regulation standards and practices of State Boards of Pharmacy to ensure the safety and protection of patient health.

However, we have substantial concerns with the current June 27th Senate bill (S. 959) that is scheduled to be voted on next week.  We do not believe that it effectively protects patient safety while preserving patients’ and practitioners’ access to compounded medications.  These medications can be vital to individuals’ health and well-being. We believe that revision of this current Senate bill is important not only in our particular lives as the founders of a compounding pharmacy, but also in the lives of thousands of patients we have worked with and witnessed benefiting from compounded medications.

To read more about Senate bill 959, we recommend the website of the International Academy of Compounding Pharmacists. We are also including below the letter that we sent to our senators on this topic:

Dear Senators Feinstein and Boxer:

We are writing to bring to your attention concerns that we have with the recently reported version of S. 959, “The Pharmaceutical Compounding Quality and Accountability Act,” which we understand the Senate may consider the week of July 15.

We are a husband and wife who opened a compounding pharmacy in San Francisco in 2009.  Our pharmacy is committed to making high quality, customized medications (as demonstrated by our accreditation by the Pharmacy Compounding Accreditation Board) and to building relationships with both patients and their doctors to ensure the best possible treatment outcomes. It was Peter’s desire to work in a pharmacy setting where he had the time to talk one-on-one with patients that led him into the compounding profession, and it is this ability to focus on patient care that continues to inspire us, as well as our staff of eleven others, in our collective work of supporting patients in their health and well-being.  One patient recently wrote to us, “The medications Peter and his group made for me have made such a difference in my life. I have never had a pharmacy call to see how I am doing on any medicine. Thank you!”

We are aware that the U.S. Senate’s Committee on Health, Education, Labor and Pensions has worked diligently and cooperatively for several months with the various stakeholders in the pharmacy and practitioner communities to draft legislation to address the tragic patient deaths and illnesses associated with the New England Compounding Center (NECC). In reviewing the Committee’s most recent version of S. 959, we wanted to make you aware of several provisions we have concerns about.  We ask you to take these concerns in consideration as the Senate debates this legislation.

Our primary concern is that the current draft of the bill would interfere with the regulation of traditional compounding pharmacies by State Boards of Pharmacy – the regulatory board that we believe is most appropriate and best able to oversee traditional compounding pharmacies.  The state of California currently has some of the strictest laws in the nation to regulate compounding pharmacies, and we believe that our State Board  – not the FDA –is best able to balance the dually important needs of ensuring the safety of compounded medications while preserving patient and practitioner access to vital compounded medications. Our understanding of S.959 is that it:

• contradicts existing and evolving state laws allowing for “office-use” and “anticipatory compounding”

• inappropriately gives the FDA (instead of State Boards of Pharmacy) authority to determine if a pharmacy is acting within the scope of its permit

• gives the FDA arbitrary authority to restrict the compounding of specific products based on ambiguous standards , permitting the FDA to create a “do not compound” list based on unclear definitions about “complex” or “difficult” to compound issues rather than true patient safety issues

• places the FDA in the role of determining whether a compounding pharmacist’s preparation and dispensing of a variation of a marketed drug is “clinically significant”

Of greatest concern to us is the fact that one of the fundamental documented problems in the NECC scenario was inaction by the Massachusetts Board of Pharmacy and the Federal Food and Drug Administration (FDA) in a situation where they had made numerous visits to the facility and had knowledge of significant problems. Despite that, they did not shut NECC down. This bill does not provide for any reporting system for the FDA, nor does it hold the agency accountable in any way. This is a significant flaw that needs to be addressed in the legislation.

We hope you will take our concerns into consideration before final consideration of S. 959. Should these provisions not be addressed before the bill goes to the Senate floor for a final vote, we urge your opposition to this well-intended but flawed legislation.

Sincerely,

Peter Koshland, PharmD and Krista Shaffer

Ensuring Quality and Safety in Compounded Medications

As a compounding pharmacist, I have been saddened by recent unfolding news about a meningitis outbreak in southern and eastern states tied to injectable medications made at a compounding pharmacy in Massachusetts. As this news is shining a national spotlight on compounding, I would like to highlight two key issues this situation raises:

1) Accreditation by the Pharmacy Compounding Accreditation Board (PCAB) is essential in the compounding profession. Although new facts continue to be uncovered in the investigation of the pharmacy in question in Massachusetts, it has been established that it was not PCAB accredited. There are currently 165 compounding pharmacies nation-wide (and  21 in the state of California) that are PCAB accredited.

Although every compounding pharmacy is regulated by its state board of pharmacy, variation does exist state to state in practice requirements. Being PCAB accredited ensures that a pharmacy has passed the highest standards for safety and quality in the profession. The Pharmacy Compounding Accreditation Board was founded and is governed by eight leading national pharmacy organizations, including the United States Pharmacopeia (USP), and it requires pharmacies to adhere to strict policies and procedures that include rigorous and consistent testing of their finished products.

2) Sterile and non-sterile compounding are two different kinds of compounding a pharmacy can specialize in. Of the approximate 7,500 pharmacies nation-wide that specialize in compounding, 3,000 provide sterile compounding.  Sterile compounding requires additional equipment and procedures to ensure the sterility of the finished products that are injected directly into the body.  The medications that are under current investigation from the Massachusetts compounding pharmacy were sterile injections.

I, along with thousands of my compounding pharmacist colleagues, am dedicated to providing patients with the valuable option of using high-quality, customized medications when standard treatments are not working for their particular situation.  To read six key questions for a patient to keep in mind when evaluating a compounding pharmacy (particularly one that makes non-sterile products), see  Koshland Pharm’s “Understanding Compounding” webpage.  To read extensive questions a doctor can ask of a compounding pharmacy (particularly one that makes sterile products), see this questionairre created by the International Academy of Compounding Pharmacists. To read another recent blog about how the Massachusetts compounding pharmacy in question appears to differ from traditional pharmacy compounding, see the National Community Pharmacists Association blog.

Your comments and questions on this important topic are welcome.

~Peter

www.koshlandpharm.com


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