View | 12/31/2013 | HM COMPOUNDING |
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 2013. Show all posts
Showing posts with label 2013. Show all posts
Monday, January 20, 2014
Saturday, January 4, 2014
Friday, December 27, 2013
FDA Starts Regulating Compounding Pharmacies Dec 27, 2013
The U.S. Food and Drug Administration on Monday began the process of regulating compounding pharmacies, which create new drug combinations or alter drugs to suit individual patient needs.
Under the Drug Quality and Security Act, signed into law Nov. 27 by President Barack Obama, these pharmacies are being encouraged to register with the FDA. The agency will then classify them as outsourcing pharmacies, enabling them to sell bulk drugs to hospitals and other health-care facilities.
The law was prompted by the deaths last year of 64 people who received fungus-contaminated steroid medications that were given in injections to treat back and joint pain. An additional 750 people in 20 states were sickened by the contaminated drug. The medication was made by the now-shuttered New England Compounding Center, in Framingham, Mass., according to federal health officials.
"The part of the law related to compounding is a step forward by creating a new pathway in which compoundersregister with FDA as an outsourcing facility," FDA commissioner Dr. Margaret Hamburg said during a Monday afternoon press briefing.
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Monday, December 23, 2013
Sunday, December 22, 2013
Michigan Board of Pharmacy Disciplinary Subcommittee Action December 11, 2013
5. REGULATORY CONSIDERATIONS
A. Dearborn Heights Pharmacy - Consent Order and Stipulation
(Conferee Almaklani)
B. Nabil Hussein Fakih, R.Ph - Consent Order and Stipulation
(Conferee Almaklani)
C. Houssein Hammoud, R.Ph - Consent Order and Stipulation
(Conferee Almaklani)
D. Icore Healthcare, L.L.C. - Consent Order and Stipulation
(Conferee Almaklani)
E. Dorian N. Lange, R.Ph - Consent Order and Stipulation
(Conferee Almaklani)
F. Kwei Kuen Leong, R.Ph - Consent Order and Stipulation
G. Anteneh Kassa Woldetsadik, R.Ph - Consent Order and Stipulation
(Conferee Almaklani)
H. Coty Lynn Alexander, R.Ph - Consent Order and Stipulation
(Conferee Schmidt)
I. Medquest Pharmacy - Consent Order and Stipulation
(Conferee Schmidt)
J. Philip Mark Neiman, R.Ph - Consent Order and Stipulation
(Conferee Schmidt)
K. David Shimp, R.Ph - Consent Order and Stipulation
(Conferee Schmidt)
L. Perry Wayne Brown, R.Ph - Consent Order and Stipulation
M. Richard James Corstange, R.Ph- Consent Order and Stipulation
N. Canniff Pharmacy – Request for Reconsideration
O. Mostapha A. Elghoul, R.Ph – Request for Reconsideration
P. Mohammed Saiful Islam, R.Ph – Request for Reconsideration
quoted from here
A. Dearborn Heights Pharmacy - Consent Order and Stipulation
(Conferee Almaklani)
B. Nabil Hussein Fakih, R.Ph - Consent Order and Stipulation
(Conferee Almaklani)
C. Houssein Hammoud, R.Ph - Consent Order and Stipulation
(Conferee Almaklani)
D. Icore Healthcare, L.L.C. - Consent Order and Stipulation
(Conferee Almaklani)
E. Dorian N. Lange, R.Ph - Consent Order and Stipulation
(Conferee Almaklani)
F. Kwei Kuen Leong, R.Ph - Consent Order and Stipulation
G. Anteneh Kassa Woldetsadik, R.Ph - Consent Order and Stipulation
(Conferee Almaklani)
H. Coty Lynn Alexander, R.Ph - Consent Order and Stipulation
(Conferee Schmidt)
I. Medquest Pharmacy - Consent Order and Stipulation
(Conferee Schmidt)
J. Philip Mark Neiman, R.Ph - Consent Order and Stipulation
(Conferee Schmidt)
K. David Shimp, R.Ph - Consent Order and Stipulation
(Conferee Schmidt)
L. Perry Wayne Brown, R.Ph - Consent Order and Stipulation
M. Richard James Corstange, R.Ph- Consent Order and Stipulation
N. Canniff Pharmacy – Request for Reconsideration
O. Mostapha A. Elghoul, R.Ph – Request for Reconsideration
P. Mohammed Saiful Islam, R.Ph – Request for Reconsideration
quoted from here
Wednesday, December 18, 2013
Hawaii Board of Pharmacy Agenda for Meeting Tomorrow December 19, 2013
2013/12/19 | ||
Time | 09:00 AM | |
---|---|---|
Recurring | ||
Event status |
| |
Title | Board of Pharmacy Meeting | |
Location | King Kalakaua Conference Room King Kalakaua Building 335 Merchant Street 1st Floor Honolulu Hawaii 96813 | |
BOARD OF PHARMACY
Professional and Vocational Licensing Division Department of Commerce and Consumer Affairs State of Hawaii
AGENDA
Date: Thursday, December 19, 2013
Time: 9:00 a.m.
Place: King Kalakaua Conference Room
1. Call to Order, Public Notice, QuorumKing Kalakaua Building 335 Merchant Street, First Floor Honolulu, Hawaii 96813 2. Chair's Report a. Announcements and Introductions b. Additions/Additional Distribution to Agenda c. Approval of the Previous Minutes - November 21, 2013 Meeting 3. Laws and Rules Committee Report on November 21, 2013 Meeting (Todd Inafuku) 4. Executive Officer's Report a. 2014 Legislature b. Report on Current Renewals 5. Correspondence a. National Association of Boards of Pharmacy (NABP) 1) November 2013 State News Roundup i. New Missouri Emergency Dispensing Legislation ii. Major Change in the OARRS Report to Address the MED Ohio Initiative iii. Ohio Board Proposed Emergency Rule Regarding Synthetic Cannabinoids/Cathinones iv. Immunizations for Public health Emergencies in Oregon v. Virginia Statutory Change to Requirement for Nonresident Pharmacies Submission of Current Inspection Report 6. Old Business a. HAR Title 16, Chapter 95 - Status Report b. Pharmacy Technician Survey - Status Report 7. Open Forum (Public comment on issues on the agenda, or not on the agenda for the Board's consideration at the next meeting.) 8. Applications (The Board may move into Executive Session in accordance with HRS §§92-4 and 92-5(a)(1) and 4) "To consider and evaluate personal information relating to individuals applying for licensure;" and "To consult with the Board's attorney on questions and issues pertaining to the Board's powers, duties, privileges, immunities, and liabilities;", Board will vote in Open Meeting.) a. Ratification Lists b. Applications 1) Miscellaneous Permit i. Express Plus Pharmacy LLC ii. Budget Discount Sales Corp., dba SoBe Compounding Apothecary iii. Biofusion LLC, dba Biofusion - Deferred from November 21, 2013 Meeting 9. Next Meeting: January 23, 2014 - New Date Queen Lilioukalani Conference Room - New Room King Kalakaua Building 335 Merchant Street, First Floor Honolulu, Hawaii 96813 10. Adjournment Individuals who require special needs accommodations are invited to call Lee Ann Teshima, Executive Officer, at (808) 586-2695 at least 4 working days in advance of the meeting. 12/10/13 quoted from here |
Saturday, December 14, 2013
Arizona Board of Pharmacy Agenda for December 17, 2013
AGENDA
The Agenda for the meeting is as follows:
1. Call to Order – President Van Hassel
2. Verified Pharmacy Program Presentation – Presentation by NABP regarding the Verified Pharmacy
Program
3. Call to the Public
The Board may make an open call to the public during the meeting, subject to reasonable time, place, and
manner restrictions, to allow individuals to address the Board on any issue within its jurisdiction. Pursuant
to A.R.S. § 38-431.91 (G), members of the Board are not allowed to discuss or take legal action on matters
raised during an open call to the public unless the matters are properly noticed for discussion and legal
action. However, the Board may ask staff to review a matter or may ask that a matter be placed on a future
agenda.
4. Adjournment
Prepared and Posted 12/13/2013 CF quoted from here
The Agenda for the meeting is as follows:
1. Call to Order – President Van Hassel
2. Verified Pharmacy Program Presentation – Presentation by NABP regarding the Verified Pharmacy
Program
3. Call to the Public
The Board may make an open call to the public during the meeting, subject to reasonable time, place, and
manner restrictions, to allow individuals to address the Board on any issue within its jurisdiction. Pursuant
to A.R.S. § 38-431.91 (G), members of the Board are not allowed to discuss or take legal action on matters
raised during an open call to the public unless the matters are properly noticed for discussion and legal
action. However, the Board may ask staff to review a matter or may ask that a matter be placed on a future
agenda.
4. Adjournment
Prepared and Posted 12/13/2013 CF quoted from here
Thursday, December 12, 2013
Ohio Ex-Pharmacist Sentenced for $2.1M Insurance Fraud December 9, 2013
Ohio officials say a former pharmacist convicted in a $2.1 million health care fraud scheme has been sentenced to 4 1/2 years in prison.
Barbara Elise Miller of Coshocton was sentenced in federal court in Akron.
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Sunday, December 1, 2013
Louisiana Board of Pharmacy Compounding for Prescriber's Use Rule Proposal Considered by Regualtion Revision Committee on November 13, 2013
2013-1.2 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-E]
01-29-2013 Board issued Declaration of Emergency & Emergency Rule, to become effective on 01-31-2013.
01-30-2013 Distributed required Notice of Emergency to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.
01-30-2013 Distributed electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
05-29-2013 Board re-issued Declaration of Emergency & Emergency Rule, effective immediately.
05-30-2013 Distributed required Notice of Emergency Rule to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.
06-01-2013 Distributed electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
09-27-2013 Board re-issued Declaration of Emergency & Emergency Rule, effective immediately.
09-27-2013 Distributed required Notice of Emergency Rule to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register. 09-27-2013 Distributed electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
2013-1.1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D]
12-13-2012 Board issued Declaration of Emgergency & Emergency Rule, effective immediately.
12-16-2012 Distributed electronic Notice of Emergency Rule to all pharmacies, all pharmacists, and List of Interested Parties.
12-17-2012 Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
01-18-2013 Louisiana Senate Committee on Health and Welfare rejected the emergency rule. The effect of that decision was to void the December 13, 2012 emergency rule, effective immediately. However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
01-18-2013 Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
01-29-2013 This project terminated with submission of replacement emergency rule, tracked as Regulatory Project 2013-1.2 (see above).
2013-1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D] 01-20-2013 1st Report: Notice of Intent published in Louisiana Register
02-27-2013 Public Hearing
03-06-2013 Board considered comments; instructed staff to submit revised language for additional comment at a future public hearing.
04-19-2013 Distributed electronic Notice of Rulemaking Activity to List of Interested Parties as well as all pharmacies and all pharmacists.
04-20-2013 Potpourri Notice
05-30-2013 Public Hearing
08-15-2013 Board considered public comments and testimony, then remanded proposed rule back to Regulation Revision Committee for further consideration.
11-13-2013 Scheduled for committee consideration
01-29-2013 Board issued Declaration of Emergency & Emergency Rule, to become effective on 01-31-2013.
01-30-2013 Distributed required Notice of Emergency to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.
01-30-2013 Distributed electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
05-29-2013 Board re-issued Declaration of Emergency & Emergency Rule, effective immediately.
05-30-2013 Distributed required Notice of Emergency Rule to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.
06-01-2013 Distributed electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
09-27-2013 Board re-issued Declaration of Emergency & Emergency Rule, effective immediately.
09-27-2013 Distributed required Notice of Emergency Rule to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register. 09-27-2013 Distributed electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
2013-1.1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D]
12-13-2012 Board issued Declaration of Emgergency & Emergency Rule, effective immediately.
12-16-2012 Distributed electronic Notice of Emergency Rule to all pharmacies, all pharmacists, and List of Interested Parties.
12-17-2012 Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
01-18-2013 Louisiana Senate Committee on Health and Welfare rejected the emergency rule. The effect of that decision was to void the December 13, 2012 emergency rule, effective immediately. However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
01-18-2013 Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
01-29-2013 This project terminated with submission of replacement emergency rule, tracked as Regulatory Project 2013-1.2 (see above).
2013-1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D] 01-20-2013 1st Report: Notice of Intent published in Louisiana Register
02-27-2013 Public Hearing
03-06-2013 Board considered comments; instructed staff to submit revised language for additional comment at a future public hearing.
04-19-2013 Distributed electronic Notice of Rulemaking Activity to List of Interested Parties as well as all pharmacies and all pharmacists.
04-20-2013 Potpourri Notice
05-30-2013 Public Hearing
08-15-2013 Board considered public comments and testimony, then remanded proposed rule back to Regulation Revision Committee for further consideration.
11-13-2013 Scheduled for committee consideration
Saturday, November 30, 2013
Florida Board of Pharmacy Compounding Rules Committee Meeting Scheduled for December 2, 2013
Next Meeting:
Dec 2 , 2013
Compounding Rules Committee
Monday, November 18, 2013
Louisiana Board of Pharmacy committee Considered Office Use or Prescriber's Use rule changes on November 13, 2013
2013-1.1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D]
12-13-2012 Board issued Declaration of Emgergency & Emergency Rule, effective immediately.
12-16-2012 Distributed electronic Notice of Emergency Rule to all pharmacies, all pharmacists, and List of Interested Parties.
12-17-2012 Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
01-18-2013 Louisiana Senate Committee on Health and Welfare rejected the emergency rule. The effect of that decision was to void the December 13, 2012 emergency rule, effective immediately. However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
01-18-2013 Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
01-29-2013 This project terminated with submission of replacement emergency rule, tracked as Regulatory Project 2013-1.2 (see above).
2013-1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D] 01-20-2013 1st Report: Notice of Intent published in Louisiana Register
02-27-2013 Public Hearing
03-06-2013 Board considered comments; instructed staff to submit revised language for additional comment at a future public hearing.
04-19-2013 Distributed electronic Notice of Rulemaking Activity to List of Interested Parties as well as all pharmacies and all pharmacists.
04-20-2013 Potpourri Notice
05-30-2013 Public Hearing
08-15-2013 Board considered public comments and testimony, then remanded proposed rule back to Regulation Revision Committee for further consideration.
11-13-2013 Scheduled for committee consideration
continue to read here
12-13-2012 Board issued Declaration of Emgergency & Emergency Rule, effective immediately.
12-16-2012 Distributed electronic Notice of Emergency Rule to all pharmacies, all pharmacists, and List of Interested Parties.
12-17-2012 Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
01-18-2013 Louisiana Senate Committee on Health and Welfare rejected the emergency rule. The effect of that decision was to void the December 13, 2012 emergency rule, effective immediately. However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
01-18-2013 Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
01-29-2013 This project terminated with submission of replacement emergency rule, tracked as Regulatory Project 2013-1.2 (see above).
2013-1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D] 01-20-2013 1st Report: Notice of Intent published in Louisiana Register
02-27-2013 Public Hearing
03-06-2013 Board considered comments; instructed staff to submit revised language for additional comment at a future public hearing.
04-19-2013 Distributed electronic Notice of Rulemaking Activity to List of Interested Parties as well as all pharmacies and all pharmacists.
04-20-2013 Potpourri Notice
05-30-2013 Public Hearing
08-15-2013 Board considered public comments and testimony, then remanded proposed rule back to Regulation Revision Committee for further consideration.
11-13-2013 Scheduled for committee consideration
continue to read here
Saturday, November 16, 2013
Saturday, November 2, 2013
Wednesday, October 30, 2013
Medscape Medical News FDA Report Outlines Approach to Personalized Medicine Miriam E. Tucker October 29, 2013
SILVER SPRING, Maryland — In a detailed new report, the US Food and Drug Administration (FDA) has outlined its approach for regulating new personalized therapies and devices.
The report, Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development, outlines the fundamental ways in which the FDA has modified its traditional approaches to drug and device regulation in the new era of products that are tailored toward specific patient subtypes, rather than broad diagnostic groups.
"We're very, very excited about this report because I think it captures the broad context of what's happening in science and medicine today and the role of the FDA as we enter the era of personalized medicine, and for us, personalized medical product development," FDA commissioner Margaret A. Hamburg, MD, said in a press briefing held at the FDA headquarters Monday.
Dr. Hamburg noted that the European Union's definition of personalized medicine, "Providing the right treatment to the right patient, at the right dose at the right time," has always been medicine's goal.
"Now, with the advance of science and technology and the understanding of both the underlying mechanisms and the human response to disease, we have so many more opportunities to target therapies in exciting ways and really improve the care that we can offer and the effectiveness of treatments," she said
Starting in 1998 with the approval of trastuzumab (Herceptin, Genentech) for the treatment of HER2-positive breast cancers, the FDA has approved more than 100 drugs that contain specific information about biomarkers in the labeling. Sometimes that information is added postlicensure.
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Saturday, October 26, 2013
Wednesday, October 23, 2013
Virginia Board of Pharmacy Was Busy with Disciplinary Action in October: Draft Minutes for October 7 and 17, 2013
Monday | October 7, 2013 9:00 a.m. |
Informal Conference Committee Board Room 1 |
Draft Minutes |
Thursday | October 17, 2013 9:00 a.m. |
Special Conference Committee & Informal Conference Committee Board Room 2 |
Draft Minutes |
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