Sunday, August 24, 2014

Third Question of the Day August 24, 2014 Is a valid basis for prescribing a compounded medication simply that a doctor, dentist or vet does not "like" a commerically available drug? Again doesn't the reason have to be because it is medically necessary?


Compounding Pharmacy for Sale in Orange County California

Available:
Compounding Pharamcy - Orange County
Posting #: 202713
Status: Active
Refreshed: 8/13/2014


Contact: Alex Levitan
Phone: 818-640-8080
Phone: 818-342-5222


Price: $265,000
Adj Net: $73,625
Down: $265,000


What a great opportunity to invest in well established, 32 years in the same location, mid size retail Pharmacy located inside well known Medical Building/Hospital in the heart of Orange County, Laguna Beach/Laguna Niguel/Mission Viejo area! This Pharmacy is located on the first floor
 

Second Question of the Day August 24, 2014 Is it right for people holding a public office or running for a public office to take money made from illegal compounded medications? Isn't this a catch 22 for those running for Congress? Compounders and the organizations that support them pour huge contributions into politicians' campaigns; however, if this money was obtained through fraud and abuse of Medicare, Medicaid and state worker's compensation then doesn't this make those accepting it look very bad?

campaigns

Question of the Day August 24, 2014 Should compounding pharmacies be prohibited from making and selling antibolic steroids such as Stanozolol, commonly sold under the name Winstrol (oral) and Winstrol Depot (intramuscular), used in bodybuilding and sports doping both for animals and humans? Should doctors be prohibited from prescribing such drugs?


NH restricts out-of-state compounding pharmacies | New Hampshire Health

NH restricts out-of-state compounding pharmacies | New Hampshire Health

Saturday, August 23, 2014

Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn't manufactured in compliance with FDA good manufacturing practices, creating another quality headache for the Indian drugmaker

Sun Conducts Massive Recall Due to Poor Quality of APIs

Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn't manufactured in compliance with FDA good manufacturing practices, creating another quality headache for the Indian drugmaker. Read More

The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests

ARTICLES

FDA Issues Safety Alert for Texas Compounder's Products

The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More

FDA 483s appearing in FDAzilla for 2014

Martin Avenue Pharmacy, Inc.

1247 Rickert Dr
Naperville, IL
06/30 - 07/21/2014
483 issued.
(not in store).

American Family Pharmacy, LLC

5520 W 84th St
Indianapolis, IN
06/11 - 07/08/2014
483 issued.
(not in store).

Pharmacy Creations

540 Route Ten West
Randolph, NJ
07/01 - 07/02/2014
No 483.

Central Admixture Pharmacy Services, Inc.

37497 Schoolcraft Rd
Livonia, MI
06/17 - 06/25/2014
483 issued.
(not in store).

Institutional Pharmacy Solutions, LLC

6520 N. Irwindale Avenue, Suite 228
Irwindale, CA
06/09 - 06/19/2014
No 483.

Wells Pharmacy Network LLC

1210 SW 33rd Ave
Ocala, FL
05/30 - 06/19/2014
483 issued.
(not in store).

Central Admixture Pharmacy Services, Inc.

6580 Snowdrift Rd
Allentown, PA
06/04 - 06/11/2014
483 issued.
(not in store).

One Way Drug, LLC dba Partell Specialty Pharmacy

8751 W Charleston Blvd Ste 120
Las Vegas, NV
05/21 - 05/30/2014
483 issued.
(not in store).

Premier Pharmacy Labs Inc

8265 Commercial Way
Weeki Wachee, FL
04/10 - 05/09/2014
483 issued.
(not in store).

South Coast Specialty Compounding, Inc.

9257 Research Dr
Irvine, CA
06/23 - 07/02/2014
483 issued.
(not in store).

US Compounding Inc

1270 Don's Lane
Conway, AR
03/17 - 03/27/2014
483 issued.
(not in store).

Stewart Compounding Pharmacy

101 Broadfoot Avenue
Fayetteville, NC
02/18 - 02/26/2014
483 issued.
(not in store).
 

Dr. Adam Mueller, DVM received a 483 from the FDA on May 22, 2014

FDA 483 was issued on 2014-07-09 Brookfield Prescription Center Inc. dba MD Custom Rx

So far in 2014 the FDA has issued less 483s than in 2013

Tenth Question of the Day August 23, 2014 If a compounding pharmacy advertising or indicates on its website that it provides sterile products to surgery centers, hospitals and physician's offices isn't this another factor or evidence they are manufacturing if they are not registered as an outsourcing facility?

 

Cronulla Sharks players accept doping bans

Cronulla captain Paul Gallen is one of 10 current NRL players to accept an ASADA deal which would result in a 12-month ban, back-dated to November 2013 for their involvement in the supplements program at the club in 2011. The players, who are set to be immediately stood down by the NRL, agreed to the deal on Friday morning after receiving assurances from the World Anti-Doping Agency that the terms would not be appealed by the international body. Cronulla teammates Nathan Gardner, Wade Graham and Anthony Tupou are all understood to have accepted the deal, along with Newcastle's Jeremy Smith and Kade Snowden, Titans halfback Albert Kelly and prop Luke Douglas plus North Queensland centre Matthew Wright. The suspension rules Gallen out of the upcoming Four Nations tournament for Australia, while Smith will be unable to represent New Zealand. With the exception of Wright, the other players would in effect serve a three-match club playing ban as they would be ruled out for the remainder of the season. Wright will miss the finals with the Cowboys and the Four Nations tournament for Samoa. Super League-based players Paul Aiton and Ben Pomeroy are understood to have rejected the offer. It is understood the players made the decision after being told WADA was "comfortable" with the backdated bans MORE TO COME quoted from here

NRL: Anti Doping Agency urged to overrule punishments

Challenge of the Day August 23, 2014 Go to Youtube and search for compounding pharmacy videos or how ot dispense compounded creams in office. What kind of comfort level does this give you regarding your compounded cream medications?

Dispensing Demo - YouTube

www.youtube.com/watch?v=sSIeVqTjlmE
18 hours ago - Uploaded by Beth OCoin
Learn how to dispense compounded creams in office. ... Pharmacy drugs medication dispensing systems For ...

Ninth Question of the Day August 23, 2014 Should all compounded pain medications be regulated by the DEA? Why or why not?

 

I have posted this board from Chronicle of the Horse before but keep reading the post. As with other boards the public is starting to catch on and call people out for breaking the law!!

Eighth Question of the Day August 23, 2014 If a compounding pharmacy is filling over 100 scripts a day through the mail why kind of red flags does this show to fraud investigators, PBMs, insurance companies etc. If the markup for those 100 scripts is $1000.00 for a $72 dollar pain cream, does the public truly understand how this is a cash cow for compounding pharmacists and pharmacies? How can this be about protecting the tradition of compounding for patients in need?


Look at the questions being possed on the boards entitled Compounding vs. Manufacturing!! Looks like employees of compounding pharmacies are starting to worry they may be breaking the law

Corporate Partner Spotlight: ATS Labs - International Academy of Compounding Pharmacists

Corporate Partner Spotlight: ATS Labs - International Academy of Compounding Pharmacists

Seventh Question of the Day August 23, 2014 How many compounding pharmacists believe they have complied with the law if they receive a script from a doctor with a specific patient/s name on it for a compounded medications? Doesn't patient specific mean something more? Doesn't it mean that compounded preparation is to be tailored for that one-individual person who has a specific need and reason for the compounded medicatons? And that need cannot and should not be the same need to make it a 30 billion dollar industry?


Sixth Question of the Day August 23, 2014 How can compounded pain creams be touted as a $30 billion dollar business if a reasonable price is being charged and it is only being given when medically necessary, there is no commerically available, and it patient-specific?


Fifth Question of the Day August 23, 2014 Aren't compounded non-sterile medications just as dangerous as sterile compounds?


Fourth Questtion of the Day August 23, 2014 Shouldn't consumers/patients/doctors be asking why a lot of the information and seminars on compounding pharmacies is geared toward or blantly states it is about increasing the number of users and making more money for the compounding pharmacy and pharmacists?


Third Question of the Day August 23, 2014 What if this statement turns out to be false: compounded pain creams ares an alternative non-addictive, non-narcotic and non-sedating pain therapy for patients of all ages? Who should be held liable for it it turns out ot be false advertising?


Second Question of the Day August 23, 2014 Has anyone else noticed how the compounding pain and scar industy has ramped up advertising recently? Is it because they believed this niche in their industry was endanger? Is it because they are almost daring Congress to pass specific regulatons as to compounding pain and scar medications? Should Congress do just that?

Here is an example of the comments I am seeing over and over in ads and marketing:

Transdermal pain therapy is a 30 billion dollar industry and growing. It is an alternative non-addictive, non-narcotic and non-sedating pain therapy for patients of all ages. Take advantage of this exciting opportunity which offers the highest commissions in the industry through an established pharmacy, compounding with only he highest quality PCCA based formulations.

Another ad for a compounding sales rep

Pharmaceutical Compounding & Toxicology Sales Reps
compensation: Commission paid per prescription adjudicated
part-time
telecommuting okay
Compensation:
You should be able to make over $100,000/yr even at a part time status if you have the relationships, experience and drive. Top reps take home $50K+ per month.

Position:
You will provide the physician with our prescription pad which clearly indicates the compounds in each product that they will fax back to the pharmacy. Get paid per prescription so recruit one doctor & get paid every time they write one of our prescriptions from our script pads.

* Scripts adjudicate from $1,000.00 to $20,000.00 (per script)
* Residual Income - Refills pay same commission rate each time they are filled
* No compensation cap
* Tiered compensation plan based on sales is ultra competitive
* Open geographical territories
* Sales portal offering updates on a per script basis
* If selected, we provide training, marketing materials and script pads


Product:
Our Specialty Pharmacy provides Compounded Transdermal Formulations for Pain Management, Wound Care, Scars & Stretch Marks, etc.. as well as an oral metabolic supplement and we also provide Toxicology and Genetic Testing

Responsibilities:
-Establish or Leverage existing physician relationships to market the products((pain management clinics, orthopedic, neurology, neurosurgery, podiatry, internal medicine, oral surgery, rheumatology, OB-GYN, ENT, Dermatology, etc).
-Conduct presentations in person, over the phone and through email
-Keep strong relationships in order to easily bring other products/services/devices in the future


Almost ALL healthcare providers treat patients with some sort of pain on a daily basis. Many providers are even medical surgeons who frequently have the opportunity to write 2 prescriptions for a patient - one being for pain and another to help with scarring. Ask any physician how many of their patients are 100% pain free and they will tell you none of them are entirely pain free.

Transdermal pain therapy is a 30 billion dollar industry and growing. It is an alternative non-addictive, non-narcotic and non-sedating pain therapy for patients of all ages. Take advantage of this exciting opportunity which offers the highest commissions in the industry through an established pharmacy, compounding with only he highest quality PCCA based formulations.
  • Principals only. Recruiters, please don't contact this job poster.
  • do NOT contact us with unsolicited services or offers
post id: 4632932947
posted:
updated:

Question of the Day August 23, 2014 Isn't a prepared, check-the-box script pad one key piece of evidence that a doctor and a compounding pharmacy are violating laws? How many of these type script pads are in doctor's offices? Should PBMs and insurance companies deny all claims when these type of scripts are used? How can the prescription be patient-specific when it is the same check-the-box script being used by the masses of people?


Friday, August 22, 2014

FDA scolds Ky. pharmacy over medications tied to deaths of horses

By Carlos E. Medina
Correspondent

Published: Friday, August 22, 2014 at 12:22 p.m.
Last Modified: Friday, August 22, 2014 at 12:22 p.m.http://www.ocala.com/article/20140822/ARTICLES/140829904?Title=FDA-scolds-Ky-pharmacy-over-medications-tied-to-deaths-of-horses
 

Bioidentical Hormones And Compounding Drug Deaths

Third Question of the Day August 22, 2014 Why do organizations supporting compounding pharmacists never address the pharmacists who are not doing traditional compounding but are in the business of illegal contempary compounding?


Patient Post that taking compounded Valium solution; Other readers warn patient to be careful using compounded medications

view discussion here

Spending On Compounded Medicine Soars Amid Questions Of Need.

David G. Miller, RPh, executive vice president and CEO, International Academy of Compounding Pharmacists (IACP), believes that the new legislation has not really changed compounding practices for traditional compounders, but it has raised some unanswered questions - See more at: http://www.policymed.com/2014/08/fda-told-to-reach-out-to-physicians-and-pharmacists-before-releasing-compounding-guidances-.html#sthash.UoKrB9g3.dpuf


For those wanting to follow the criminal procedeeings in the Landmark case with the baby death from compounded creams Karen Foshay an investigative producer for Southern California Public Radio 89.3 KPCC is regularly tweeting about it; one of her recent tweets was that prosecutors allege $72 compounded cream was billed to California worker's comp for $1900!!!

 

Second Question of the Day August 22, 2014 If a PBM knows or thinks a compounding pharmacy or doctors prescribing compounding medications is violating the law don't they have a duty to report those companies or people to the proper authorities? If they know and do not report it, what is the civil and criminal liability of the PBM?


New Catamaran Effort to Control Compounds Looks at Safety, Cost with SECURE Plan; concerned about compounds made in bulk

The increased use and spend associated with compounded medications has become a hot-button topic in recent months as payers have noticed these therapies creeping into their top 10 drug spend lists and Express Scripts Holding Co. reported that utilization among its clients jumped 30% in 2013 (DBN 4/18/14, p. 1). Similarly, Catamaran Corp. witnessed a five-fold increase in annual spending on compounded medications across its commercial book of business from 2012 to 2013.
As a result, Catamaran has put together a “robust menu of services” that can be tailored to meet clients’ specific needs. The company on June 16 unveiled the new Safe & Effective Compound Use Reassurance Effort (SECURE) program dedicated solely to addressing compounded medications from both a clinical and a financial perspective.

continue to read here

Question of the Day August 22, 2014 Isn't the real question that everyone should be asking about insurance companies and PBM excluding compounded drugs whether those drugs and APIs should have been covered in the first place? See comment from reader below.

Anonymous said...
They should be cautious not to protest too loudly--unapproved chemicals, including APIs, probably should not have been added to preferred specialty provider tiers in the first place?

Will PBMs’ Latest Round of Formulary Exclusions Stir Payers?

Earlier this month, CVS Caremark Corp. and Express Scripts Holding Co. released updates to their 2015 formulary exclusion lists. CVS Caremark now excludes nearly 100 products from its Standard Formulary and automatically will leave out new-to-market products, including line extensions and new strengths, until they’ve been reviewed by the PBM’s pharmacy and therapeutics committee. Meanwhile, Express Scripts updated its National Preferred Formulary to exclude 66 products.
While these tactics have so far heard little public opposition from plan sponsors, the National Business Coalition on Health (NBCH) recently issued a brief advising payers to approach the strategy with caution and consider the risks and benefits. NBCH raised a good point, which is that there’s been no independent third-party research to assess the impact on drug costs or larger medical spend. As one industry observer tells DBN, “People on various sides are freaked out about the heavy hand that [Express Scripts] is putting out there….Things are very much in flux; I don’t think anyone has studied this, including the costs of unintended consequences (e.g., Rx abandonment, hospitalization, physician time and frustration, etc.).”
continue to read here

The Texas State Board of Pharmacy (TSBP) is hosting a free one-hour webcast on Thursday, September 25, 2014, at 10:00 a.m.

Texas Pharmacy Laws and Rules Update

Powered by GoToTraining®
The Texas State Board of Pharmacy (TSBP) is hosting a free one-hour webcast on Thursday, September 25, 2014, at 10:00 a.m. The program will review recent changes to pharmacy rules; and review the most common deficiencies found during inspections of pharmacies. One hour of continuing education (CE) credit approved by TSBP is available for attendees of the program.

Pharmacy techs plead guilty in $2.5M Rx fraud case

Maryland pharmacy technicians Vipinkumar Patel and Jigar Patel entered guilty pleas in a case involving $2.5 million worth of false prescription refill claims. The unrelated defendants face up to five years each in prison upon sentencing.
View Full Article in:
Washington Post (tiered subscription model), The

Lawmakers Join All-Out Push to Combat Medicare Fraud

WASHINGTON, DC  - As law enforcement announced a nationwide sting against Medicare fraudsters today, a bipartisan group of lawmakers in Washington was putting the finishing touches on legislation aimed at making a significant dent in the problem.
Federal law enforcement officials in Miami today announced the details of a multi-agency strike force operation that resulted in the arrest of 90 people nationwide for defrauding Medicare out of some $260 million.
U.S. Senate Special Committee on Aging Chairman Bill Nelson (D-FL) and Ranking Member Susan Collins (R-ME), who have spent a great deal of time examining the problem of Medicare fraud and ways to curtail it, commended the actions announced today by federal officials while also saying that the crackdown illustrates the need to do more to stop Medicare fraud.
Nelson and Collins, along with Sens. Tom Carper (D-DE) and Chuck Grassley (R-IA), have authored legislation to strengthen the government’s hand in stopping Medicare fraud.  The lawmakers plan to formally file the legislation on Thursday.
“This is exactly why we’re doing the legislation,” said U.S. Sen. Bill Nelson (D-FL) who chairs the Senate Special Committee on Aging.  “We’ve got to get the problem under control.”
Senator Collins added, “For decades, the GAO has identified Medicare as being at high risk for improper payments.  This is unacceptable.  The loss of these funds not only compromises the financial integrity of the Medicare program, but it also undermines our ability to provide needed health care services to the more than 54 million older and disabled American workers who depend on this vial program. Our legislation emphasizes a strategy to prevent fraud from happening in the first place.”
“Medicare provides lifesaving care to some of our nation’s most vulnerable citizens,” said Sen. Carper. “Unfortunately, too many unscrupulous individuals take advantage of this vital program and end up costing taxpayers millions and shortchanging beneficiaries. It is critical that we do all that we can to curb fraud while protecting beneficiaries and ensuring effective care. This legislation is an important step in combating Medicare fraud and preserving this essential program for the future generations. I commend Sens. Nelson and Collins for their leadership in this effort.”
“Our bill will build on the Physician Payments Sunshine Act that I co-authored,” Grassley said.  “It requires HHS to use available data, including data from the Sunshine Act, to verify doctors’ reported information about ownership interests in organizations that bill Medicare.  This will help flush out any doctors who commit fraud from their own facilities.”
Specifically, the legislation will require Medicare to verify that those wishing to enroll in the program have not owned a company that previously defrauded the government.  Currently, Medicare relies on self-reported information.  As a consequence, a provider who previously had an ownership interest in an organization that defrauded Medicare could potentially get back into the program by using a different name and failing to disclose their interest in the previous organization.
The bill will also allow private insurers to share information about potentially fraudulent providers with Medicare, and requires new medical coding systems to be tested before they’re deployed to ensure Medicare’s fraud prevention systems work properly.  Additionally, the Medicare Payment Advisory Commission will be allowed to make recommendations regarding fraud prevention and Medicare will be required to develop a strategy to reliably estimate just how many taxpayer dollars are lost each year to fraud.
According to a recent estimate, fraud in the country’s Medicare system takes some $60 billion to $90 billion annually out of the system and puts it into the pockets of crooks.
The lawmakers’ legislation already has the support of the National Health Care Anti-Fraud Association, the Coalition Against Insurance Fraud, the National Insurance Crime Bureau, America’s Health Insurance Plans, Humana and the Blue Cross Blue Shield Association.
Copy of legislation can be read here

A Medicare scam that just kept rolling

The government has paid billions to buy power wheelchairs. It has no idea how many of the claims are bogus. read the Washington Post Article here

Pervasive Medicare Fraud Proves Hard to Stop

BALTIMORE — The ordinary looking office building in a suburb of Baltimore gives no hint of the high-tech detective work going on inside. A $100 million system churns through complicated medical claims, searching for suspicious patterns and posting the findings on a giant screen.
Hundreds of miles away in a strip mall north of Miami, more than 60 people — prosecutors, F.B.I. agents, health care investigators, paralegals and even a forensic nurse — sort through documents and telephone logs looking for evidence of fraudulent Medicare billing.
 
continue to read here

National Health Care Anti-Fraud Association Annual Conference Dallas, TX November18-21, 2014 with Include Pharmacy Fraud Track including Part D Fraud, J code schemes, intersection with DMEs, Compounded Sterile Injectibles etc.

Latest Trends in Pharmacy Fraud, Waste and Abuse Audits
Wednesday, 11:00 a.m. - 12:00 pm.
Level II
Jessica Schmor, RN, AHFI, CPC, CCS
Executive Director, Amenity Consulting
Mike Debelle, MBA
Senior Manager, Optimity Advisors
Faculty will review the latest pharmacy Fraud, Waste, and Abuse trends, identification practices, and algorithm build. Participants will learn how to construct a robust Fraud, Waste, and Abuse audit program that does not simply focus on pharmacy claims, but includes often overlooked categories such as DME and the intersection of pharmacy and medical claims, and how to build an effective audit team across all audit disciplines. Throughout the session faculty will use case studies to support and reinforce the topics being presented.
Compounded Injectible Drugs
Wednesday, 1:30 p.m. - 2:30 p.m. | Thursday, 10:15 a.m. - 11:15 a.m.
Level III
Ayms Lang, MD, CPC, AHFI, CFE
Senior Investigator, WellPoint, Inc.
The presenter will identify emerging trends and schemes regarding compounded injectible drugs, specifically, testosterone pellets and hyaluronic acid. The discussion will cover topics of "drug piracy" and regulations unique to hyaluronic acid, which the FDA has classified as a device rather than a drug. These cases have escalated into a multi-state, multi-agency investigation.
Pharmaceutical Wholesalers and Part D Fraud LEL Path
Thursday, 8:15 a.m. - 9:30 a.m. | Friday, 9:45 a.m. - 11:00 a.m.
Level II
Stephen Mahmood
Special Agent, U.S. Department of Health & Human Services, OIG-OI
Daniel Crespi
Special Agent, U.S. Department of Health & Human Services, OIG-OI
Houston E. Ramsey, Jr.
Special Agent, U.S. Food & Drug Administration, OCI
Donald W. DeGroff
Senior Principal, IMS Government Solutions
The panel will present a case study focused on a pharmaceutical wholesaler located in Miami-Dade County, FL. The wholesaler provided fraudulent drug pedigrees and invoices to Medicare Part D providers in the South Florida area. These providers were submitting false claims to Medicare Part D plan sponsors and the fraudulent invoices/pedigrees were used to support the false claims. The topics to be covered include referrals to the OIG, Part D fraud and the need for fake invoices, FDA nexus and drug pedigrees, NBI-MEDIC coordination with PBMs, invoice analysis and invoice review, criminal prosecution and spinoff investigations.
Investigation Techniques for Part D Cases LEL Path
Thursday, 11:30 a.m. - 12:30 p.m.
Level II
Robert Breeden
Special Agent, U.S. Department of Health & Human Services, OIG-OI
Heather Tucci
Special Agent, U.S. Department of Health & Human Services, OIG-OI
The workshop will include how undercover operations can assist in the effective investigation and prosecution of physicians and civilians involved in the criminal distribution of narcotics. Faculty will demonstrate how this distribution results in the fraudulent use of the Part D program. The presentation will highlight those areas to focus an investigation and lessons learned from prior investigations, examining the overlap that exists between healthcare fraud in the Part D and Part B programs, and how to use that overlap to enhance your investigation.

Thursday, August 21, 2014

Reminder the Legislation to Amend the law to permit direct payment to pharmacies for certain compounded drugs that are prepared by the pharmacies for a specific beneficiary for use through an implanted infusion pump has not been passed

Congress (2013 - 2014)
H.R.232


NEW SEARCH | HOME | HELP




H.R.232
Latest Title: To amend title XVIII of the Social Security Act to permit direct payment to pharmacies for certain compounded drugs that are prepared by the pharmacies for a specific beneficiary for use through an implanted infusion pump.
Sponsor: Rep Harper, Gregg [MS-3] (introduced 1/14/2013)      Cosponsors (7)
Related Bills: S.914
Latest Major Action: 1/28/2013 Referred to House subcommittee. Status: Referred to the Subcommittee on Health.
S. 914 (Related)
A bill to amend title XVIII of the Social Security Act to permit direct ...
Referred to Committee
Last Action: May 9, 2013
 
prediction is zero percent chance of enactment more here

Veterinary Compound Pharmacy Has Reinforced Standards

A Lexington pharmacy that makes compound products for horses said it has taken steps to reinforce its safety and quality standards and has cooperated with a federal agency's inquiry into "adverse events earlier this year."
The U.S. Food and Drug Administration recently sent a letter to Wickliffe Veterinary Pharmacy, notifying the firm that tests show its drug products are "adulterated and misbranded" under the federal Food, Drug, and Cosmetic Act.
MITCHELL: FDA Sends Warning Letter to Compounding Firm
"Wickliffe Veterinary Pharmacy, a high-quality provider of customized medicinal solutions for veterinarians, cooperated fully with federal health officials' inquiry into the adverse events involving horses earlier this year," the company said in a statement in response to the FDA letter. "The recent compliance letter issued by the U.S. Food and Drug Administration is related solely to this previous incident. We took prompt action last spring in response to the incident to reinforce our high safety and quality standards for Wickliffe's compounded products. We are preparing a response to the FDA that outlines the steps that we have taken and the quality assurance program that we maintain."


Read more on BloodHorse.com: http://www.bloodhorse.com/horse-racing/articles/86899/compound-pharmacy-has-reinforced-standards#ixzz3B4QZV2Fg

Independent Pharmacists RX PAC GENERAL-PURPOSE COMMITTEE Ethics Report to Texas Ethics Commission --a Number of Compounding Pharmacists Are Listed for 2014

Update List of Release 483s issued to Compounding Pharmacies in 2014

  • Advanced Pharma Inc., Houston, TX, 483 Issued 3/17/2014 (PDF - 638KB)
  • Alexander Infusion, LLC dba Avanti Health Care Services, New Hyde Park, NY, 483 Issued 7/9/2014 (PDF - 1.4MB)
  • AnazaoHealth Corporation, Tampa, FL, Referral Letter to FL BOP Issued 2/21/2014 (PDF - 375KB)
  • Central Admixture Pharmacy Services, Inc. (CAPS), San Diego, CA, 483 Issued 8/8/2014 (PDF - 1.5MB)
  • Central Admixture Pharmacy Services, Inc. (CAPS), Livonia, MI, 483 Issued 6/25/2014 (PDF - 928KB)
  • Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA, 483 Issued 6/11/2014 (PDF - 2.1MB)
  • Central Admixture Pharmacy Services, Inc. (CAPS), Woburn, MA, 483 Issued 2/20/2014 (PDF - 1.9MB)
  • Downing Labs, LLC, Dallas, TX, 483 Issued 7/16/2014 (PDF - 2.1MB)
  • Eastern Pharmacy, Inc., Ocala, FL, 483 Issued 2/4/2014 (PDF - 516KB)
  • Foundation Care, LLC, Earth City, MO, Referral Letter to MO Board of Pharmacy Issued 2/26/2014 (PDF - 396KB)
  • Franck's Lab Inc dba Trinity Care Solutions, Ocala, FL, 483 Issued 5/23/2014 (PDF - 856KB)
  • Healix Infusion Therapy, Inc., Sugar Land, TX, 483 Issued 5/16/2014 (PDF - 628KB)
  • Hopewell Pharmacy, Hopewell, NJ, Referral Letter to NJ Board of Pharmacy Issued 2/21/2014 (PDF - 1.3MB)
  • Infusion Options, Inc., Brooklyn, NY, 483 Issued 4/23/2014 (PDF - 2.3MB)
  • I.V. Specialty Ltd., Austin, TX, 483 Issued 7/22/2014 (PDF - 1019KB)
  • John W. Hollis Inc dba John Hollis Pharmacy, Nashville, TN, 483 Issued 3/21/2014 (PDF - 1.3MB)
  • Kings Park Slope, Inc., Brooklyn, NY, 483 Issued 3/14/2014 (PDF - 3.2MB)
  • KRS Global Biotechnology, Inc., Boca Raton, FL, 483 Issued 3/17/2014 (PDF - 735KB)
  • LeeSar, Inc., Fort Myers, FL, 483 Issued 8/8/2014 (PDF - 541KB)
  • Leiter's Cambrian Park Drugs, Inc., dba Leiter's Pharmacy, San Jose, CA, 483 Issued 3/6/2014 (PDF - 1.3MB)
  • Leiter's Compounding Pharmacy, San Jose, CA, 483 Response Dated 3/26/2014 (PDF - 3.6MB)
  • Lowlyn Pharmacies, Inc., d/b/a Red Cross Drug, Blanchard, OK, Referral Letter to OK Board of Pharmacy Issued 2/25/2014 (PDF - 2.4MB)
  • Martin Avenue Pharmacy, Inc., Naperville, IL, 483 Issued 7/21/2014 (PDF - 1.8MB)
  • One Way Drug, LLC dba Partell Specialty Pharmacy, Las Vegas, NV, 483 Issued 5/30/2014 (PDF - 1.3MB)
  • People’s Pharmacy, Inc. #2, Austin, TX, 483 Issued 7/28/2014 (PDF - 560KB)
  • Pharmakon Pharmaceuticals, Inc. Noblesville, IN, 483 Issued 3/13/2014 (PDF - 1.9MB)
  • Pharmakon Pharmaceuticals, Noblesville, IN, 483 Issued 4/8/2014 (PDF - 350KB)
  • Portage Pharmacy Inc., Portage, MI, Referral Letter to MI Board of Pharmacy Issued 2/25/2014 (PDF - 357KB)
  • Premier Pharmacy Labs, Inc., Weeki Wachee, FL, 483 Issued 5/9/2014 (PDF - 2.5MB)
  • Region Care, Inc., Great Neck, NY, 483 Issued 3/20/2014 (PDF - 922KB)
  • RX South LLC DBA RX3 Pharmacy, Chester, VA, 483 Issued 2/21/2014 (PDF - 5MB)
  • SCA Pharmaceuticals, LLC, Little Rock, AR, 483 Issued 4/1/2014 (PDF - 1.7MB)
  • Stewart Compounding Pharmacy, Fayetteville, NC, 483 Issued 2/26/2014 (PDF - 1.4MB)
  • Unique Pharmaceuticals, Ltd. FDA Requested Recall Letter Issued 7/11/2014 (PDF - 754KB)
  • Unique Pharmaceuticals Ltd., Temple, TX, 483 Issued 6/20/2014 (PDF - 1MB)
  • Unique Pharmaceutical, Ltd., Temple, TX, Amended 483 Issued 4/4/2014 (PDF - 4.3MB)
  • Unique Pharmaceutical, Ltd., Temple, TX, 483 Issued 4/2/2014 (PDF - 748KB)
  • University Pharmacy, Inc., Salt Lake City, UT, Referral Letter to UT Board of Pharmacy Issued 2/20/2014 (PDF - 240KB)
  • US Compounding Inc., Conway, AR, 483 Issued 3/27/2014 (PDF - 1.1MB)
  • Wells Pharmacy Network LLC, Ocala, FL, 483 Issued 6/19/2014 (PDF - 1MB)
  • Wells Pharmacy Network LLC, Ocala, FL, 483 Issued 3/7/2014 (PDF - 1.2MB)
  • Zions RX Formulations Services LLC dba Rx Formulation Serv., Mesa, AZ, 483 Issued 1/9/2014 (PDF - 1MB)

  • FDA List Continues to Grow: Compounding Registered Outsourcing Facilities

    Compounding Registered Outsourcing Facilities