Showing posts with label 2013. Show all posts
Showing posts with label 2013. Show all posts

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

Isabell Werth fights back in doping affair December 23, 2013

There is movement in the doping case of dressage rider Isabell Werth. The FN accused Werth of administering the medicine Cimetidine to her Grand Prix horse El Santo. For this, they can get a competition ban for six months. 
continue to read here

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

Wednesday, December 18, 2013

Hawaii Board of Pharmacy Agenda for Meeting Tomorrow December 19, 2013


2013/12/19
Time09:00 AM
Recurring
Event status
Handicap access, ADA Contact info: Lee Ann Teshima, 808-586-2695
TitleBoard of Pharmacy Meeting
LocationKing 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
King Kalakaua Building
335 Merchant Street, First Floor
Honolulu, Hawaii 96813
1. Call to Order, Public Notice, Quorum
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

Georgia Board of Pharmacy Teleconference December 19, 2013

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

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

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


Meeting Materials 

FAW Notice (PDF) | Agenda (PDF)AGENDA 
DEPARTMENT OF HEALTH 
BOARD OF PHARMACY 
COMPOUNDING RULES COMMITTEE 
DECEMBER 2, 2013 
Hilton Hotel University of Florida 
1714 SW 34th Avenue 
Gainesville, FL 32607 
(352) 371-3600 
 
 
Committee Members: Board Staff: 
Michele Weizer, PharmD, Boca Raton, Chair Tammy Collins, Acting Executive Director 
Debra Glass, BPharm, Tallahassee Christy Robinson, Program Operations Administrator 
 Jay Cumbie, Regulatory Specialist II 
 Board Counsel: 
David Flynn, Assistant Attorney General 
 
Participants in this public meeting should be aware that these proceedings are being recorded. 
 
Monday, December 2, 2013 – 1:00p.m. 
1. Rule 64B16-27.700, F.A.C. 
2. Rule 64B16-27.797, F.A.C. 
3. USP on Compounding 64B16-27.700 Definition of Compounding.
“Compounding” is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any 
branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for 
administration by a practitioner or the practitioner’s agent; and shall specifically include the professional act of preparing a unique 
finished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S. The term also includes the 
preparation of nuclear pharmaceuticals and diagnostic kits incident to use of such nuclear pharmaceuticals. The term “commercially 
available products,” as used in this section, means any medicinal product as defined by Sections 465.003(7) and (8), F.S., that are 
legally distributed in the State of Florida by a drug manufacturer or wholesaler. 
(1) Compounding includes: 
(a) The preparation of drugs or devices in anticipation of prescriptions based on routine, regularly observed prescribing patterns. 
(b) The preparation pursuant to a prescription of drugs or devices which are not commercially available. 
(c) The preparation of commercially available products from bulk when the prescribing practitioner has prescribed the 
compounded product on a per prescription basis and the patient has been made aware that the compounded product will be prepared 
by the pharmacist. The reconstitution of commercially available products pursuant to the manufacturer’s guidelines is permissible 
without notice to the practitioner. 
(2) The preparation of drugs or devices for sale or transfer to pharmacies, practitioners, or entities for purposes of dispensing or 
distribution is not compounding and is not within the practice of the profession of pharmacy, except that the supply of patient 
specific compounded prescriptions to another pharmacy under the provisions of Section 465.0265, F.S., and Rule 64B16-28.450, 
F.A.C., is authorized. 
(3) Office use compounding, “Office use” means the provision and administration of a compounded drug to a patient by a 
practitioner in the practitioner’s office or by the practitioner in a health care facility or treatment setting, including a hospital, 
ambulatory surgical center, or pharmacy. A pharmacist may dispense and deliver a quantity of a compounded drug to a practitioner 
for office use by the practitioner in accordance with this section provided: 
(a) The quantity of compounded drug does not exceed the amount a practitioner anticipates may be used in the practitioner’s 
office before the expiration date of the drug; 
(b) The quantity of compounded drug is reasonable considering the intended use of the compounded drug and the nature of the 
practitioner’s practice; 
(c) The quantity of compounded drug for any practitioner and all practitioners as a whole, is not greater than an amount the 
pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the 
compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices. 
(d) The pharmacy and the practitioner enter into a written agreement. The agreement shall specifically provide: 
1. That the compounded drug may only be administered to the patient and may not be dispensed to the patient or sold to any 
other person or entity; 
2. That the practitioner shall include on the patient’s chart, medication order, or medication administration record the lot number 
and the beyond-use-date of any compounded drug administered to the patient that was provided by the pharmacy; 
3. That the practitioner will provide notification to the patient for the reporting of any adverse reaction or complaint in order to 
facilitate any recall of batches of compounded drugs. 
(e) The pharmacy shall maintain readily retrievable records of all compounded drugs ordered by practitioners for office use. The 
records must be maintained for a minimum of four (4) years and shall include: 
1. The name, address and phone number of the practitioner ordering the compounded drug for office use and the date of the 
order; 
2. The name, strength, and quantity of the compounded drug provided, including the number of containers and quantity in each; 
3. The date the drug was compounded; 
4. The date the compounded drug was provided to the practitioner; 
5. The lot number and beyond use date. 
(f) The pharmacy shall affix a label to any compounded drug that is provided for office use. The label shall include: 
1. The name, address, and phone number of the compounding pharmacy; 
2. The name and strength of the preparation of a list of active ingredients and strengths; 
3. The pharmacy’s lot number and beyond-use-date; 4. The quantity or amount in the container; 
5. The appropriate ancillary instructions such as storage instructions, cautionary statements, or hazardous drug warning labels 
were appropriate; and 
6. The statement “For Institutional or Office Use Only – Not for Resale,” or if the drug is provided to a veterinarian the 
statement “Compounded Drug.” 
Rulemaking Authority 465.005 FS. Law Implemented 465.003(12), 465.0155, 465.0265 FS. History–New 10-1-92, Formerly 21S-27.700, 61F10-
27.700, 59X-27.700, Amended 11-2-03, 10-7-08, 3-21-13. 



Monday, November 18, 2013

Any Reports from the Texas Board of Pharmacy Public Hearing on November 4-6, 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

District of Columbia Board Meeting Information and Materials for November 7, 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 reportPaving 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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Wednesday, October 23, 2013