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Monday, March 31, 2014

Second Question of the Day March 31, 2014 With the line now drawn in the sand and the heat on the state boards of pharmacy, what is the first thing state boards of pharmacy need to do? How about educating the inspectors? Wouldn't it be great if the NABP hired a person just to train and educate all the state inspectors on what to look for at compounding pharmacies? Even though each state has their on set of unique rules and regulations there are key things to inspect at look for at all traditional compounding pharmacies If the inspectors aren't trained on the specifics they won't know what to look for.


TimAllenMDJD: Understanding medication compounding issues

TimAllenMDJD: Understanding medication compounding issues: AORN J.  2014 Apr;99(4):466-79. doi: 10.1016/j.aorn.2013.07.021. Understanding medication compounding issues. Hicks RW . Abstract ...

Question of the Day March 31, 2014 Will State Boards of Pharmacy Now Step Up to the Plate and Make Sure Traditional Compounding Pharmacy and Those Compounding Pharrmacies That Do Not Register As Outsourcing Facilities are Following the rules and regulations? What is the answer if they don't?


The Pink Sheet Reports State inspectors left early when accompanying the FDA during inspections of Compounding Pharmacies

FDA Compounder Inspections: States Taking Early Leave / State inspectors did not accompany FDA for the full duration of facility inspections and now the agency is turning over the findings to them. / “The Pink Sheet” March 31 2014 12:02 AM

The Pink Sheet Reports that the FDA is REfining Post-inspection Hand-off to States--for traditional compounders it is up to state boards of pharmacy to ensure correctness--just as groups representing compounders requested!

 

Compounding: FDA Refining Post-Inspection Hand-off To States / When the agency finds a traditional compounder during an inspection, it asks state boards of pharmacy to ensure corrections are made. / “The Pink Sheet” March 31 2014 12:02 AM
 

First Meeting of the International Horse Sports Confederation

read about here

Compounding drugs – myth v reality

Compounding drugs – myth v reality

FDA Guidance Sets up User Fee System for Pharmaceutical Compounders

FDA Guidance Sets up User Fee System for Pharmaceutical Compounders

FDA Issues Guidance on Fees for Human Drug Compounding Outsourcing Facilities

[PDF]

Fees for Human Drug Compounding Outsourcing Facilities

 
3 hours ago - Compounding Outsourcing. Facilities Under Sections 503B and. 744K of the FD&C Act. DRAFT GUIDANCE. This guidance document is being distributed for ...

Meningitis victims say Michigan's finest legal mind mostly just grandstanding on their suffering

read comments here

CLE: Fundamentals of Medicare/Medicaid and Health Care Fraud

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DSCSA: Transaction Statement

DSCSA: Transaction Statement

Drug Safety and Availability FDA provides update on Saline drug shortage

Drug Safety and Availability FDA provides update on Saline drug shortage

Sunday, March 30, 2014

University of Texas 26th Annual Health Law Conference Scheduled for April 9, 10-11, 2014 15 hours CLE for Texas and 18 hours for Oklahoma Lawyers-including section on compounding pharmacy law

26th Annual

Health Law Conference

Houston Apr 9*, 10-11, 2014 – Four Seasons Hotel
*Pre-Conference Concurrent Sessions
$595 Individual  |  $645 after Apr 2
Also available as: Materials, In-House CLE

SPONSORS

BakerHostetler LLP
Beatty Bangle Strama P.C.
Brown & Fortunato, P.C.
Cox Smith
Gray Reed & McGraw, P.C.
Husch Blackwell LLP
Jackson Walker L.L.P.
King & Spalding
Locke Lord LLP
Norton Rose Fulbright
Polsinelli PC
Seyfarth Shaw LLP
Strasburger & Price, LLP
Waller
Program Features
UT Law’s 26th Annual Health Law Conference brings together leading in-house attorneys from major hospitals and medical institutions, government officials, as well as legal and financial advisors representing hospitals, healthcare providers and physicians.
The conference provides practical and detailed coverage of the updates, key issues, strategies and opportunities facing members of the healthcare community, including:
  • Wednesday evening Pre-Conference Concurrent Sessions—Health Law Fundamentals provides an introduction to health law; and In-House Counsel Issues (limited to in-house counsel only) facilitates active discussion and sharing among panelists and participants
  • Healthcare Year-in-Review addresses important healthcare developments in the last year, including regulatory changes and policy initiatives
  • Learn strategies for navigating through a healthcare breach investigation and how to report it
  • Examine the complex and difficult pressures facing physicians in diverse environments and learn options to prepare your physician client for the future
  • Look at the new age of  False Claims Act enforcement and investigation, including lessons learned from landmark cases such as Tuomey, Bradford, Halifax, All Children’s and Citizens
  • Impact of the Affordable Care Act on Texas discusses current news-making topics  as well as other issues affecting healthcare providers and insurers
  • Explore the ethical dilemmas most commonly encountered by health lawyers, both in transactions and operations
  • Multiple networking opportunities including Thursday’s Table Topics Luncheon and the Thursday Evening Reception

New York Times: Jockey Club Wants U.S. Anti-Doping Agency in Charge

The Jockey Club, one of horse racing’s most influential groups, said it would support federal legislation to put the United States Anti-Doping Agency in charge of bringing law and order to a sport that has been unable to eradicate a pervasive drug culture that has put horses and riders at risk and alienated some fans.

Continue to read here

Racing must clean own house

Following the allegations raised by People for the Ethical Treatment of Animals and reported by The New York Times, many of us in the Thoroughbred industry are eagerly awaiting the final determination of these issues by the New York State Gaming Commission and the Kentucky Horse Racing Commission.
It is my hope they use all the prosecutorial powers available to determine if there is evidence of animal cruelty, medication violations and cheating.
Like so many others, I was upset by what I read in the Times and disgusted by what I saw and what was alleged in that PETA video. Any person abusing a horse or caught with an electronic stimulation device like the one described in the video should be banned from the sport for life.
Continue to read here

Read more here: http://www.kentucky.com/2014/03/30/3169367/racing-must-clean-own-house.html?sp=/99/349/#storylink=cpycontinuec

Louisiana Faced With Revealing Lethal Injection Details


The Louisiana Department of Corrections does not plan to appeal a U.S.
Court decision this week that compels it to reveal to inmates on death row the content and maker of drugs used in lethal injections, a prisons official said on Friday.
The decision by the U.S. Court of Appeals for the Fifth Circuit on Thursday was one in a series in favor of inmates who have sought delays for their execution while they seek information about the contents of lethal injection cocktails and clarity on who would be supplying the drugs.
Continue to read here

AVA Responds to NSW Court Decision on Vet Licensing

The Australian Veterinary Association (AVA) believes that a recent decision by the Supreme Court of New South Wales (NSW), allowing Racing NSW to license veterinarians in Thoroughbred racing, will be detrimental to the sport.
“We’re extremely disappointed that (the court) has decided that current legislation gives Racing NSW the power to implement the proposed licensing scheme,” said AVA President Ben Gardiner, BVSc, CMAVA. “Unfortunately we fear that this licensing scheme will be very detrimental to racing. Our members have already told us and Racing NSW that they will not participate in racing with a license creating confusion in a dual regulatory regime.
Continue to read here

Schuette comments anger meningitis victims

Michigan Attorney General Bill Schuette called himself the “voice” for victims of the 2012 fungal meningitis outbreak when he visited Livingston County last week.

Continue to read here

Texas must tell attorneys execution drug supplier- daily oklahoman



AUSTIN, Texas (AP) — A judge ordered Texas prison officials Thursday to disclose the supplier of a new batch of lethal injection drugs to attorneys for two inmates set to be executed next month, but she stopped short of revealing the identity of the manufacturer to the public.

Continue to read here

Louisiana Board of Pharmacy Regulatory Proposals Regarding Pharmacy Records, Veterinarian Exclusions and PMP Program

2014-3 ~ Pharmacy Records [Source: Regulatory Proposal 2013-A]
               03-10-2014    
1st Report submitted to Joint Legislative Oversight Committee on Health & Welfare
               03-10-2014     Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, pharmacy interns, and pharmacy technicians.
               03-20-2014     Notice of Intent published in Louisiana Register.
               04-29-2014     Public Hearing

2014-2 ~ Veterinarian Exclusion from Prescription Monitoring Program [Source: Regulatory Proposal 2014-B]
               03-10-2014    
1st Report submitted to Joint Legislative Oversight Committee on Health & Welfare
               03-10-2014     Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, pharmacy interns, and pharmacy technicians..
               03-20-2014     Notice of Intent published in Louisiana Register
               04-29-2014     Public Hearing

2014-1 ~ Prescription Monitoring Program (PMP) Delegates [Source: Regulatory Proposal 2014-A]
               03-10-2014    
1st Report submitted to Joint Legislative Oversight Committee on Health & Welfare
               03-10-2014     Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, pharmacy interns, and pharmacy technicians..
               03-20-2014     Notice of Intent published in Louisiana Register.
               04-29-2014     Public Hearing

Louisiana Board of Pharmacy Regulatory Proposals Regarding Pharmacy Records, Veterinarian Exclusions and PMP Program

2014-3 ~ Pharmacy Records [Source: Regulatory Proposal 2013-A]
               03-10-2014    
1st Report submitted to Joint Legislative Oversight Committee on Health & Welfare
               03-10-2014     Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, pharmacy interns, and pharmacy technicians.
               03-20-2014     Notice of Intent published in Louisiana Register.
               04-29-2014     Public Hearing

2014-2 ~ Veterinarian Exclusion from Prescription Monitoring Program [Source: Regulatory Proposal 2014-B]
               03-10-2014    
1st Report submitted to Joint Legislative Oversight Committee on Health & Welfare
               03-10-2014     Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, pharmacy interns, and pharmacy technicians..
               03-20-2014     Notice of Intent published in Louisiana Register
               04-29-2014     Public Hearing

2014-1 ~ Prescription Monitoring Program (PMP) Delegates [Source: Regulatory Proposal 2014-A]
               03-10-2014    
1st Report submitted to Joint Legislative Oversight Committee on Health & Welfare
               03-10-2014     Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, pharmacy interns, and pharmacy technicians..
               03-20-2014     Notice of Intent published in Louisiana Register.
               04-29-2014     Public Hearing

Louisiana Board of Pharmacy "Compounding of Drugs" Draft 3 of Rule Relating to Pharmacy-generated drugs made in response to non-patient specific order

2014-C ~ Amends Chapter 25 of the Board's rules, more specifically Subchapter C - Compounding of Drugs. Act 168 of the 2013 Legislature introduced a new term "pharmacy-generated drug" to describe a drug made by a pharmacy in response to a non patient-specific order.  Compounding is used to describe the process whereby a pharmacy makes a drug in response to a patient-specific order.  In addition to incorporating the new legislatively-defined term, the proposal also retains the basic elements of the currently-pending emergency rule and also incorporates suggestions and comments offered during public hearings on the emergency rule.
               11-13-2013 - Committee reviewed Draft #1 and requested further changes and discussion.
               02-06-2014 - Committee discussed further changes and requested new draft; Draft #2 prepared.
               02-25-2014 - Draft #2 scheduled for review by the committee; revisions approved and committee approved Draft #3.  Coded and clean versions posted here.

Louisiana Board of Pharmacy Legislative Proposals re: prescription monitoring and controlled substances

Legislative Proposals

2014-B ~ Amends the Prescription Monitoring Program Law relative to the frequency of reporting prescription transactions to the program database.
               02-06-2014 - Reviewed by Regulation Revision Committee which voted to recommend approval of Draft #2 to the Board.
               02-12-2014 - Approved for filing by the Board.


2014-A ~ Amends the Louisiana Controlled Substances Law to add new drugs to Schedules II, III, and IV.
               02-06-2014 - Reviewed by Regulation Revision Committee which voted to recommend approval of Draft #1 to the Board.
               02-12-2014 - Approved for filing by the Board.


2013-D ~ Amends the Prescription Monitoring Program law to allow authorized prescribers and dispensers to appoint certain delegates for the purpose of accessing program information.
               03-06-2013 - Approved for filing by the Board.
               03-28-2013 - Incorporated in HB 355; prefiled for 2013 Regular Session.

Oklahoma Board of Pharmacy February 19, 2014 Meeting Minutes

read here

Alaska Board of Pharmacy Discusses Sterile Compounding Inspections at January 2014 meeting

AGENDA ITEM 2 – Sterile Compounding Inspection

544

545 Mr. Cotter presented and reviewed a preliminary Sterile Compounding Inspection

546 Report that he and Lori DeVito another board member who is not in attendance at

547 this board meeting have been working on for the upcoming renewal period.

548

549 Mr. Cotter and Ms. DeVito after reviewing other states inspections forms chose to

550 utilize the state of California’s inspection report as the model from which this

551 preliminary report was created due to it being one of the most comprehensive

552 inspection reports. Mr. Cotter made a table sheet that the left hand column has the

553 California Inspection standards so have the inspection element and the appropriate

554 standard that support the element. On the right hand side is Alaska. The first

555 number of pages has compounding, not sterile compounding information and Mr.

556 Cotter skipped over that. Mr. Cotter started the comparison with element #7

557 Training of Compounding Staff with the Alaska standard next to it. One of the

558 problems Mr. Cotter came across is that every time we quote a standard you can go

559 back to regulation, but when you get into Sterile Product Standards you cannot do

560 the same thing. It simply is an attachment without a numbering system included to

561 get to the line element. Secondly, we have general statements without definitive

562 requirements, i.e. for how many years to keep training records or you have to

563 maintain the temperature of your refrigerator, but it does not specifically state a

564 temperature. More specific standards need to be behind the element so when the

565 investigator goes to inspect a “high risk” pharmacy he/she has a specific standard to

566 be inspecting against. Mr. Cotter’s concern is when we start writing up deficiencies

567 is whether or not there is enough behind in regulations to support it. Upon review of

568 Mr. Cotter’s comparison of the preliminary inspection report, Ms. Giessel stated that

569 our information should be a lot more quantitative for our investigator to acquire

570 good data from an inspection. Mr. Cotter stated that in‐state compounding

571 pharmacies are doing what the California inspection report asks, it is just that

572 Alaska regulations do not drill down to the specifics and they should.

573 The board is in agreement that more specific regulations need to be developed for

574 sterile compounding and will look further into starting it even if it means rewriting

575 the whole section currently used for compounding. Mr. Cotter suggested for the
interim to develop a simplified version 576 of the inspection form that can be used

577 starting this fall and then for the longer term develop an inspection form that is

578 inclusive of more specific standards and also research to include any changes from

579 the recently enacted by HR 3204, the “Drug Quality and Security Act”.

580

581 Mr. Cotter and Ms. DeVito will continue to work on a consolidated version and will

582 have something to present at the next meeting.

583

584 Mr. Holm stated that we may need to work with the Regulation Specialist on how to

585 turn what the compounding pamphlet that is in the regulations now, be utilized for

586 compounding regulations that are more specific and less subjective.
quoted from here

Alaska Board of Pharmacy: Attorney General's office points out it is not allowed to require more of out- of- state pharmacy than in- state pharamcies-board agrees to level playing field

12 AAC 52.150, Inspection of pharmacies – Again this has the same issue with the


290 “high risk pharmacy” and another overarching issue is we seem to be requiring

291 more from an out‐of‐state pharmacy than what we require of in‐state pharmacies
and this is not allowable. Mr. Holm explained to AAG Araujo that the reason we

293 require an inspection report from out‐of‐state pharmacies is that whenever we

294 license a pharmacy from out of the state we are relying that pharmacy is being

295 regulated properly and efficiently by their particular board in their home

296 jurisdiction. The inspection report is the only way we can put the responsibility on

297 their home state Board of Pharmacy to regulate and make sure their pharmacies are

298 in compliance and have an inspection. This is the reason why we require the report.

299

300 Pharmacies in our state we can and do inspect at any time. We do not have the

301 funds or the man power to inspect out‐of‐state pharmacies.

302

303 Mr. Cotter stated that the aspect on the “high risk” component is as Mr. Holm stated

304 that out‐of‐state pharmacies just have to provide an inspection report, all the in305

state “high risk” pharmacies are going to be required to be inspected. They both will

306 be inspected per a regulatory period it is just by slightly different methods. One

307 from the out‐of‐state pharmacy that has to provide a report and the in‐state

308 pharmacies will be inspected by us. Mr. Cotter then stated he does not see a

309 discrepancy in that.

310

311 Mr. Holm agreed that there isn’t a discrepancy if anything there is more required of

312 in‐state pharmacies because they are going to be required to pass an inspection. We

313 are only asking for an inspection report from the out‐of‐state pharmacy. It is the

314 only way we know if there are any issues with an out‐of‐state pharmacy.

315

316 AAG Araujo then asked if the physical inspection that is contemplated in 12 AAC. 52

317 150(b) will also be required of in‐state pharmacies prior to licensing? Mr. Holm

318 answered no, but you have to pass an inspection before you can renew your license

319 before the next licensing renewal period. Ms. Giessel then stated we are trying to

320 capture all of them into inspection, it hasn’t been there previously. Mr. Holm stated

321 we have a problem with getting pharmacies inspected in a timely fashion so that

322 licenses are not held up. The in‐state “high risk” pharmacies are being flagged so

323 our investigator who does the inspections knows what pharmacies have priority for

324 inspection. Our investigator is being trained now on how to inspect a “high risk”

325 pharmacy.

326

327 AAG Araujo then restated his concern that under 12 AAC. 52 150(b) the difference

328 between in‐state and out‐of‐state is still an uneven playing field by requiring a

329 current inspection report prior to licensing but do not require the same from in330

state pharmacies prior to licensing.
Mr. Holm stated we have to start some place and that most states do inspections on

333 a regular basis of all their pharmacies and so we are asking for the most current

334 inspection report. Mr. Holm then advised that in‐state pharmacy inspections have

335 not been done in Alaska for almost 30 years when they were performed it was the

336 actual board members who did the inspections. Since then we operated under an

337 honor system by having in‐state pharmacies complete a “Self Inspection” report.

338 Under the current circumstances with what is going on in the country we can no

339 longer rely on that and since we are moving into a new realm if you will, we will

340 have a problem only with the upcoming license renewal period this June. There is

341 no way that our investigator can complete a physical inspection before licensure

342 this time. Going forward it is the board’s intent to require a pharmacy inspection be

343 done before a pharmacy opens and the license is issued.

344

345 With the renewal licensing period coming up so quickly and due the current

346 regulations changes not ready for implementation, the Board with AAG Araujo

347 agreed to level the playing field and eliminate the discrepancy between in‐state and

348 out‐of‐state with a regulation change that will now require an inspection for in‐state

349 pharmacies before licensing for the next renewal period.
quoted from here

Saturday, March 29, 2014

California Board of Pharmacy Enforcement and Compounding Committee Meeting Materials for Meeting that was Held on March 27, 2014

Pharmaceutical fraud spreads in Florida

March 26, 2014|By William E. Gibson, Washington Bureau
WASHINGTON – Pharmacy fraud has become a rampant problem spreading from Miami across much of Florida, as drug traffickers conspire with doctors and sometimes patients to cheat the Medicare system, a federal investigator told the Senate Committee on Aging on Wednesday.
A crackdown in Miami – often called ground zero for Medicare fraud – has pushed fraudulent operations father north into Broward and Palm Beach counties, along the Treasure Coast and into Central Florida, said Brian Martens, assistant special agent in charge of the Miami inspector general's office for the Department of Health and Human Services.

continue to read here

Vt pharmacist charged with giving drugs without a prescription - WCAX.COM Local Vermont News, Weather and Sports-

Vt pharmacist charged with giving drugs without a prescription - WCAX.COM Local Vermont News, Weather and Sports-

FDA Crackdown in India Leads to Bans on Imports

New U.S.-imposed regulations meant to improve quality have forced Indian pharmaceutical manufacturers to make adjustments. The pressure for those changes has proved to be too cumbersome for one Gujarat-based facility owned by Sun Pharmaceuticals. The largest drug manufacturer in India will no longer be able to export the same high volume to the world’s largest drug market, after the U.S. Food and Drug Administration forced the stop.
“The FDA is becoming more stringent. It’s a learning curve for everyone. You have to invest more,” said B&K Securities analyst Rohit Bhat. “Companies will have to pull up their quality parameters.”
continue to read here 

Legal and Practical Issues in Compounding Pharmacy CE

Legal & Practical Issues in Compounding Pharmacy

To pre-register for this event please log in and click the pre-register button.

If you are not registered with the site, click the log in button, then choose the link labeled "Register Here". Once the new user account is created you will be redirected back to this page to complete pre-registration for this event.

Type: Internet
Date(s): 03/30/14
Times: 7:00 PM - 9:00 PM ET
6:00 PM - 8:00 PM CT
5:00 PM - 7:00 PM MT
4:00 PM - 6:00 PM PT
Facility: RxSchool E-Classroom
  http://www.rxschool.com
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1-866-960-5334
info@rxschool.com
Fee: $37.00

Course Category: This activity has been designated as Knowledge-Based

American Association of Equine Practitioners White Papers on Putting the Horse First

read here

A Veterinarian's Take: Lasix Encourages Racehorse Doping in America

A Veterinarian's Take: Lasix Encourages Racehorse Doping in America: The Florida Derby racehorses will be injected with two performance enhancing drugs before heading to the paddock for their derby run, predn...

Company seeks compounding pharmacist

Compounding Pharmacy seeks Part-Time Relief Pharmacist (Lexington)
compensation: $45/hour
part-time
Veterinary compounding pharmacy seeks part-time relief pharmacist. No compounding experience necessary. Contact BET Pharm at bdoug1222@aol.com
  • Principals only. Recruiters, please don't contact this job poster.
  • do NOT contact us with unsolicited services or offers
quoted from here

Chinese task force to target counterfeit food and drugs

New group will investigate rising number of crimes requiring more specialist knowledge

read here

Execution drug disclosure dispute rises to high court

watch video and read here

Louisiana faced with revealing lethal injection details to inmate

Reuters) - The Louisiana Department of Corrections does not plan to appeal a U.S. Court decision this week that compels it to reveal to inmates on death row the content and maker of drugs used in lethal injections, a prisons official said on Friday.
The decision by the U.S. Court of Appeals for the Fifth Circuit on Thursday was one in a series in favor of inmates who have sought delays for their execution while they seek information about the contents of lethal injection cocktails and clarity on who would be supplying the drugs.
continue to read here

Seeing More Signs that Walgreens is Ramping Up Compounding Business (See Previously Posted Picture of Sign in Norman, Oklahoma Advertising Compounding) and now Hiring Manager in Dallas

Manager Compounding Specialty Pharmacy Jobs in Dallas at Walgreens - Walgreens Jobs

more information here

The Drug Quality & Security Act – Impact Will Take Time

read here

New lawsuit filed over Mississippi's execution drugs

JACKSON — A new lawsuit by a human rights group raises questions about the quality of the drugs used to execute Mississippi prison inmates.
The suit against the Mississippi Department of Corrections was filed Friday in Hinds County Chancery Court by the MacArthur Justice Center on behalf of death row inmates Michelle Byrom and Charles Ray Crawford.
MacArthur attorney Vanessa Carroll charges the state buys drugs from a compounding pharmacy and their integrity cannot be verified.
The lawsuit argues that by buying drugs that are locally mixed and not from a primary manufacturer the Corrections Department could acquire drugs that are counterfeit, contaminated, expired or not potent enough to work properly.
The lawsuit asks a judge to bar executions of the inmates until the state proves the integrity of the drugs.

continue to read here

Another Sales Rep Opening for Compounding Pharmacy

ProMed Pharmacy, Inc. is a rapidly growing compounding pharmacy located on Long Island. In our state of the art facility, we prepare transdermal compounds with only FDA-approved drugs. ProMed Pharmacy compounds full lines of anti-inflammatory, neuropathic, combination pain, fungal, skin infection, wart, and gout products, among many more.

We are currently seeking experienced sales professionals with a proven track record of success working in a business-to-business sales role calling on OB/GYN healthcare professionals. Open territories are available on Long Island as well as NY Metropolitan areas.

ProMed Pharmacy offers a comprehensive training program as well as a highly competitive compensation package.

If you feel that you could be an asset to our sales team and have what it takes to succeed in a
fast-paced, competitive field, then please submit your resume to saeed7313@yahoo.com

We look forward to hearing from you.
  • Principals only. Recruiters, please don't contact this job poster.
  • do NOT contact us with unsolicited services or offers
quoted from here

Friday, March 28, 2014

American Association of Equine Practitioners Application and Contract for Exhibit Space December 7-9, 2014 Salt Lake City, Utah--Includes Compounding Pharmacies This Year

 
see application here
 
 
 
 
 
 

Another Indian Pharmaceutical Company Hammered by FDA for Data Integrity Issues

Another Indian Pharmaceutical Company Hammered by FDA for Data Integrity Issues

Wisconsin Updated Pharmacy and Compounding Laws

CHAPTER 450 - Wisconsin Legislative Documents

https://docs.legis.wisconsin.gov/document/.../450.p...
Wisconsin Legislature
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3 days ago - scription order of a practitioner, including the compounding, packaging or labeling ..... 449 or to practice veterinary medicine under ch. 453, or as otherwise ...

USP Expert Committee Meeting Agenda for April 3, 2014 Includes discussion of compounding policy topics

Expert Committee

Meeting #08

Thursday, April 3, 2014

Meeting #8

USP Headquarters, Rockville, Maryland

Briggs Parker Room; Marshall Room; Wiley Room; Wood Room

Preliminary Agenda

_____________________
Goals and Anticipated Outcomes

1. Discuss compounding policy topics

2. Discuss subcommittee reports

Attendees



Attendee list provided on the day of the meeting Thursday, April 3, 2014
7:30 a.m. Chair / Vice Chair Meeting
8:00 a.m. CONTINENTAL BREAKFAST All
8:30 a.m. 1. Welcome
 
a. Welcome, Call Meeting to Order
Ms. Davidson
b. Procedural Announcements
Mr. Knaack/Ms. Meyer
c. Introduction of new CEO
Ron Piervincenzi, Ph.D.
Ms. Long
d. Approval of Minutes
Ms. Davidson
e. Approval of the Agenda
Ms. Davidson
f. Chair Overview of Expert Committee Progress
Ms. Davidson
9:00 a.m. 2. Progress Updates/Subcommittee Reports
 
a. General Chapter <797>
Ms. Davidson
b. General Chapter <795> and <1163>
Ms. Ashworth

2:00 p.m. 4. Compendial Updates
 
a. COE Call for Candidates
Mr. Sindaco
b. Proposed General Chapter <909> Uniformity of Dose From Oral Suspensions In Multiple-Unit Containers
Mr. Brown
c. Safety and Labeling Updates
Ms. Bohannon
d. Organic Impurities in Drug Substances and Drug Products
Dr. Parr/ Mr. Hernandez-Cardoso
e. Good Distribution Practices
Dr. Hunt
quoted from here

Be Sure and Checkout PCCA's Compounding Success Stories--Showing There Are Good Compounding Pharmacies and Pharmacists and Why We Need and Must Have Good Compounding Pharmacists

PCCA's Compounding Success Stories can be found here

Maryland Senate holds hearing on Compounding Legislation

Health Occupations - Compound Drugs - Provision to Ophthalmologists for Office Use

Sponsored by:

Delegate Morhaim

Status:

In the Senate - Hearing 3/27 at 1:00 p.m.



Synopsis:Authorizing a pharmacy for which a pharmacy permit has been issued by the State Board of Pharmacy and a sterile compounding facility to provide to an ophthalmologist for office use, without a patient-specific prescription, specified compound drugs for specified purposes; requiring the pharmacy or sterile compounding facility to require the ophthalmologist to provide to the pharmacy or sterile compounding facility the identity of any patient to whom the drugs are administered; etc.
Analysis:Fiscal and Policy Note (Revised)
All Sponsors:Delegates Morhaim, Bromwell, Costa, Cullison, Donoghue, Elliott, Hammen, Hubbard, Kach, A. Kelly, Kipke, Krebs, McDonough, Murphy, Nathan-Pulliam, Pena-Melnyk, Pendergrass, Ready, Reznik, Tarrant, and V. Turner
Additional Facts:Bill File Type: Regular
Effective Date(s): July 1, 2014
Committee(s):
Health and Government Operations   View Committee HearingEducation, Health, and Environmental Affairs   Listen to Committee Hearing
Broad Subject(s):Health Occupations
Narrow Subject(s):Committees and Commissions -see also- Political Committees
Drugs -see also- Controlled Dangerous Sub; Substance Abuse
Emergency Medical Services
Federal Government
Ophthalmologists
Pharmacists and Pharmacies
Reports
Storage
Statutes:Article - Health Occupations
(12-403, 12-4A-12)

‘Enough is enough’: Jockey Club urges medication reforms in wake of PETA scandal

‘Enough is enough’: Jockey Club urges medication reforms in wake of PETA scandal

Letter: Consumers must be able to make decisions on meds

To the editor of THE EAGLE: I visit the Berkshires often and will retire here in a few years. Born and raised in Connecticut, I love this part of the country. It’s home. For a few more years, though, we must live in New Jersey, as that’s where my husband works. Our doctors are in New Jersey. When I need a prescription there, I can tell my pharmacist when I want a brand name drug. I don’t need permission from anyone to do this. I just need to pay more money, as the cost of the brand is more than the generic and insurance doesn’t usually cover the brand.
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TDCJ Will Appeal Judge's Ruling on Execution Drugs

Amid national debate over the disclosure of information about drugs used in executions, Texas Department of Criminal Justice officials said Thursday that they will appeal a judge’s order to disclose the supplier of a new batch of its execution drugs.
“We are disappointed in the district court's decision and will be appealing the ruling to a higher court,” TDCJ spokesman Jason Clark said in an email.

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Imprimis Announces Compounding Pharmacy Strategy

Compounding Pharmacy Strategy


One of our key strategies is the use of compounding pharmacies to formulate our proprietary compounded drug formulations and technologies and distribute them to physicians and patients.  Governed by state and federal statutes and regulations, including the Drug Quality and Security Act of 2013 (DQSA), compounding pharmacies work with physicians to develop medications for individually identified patients. Examples of compounded formulations include medications with alternative dosage strengths or unique dosage forms, such as topical creams or gels, suspensions or solutions with more tolerable drug delivery vehicles.  A physician may also work together with a pharmacist to repurpose or reformulate FDA-approved drugs via the compounding process to meet a patient’s specific medical needs.  We are strategically attentive to the ideas generated by pharmacists dealing directly with doctors and their patients to address specific and often unmet patient needs, and we believe in and support the important role and contribution of the compounding pharmacist and compounding pharmacies in the U.S. healthcare system.

quoted from here

UPDATE! Compounding Registered Outsourcing Facilities

Compounding Registered Outsourcing Facilities

Concern About Authenticity of Alli

03/27/2014Alli Alli Weight Loss Product Concerns about authenticity of product

GlaxoSmithKline (GSK) Consumer Healthcare
source found here


 

Save the Date for the American Society for Pharmacy Law Developments in Pharmacy Law Seminar XXV

American Society for Pharmacy Law
Developments in Pharmacy Law Seminar XXV

November 69, 2014

Hyatt Regency Indian Wells Resort & Spa
Indian Wells, California

 Interested in sponsoring the ASPL DPLXXV Seminar?
Click here for more information.

Thursday, March 27, 2014

IACP Summarizes the FDA Fiscal Year 2015 Budget

The President released his budget on March 4th, requesting $4.7 billion for the Food and Drug Administration (FDA), which is $358 million, or 8% above the FY 2014 Enacted level. The President specifically requested $25 million of the total for agency-wide oversight of drug compounding, including enforcement, inspections, and collaboration with States.
Click here to read IACP's Summary of the FDA FY 2015 Budget http://bit.ly/1gueIZE

PETA Makes Case; Medication Reforms Touted

PETA Makes Case; Medication Reforms Touted

PETA Video Fallout and Horse Doping Issues Continue to be a huge topic--Here are Some Must Reads for those Dealing With Horse Doping and Veterinary Compounding Issues

PETA video fallout and reaction continues:
.
>>> Zayat press release: "Then Scott Blasi texted me Friday night ... 'I want to apologize ... I was clearly under the influence of alcohol and a woman."
>>> Ehalt: "The report has been both hailed and assailed ... And the truth is somewhere in the middle."
>>> Pricci: "Racing on hay, oats and water is the only remedy that's acceptable now, the general public will demand no less, nor should they."
>>> PETA VP: "It's time for the U.S. Anti-Doping Agency to step in and clean up the thoroughbred racing industry's addiction to drugs."
>>> Sulky side blog: "So based on the reaction thus far, can we draw any conclusions for harness racing?"
>>> MacAdam: "All ripping PETA does is deflect attention from the fact that racing continues to be its own worst enemy."
>>> Towers' Pull the Pocket blog offer some on-going commentary
>>> Scribe from the New Orleans area: Thought, feelings, observations on Asumussen video scandal
>>> Noonan: Yet another wake-up call for racing>>> Owner Zayat transferring horses from Asmussen stable
>>> The Atlantic/Cohen: The ugly truth about horse racing... An expose by PETA, published in The New York Times, shows a side of the sport that the industry has tried hard to shield from public view
>>> Jicha: "If this forces racing to step up and finally take meaningful action to clean up the game, it could be worth this latest embarrassment. The question is how."
>>> Scott: "One thing is certain - the time remaining for racing to put its house in order, on more or less its own terms, just got a whole lot shorter."
>>> TDN commentary: "What is required right now is for tracks and owners to sit down and write our Declaration of Independence."
>>> Top Australian vet suggests common practices in the US racing are alarming by international standards 

KPIC Training Courses Planned for 2014 - Kennedy Pharmacy ...

kennedycenter.sc.edu/.../KPIC-ACE_Mailer-...
University of South Carolina
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23 hours ago - All courses are conducted at the state-of-the-art Aseptic Compounding Experience (ACE) Lab at the South Carolina College of Pharmacy in Columbia. Kennedy ...

IACP Town Hall Meeting Update


ABA Civil False Claims Act 2014 CLE


 
  • Meeting Materials

  • Program Description

The Civil False Claims Act (FCA) is the fastest growing area of federal litigation, particularly because of its unique qui tam enforcement mechanism. Amendments in 2009 made this law even more powerful. The 10th Annual National Institute on the Civil False Claims Act and Qui Tam Enforcement will bring together experts from all areas—U.S. Department of Justice, state attorney general offices, federal agencies, leading defense and plaintiff firms—to discuss this ever-growing area of litigation and enforcement.

11th Annual Washington Health Law Summit Materials

11th Annual Washington Health Law Summit Materials

11th Annual Washington Health Law Summit Materials
Product Code:5630124PDF
Publication Date:February 2014
Sponsoring Entities:Health Law Section
Topics:Health Law
Format:PDF - 5630124PDF
Pricing:$250.00 (Regular)
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About the Washington Health Law Summit

The Washington Health Law Summit serves to bring attendees up to date on the latest legislative and policy developments and the implementation of significant healthcare initiatives emanating from HHS, CMS, IRS, DOJ, OIG and other key government agencies.
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