483 issued
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Sunday, December 29, 2013
California Board of Pharmacy Disciplinary Action--Kudos for already issued cease and desist against Abrams Royal Pharmacy--also action against several others including Westside Pharmacy
Abrams Royal Pharmacy, NSC 99466
Dallas, TX
Cease and desist immediately from compounding sterile injectable drug products.
Decision effective 12/23/2013.
View the Decision
De Soto Pharmacy, PHY 32271, Administrative Case AC 3662
Canoga Park, CA
Through a disciplinary action of the board, the license is voluntarily surrendered.
Decision effective 11/27/2013.
View the Decision
De Soto Pharmacy, PHY 50809, Statement of Issues Case SI 4311
Canoga Park, CA
Through a disciplinary action of the board the license is issued, and the license is subject to a Letter of Public Reprimand.
Decision effective 11/27/2013.
View the Decision
Fountain Valley Cancer Center Pharmacy, PHY 43274, LSC 99020, Administrative Case AC 4551
Fountain Valley, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for three months or by January 1, 2014, which ever date comes first, the stay will be automatically lifted and the license will be permanently revoked.
Decision effective 11/27/2013.
View the Decision
Half Moon Bay Pharmacy, PHY 44400, Administrative Case AC 4349
Half Moon Bay, CA
Through a disciplinary action of the board, the license is subject to a letter of public reprimand.
Decision effective 10/9/2013.
View the Decision
RX Care Pharmacy, PHY 46138, Administrative Case AC 3254
Torrance, CA
Through a disciplinary action of the board, the license is revoked and canceled and the right to practice or operate has ended. President Michael Voldman is prohibited from owning any board licensed entity.
Decision effective 11/27/2013.
View the Decision
UPAS Pharmacy, PHY 36112, Administrative Case AC 4190
San Diego, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed, and the license shall continue on probation for an additional four years. The terms and conditions of probation include posting a notice of probation.
Decision effective 10/7/2013.
View the Decision
Walgreens No 06683, PHY 46263, Administrative Case AC 3695
Visalia, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for three years. The terms and conditions of probation include posting a notice of probation.
Decision effective 11/12/2013.
View the Decision
Westlake Care Pharmacy, PHY 49290, Administrative Case AC 4231
Westlake Village, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for sixty days or by December 1, 2013, which ever date comes first, the stay will be automatically lifted and the license will be permanently revoked.
Decision effective 11/27/2013.
View the Decision
Westside Pharmacy, PHY 15178, Administrative Case AC 4385
Fresno, CA
Through a disciplinary action of the board, the license is voluntarily surrendered.
Decision effective 12/17/2013.
View the Decision
Dallas, TX
Cease and desist immediately from compounding sterile injectable drug products.
Decision effective 12/23/2013.
View the Decision
De Soto Pharmacy, PHY 32271, Administrative Case AC 3662
Canoga Park, CA
Through a disciplinary action of the board, the license is voluntarily surrendered.
Decision effective 11/27/2013.
View the Decision
De Soto Pharmacy, PHY 50809, Statement of Issues Case SI 4311
Canoga Park, CA
Through a disciplinary action of the board the license is issued, and the license is subject to a Letter of Public Reprimand.
Decision effective 11/27/2013.
View the Decision
Fountain Valley Cancer Center Pharmacy, PHY 43274, LSC 99020, Administrative Case AC 4551
Fountain Valley, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for three months or by January 1, 2014, which ever date comes first, the stay will be automatically lifted and the license will be permanently revoked.
Decision effective 11/27/2013.
View the Decision
Half Moon Bay Pharmacy, PHY 44400, Administrative Case AC 4349
Half Moon Bay, CA
Through a disciplinary action of the board, the license is subject to a letter of public reprimand.
Decision effective 10/9/2013.
View the Decision
RX Care Pharmacy, PHY 46138, Administrative Case AC 3254
Torrance, CA
Through a disciplinary action of the board, the license is revoked and canceled and the right to practice or operate has ended. President Michael Voldman is prohibited from owning any board licensed entity.
Decision effective 11/27/2013.
View the Decision
UPAS Pharmacy, PHY 36112, Administrative Case AC 4190
San Diego, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed, and the license shall continue on probation for an additional four years. The terms and conditions of probation include posting a notice of probation.
Decision effective 10/7/2013.
View the Decision
Walgreens No 06683, PHY 46263, Administrative Case AC 3695
Visalia, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for three years. The terms and conditions of probation include posting a notice of probation.
Decision effective 11/12/2013.
View the Decision
Westlake Care Pharmacy, PHY 49290, Administrative Case AC 4231
Westlake Village, CA
Through a disciplinary action of the board, the license is revoked, the revocation is stayed and the license is placed on probation for sixty days or by December 1, 2013, which ever date comes first, the stay will be automatically lifted and the license will be permanently revoked.
Decision effective 11/27/2013.
View the Decision
Westside Pharmacy, PHY 15178, Administrative Case AC 4385
Fresno, CA
Through a disciplinary action of the board, the license is voluntarily surrendered.
Decision effective 12/17/2013.
View the Decision
Industry Uncertain What Effect New Law Will Have
By FRED HIERS
HALIFAX MEDIA SERVICES
Published: Sunday, December 29, 2013 at 10:47 p.m.
Last Modified: Sunday, December 29, 2013 at 10:47 p.m.
It was too much for federal regulators to ignore and the public to tolerate: 64 people dead after a Massachusetts pharmacy shipped contaminated drugs to 23 states.
The New England Compounding Center in Massachusetts had already been in hot water with both federal and state regulators for a decade leading up to the debacle. The Massachusetts violations had left many angry national lawmakers asking why federal regulators had not closed the business down, much less allowed it to pump thousands of doses of fungal-contaminated drugs into the patient stream.
continue to read here
Unknown Risks of Pharmacy-Compounded Drugs
Larry D. Sasich, PharmD, MPH, Chair;
- Sana R. Sukkari, BScPharm, MPhil, Assistant Professor
+ Author Affiliations
To the Editor: In August 2006, the United States Food and Drug Administration (FDA) announced that warning letters had been issued to three pharmacies that were producing and distributing thousands of doses of compounded inhalation medications not approved by the FDA.1 These inhalation medications were used to treat patients with such respiratory diseases as asthma, bronchitis, cystic fibrosis, and emphysema.1
Pharmacy compounding traditionally involves such practices as manipulating an FDA-approved dosage form, such as a tablet or capsule, to prepare a solution or suspension for individual patients who have difficulties in swallowing.2 Traditional pharmacy compounding may also involve preparing an FDA-approved medication excluding a specific ingredient to which an individual patient may have a hypersensitivity.2 The FDA permits such traditional practices by pharmacies.
By contrast, nontraditional practices of pharmacy compounding—such as those that prompted the FDA warnings—include the mass production of drug combinations from bulk substances that are sometimes of unknown origin.1 These drug combinations may be exact copies or slightly modified versions of FDA-approved pharmaceutical products.2 The FDA has expressed concern that such nontraditional practices of pharmacy compounding may expose patients to unnecessary health risks.1,2
The true extent of nontraditional pharmacy compounding in the United States is unknown. However, the FDA and many state public health authorities have expressed serious concerns about quality and safety issues regarding compounded inhalation drugs.2,3 For example, minutes from the May 2007 meeting of the Ohio State Board of Pharmacy reveal disciplinary action against one pharmacy-compounding facility.3 According to our calculations based on numbers provided in these minutes, between July 2005 and November 2005, the pharmacy in question compounded and dispensed 119 prescriptions for an estimated 7530 doses of inhalation medications, including five different drug-combination products.3 Two of the five compounded products were identical to FDA-approved medications, while three were unapproved combinations.3 Of the seven drug substances that were used to produce the combinations, five were available as FDA-approved inhalation medications, while two (betamethasone and dexamethasone) were not.3
continue to read hereJustice Department Recovers $3.8 Billion from False Claims Act Cases in Fiscal Year 2013
Justice Department Recovers $3.8 Billion from False Claims Act Cases in Fiscal Year 2013
Second Largest Annual Recovery in History Whistleblower Lawsuits Soar to 752
The Justice Department secured $3. 8 billion in settlements and judgments from civil cases involving fraud against the government in the fiscal year ending Sept. 30, 2013, Assistant Attorney General for the Civil Division Stuart F. Delery announced today. This dollar amount, which is the second largest annual recovery of its type in history, brings total recoveries under the False Claims Act since January 2009 to $ 17 billion – nearly half the total recoveries since the Act was amended 27 years ago in 1986.
The Justice Department’s fiscal year 2013 efforts recovered more than $3 billion for the fourth year in a row and are surpassed only by last year’s nearly $5 billion in recoveries. As in previous years, the largest recoveries related to health care fraud, which reached $2. 6 billion. Procurement fraud (related primarily to defense contracts) accounted for another $ 890 million – a record in that area.
“It has been another banner year for civil fraud recoveries, but more importantly, it has been a great year for the taxpayer and for the millions of Americans, state agencies and organizations that benefit from government programs and contracts,” said Assistant Attorney General Delery. “The $3. 8 billion in federal False Claims Act recoveries in fiscal year 2013, plus another $443 million in recoveries for state Medicaid programs, restores scarce taxpayer dollars to federal and state governments. The government’s success in these cases is also a strong deterrent to others who would misuse public funds, which means government programs designed to keep us safer, healthier and economically more prosperous can do so without the corrosive effects of fraud and false claims.”
Southern District of Texas Prosecutes Doctor for introducing misbranded drugs
LAREDO, Texas – Eduardo Miranda M.D., 55, of Laredo, has pleaded guilty to one count of introducing misbranded drugs into the country, announced United States Attorney Kenneth Magidson.
From October 2007 through January 2009, Miranda, a doctor who specializes in treating patients with cancer, ordered cancer drugs from a pharmacy called QSP, based in Canada. These drugs were not approved for distribution or use in the U.S. and did not bear adequate labeling for use. Some of the drugs had instructions and labeling in other languages. QSP was also not an authorized distributor or a retailer of these drugs in Canada.
Miranda then used these drugs interchangeably with Food and Drug Administration (FDA) - approved versions on his patients and filed insurance claims with Medicaid, Medicare and Blue Cross/Blue Shield of Texas as if he were using lawfully-approved versions.
From October 2007 through January 2009, Miranda, a doctor who specializes in treating patients with cancer, ordered cancer drugs from a pharmacy called QSP, based in Canada. These drugs were not approved for distribution or use in the U.S. and did not bear adequate labeling for use. Some of the drugs had instructions and labeling in other languages. QSP was also not an authorized distributor or a retailer of these drugs in Canada.
Miranda then used these drugs interchangeably with Food and Drug Administration (FDA) - approved versions on his patients and filed insurance claims with Medicaid, Medicare and Blue Cross/Blue Shield of Texas as if he were using lawfully-approved versions.
As part of the plea agreement, Miranda has agreed to pay back the reimbursement he had received while using non-approved versions - more than $1 million.
He was permitted to remain on bond pending his sentencing, which will be set at a later date. At that time, he will face up to a year in federal prison and/or a possible $100,000 fine.
The case was investigated by the FDA and Texas Attorney General’s Office-Medicaid Fraud Control Unit and prosecuted by Assistant United States Attorneys (AUSA) Raul Guerra and Sonah Lee and former AUSAs Sam Louis, Diana Song and D.J. Young.
The case was investigated by the FDA and Texas Attorney General’s Office-Medicaid Fraud Control Unit and prosecuted by Assistant United States Attorneys (AUSA) Raul Guerra and Sonah Lee and former AUSAs Sam Louis, Diana Song and D.J. Young.
You will Want to Read the Discussion the Alabama Board of Pharmacy Had About the DQSA (sorry about format but it was in transcript form and difficult to reformat)
MS. ALVERSON: All right. As was
mentioned, the Senate passed the compounding bill this week on Monday. Donnie mentioned it
and once that gets implemented, and of course
when things get implemented, what you expect is going to happen doesn't always happen and the agency that writes it comes up with different
quirks in there but I think it's -- this bill is going to put us in a more difficult position in that the bill allows manufacturers -- what we all know to be manufacturers -- to make a choice: Do you want to put yourself under FDA compliance or don't you?
And you might think that most people would say, well, why would I want to be inspected by the FDA but some businesses to be
able to sell what they're manufacturing aregoing to need that FDA certification because
their customers are going to demand it but there will be others that don't and so for our office, it's going to mean much more in-depth inspections going through a lot more paperwork,looking at shipping records, looking at compounding records, all of which we most certainly intend to do but it is going -- it's going to be balancing whether the FDA picks up certain components or if -- or if we pick up those components for manufacturers in the State
and I guess we won't know until we actually see
how that law is implemented.
Important Fact:
In March 2013, eight states (New York, Pennsylvania, Maryland, New Jersey,
Delaware, Virginia, West Virginia, and Massachusetts) agreed to operate all of their racetracks
under strict new rules that will limit the number of approved medications for racehorses to 24
and will require the drugs to be accredited under standards set forth by the Racing Medication
and Testing Consortium. The agreement is set to take effect on January 1, 2014.Some Aspects of Doping and Medication Control in Equine Sports
Purchase on Springer.com
$29.95 / €24.95 / £19.95*
* Final gross prices may vary according to local VAT.
Abstract
This chapter reviews drug and medication control in equestrian sports and addresses the rules of racing, the technological advances that have been made in drug detection and the importance of metabolism studies in the development of effective drug surveillance programmes. Typical approaches to screening and confirmatory analysis are discussed, as are the quality processes that underpin these procedures. The chapter also addresses four specific topics relevant to equestrian sports: substances controlled by threshold values, the approach adopted recently by European racing authorities to control some therapeutic substances, anabolic steroids in the horse and LC–MS analysis in drug testing in animal sports and metabolism studies. The purpose of discussing these specific topics is to emphasise the importance of research and development and collaboration to further global harmonisation and the development and support of international rules.
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