USP-Part 2: USP Expert Committee Procedures
The "general" procedures followed by the USP Expert Committees are as follows. First, a topic or subject is presented that needs to be addressed. It may be a request for a change in a general chapter, an entirely new general chapter, a monograph, etc. These topics can come from practitioners, organizations, committee members, etc. Background information is obtained and the topic is added to the agenda for the next meeting. The materials to be covered at a meeting are provided to the committee members in advance of the meeting so they can be reviewed and any suggestions for further information that might be needed can be obtained.
At the meeting, each agenda item is discussed and some action recommended. This may involve approval, approval after changes, denial, or postponement until further information is obtained. The item may involve other committees so it may be important to obtain additional input on some topics.
In the event of approval, the item (general chapter change, new general chapter, monograph, etc.) may go through the Nomenclature Committee if a new name or title is involved and then the item is advanced to the Executive Committee. After approval, it is published in Pharmacopeial Forum (PF) for public comment. Pharmacopeial Forum is published six times per year and contains information on the activities of the various committees. This is the opportunity for all to read and comment on the actions of the various committees. (Note: It would be advisable for all pharmacy compounding organizations to subscribe to PF to keep up to date on activities of the USP committees).
After publication in PF, the staff liaison gathers any inquiries and discusses them with the Chair of the Expert Committee. If the comments are significant, they are brought to the committee for consideration. After the committee discusses them they reach a decision. If the decision it so make a significant change in the chapter or monograph, the process is repeated and the item is published again in PF for public review and comment. If the change is insignificant, the item moves forward.
After the opportunity for public comment is completed, the item moves forward in the process and ultimately will be assigned a date for becoming official in the USP-NF. On average, it will take about a year for an item to move through the committee; some will take longer.
One project that is now necessary since compounding is becoming a larger part of the USP is a review of all the General Chapters. Keep in mind that over the past 75 years or so the primary emphasis and activities of the USP have been oriented towards establishing standards for the pharmaceutical industry. All the General Chapters, with the exception of <795>, <797>, <1075> and <1160>, have been written for the pharmaceutical industry. Now, we have the compounding chapters that refer to other General Chapters and we have many General Chapters that directly or indirectly impact pharmacy practice and pharmacy compounding. Obviously, when a General Chapter is written for the pharmaceutical industry, there is a different approach and the content is somewhat different. Some items in the General Chapters need to be addressed and may require some modification so that pharmacists can comply. Let me request that if you have a current USP-NF and are aware of any of the General Chapters that contain areas that are problematic, please send an e-mail and we can put them on the agenda of the committee. The USP process is designed to be transparent and open for input. The USP-NF is a book that is never completed. USP 28-NF 23 is actually the 27th revision of the first edition of the USP and the 22nd revision of the first edition of the NF.
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief |
|
Dr. Allen, the Editor-In-Chief of the International Journal of Pharmaceutical Compounding was interviewed for PrimeTime Live's Expose' featuring pharmaceutical compounding. The expose' aired April 21, 2005, but unfortunately not one segment of Dr. Allen's over one hour interview was used. IJPC is asking ABC for a copy of the transcript from his interview but we doubt it will be made available.
As a result of Dr. Allen's experience with the interview he has written four white papers discussing the positive role that compounding plays in patient care. These papers were also made available to ABC prior to the airing of their expose'. However, like Dr. Allen's interview, nothing from these papers was used by ABC . We have made the white papers available for download, copy and distribution at no charge to you. Please download your own copies by going to http://www.compoundingtoday.com/WhitePapers/.
Time and time again the mainstream press has proven biased and tainted refusing to cover compounding fairly. Therefore individual pharmacists, their patients and prescribers must communicate the importance of compounding. We hope these four white papers help you do just that. Use them broadly.
It is our understanding that the horrible photographs appear to be quite similar to some presented to the FDA Compounding Advisory Committee back in 1998-1999 by a state board of pharmacy official. When questioned by the committee, he admitted that the photos were over 10 years old; that means that by now, they are over 15 years old, and still being used.
We are printing copies of these white papers and will distribute them to pharmacy media, state boards of pharmacy, state associations, pharmacy schools, bureaucrats and the like within the next few weeks. If you would like sets of these white papers in quantities of 25 or more in print, please contact Shelly Schluter via email at sschluter@ijpc.com. |
|
www.compoundingtoday.com hosts the only database of compounding specific abstracts in the world. From our regular search of more than 439 medical and pharmacy titles, CT.com now has more than 1200 abstracts posted all supporting compounding. Search our fast growing database at http://compoundingtoday.com/articles/index.cfm and obtain abstracts to provide to prescribers and patients. Or contact a publisher of a particular article and get the full text. Links to each publisher is provided within the CT.com database.
This week abstracts related to Irritable Bowel Syndrome and Probiotics were uploaded to the database. Here is a sampling of some of those abstracts.
- Cummings JH, Kong SC. Probiotics, prebiotics, and antibiotics in inflammatory bowel disease. Novartis Found Symp 2004; 263: 93-111, 111-114.
- Fedorak RN, Madsen KL. Probiotics and prebiotics in gastrointestinal disorders. Curr Opin Gastroenterol 2004; 20(2): 146-155.
- Furrie E, Macfarlane S, Kennedy A et al. Synbiotic therapy (Bifidobacterium longum/Synergy 1) initiates resolution of inflammation in patients with active ulcerative colitis: A randomized controlled pilot trial. Gut 2005; 54(2): 242-249.
- Klotz U, Schwab M. Topical delivery of therapeutic agents in the treatment of inflammatory bowel disease. Adv Drug Deliv Rev 205; 57(2): 267-279.
- Sartor RB. Probiotic therapy of intestinal inflammation and infections. Curr Opin Gastroenterol 2005; 21(1): 44-50.
|
|
Government Replies to Midland Amicus Briefs
On March 15th, the government responded to the amicus briefs (IACP, APhA, TPA, Kohll's pharmacy et al and AAPS) that were filed in opposition to the government's motion to
dismiss in the Midland case. The government replied collectively to the amicus briefs. Click here to view a copy of the brief.
Tobramycin Manufacturer Chiron Settles with Pharmacies, Mandates Disclaimer
Under a recent settlement with Chiron, compounding pharmacies in the Respiratory Disease Network must include a disclaimer in marketing and promotional materials related
to the drug tobramycin. "The disclaimer must warn that compounded prescriptions are not evaluated by the FDA for safety or efficacy..." Read more>>
|
