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Editorial: It's "D�j� vu all over again"�but it's real!

Well, it has been a very interesting week with the events surrounding HR 3204 and its implementation. There have been teleconferences, meetings, telephone calls, Town Hall Meetings, etc. In summary, the "new" Section 503a is in force as well as the introduction of a new 503b section for outsourcing facilities involved with sterile products. The bill requires the establishment of an FDA Pharmacy Compounding Advisory Committee (PCAC) to address certain components of the bill.

This is the same as it was in FDAMA 97 where 503a was established and an FDA PCAC was formed to address many of the identical issues. It may be of interest to revisit the PCAC and its activities in the 1998-2000 timeframe. I would strongly encourage all to read through these transcripts of the three meetings held by the first FDA PCAC and how they were conducted; this may help in preparation for the new PCAC meetings in the future. It will take some time to read through these but, "It's Your Profession"! These are available on the FDA website as follows:

October 14-16, 1998 First Meeting of the Pharmacy Compounding Advisory Committee

• Committee Roster for the October 14-16, 1998 Meeting of the Pharmacy Compounding Advisory Committee
  http://www.fda.gov/ohrms/dockets/ac/98/roster/1998-3454R1_01_Committee.pdf
  
  
• Transcript for the October 14, 1998 Meeting of the Pharmacy Compounding Advisory Committee
  http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3454t1.pdf
  
  
• Transcript for the October 15, 1998 Meeting of the Pharmacy Compounding Advisory Committee (PDF - 154KB)
  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
  PharmacyCompounding/UCM290730.pdf
  
  
• Slides for the October 14-16, 1998 Meeting of the Pharmacy Compounding Advisory Committee
  http://www.fda.gov/ohrms/dockets/ac/98/slides/1998-3454-Slide_Index.htm

May 6-7, 1999 Second Meeting of the Pharmacy Compounding Advisory Committee

• Transcript for the May 6, 1999 Meeting of the Pharmacy Compounding Advisory Committee (PDF - 400KB)
  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
  PharmacyCompounding/UCM290732.pdf
  
  
• Transcript for the May 7, 1999 Meeting of the Pharmacy Compounding Advisory Committee (PDF - 151KB)
  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
  PharmacyCompounding/UCM290733.pdf
  
  
• Minutes for the May 6-7, 1999 Meeting of the Pharmacy Compounding Advisory Committee
  http://www.fda.gov/ohrms/dockets/ac/99/minutes/3513m1.pdf
  
  
• Slides for the May 6-7, 1999 Meeting of the Pharmacy Compounding Advisory Committee (Part 1)
  http://www.fda.gov/ohrms/dockets/ac/99/slides/3513b1a.pdf
  
  
• Slides for the May 6-7, 1999 Meeting of the Pharmacy Compounding Advisory Committee (Part 2)
  http://www.fda.gov/ohrms/dockets/ac/99/slides/3513b1b.pdf

July 13-14, 2000 Third Meeting of the Pharmacy Compounding Advisory Committee

• Transcript for the July 13, 2000 Meeting of the Pharmacy Compounding Advisory Committee (Pages 1-100)
  http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3634t1a.pdf
  
  
• Transcript for the July 13, 2000 Meeting of the Pharmacy Compounding Advisory Committee (Pages 101-200)
  http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3634t1b.pdf
  
  
• Transcript for the July 13, 2000 Meeting of the Pharmacy Compounding Advisory Committee (Pages 201-235)
  http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3634t1c.pdf
  
  
• Slides for the July 13, 2000 Meeting of the Pharmacy Compounding Advisory Committee
  http://www.fda.gov/ohrms/dockets/ac/00/slides/3634s1.htm
  
  
• Transcript for the July 14, 2000 Meeting of the Pharmacy Compounding Advisory Committee
  http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3634t2.pdf
  
  
• Slides for the July 14, 2000 Meeting of the Pharmacy Compounding Advisory Committee
  http://www.fda.gov/ohrms/dockets/ac/00/slides/3634s2.htm
  
  
• Minutes for the July 13-14, 2000 Meeting of the Pharmacy Compounding Advisory Committee
  http://www.fda.gov/ohrms/dockets/ac/00/minutes/3634m1.pdf

There are many questions to be addressed as evidenced by these meetings. One might get a sense of the approach used in these earlier meetings by reading these transcripts.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

FDA Implementing Plans with New Compounding Pharmacy Powers
FDA has said for years that they want more power; now, they have been given some, but not all, of the powers it wants. The FDA has very quickly begun to discuss how it plans to use its new authority; the agency outlines how compounding pharmacies can voluntarily register as "outsourcers" and submit information about their products. If drug buyers favor registered facilities, the registered compounders may gain a competitive edge. As part of the FDA "marketing" push, they plan to explain the benefits of buying from registered compounders to hospitals and other drug purchasers. If purchasers do not make their preference for registered facilities standard practice, the FDA's struggles to oversee compounding pharmacies could continue. "It will be difficult for us to identify compounding pharmacies that choose not to register with us. We will not be able to do proactive inspections and will have to wait until we have a complaint," FDA associate director for policy Jane Axelrad said.
http://www.reuters.com/article/2013/12/02/us-fda-compounding-idUSBRE9B10UP20131202

FDA Bans Another Plant in India
India's Wockhardt Ltd was hit by the U.S. FDA's "import alert"-effectively a ban. This results in the detention without physical examination of drugs from firms that have not met GMPs. This latest FDA action comes within a group of regulatory rejections in recent months, which has eliminated nearly three-quarters of the company's share value this year. The U.S. is Wockhardt's No.1 market, accounting for 43% of its revenue in the quarter ending in September. Drug companies in India produce nearly 40% of generic and over-the-counter drugs for the U.S. but have recently been hammered by many regulatory actions, including a record fine for Ranbaxy Laboratories Ltd. India is home to more than 150 FDA-approved plants, and pharmaceutical exports from India to the U.S. rose nearly 32% last year to $4.23 billion.
http://in.reuters.com/article/2013/11/27/wockhardt-ban-fda-idINL4N0JC0U620131127?rpc=401&feedType=RSS&feedName=domesticNews&rpc=401

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Please take time to get involved in the implementation of HR 3204. Start by reading the PCAC referenced above and participate in shaping pharmacy's future.

Leaves face soft,
As woman's touch.
Yet doesn't cost you
Near as much!
      Burma Shave

PCAB is proud to announce the accreditation of the following pharmacies:

Compoundia Pharmacy, Westlake Village, CA; Betty Viso, Owner, betty@compoundiapharmacy.com. Initial Accreditation for Sterile & Nonsterile Compounding

Stark Pharmacy, Overland Park, KS; Jeff Kivett, RPh, Sterile Lab Manager, jeff@starkpharmacy.com. Initial Accreditation for Sterile & Nonsterile Compounding

Pharmaceutical Press, the publisher of the flagship textbook. Remington: The Science and Practice of Pharmacy is considering a new edition and would like to start planning now to make sure the content and structure of this title continues to meet customer needs. We would also like to hear about your preferences for print, ebook downloads, and online access to pharmacy reference publications.

We have prepared a survey which will take approximately 5 minutes to complete. Your feedback is important to us in our plans for the new edition. We welcome views of both current users of the text and those who may use other resources or an alternative publication.

This survey is optimized for viewing in Firefox, Safari, or Chrome browsers. Responders viewing with Internet Explorer 11 are advised to revert to Internet Explorer 10 in order to complete the survey successfully.

Please click here to take part:
www.surveymonkey.com/s/REMINGTON22

Thank you in advance for your participation!

Pharmaceutical Press

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Pharmacist Needed
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