here
Tuesday, March 31, 2015
Verified Pharmacy Program (VPP) helping to ease burden of all the nonresident pharmacy inspections that need to be completed
On-Demand Inspections
Pharmacy boards around the country are being faced
with nonresident pharmacies that have not been inspected
in a reasonable time or in some cases have never been
inspected. This of course puts the state in a position of
not being sure that the pharmacy is operated in a safe or
even a legal manner. As a result, many states are requiring
that a recent copy of an inspection by the state of domicile
accompany an initial or renewal nonresident application.
This puts a hardship on the state of domicile at a time when
budgets prohibit most states from performing what has
come to be known as the “on-demand” inspection. Fortunately,
the National Association of Boards of Pharmacy®
(NABP®) has developed the Verified Pharmacy Program™
(VPP™), which can assist nonresident pharmacies in meeting
the inspection requirement for some states. More information
about VPP, including details on the application process,
fees, and processing time, is available in the Programs section
of the NABP website, www.nabp.net
quoted from Arizona Board of Pharmacy April 2015 Newsletter
quoted from Arizona Board of Pharmacy April 2015 Newsletter
Updated List of FDA 483s Released for Compounding Pharmacies in 2015 as of March 30, 2015
Advanced Physician Solutions, Inc., N Hollywood, CA, 483 Issued 1/16/2015 (PDF - 2.4MB)AnazaoHealth Corporation, Las Vegas, NV, 483 Issued 1/30/2015 (PDF - 2MB)Burklow Pharmacy, Inc., Pace, FL 483 Issued 3/4/2015 (PDF - 53KB)Central Admixture Pharmacy Services, Inc., Allentown, PA 483 Issued 2/11/2015 (PDF - 888KB)D.R. Pharmacy, Inc., Midland, TX 483 Issued 3/6/2015 (PDF - 647KB)Infupharma LLC d.b.a. President Pharmacy, Hollywood, FL 483 Issued 2/5/2015 (PDF - 685KB)Jungle Jim’s Pharmacy, Fairfield, OH 483 Issued 1/26/2015 (PDF - 500KB)Lato Drug Company, Inc. d.b.a. Post Haste Pharmacy, Hollywood, FL 483 Issued 2/20/2015 (PDF - 712KB)Physician Preferred Medical, LLC, Oklahoma City, OK 483 Issued 2/19/2015 (PDF - 1.6MB)Spoonamore Drug Co Inc, Louisville, KY 483 Issued 2/3/2015 (PDF - 543KB)The Apothecary Shoppe, LLC, Tulsa, OK 483 Issued 3/13/2015 (PDF - 1.3MB)Triad Isotopes Inc., Kansas City, MO, Amended 483 Issued 1/9/2015 (PDF - 622KB)Triad Isotopes Inc., Kansas City, MO, 483 Issued 1/9/2015 (PDF - 642KB)Tri-Med, Inc. dba Advanced Care Infusion-Shelby, Shelby Township, MI 483 Response Dated 3/12/2015 (PDF - 2.1MB)Tri-Med, Inc. dba Advanced Care Infusion-Shelby, Shelby Township, MI 483 Issued 2/23/2015 (PDF - 1.6MB)Unique Pharmaceutical, Ltd, Temple, TX 483 Issued 1/23/2015 (PDF - 560KB)Wood’s Pharmacy, Inc., dba The Medicine Shoppe, Boones Mill, VA 483 Issued 1/15/2015 (PDF - 2.4MB)
Warning Letters Moy-Fincher Medical Group 2/12/15 Examples of some ofthe claims on the website www.dnaegfrenewal.com include: DNA Eye Renewal • "Beta Glucan: Helps stimulate collagen production for added strength to the dermal matrix ... " • "Willowherb ... control inflammation." • "Spanish Lavender ... inhibit muscle fibers from contracting ... " • "Matrixyl3000 ... stimulating the production of collagen, elastic, and hyaluronic acid and decreasing cell damage caused by glycation and inflammation." • "Tetrapeptide . .. mimic the activity of the youth hormone thymopoietin ... reinforcing the cutaneous immune defenses in the skin ... stimulate the growth of new cells in the epidermis."
11th Circ. Affirms 20-Year Sentence For $7M Medicare Fraud
11th Circ. Affirms 20-Year Sentence For $7M Medicare Fraud
Law360 (subscription)-20 hours agoAffirms 20-Year Sentence For $7M Medicare Fraud ... sentence for the owner of a Miami home health care business accused of $7 million in Medicare fraud, ...
Horizon Blue Cross Blue Shield of New Jersey Saves Members 45.4 m by fighting fraud
Horizon fought fraud to the tune of $45.4M in savings in 2014
NJBIZ-3 hours ago
Horizon said that, since 2005, its anti-fraud efforts have saved $261 million. ... The company said fraud and abuse can involve bothhealth care providers and ...
Horizon Blue Cross Blue Shield of New Jersey Saves Members ...
Insurance News Net-5 hours ago
Insurance News Net-5 hours ago
Explore in depth (3 more articles)
“The Department of Justice has longstanding concerns about improper financial relationships between health care providers and their referral sources, because such relationships can alter a physician’s judgment about the patient’s true health care needs and drive up health care costs for everybody,” said Acting Assistant Attorney General Benjamin C. Mizer --Ohio-Based Health System Pays United States $10 Million to Settle False Claims Act Allegations
23 clinic workers arrested in health care fraud bust
23 clinic workers arrested in health care fraud bust
News 12 Brooklyn-2 hours ago
A total of 23 people were arraigned in Downtown Brooklyn Tuesday on a slew of charges, including health care fraud, enterprise corruption and money ...
Highly Recommend: Free Online Seminar from Loyola: Overview of Health Care Fraud Enforcement from OIG's Perspective Felicia Heimer, Esq. Office of Counsel to the Inspector General U.S. Department of Health & Human Services
Overview of Health Care Fraud Enforcement from OIG's Perspective
Felicia Heimer, Esq.
Office of Counsel to the Inspector General
U.S. Department of Health & Human Services
Office of Counsel to the Inspector General
U.S. Department of Health & Human Services
Wednesday, April 1, 2015
7:00 - 8:00 pm Central Time
This online session is free of charge. Login information will be sent upon registration.
Europe bans Chinese API maker over contamination issues March 31, 2015 | By Eric Palmer
The European Directorate for the Quality of Medicines has banned products from a Chinese maker of iodine after an inspection at its plant by French inspectors turned up contamination issues in its manufacturing processes, issues with its purified water system and a piece of testing equipment that may have been put in the facility just for show.
In a filing in the European Inspections database, French regulators said they recommended the suspension of the marketing authorization of Huzhou Sunflower Pharmaceutical this month after an inspection in late January of its plant in Huzhou, Zhejiang Province, documented 27 deficiencies, including one critical and four major deficiencies. more
In a filing in the European Inspections database, French regulators said they recommended the suspension of the marketing authorization of Huzhou Sunflower Pharmaceutical this month after an inspection in late January of its plant in Huzhou, Zhejiang Province, documented 27 deficiencies, including one critical and four major deficiencies. more
Supreme Court rules Providers cannot sue states for higher medicaid pay
Providers Can't Sue States for ...
Wall Street Journal-1 hour ago
WASHINGTON—The Supreme Court said Tuesday that Medicaid providers can't sue states claiming ...
More source
With over 700 licensed manufacturers, Pakistan’s pharmaceutical industry is valued at about US$2 billion, placing it amongst the ten biggest markets in Asia and making it a highly lucrative industry. Unfortunately, the country also suffers from rampant counterfeiting of popular medicines, with some estimates declaring that approximately 30 percent of drugs in the supply chain are spurious and substandard copies
An online pharmacy wants to end Pakistan's deadly trade in fake ...
Tech in Asia-7 hours ago
Alarmingly, fake medicines sometimes reach pharmacies in government
BREAKING: Providers can't sue state Medicaid agencies over rates, Supreme Court rules
Private healthcare providers cannot sue state Medicaid agencies over low reimbursement rates, the U.S. Supreme Court decided Tuesday in a 5-4 decision, reversing a lower court's ruling. READ MORE
OnePoint Patient Care Makes $1.5 Million Gift to University of Iowa's ...
OnePoint Patient Care Makes $1.5 Million Gift to University of Iowa's ...
SYS-CON Media (press release)-7 hours ago
The gift, which was announced in 2014 and recently finalized, will also provide UI College ofPharmacy students the ...
Drug Companies Replace Sales Reps In India With Medical ...
Drug Companies Replace Sales Reps In India With Medical ...
International Business Times-46 minutes ago
India is a rapidly expanding region for the pharmaceutical industry with an annual compoundedgrowth rate of 15 ...
Pharmacist Sentenced in Manhattan Federal Court to 36 Months in Prison in Multi-Million-Dollar Medicare/Medicaid Fraud Scheme The Defendant Sold and Received Reimbursement from Medicare and Medicaid for Illegally Diverted Prescription Drugs Obtained from Patients
| OfficeMarch 26, 2015 |
Preet Bharara, the United States Attorney for the Southern District of New York, announced that PURNA CHANDRA ARAMALLA was sentenced today to 36 months in prison, and ordered to pay over $7 million in restitution, for conducting a scheme to defraud Medicaid, Medicare, and the New York State-funded AIDS Drug Assistance Program (“ADAP”) through the purchase and sale of illegally diverted prescription drugs, including HIV medication. ARAMALLA was also sentenced for tax evasion. He was sentenced by U.S. District Judge Paul A. Crotty.
Manhattan U.S. Attorney Preet Bharara said: “Purna Aramalla’s prescription drug diversion scheme defrauded millions of dollars from programs established to provide health care assistance for the elderly and indigent. The scheme also jeopardized the health of anyone induced to sell his or her prescription or medication, and anyone who unwittingly purchased repackaged drugs.”
ARAMALLA, a pharmacist, owned and operated A Fair Deal Pharmacy Inc. in Queens, New York, and Quality Drug Inc. in the Bronx, New York. Using these pharmacies, ARAMALLA carried out a multimillion-dollar scheme to defraud the New York State Medicaid, Medicare, and ADAP programs through the sale of diverted prescription drugs, that is, drugs not obtained from legitimate sources.
As part of the scheme, ARAMALLA purchased prescription drugs, including high-cost medications used to treat HIV, that were obtained from patients who sold the drugs rather than use them to treat their illnesses. ARAMALLA then repackaged and resold those prescription drugs to his customers, as if they were new drugs obtained from legitimate sources. ARAMALLA requested and received reimbursement from Medicaid, Medicare, and ADAP in connection with these sales, even though these programs would not have been willing to reimburse the cost of second-hand drugs. In addition, in some cases, these programs had already paid for the prescription drugs when they were initially dispensed. In order to make the diverted drugs appear to be new drugs from legitimate sources, ARAMALLA and his co-conspirators used lighter fluid and other means to dissolve the adhesive on the patient labels on prescription bottles so that they could be removed and replaced with new labels.
ARAMALLA also sought and obtained reimbursement for prescription drugs that were never actually dispensed to patients. Instead, customers with prescriptions for drugs essentially “sold” their prescriptions to ARAMALLA, agreeing not to take delivery of the drugs in exchange for a share of the reimbursed proceeds.
From January 2010 to September 2013, ARAMALLA’s pharmacies received more than $10 million in reimbursements from Medicaid, Medicare, and ADAP that cannot be accounted for by ARAMALLA’s purchases from legitimate wholesalers.
In addition to his prison term, ARAMALLA, 67, of Port Washington, New York, was ordered to forfeit $7,503,605, pay restitution to his victims in the same amount, file amended tax returns for the years 2010 through 2012, and pay back taxes and applicable penalties.
Mr. Bharara praised the outstanding investigative work of the New York FBI Health Care Fraud Task Force and the Internal Revenue Service. He also thanked the U.S. Department of Health and Human Services, Office of Inspector General, the New York State Office of Medicaid Inspector General, and the New York City Human Resources Administration.
The New York FBI Health Care Fraud Task Force was formed in 2007 in an effort to combat health care fraud in the greater New York City area. The task force comprises agents, officers, and investigators from the Federal Bureau of Investigation, the New York City Police Department, the New York State Insurance Fraud Bureau, U.S. Department of Labor, U.S. Office of Personnel Management Inspector General, U.S. Food and Drug Administration, New York State Attorney General’s Office, New York State Office of Medicaid Inspector General, New York State Health and Hospitals Inspector General, and the National Insurance Crime Bureau.
The case is being prosecuted by the Office’s Complex Frauds and Cybercrime Unit. Assistant U.S. Attorneys Niketh Velamoor and Andrew Adams are in charge of the prosecution.
15-081
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Washington, D.C.-Area Pharmacist Indicted and Arrested on Charges Involving Illegal Pharmaceutical Shipments Defendant is Accused of Operating a Rogue Internet Pharmacy, Generating About $8.3 Million in Illegal Proceeds
| U.S. Attorney’s OfficeMarch 30, 2015 |
WASHINGTON—A man who owned a pharmacy in Washington, D.C. has been arrested following his indictment on federal charges that he and a physician from Florida operated an Internet pharmacy site that illegally shipped prescription-required controlled and non-controlled drugs from Washington, D.C. to more than 38,000 customers in the United States.
Titilayo (Tomi) Akintomide Akinyoyenu, 47, a naturalized U.S. citizen born in Nigeria, was arrested March 27, 2015, at his home in Bethesda, Md., by the FBI’s Washington Field Office. The arrest followed his indictment in the U.S. District Court for the District of Columbia. The defendant, also known as Tommy Akin, appeared in court later that day and was released on personal recognizance pending a hearing on April 3, 2015.
The indictment, which was unsealed March 27, was announced today by U.S. Attorney Ronald C. Machen Jr.; Andrew G. McCabe, Assistant Director in Charge of the FBI’s Washington Field Office; Karl C. Colder, Special Agent in Charge of the Washington Division Office of the Drug Enforcement Administration (DEA); David M. McGinnis, Acting Inspector in Charge of the U.S. Postal Inspection Service’s (USPIS) Washington Division, and Antoinette V. Henry, Special Agent in Charge of the Metro Washington Field Office of the U.S. Food and Drug Administration’s Office of Criminal Investigations.
The indictment alleges that Akinyoyenu, a pharmacist licensed by the District of Columbia Board of Health, owned and operated an Internet pharmacy website known as apexonlinepharmacy.com between January 2005 and June 29, 2010. According to the indictment, pharmaceutical orders were illegally shipped to more than 38,000 U.S. customers from Apex Care Pharmacy, a pharmacy owned by the defendant that previously was located in the 4000 block of Minnesota Avenue NE.
Between June 2006 and June 2010, sales income for online transactions totaled at least $8.3 million, the indictment alleges.
The indictment also charges Alan J. Saltzman, 65, a physician from Coral Springs, Fla., with joining in the crimes. Saltzman, an osteopath who is licensed in Florida and Pennsylvania, has been sent a judicial summons to appear to answer the charges.
Physicians who write or authorize prescriptions without a valid doctor-patient relationship are issuing invalid prescriptions because the physicians are acting outside the usual course of professional practice. Likewise, pharmacists who knowingly fill such prescriptions, or who have reason to know such prescriptions are invalid, are violating the law.
The indictment alleges that Akinyoyenu, as chief pharmacist, filled more than 58,000 prescriptions (including refills) for pharmaceuticals for customers who ordered drugs over the Internet solely on the basis of their answers to an on-line medical questionnaire. Such prescriptions are invalid and hence illegal, according to the indictment, because no valid doctor/patient relationship exists by a customer requesting prescription required drugs over the Internet solely on the basis of completing an on-line questionnaire. A doctor approving such prescription requests never sees or examines the customer making the request, cannot verify the identity of such a customer, makes no physical examination, cannot verify the nature of the malady, makes no diagnosis, conducts no medical tests, and implements no treatment plan.
For example, according to the charges, Akinyoyenu filled more than 9,000 Internet orders for Fioricet, which contains butalbital, a Schedule III controlled substance. The indictment charges that these and other prescriptions were illegally filled, then shipped to Internet customers across the country, all from the back of the Apex Care Pharmacy in Northeast Washington.
The indictment alleges that Saltzman conspired with Akinyoyenu, and that he agreed to approve prescriptions requested on-line by the customers over the Internet; the indictment alleges he did so for a negotiated fee per each approved prescription. Saltzman is accused of approving all 38,000 customer requests for the Internet customers coming from all over the United States, based solely on their answers to an on-line medical questionnaire.
Both defendants are charged with four offenses: conspiracy to distribute and dispense controlled substances, which carries a maximum possible sentence of imprisonment of 10 years and a fine of up to $500,000; conspiracy to distribute controlled drugs over the Internet, which carries a maximum imprisonment of up to 10 years, and a fine of up to $500,000; conspiracy to introduce misbranded drugs into interstate commerce, which carries a maximum period of imprisonment of up to five years and a fine of up to $500,000; and conspiracy to engage in mail fraud, which carries a maximum sentence of imprisonment of up to 20 years and a fine of up to $250,000. The indictment also makes a forfeiture allegation for at least $8.3 million, which is the amount of funds allegedly involved in the illegal Internet operation.
An indictment is merely a formal charge that a defendant has committed a violation of criminal laws and every defendant is presumed innocent until, and unless, proven guilty.
This investigation was sponsored and supported by the Department of Justice’s Organized Crime Drug Enforcement Task Force. The case was investigated by the FBI’s Washington Field Office; the Drug Enforcement Administration; the U.S. Postal Inspection Service, and the FDA’s Office of Criminal Investigations. Senior Litigation Counsel Linda I. Marks of the U.S. Department of Justice Civil Division’s Consumer Protection Branch provided assistance in the investigation. The case is being prosecuted by Assistant U.S. Attorney John P. Dominguez, who coordinated the investigation and presented the evidence to the grand jury.
This content has been reproduced from its original source.
Is Healthcare Making the Most of EHRs? Changing the Record White Paper by Grey Healthcare Group
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Drug importer Shane Charter admits secrecy over peptide shipment ...Day of reckoning arrives for Essendon and its players
Drug importer Shane Charter admits secrecy over peptide shipment ...
www.bigfooty.com › ... › Hot Topic - The AFL, ASADA and Drugs
22 hours ago - 25 posts - 17 authors
"so a drug importer would not be cut out of future deals." and “I would always .... How would he know what to compound it with, to what strength etc. I don't buy it, ...Day of reckoning arrives for Essendon and its players - ABC
www.abc.net.au/...03.../6360326
Australian Broadcasting Corporation
Secret report finds Essendon's drugs record-keeping was 'deplorable'
Secret report finds Essendon's drugs record-keeping was 'deplorable'
The Age-4 hours ago
There was some inference in correspondence from Alavi that he hadcompounded the drug. But the tribunal was not sure that Dank had received the drug in his ...
Question of the Day March 31, 2015 Some pharmacy groups are recommending that their members not supply lethal injection drugs. With some of the issues already in the Supreme Court was this message to members too late in coming? Isn't the potential still there for the Supreme Court to issue a damaging opinion regarding compounded drugs? Isn't the potential also there for the Supreme Court to issue a very favorable opinion toward compounded drugs used in lethal injection? If this happens will these groups stand by their positions?
Search Results
Pharmacy Groups Balk at Supplying Lethal Injection Drugs
NBCNews.com-13 hours agoDeath-penalty states scrambling to find drugs for lethal injections are facing a new hurdle: two groups that represent compounding pharmacists have told their ...Pharmacy association dissuades members from providing drugs for ...
In-Depth-Kansas City Star-11 hours agoPharmacists Group Tells Member Not to Participate in Executions
Blog-Wall Street Journal (blog)-1 hour ago
Explore in depth (227 more articles)
Provider status, government affairs overviews presented at APhA2015
Provider status, government affairs overviews presented at APhA2015
American Pharmacists Association, pharmacist.com-14 hours agoTopics on the regulatory side included health care reform; CMS activity; FDA activity on biosimilars, drug importation, compounding, track and trace, pregnancy ...
Temple, Texas: Unique Pharmaceuticals, a 503B outsourcing facility, today announced its operational transformation is complete and the company has initiated sterile compounding operations meeting the newly established federal guidelines.
Unique Pharmaceuticals Launches Sterile Operations under New ...
PR Newswire (press release)-16 minutes agoPassage of the DQSA brought definition to the regulation of the compounding industry by establishing a new oversight section of the FDA for "outsourcing ...
Restrictions on pharmacy ownership in Hungary
Restrictions on pharmacy ownership in Hungary - Eversheds
www.eversheds.com/global/.../index.page?...pharmacy...EvershedsFeb 11, 2015 - Since the introduction of a new law in 2011, the rules governingpharmacy ownership in Hungary have been made stricter each year, resulting in one of the most ...
The Pharmacy Guild in Australia: Community Pharmacy: A trusted public-private partnership
Community Pharmacy: A trusted public-private partnership
www.guild.org.au/.../pgoa-submission-to-the-competition-policy-review-ju...
Monday, March 30, 2015
Colorado Board of Pharmacy issues cease and desist order against Apotheca Compounding Pharmacy
Apotheca Compounding Pharmacy, unregistered 2014-4110
The Board voted unanimously to issue a Cease and Desist Order against Apotheca
Compounding Pharmacy for the alleged unlawful dispensing and delivery of prescription
drugs into Colorado without a Board-issued nonresident pharmacy registration.
quoted from Colorado Board of Pharmacy January 15, 2015 minutes
quoted from Colorado Board of Pharmacy January 15, 2015 minutes
Colorado Board of Pharmacy Agrees to Write Letter to EverPet LLC
EverPet LLC, PDO 168-22
The Board reviewed an Agenda Memorandum from Inspector Susan Martin regarding a
recent routine inspection of Everpet LLC. After careful consideration of the available
information, the Board voted unanimously to write a letter to this newly registered
pharmacy explaining that future violations (particularly when repeated) may result in the
initiation of a complaint and disciplinary action against both the pharmacy and its
pharmacist manager. They may not conduct business in another state without first
obtaining a nonresident pharmacy registration from that state unless otherwise not
required by a state.
quoted from January 2015 minutes
quoted from January 2015 minutes
The Short Answer Pharmacy-Benefit Managers
- The Short Answer Pharmacy-Benefit ManagersWall Street Journal - 6 hours ago
Pharmacy Groups Balk at Supplying Lethal Injection Drugs
Pharmacy Groups Balk at Supplying Lethal Injection Drugs
Death-penalty states scrambling to find drugs for lethal injections are facing a new hurdle: ...
NBCNews.com - 2 hours ago
Dr. Margaret Hamburg, Commissioner, Food and Drug Administration
Dr. Margaret Hamburg, Commissioner, Food and Drug Administration
FederalNewsRadio.com-7 hours ago
The compounding pharmacy scare and passage of a major reform bill are just a couple of the big episodes. Ahead of her departure, she sat down with Federal ...
Clinic staffers paid commission on prescriptions sold
Clinic staffers paid commission on prescriptions sold
www.cincinnati.com/.../70627330/
PharmacyChecker Blog | Discussing personal drug importation ...
PharmacyChecker Blog | Discussing personal drug importation ...
pharmacycheckerblog.com/
Wisconsin Legislative Documents Relating to Pharmacy
CHAPTER 450 - Wisconsin Legislative Documents
docs.legis.wisconsin.gov/.../450.pdf
Import Alert Miscellaneous Patent Medicines, Antibotics and Eye Drops
Melcare Biomedical Pty
Date Published : 03/24/2015
451 West Mount Cotton Rd , Mount Cotton, Qld AUSTRALIA
56 K - - 99 Miscellaneous Antibiotics, N.E.C.
Date Published: 03/24/2015
Desc:Optimel Antibacterial Manuka Eye Drops
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/24/2015
Desc:Optimel Antibacterial Manuka Eye Drops
Import Alert on Nestle Canada Inc. Vitamin & Mineral Supplement
Nestle Canada, Inc.
Date Published : 03/26/2015
25 SHEPPARD AVE W , North York, Ontario CANADA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 03/26/2015
Notes:Nestle Materna Pre-natal Postpartum Vitamin & Mineral Supplement
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/26/2015
Desc:Nestle Materna Pre-natal Postpartum Vitamin & Mineral Supplement
Source Import Alert 66-41
Import Alert on Jamieson Laboratories Supplements
Jamieson Laboratories
Date Published : 03/26/2015
2 St.Clair Ave. West , 16 th Floor , Toronto, ON CANADA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 03/26/2015
Notes:Jamieson Calcium Magnesium Caplets
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 03/26/2015
Desc:Jamieson Calcium Magnesium Caplets
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