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Medscape News: Regulating Compounding Pharmacies

Posted Jan 02 2013 12:01am
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 Since the fungal meningitis health scandal that rocked the compounding pharmacy industry in 2012, there have been rumblings among legislatures and lawmakers to increase federal regulatory oversight of compounding pharmacies.

 I have been following this issue because compounding pharmacies provide bioidentical hormones for hundreds of thousands of women going through perimenopause.  It is an issue that I believe we need to be paying close attention.  Medcape News Today has published this article and several others on this topic that I think might be of great interest to The Perimenopause Blog readers.

 I do not have permission to reprint the articles in their entirety (simply because I did not request it) and so, instead, I thought I would link to the Medscape site and let you read them for yourself there.  You have to open an account to have access to the articles, but it is free, and definitely something I recommend if you are interested in keeping up with medical news.

Click through below to go to Medscape for the rest of the article.

How should prescribers evaluate a compounding pharmacy? What is the most appropriate education for patients and families? Medscape spoke with David G. Miller, RPh, Executive Vice President and Chief Executive Officer at the IACP about these and other important clinical questions.

Medscape: Can you provide a “regulation 101″ tutorial for prescribers? Who regulates compounding pharmacies, and how can a prescriber check on the accreditation status of a particular pharmacy?

Mr. Miller: The answer depends on the state you are in because compounding pharmacies are regulated by state boards of pharmacy. Those boards have varying levels of rules and practices, and the boards also have different levels of enforcement and oversight policies. The FDA does not have primary responsibility for regulating compounding pharmacies, but it does have the right to inspect compounding pharmacies and has exercised that right in the past.

Medscape: ISMP urges healthcare providers to use commercially available, ready-to-use, FDA-approved products from pharmaceutical manufacturers as often as possible. When these products are not available, the agency suggests that prescribers carefully assess and select a compounding pharmacy for medically necessary medications. How can prescribers evaluate a compounding pharmacy?

Mr. Miller: IACP actually has a tool that prescribers can use to assess the quality of compounding pharmacies. Our Compounding Pharmacy Assessment Questionnaire provides for exhaustive screening of the capabilities and quality of any compounder.

Medscape: Guidelines for selecting a compounding pharmacy are available from the American Society of Health-System Pharmacists. What is IACP’s view of these guidelines? Are they useful?

 Mr. Miller: Any tool developed by a professional association in pharmacy can potentially have a benefit to prescribers and help assure a good fit between prescriber and pharmacy. We often collaborate with the other pharmacy associations.

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