Meningitis lawsuits to stay local for now

In a major victory for a handful of the local victims of a nationwide fungal meningitis outbreak, a federal judge has ruled that, at least for now, their cases will proceed before a circuit court judge in Nashville and could eventually be tried by a local jury.

In a 33-page ruling issued late Friday, U.S. District Judge F. Dennis Saylor IV in Boston ruled that those victims who have sued the health care providers who gave the tainted steroid shots but not the bankrupt compounder who provided the drugs in the first place can remain in courts in Tennessee and at least two other states.

The more than 100 suits that either directly or indirectly assert claims against the New England Compounding Center, which produced the tainted methylprednisolone acetate, will be consolidated in Saylor’s court room.

The cases that can remain in Nashville include the suit brought by Wayne Reed of Nashville, a victim of Lou Gehrig’s disease who lost his wife and primary caregiver in the meningitis outbreak.

Reed’s and three other local suits were filed against Saint Thomas Outpatient Neurosurgical Center, where the four got their injections, but not the drug compounding firm.

Mark Chalos, a Nashville attorney representing some of the victims, said the ruling means that “a narrow subset of cases” will stay in state courts “at least for now.”

“This is an important step on the path to justice for the families who were harmed,” he said.

continue reading here

FDA Budget May Need To Be Trimmed 5% In FY 2015

By Derrick Gingery / Email the Author / May 31, 2013 
Word Count: 829 / Article # 14130531005 / Posted: May 31 2013 6:10 PM

---

Executive Summary

OMB memo states that agencies should reduce net discretionary spending from the initial FY 2015 estimate and provide options for additional cuts.

subscription required

CBO Says House Rx Tracing Bill Would Generate $24 Million Over 8 Years

The House version of drug tracing legislation would increase federal revenue by $24 million from 2015 to 2023 because of licensing fees, according to an analysis released Friday (May 31) by the Congressional Budget Office. The full House will consider the bill Monday under suspension of the rules alongside legislation reauthorizing animal drug user fees, according to the majority leader's schedule.

 

quoted from here

USP Key Issue: Standards for Veterinary Drugs May 31, 2013

Original Posting: 31–May–2013

Contacts

• Scientific Liaison: stdsmonographs@usp.org
• Media: Claudia Costabile (cac@usp.org or 301-816-8264)

Consistent with its commitment to provide public standards for the quality, consistency, purity, identity, and strength of all medicines, USP is advancing its standards for drugs for veterinary use. These standards include monographs and general chapters (including those devoted to veterinary drug topics) applicable to any articles recognized in the United States Pharmacopeia–National Formulary (USP–NF), whether in the form of a manufactured or a compounded preparation. USP has been active in setting standards for veterinary drugs for many years, and recently has expanded its mission statement to acknowledge this.

Current Activities

Solubility Criteria for Veterinary Drugs

A summary of the discussions during the Workshop on Solubility Criteria for Veterinary Productsthat took place at USP headquarters in Rockville, MD on November 7–8, 2012 will be published in Pharmacopeial Forum 39(4), together with Stimuli articles that will provide explanations for the approaches to be included in a new USP General Chapter <1236>, provisionally titled Determination of Thermodynamic Solubility of Active 

Pharmaceutical

 Ingredients for Veterinary Species.

• Solubility Criteria for Veterinary Drugs—Workshop Report. Pharmacopeial Forum, Vol. 39, No. 4 [Jul.–Aug. 2013] (31–May–2013)
• Solubility Criteria for Veterinary Drugs. Pharmacopeial Forum, Vol. 38, No. 4 [Jul.–Aug. 2012] (31–May–2013)
• Veterinary Application of In Vitro Dissolution Data and the Biopharmaceuticals Classification System. Pharmacopeial Forum, Vol. 30, No. 6 [Nov.–Dec. 2004] (31–May–2013)

For additional information, contact Margareth Marques, Ph.D., Senior Scientific Liaison (mrm@usp.org or +1-301-816-8106).

Veterinary Drugs Stakeholder Forum

On November 9, 2012, USP held its first Veterinary Drugs Stakeholder Forum, which provided an opportunity to educate stakeholders on USP activities, help USP staff understand veterinary drug issues, and discuss compendial issues and emerging USP initiatives that may affect veterinary drug stakeholders. USP anticipates holding a second Veterinary Drugs Stakeholder Forum on November 20–21, 2013.

Compounding Monographs

The USP–NF includes standards of identity  continue reading here

ASCRS Urges Exemption for Office Use in Drug Compounding Legislation

This week, ASCRS sent a letter to the Senate Committee on Health, 

Education

, Labor, and Pensions (HELP) regarding S. 959, the Pharmaceutical Compounding Quality and Accountability Act, requesting that the bill be amended to exempt compounded biologics and other Food and Drug Administration (FDA) marketed drugs so that ophthalmologists have access to drugs that may be administered in their offices without specific patient prescriptions. The bill was introduced to address concerns over safety at compounding pharmacies in the wake of the deadly 

meningitis

 outbreak last fall. The bill would consolidate oversight of these pharmacies under the FDA and tighten access to compounded drugs to the point that physicians would not be permitted to stock compounded drugs in the office for emergent cases. S. 959 passed the Senate HELP committee without this exemption. ASCRS is working in conjunction with the American Academy of Ophthalmology to ensure the final version of the bill includes office use exemptions.

quoted from here

Strengthened Accreditation Process Charles Leiter, President and CEO of Leiter’s Compounding Pharmacy, cited in support of PCAB’s renewed survey policy. San Jose, CA (PRWEB) June 01, 2013

Supporting a strengthened accreditation process, Leiter’s Compounding Pharmacy commended the Pharmacy Compounding Accreditation Board (PCAB) in its effort to distinguish accredited compounding pharmacies from unaccredited ones. PCAB announced that it will be conducting unannounced surveys of compounding pharmacies seeking to renew accreditation from the group starting September 1, 2013.

“We welcome the unannounced surveys,” said Charles Leiter, President and CEO of Leiter’s CompoundingPharmacy in San Jose, CA. “This new process helps level the playing field for all of us. Now if a hospital, patient or doctor needs a compounded preparation and they select a PCAB accredited pharmacy, they can feel comfortable with their decision.”

Leiter’s Compounding Pharmacy is a PCAB Accredited pharmacy and offers sterile and non-sterile compounds both locally and nationwide.

Florida Board of Pharmacy Agenda and Materials for Meeting June 4-5, 2013

June 4-5, 2013
DoubleTree Miami Airport Convention Center
711 N.W. 72nd Avenue
Miami, FL 33126
(305) 261-3800

AGENDA
DEPARTMENT OF HEALTH
BOARD OF PHARMACY
FULL BOARD MEETING
June 4-5, 2013
DoubleTree Miami Airport Convention Center
711 N.W. 72
nd
Avenue
Miami, FL 33126
(305) 261-3800
PLEASE TURN OFF ALL CELL PHONES, PAGERS AND BEEPERS DURING THE MEETING.
THANK YOU.
Board Members Board Staff
Albert Garcia, BPharm, MHL, Chair, Miami Mark Whitten, Executive Director
Jeffrey J. Mesaros, PharmD, Vice Chair, Tampa Tammy Collins, Program Operations Administrator
Leo J. “Lee” Fallon, BPharm, PhD, The Villages Jay Cumbie, Regulatory Specialist II
Debra B. Glass, BPharm, Tallahassee
Cynthia Griffin, PharmD, Jacksonville Board Counsel:
Gavin Meshad, Consumer Member, Sarasota David Flynn, Assistant Attorney General
DeAnn Mullins, BPharm, Lynn Haven
Lorena Risch, Consumer Member, Bradenton Department of Health Staff
Michele Weizer, PharmD, Boca Raton John J. Truitt, Assistant General Counsel
Participants in this public meeting should be aware that these proceedings are being recorded and
that an audio file of the meeting will be posted to the board’s website.
Tuesday, June 4, 2013 - 9:00a.m.
TAB 1: REPORTS
A. Chair’s Report - Albert Garcia, BPharm, MHL, Chair
          1.  NABP 109
th
Annual Meeting – St. Louis, MO
    2.  Letter from Dr. Armstrong, MD, FACS
3.  Federal Legislation Draft Proposal on Pharmaceutical Compounding
B. Executive Director's Report - Mark Whitten
1.  Gavin Meshad
i. Prescription Drug Abuse Committee Update
2.  Michele Weizer
i. Compounding Rules Committee Update
3. Correspondence
i.  Martin R. Dix – Akerman Senterfitt
ii. Edwin Bayo, Esquire
     iii. Faustino Gonzalez, MD, FACP, FAAHPM – Hospice
   iv. Robert V. Burwen, C.Ph – Hospice
4.  Request for PDM at Multiple Locationsi. TeamCare Pharmacy
5.  Legislative Update
C. Attorney General's Report - David Flynn, Assitant Attorney General
1.  Rules Report
D. Prosecuting Attorney's Report - John Truitt, Assitant General Counsel
1. Prosecuting Services Report
E. Chief Investigative Services Report - Jeane Clyne
TAB 2: BUSINESS - Albert Garcia, BPharm, MHL, Chair
A. Ratification of Issued Licenses/Certificates & Staffing Ratios
1. Pharmacist (Licensure)(Client 2201) – 117
2. Pharmacist (Exam Eligibility)(Client 2201) - 93
3. Pharmacist Interns (Client 2202) – 128
4. Registered Pharmacy Technicians (Client 2208) - 893
5. Consultant Pharmacist (Client 2203) – 33
6. Nuclear Pharmacist (Client 2204) – 1
7. Pharmacist/Facilities (Client 2205) – 106
8. Registered Pharmacy Technician Ratios (2:1 or 3:1) – 54
9. Pharmacy Technician Training Program (Client 2209) – 23
10. CE Providers – 14
11. CE Courses – 23
12. CE Individual Request (Approved) – 0
13. CE Individual Request (Denied) – 0
B. Review and Approval of Minutes
1. April 2-3, 2013 Meeting Minutes
   C. Proposed 2014 Meeting Dates and Locations
   D. Presentations
   1. Rebecca Poston – PDMP (Prescription Drug Monitoring Program)
     2. Susan Langston – Drug Enforcement Agency (DEA)
Wednesday, June 5, 2013 - 8:00a.m.
TAB 3: DISCIPLINARY CASES - John Truitt, Esq. & Albert Garcia, BPharm, MHL, Chair
SETTLEMENT AGREEMENTS - APPEARANCE REQUIRED
A-1  Robert Edward Levy, R.Ph., Case No. 2011-11766
(Garcia/Mesaros)
A-2 Justa Almeida, R.Ph., Case No. 2011-10399
    (Fallon/Weizer)
A-3 Alan E. Wingerter, R. Ph., Case No. 2012-12447
(Fallon/Risch)
A-4 Tyronda Sanks, RPT, Case No. 2012-14090
(Mesaros/Mullins)
A-5 Hal Goldman,  R.Ph., Case No. 2012-04357
(Risch/Glass)
A-6 Terry Dean Mundorff, R.Ph., Case No. 2012-13902
(Fallon/Risch)
A-7 Zhaoqi Zhu, R.Ph., Case No. 2012-16132
(Mullins/Glass)A-8 Steven Hunter, R.Ph., Case No. 2009-08335
(Fallon/Risch)
DETERMINATION OF WAIVERS
DOW-1 L & E Pharmacy, Corp., Case No. 2012-09709
                                              (Risch/Glass)
DOW-2 Your Neighbor Pharmacy, LLC, Case No. 2012-09807
(Glass/Meshad)
DOW-3 Neighbors Pharmacy, Inc., Case No. 2012-05736
(Weizers/Mesaros)
DOW-4 Healthy Options, Inc., Case No. 2012-15844
(Fallon/Meshad)
DOW-5 Alene Lavon Thomas, RPT, Case No. 2012-09425
(Glass/Mullins)
DOW-6 Apollo II Services, Inc., Case No. 2011-19015
(Fallon/Risch)
DOW-7 Teresa Hilliard Faulkner, RPT, Case No. 2011-16981
   (Fallon/Risch)
   DOW-8 S C I Medical Supply, PH, Case No. 2012-09140

Colorado Board of Pharmacy Special Meeting to Be Held June 5, 2013 Regarding Proposed Amendments and Additions to Rules-- copy of Agenda Attached

Colorado State Board of Pharmacy Special MeetingDate: 06/05/2013 - 06/05/2013 Time: 10:00 AM - 12:00 PM Title: Colorado State Board of Pharmacy Special Meeting Location: 1560 Broadway, Rm 1250A, Denver,CO 80202
This is a Special Meeting of the Colorado State Board of Pharmacy, which will also be held via Webinar at https://www1.gotomeeting.com/register/807345993 ,  to solicit feedback from potenial stakeholders regarding proposed amendments and/or additions to Board Rules 3.00.21, 3.00.22, 3.00.55, 3.00.90, 3.01.00, 4.00.00, 5.00.00, 15.00.00 and 23.00.00.

Attachment(s):

File

June Agenda.pdf

Colorado Board of Pharmacy March 2013 Minutes--including discussion of compounding task force

can be viewed here

Colorado Board of Pharmacy Answers Question Regarding Compounding Pharmacy Shipping to Second Pharmacy to Dispense Patient Prescription.

The Board reviewed an inquiry regarding whether Colorado law permits a pharmacy to prepare a sterile compound per prescription, and then ship the prescription to a second pharmacy to be dispensed. After careful consideration of the available information, the Board determined that Colorado law does not permit a pharmacy to prepare a sterile compound pursuant to a prescription order, and then ship the prescription to a second pharmacy to be dispensed.

source found here