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Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Showing posts with label advisory committee. Show all posts
Showing posts with label advisory committee. Show all posts
Friday, January 10, 2014
FDA seeking Nominations for 12 voting members of the Pharmacy Compounding Advisory and representative groups to determine consumer who should serve on committee
Monday, January 14, 2013
FDA SiIGNALS IT WILL REFORM PHARMACY COMPOUNDING DRUGS ADVISORY COMMITTEE
In With The Old? 2013 To Mark Rebirth Of CDER’s Pharmacy Compounding, Medical Imaging AdComms
By Sue Sutter / Email the Author / Jan. 14, 2013
Year In Review And The Year Ahead / Word Count: 3003 / Article # 00130114001 / Posted:January 14 2013 12:01 AM
Year In Review And The Year Ahead / Word Count: 3003 / Article # 00130114001 / Posted:January 14 2013 12:01 AM
Executive Summary
FDA has signaled that it will re-form its Pharmacy Compounding Drugs Advisory Committee, which was dissolved in 2002, as it deals with an ongoing meningitis outbreak related to compounded steroid injections. 2012 proved to be another busy year for the Oncologic Drugs Advisory Committee, but the full drug safety/risk management panel saw a significantly lighter workload than in recent years.
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Monday, January 7, 2013
FDA’s Advisory Committee Schedule Hints At Re-formulated Compounding Panel
By Cathy Dombrowski / Email the Author / Jan. 4, 2013
Word Count: 608 / Article # 14130104003 / Posted: January 4 2013 4:30 PM
Word Count: 608 / Article # 14130104003 / Posted: January 4 2013 4:30 PM
Executive Summary
The agency has not set a meeting date for the Pharmacy Compounding Drugs Advisory Committee, defunct since 2002, in its tentative schedule, but has included 13 vacancies on the panel in its list of committees in need of new members.
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Sunday, November 11, 2012
NH State Board of Pharmacy Meeting 11/14/2012: Compounding Pharmacy Advisory Committee is on Agenda
Board Meeting
Wednesday, November 14, 2012
9:00 A.M.
1. Minutes of 10/17 - Public Board Meeting
2. Minutes of 10/31 - Emergency Teleconference (Moved to Non-Public - Item B –
Pending Notification of Licensees, at which time action will be made Public)
3. Executive Secretary's Report
4. Compliance Report
5. Hannaford Pharmacy- Meredith (New Pharmacy Application)
6. Compounding Pharmacy Advisory Committee
7. Richard Fortier – Omnicare of NH - Pharmacy Remodel
8. Elizabeth Toabe - Pharmacist Application - Review
9. Ph 800 - Proposed Rules
10. Ph 1300 - Approve Minor Grammatical Changes
11. Review of 3 Non-Resident Pharmacy Applications
12. FYI's
To see source click here
Friday, November 9, 2012
Shouldn't all State Boards of Pharmacy and Maybe Even State Veterinary and Medical Boards Have Compounding Pharmacy Working Groups or Advisory Committees?
The following notice appears on the North Carolina State Board of Pharmacy:
I am wondering how many states had compounding pharmacy working groups or advisory committees before the meningitis outbreak. How many have recently put together such groups or committees or plan to do so? It would be a great idea if all state boards of pharmacy and perhaps even state veterinary and medical boards also established compounding pharmacy working groups or committees. This would be another sign that states are being proactive in this area and want to retain jurisdiction over compounding regulations.
Who should be appointed to these working groups and committees? Obviously, experts who know about compounding and the compounding world need to be appointed. Pharmacy Boards are typically made up of pharmacists so an expert compounding pharmacist should be on the working group or committee. This does not mean that all members should be pharmacists. Nor does this mean that the pharmacists should represent or work for a special interest group or have a conflict of interest as we saw on the Massachusetts State Board of Pharmacy. How about having a physician and a veterinarian who will know how the medications are used, what they are used for, etc. One of the most important people to include may be a marketing consultant or pharmaceutical rep (one both on the human side and one on the vet side). However, you will want to make sure this person knows the trenches, what really goes on in the compounding world, and truly understands the legalities of compounding because there are some that clearly don't . Should the committee or group also include a member from the general public? an attorney? Who else should the committee or group include or not include?
COMPOUNDING PHARMACY WORKING GROUP. The Board decided at its October meeting to put together a small working group to review all aspects of North Carolina regulation of compounding pharmacy and to make a report and recommendation. North Carolina pharmacists with an interest in participating should communicate that interest to Jay Campbell, the Board’s Executive Director, by Friday, November 2. The Board will select the members shortly afterward.
I am wondering how many states had compounding pharmacy working groups or advisory committees before the meningitis outbreak. How many have recently put together such groups or committees or plan to do so? It would be a great idea if all state boards of pharmacy and perhaps even state veterinary and medical boards also established compounding pharmacy working groups or committees. This would be another sign that states are being proactive in this area and want to retain jurisdiction over compounding regulations.
Who should be appointed to these working groups and committees? Obviously, experts who know about compounding and the compounding world need to be appointed. Pharmacy Boards are typically made up of pharmacists so an expert compounding pharmacist should be on the working group or committee. This does not mean that all members should be pharmacists. Nor does this mean that the pharmacists should represent or work for a special interest group or have a conflict of interest as we saw on the Massachusetts State Board of Pharmacy. How about having a physician and a veterinarian who will know how the medications are used, what they are used for, etc. One of the most important people to include may be a marketing consultant or pharmaceutical rep (one both on the human side and one on the vet side). However, you will want to make sure this person knows the trenches, what really goes on in the compounding world, and truly understands the legalities of compounding because there are some that clearly don't . Should the committee or group also include a member from the general public? an attorney? Who else should the committee or group include or not include?
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