for more information click here
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, August 25, 2013
A Short Law Summary: A Followup to Written Agreements in the Compounding World
If you are a doctor, dentist, or veterinarian, etc. currently doing business with a compounding pharmacy in a state that requires a written agreement for office use and that pharmacy has never provided you with a written agreement to sign, then both you and the compounding pharmacy are in violation of the law. You should consider what other laws this compounding pharmacy may be also violating if they are not in compliance with this law. Besides not doing business with noncompliant compounding pharmacies, you should report them to their resident state board of pharmacy and the state board of pharmacy whose laws they are breaking. Also note that most compounding pharmacies which provide you with written agreements to sign have a clause in their written agreement that you cannot disclosure the terms of the agreement or the actual agreement. This is to prevent you or another compounding pharmacy from merely using their written agreement which they in all likelihood sought legal advice and paid to have drafted in order to be compliant with the law and which you paid nothing to obtain. More compounding pharmacies and those who use them nee to comply with the laws-state and federal. State boards of pharmacy need to be more proactive about enforcing these laws
FLORIDA PHARMACISTS WIN $597 MILLION BLOWING WHISTLE ON SCHEME By David Voreacos – Aug 13, 2013 12:00 AM ET
T. Mark Jones learned about the costs and benefits of health-care delivery when he treated AIDS patients in Key West, Florida, in the late 1980s. The pharmacy he co-founded — unusual at the time — provided a humane last step for gay men who didn’t want to spend their final weeks confined to a hospital.
ones, a registered nurse, went into homes to dispenseinfusion-therapy drugs and teach patients to care for themselves.
“I was worn out,” he says. “But I loved it.”
His dream job began to unravel in 1991, when a national health-care chain came to Key West to open an AIDS clinic. It secured the support of local doctors by offering them padded insurance reimbursements, Jones says, Bloomberg Markets magazine will report in its September issue.
http://about.bloomberglaw.com/legal-news/florida-pharmacists-win-597-million-blowing-whistle-on-scheme/?utm_source=tw
ones, a registered nurse, went into homes to dispenseinfusion-therapy drugs and teach patients to care for themselves.
“I was worn out,” he says. “But I loved it.”
His dream job began to unravel in 1991, when a national health-care chain came to Key West to open an AIDS clinic. It secured the support of local doctors by offering them padded insurance reimbursements, Jones says, Bloomberg Markets magazine will report in its September issue.
http://about.bloomberglaw.com/legal-news/florida-pharmacists-win-597-million-blowing-whistle-on-scheme/?utm_source=tw
A Short Law Summary: Written Agreements for office use of Compounded Preparations
Three such states that provide written agreements or contracts for office use of compounded preparations are Florida, Oklahoma and Texas. The language of each law is very similar. Be sure to check your state law to make sure you are in compliance.
Florida
Florida revised its limited in-office use exception where it only applies to patient-specific compounding. See Fla. Admin. Code R. 64B16-27.700(3). This amendment became effective March, 21, 2013. As modified, the exception now requires the compounding pharmacy and the practitioner must enter into a written agreement which provides:
Florida
Florida revised its limited in-office use exception where it only applies to patient-specific compounding. See Fla. Admin. Code R. 64B16-27.700(3). This amendment became effective March, 21, 2013. As modified, the exception now requires the compounding pharmacy and the practitioner must enter into a written agreement which provides:
- The compounded drug may only be administered to the patient listed in the prescription, and may not be dispensed to the patient or sold to anyone else
- The practitioner must record on the patient’s chart the lot number and beyond-use date of the compounded drug
- The practitioner must provide the patient with a means to report complaints or adverse reactions to facilitate recalls.
Oklahoma
In Oklahoma, the applicable section of the administrative code is codified in the Oklahoma Statutes and provides:
(d) A retail pharmacy that provides compounded preparations to practitioners for office use
or to an institutional pharmacy shall enter into a written agreement with the practitioner or
pharmacy. The written agreement shall:
(1) Address acceptable standards of practice for each party entering into agreement
and include a statement that the compounded preparation may only be administered
to the patient and may not be dispensed to the patient or sold to any other person or
entity
(2) Include liability language, references to performance improvement and quality
controls
(3) require the practitioner or receiving pharmacy to include on patient’s record,
medication order, or medication administration record the batch number and BUD of
the compounded preparation administered to a patient
(4) Describe the scope of services to be performed by the filling pharmacy and
practitioner or receiving pharmacy, including a statement of the process for:
(A) A patient to report an adverse reaction or submit a complaint; and
(B) The pharmacy to recall compounded preparations.
535 O.S. § 15-10-64(d)(1)-(4).
Texas
In Texas, the administrative code provides:
(2) Written Agreement. A pharmacy that provides sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy. The written agreement shall:
(A) address acceptable standards of practice for a compounding pharmacy and a practitioner and receiving pharmacy that enter into the agreement including a statement that the compounded drugs may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity except as authorized by §563.054 of the Act;
(B) require the practitioner or receiving pharmacy to include on a patient's chart, medication order or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient;
(C) describe the scope of services to be performed by the pharmacy and practitioner or receiving pharmacy, including a statement of the process for:
(i) a patient to report an adverse reaction or submit a complaint; and
(ii) the pharmacy to recall batches of compounded preparations.
Tex. Adm. Code R. §291.133
Question of the Day August 25, 2013 How many compounding pharmacies, pharmacists and doctors, dentists, and vetererinarians comply with the laws in Florida, Oklahoma, Texas and other states that Require a Written Agreement Between the Parties? Why Do State Boards of Pharmacy Not Enforcement The Rules Requiring these Agreements?
Oklahoma State Board of Pharmacy v. Flourish Integrative Pharmacy, LLC and Christopher Darwin Rice disciplinary action for not being registered in New Mexico and dispensing mis-filled injectable
OSBP vs. Flourish Integrative Pharmacy, LLC #1-5179 – Case No. 1195:
The Board was called to order by President Gourley to hear the case of Flourish Integrative
Pharmacy. Mr. Jerrod Roberts was present as Representative and owner of Flourish Integrative
Pharmacy and chose to appear without Counsel. Mr. Roberts is also the Pharmacist in Charge at the
pharmacy.
Assistant Attorney General, Brinda White presented the Board with the Complaint for review.
The Board of Pharmacy received notification from the New Mexico Board of Pharmacy that they had
received a complaint on the Respondent pharmacy and that they were not registered with the New
Mexico Board as a non-resident pharmacy. The Respondent pharmacy had dispensed a miss-filled
injectable medication to a patient in New Mexico.
Ms. White presented the Board with an Agreed Order. If the Board accepts the Agreed Order,
The Respondent would agree to the following terms: Respondent neither admits nor denies guilt on
Counts 1 and 2. The Respondent would agree to pay a fine of $1500.00 per count on Counts 1 and 2
for a total of $3,000.00 which would be due immediately.
Motion was made by Dr. John Lassiter and seconded by Dr. Greg Adams to accept the Agreed
Order. Motion passed on roll call vote.
OSBP vs. Christopher Darwin Rice, D.Ph. #14993 – Case No. 1196:
The Board was called to order by President Gourley to hear the case of Chris Rice. Mr. Rice
was present and chose to appear without Counsel.
Assistant Attorney General, Brinda White presented the Board with the Complaint for review.
The Board of Pharmacy received notification from the New Mexico Board of Pharmacy that they had
received a complaint on Flourish Integrative Pharmacy. The patient had been given an injectable that
had been improperly filled and that the pharmacy was not registered with them as a non-resident
pharmacy. Mr. Rice was the verifying pharmacist for this prescription.
Ms. White then presented the Board with an Agreed Order. If the Board accepts the Agreed
Order, Mr. Rice would agree to the following terms: Mr. Rice would neither admit nor deny guilt on
Counts 3-5. He would agree to pay a fine of $1,000.00 per count on Counts 3-5 for a total of Page 6 of 6
$3,000.00 which would be due immediately.
Motion made by Dr. John Lassiter and seconded by Dr. Greg Adam to accept the Agreed
Order on both cases. Motion passed on roll call vote
quoted from here
The Board was called to order by President Gourley to hear the case of Flourish Integrative
Pharmacy. Mr. Jerrod Roberts was present as Representative and owner of Flourish Integrative
Pharmacy and chose to appear without Counsel. Mr. Roberts is also the Pharmacist in Charge at the
pharmacy.
Assistant Attorney General, Brinda White presented the Board with the Complaint for review.
The Board of Pharmacy received notification from the New Mexico Board of Pharmacy that they had
received a complaint on the Respondent pharmacy and that they were not registered with the New
Mexico Board as a non-resident pharmacy. The Respondent pharmacy had dispensed a miss-filled
injectable medication to a patient in New Mexico.
Ms. White presented the Board with an Agreed Order. If the Board accepts the Agreed Order,
The Respondent would agree to the following terms: Respondent neither admits nor denies guilt on
Counts 1 and 2. The Respondent would agree to pay a fine of $1500.00 per count on Counts 1 and 2
for a total of $3,000.00 which would be due immediately.
Motion was made by Dr. John Lassiter and seconded by Dr. Greg Adams to accept the Agreed
Order. Motion passed on roll call vote.
OSBP vs. Christopher Darwin Rice, D.Ph. #14993 – Case No. 1196:
The Board was called to order by President Gourley to hear the case of Chris Rice. Mr. Rice
was present and chose to appear without Counsel.
Assistant Attorney General, Brinda White presented the Board with the Complaint for review.
The Board of Pharmacy received notification from the New Mexico Board of Pharmacy that they had
received a complaint on Flourish Integrative Pharmacy. The patient had been given an injectable that
had been improperly filled and that the pharmacy was not registered with them as a non-resident
pharmacy. Mr. Rice was the verifying pharmacist for this prescription.
Ms. White then presented the Board with an Agreed Order. If the Board accepts the Agreed
Order, Mr. Rice would agree to the following terms: Mr. Rice would neither admit nor deny guilt on
Counts 3-5. He would agree to pay a fine of $1,000.00 per count on Counts 3-5 for a total of Page 6 of 6
$3,000.00 which would be due immediately.
Motion made by Dr. John Lassiter and seconded by Dr. Greg Adam to accept the Agreed
Order on both cases. Motion passed on roll call vote
quoted from here
Overview of Compounding Pharmacy Law in Florida
Florida Pharmacy Compounders Beware
| ||
| August 24, 2013 Previously published on August 22, 2013
New dispensing requirements for physician in-office use
Florida compounding pharmacies should be aware the DEA's Five Percent Rule for in-office use does not apply in Florida and that they must comply with more-stringent restrictions of Florida law.
What is “wholesale distribution”?
Generally, “wholesale distribution” is the provision of a drug product (whether commercially available or not) to an individual who is not the ultimate user. For example, providing a compounded product for resale to third parties could be construed as a form of wholesale distribution. Another form of wholesale distribution is providing a prescription drug to
Is a special license required for wholesale distribution?
States generally prohibit wholesale distribution unless the pharmacy obtains a separate wholesale distributor license. Engaging in wholesale distribution without the proper licensure (unlicensed wholesale distribution) or without falling within a recognized legal exception (see below) can result in disciplinary action against the pharmacy license, including monetary fines, reprimands, suspensions, and even license revocation in extreme cases.
In situations where samples are being dispensed, a pharmacy board may even require the pharmacy entity be licensed as a manufacturer with the federal Food and Drug Administration before providing such samples. Some states (Florida, for example) require separate state licensure to dispense samples. See Fla. Stat. 499.028.
Are there legal exceptions that allow a pharmacy to do limited wholesale distribution without a separate wholesale distributor’s license?
Historically, both state and federal laws have permitted a limited amount of wholesale distribution for in-office use. Notably, the federal government and various states have different requirements in this area of the law.
At the federal level, the Drug Enforcement Administration (DEA) recognizes a five percent limited exception to the ban on unlicensed wholesale distribution. The so-called “Five Percent Rule” allows any pharmacy (including a compounding pharmacy) to distribute controlled substances without possessing a wholesale distributor license as long as the quantity of units distributed is limited to five percent of all controlled substances produced by the pharmacy in a given year. See 21 C.F.R. 1307.11. Many states model their laws after the DEA Five Percent Rule and provide for similar safe harbors.
Does Florida law contain an in-office use exception?
Although Florida law contains a limited in-office use exception, Florida does not recognize a Five Percent Rule for unlicensed wholesale distribution. As a result, compliance with the DEA Five Percent Rule does not insulate a Florida compounding pharmacy from state regulatory sanctions.
Florida recently revised its limited in-office use exception. See Fla. Admin. Code R. 64B16-27.700(3). As of March, 21, 2013, Florida in-office use applies only to patient-specific compounding. As modified, the exception now requires the pharmacy to
1. Written agreement: The compounding pharmacy and the practitioner must enter into a written agreement which provides:
|
Saturday, August 24, 2013
ACA What's Happening in Compounding in Chicago November 1-2, 2013
Compounding What's Happening?
Educational & legislative updates for your compounding pharmacy. CE sessions include:
- The Difference Between Compounding and Manufacturing
- How Congress is Impacting Your Compounding Business: Navigating Legislative Updates and Remaining Compliant
- Third-Party Billing & Reimbursement
- Collaborative Practice: A New Look at the Old Paradigm of Health and Healing
- Contracts
- Transdermal Drug Delivery - Human & Veterinary
- Compounding Quality Ophthalmic Preparations - What You Need to Know
- This Works for Me!
- USP Update & more!
Arrive early for the Thursday evening "Meet & Greet" reception.Continuing education sessions will be all day Friday and until noon on Saturday. To download the program agenda Click Here!
more information here
Question of the Day August 24, 2013 Does Congress, both the House and the Senate, Need to Put More Research and Time into Making the Compounding Legislation the Best Possible Fix for What is now Clearly a Multi-Layer, Multi-Wide Problem?
The multi-layer. multi-wide issues include both ANIMAL and HUMAN compounded drugs, problems with the raw or bulk chemicals and where they are coming from, the testing being done on them, the actual compounding facilities and the procedures there, and now the laboratory testing facilities that test for sterility, potency, etc.
Are do readers think it is better to go ahead and pass a bill giving the FDA authority and then tweak and amended it as more information comes to light?
Are do readers think it is better to go ahead and pass a bill giving the FDA authority and then tweak and amended it as more information comes to light?
Study will track long-term effects of meningitis outbreak from compounding nightmare
By Kay Lazar | GLOBE STAFF
AUGUST 24, 2013
Federal regulators have launched a study of the long-term health effects of a lethal fungal meningitis outbreak last fall linked to tainted steroids from a Framingham pharmacy.
The federal Centers for Disease Control and Prevention said Friday that it would fund a $216,000 study led by Dr. Peter Pappas, an infectious disease specialist at the University of Alabama School of Medicine, who leads a nationwide consortium of scientists who specialize in fungal infections.
Pappas’s team will track 500 patients from the states hardest hit in the outbreak — Indiana, Michigan, Tennessee, and Virginia — said Dr. Mary Brandt, who leads the CDC’s fungal diseases branch.
Overall, the CDC says medications from the New England Compounding Center of Framingham are believed to have sickened 749 people, including 63 who have since died.
continue to read here
Drug Shortages: New Ones Down, Old Ones Persist
By David Pittman, Washington Correspondent, MedPage Toda
WASHINGTON -- The number of new drugs added to the shortage list has fallen off sharply in the last year, but those already on the list show few signs of moving off, according to the University of Utah Drug Information Service.
The system has tracked just 86 new shortages through July 31 this year, down from 204 in all of last year, 267 in 2011, and 211 in 2010. However, the number of active shortages as of the end of July was 302 -- roughly what it has been since the third quarter of 2012.
Existing shortages continue to be a problem "because it is taking a long time for the companies to fix their [manufacturing] quality problems" that cause the shortages, Erin Fox, PharmD, director of the Utah center, told MedPage Today.
Shortages of antimicrobials, chemotherapy agents, and electrolyte and parenteral nutrition products -- such as sodium phosphate, potassium phosphate, calcium gluconate, calcium chloride -- continue to be a problem, Fox said.
The FDA has declined to release updated information on the 2013 drug shortages until the new calendar year, spokesman Stephen King told MedPage Today. He added that the FDA successfully prevented 282 shortages last year.
King and Fox said changes included in last year's FDA Safety and Innovation Act (FDASIA)that require manufacturers to alert the agency to possible shortages in "life-supporting" or "life-sustaining" drugs are helping. The FDA is able to prevent many new shortages from occurring, the two said.
"However, there is nothing in FDASIA that makes the manufacturers devote more resources to quality or to generic products over brand products, so the shortages that we have are persisting until the factories are updated," Fox said.
Quality control is a major cause of shortages, particularly of generic products. Production issues -- such as glass particles or other particulates found in products -- have caused some of the already small handful of sterile injectable manufacturers to shut down.
In the case of IV electrolytes, the shortages are occurring because one manufacturer -- American Regent in Shirley, N.Y. -- ran into production troubles and had to shut down entirely.
Fox noted that a July 23 decision in the Court of Appeals for the District of Columbia Circuit could hurt FDA efforts to alleviate drug shortages. The 3-judge panel permanently enjoined the FDA from allowing imported versions of thiopental -- a drug used in executions -- into interstate commerce.
continue to read here
Friday, August 23, 2013
Appears Fall Out from Front Range Lab Is beginning with Park Pharmacy and Compounding Center Recall
The Press Release states:
FDA investigators observed that methods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable.
One can assume the laboratory that is being referred to is that of Front Range Labs. The
notice is found here
FDA investigators observed that methods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable.
One can assume the laboratory that is being referred to is that of Front Range Labs. The
notice is found here
Reminder Front Range Labs was not lab involved in NECC
PDF]
FrontRangeLabs.com. 10/04/2012 - Front Range ...This gives us the ability to notify clients in an expedited manor if.
Front Range Laboratories Response - Meningitis Outbreak
www.frontrangelabs.com/.../Front%20Ra...
Prefill Flush Syringes Recalled by Covidien
Covidien is recalling 14 lots of its Monoject prefill flush syringes sold in the U.S. and Bermuda, as they contained nonsterilized water which could cause life-threatening infections. In addition, some of the syringes also had mismatched caps, labels, and wrappers.
http://www.reuters.com/
Question of the Day August 23, 2013 Just Months Ago Front Range was a Growing Company Moving to A New Building. Revenue Last Year Around 1.6 million dollars and with only three competitors its size analyzing drugs for compounding pharmacies. Did this impact the quality of its compounding test?
to read article about Front Range expansion click here
FDA notes data falsification at Indian plant
The FDA placed one of Wockhardt's Indian plants on an import alert in May when it found, among other problems, that it was hiding data about test failures from the FDA. And last month German drugmaker Fresenius Kabi fired the managers at an Indian facility for essentially the same thing. However, the data-manipulation trend in India continues.
This time, an FDA warning letter to an Indian drugmaker says a quality-control chemist admitted he "had recorded false visual examination data in the logbooks for reserve samples" at the order of a manager. The observation was made during a March inspection of the Posh Chemicals plant in Hyderabad. The FDA posted the warning letter this week to its website. The agency has asked for a thorough investigation into the extent of the falsification, the role played by the manager and how the API maker intends to prevent future problems.
That was not the only record-keeping concern the FDA found. It also found that there were no restrictions to access lab data tied to testing equipment and no audit trails to follow, raising questions about whether other employees may have altered or deleted test results.
Read more: FDA notes data falsification at Indian plant - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-notes-data-falsification-indian-plant/2013-08-22#ixzz2co4FizFD
Subscribe at FiercePharma Manufacturing
Compounded products accounted for up to 3 percent of the $320 billion spent on prescription drugs in the United States in 2011, according to a report from the California State Board of Pharmacy.
read more here
Another Compounding Pharmacy Debacle in Texas Posted by Greg Webb The Legal Examiner August 23, 2013
The FDA should have closed a Texas compounding pharmacy in March shortly after inspectors found sterility problems, an action that would have prevented the recent hospitalization of 15 patients, public health advocates charged” recently. The statement by David Pittman, a MedPage Today correspondent, goes to the essence of what I’ve talked about in recent articles about the FDA and compounding pharmacies. The oversight and regulation of these manufacturers needs to be intensified. And it needs to happen before more people are harmed or killed as a result of unsterile, contaminated medical products.
According to the timeline reported in the story, the FDA inspected Specialty Compounding, near Austin, Texas in March of this year. This was a thorough inspection that took four days. And though it was reported to have found significant problems with the facility the FDA has yet to issue an alert or a recall. In fact it was early August, four months later, when the FDA filed its report with the Texas Department of State Health Services.
According to the FDA inspection report, employees were not preventing possible contaminations and were cited with a number of infractions which included picking up items on the floor while wearing gloves and then not changing the gloves.
“The FDA knew there was a serious problem here but didn’t use its existing legal authority to take prompt, aggressive enforcement action against the company. That exposed patients to unnecessary risk and might have contributed to 15 people being infected,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in a press release. “What’s the purpose of inspecting a facility if you’re not going to take appropriate action when you find conditions that pose a safety threat to patients?” (MedPage Today, 8/14/13)
Congress is still debating legislation that would give the FDA more power to oversee compounding pharmacies in the wake of the recent New England Compounding Center problem. Legislators seem willing to give greater oversight when medications are shipped across state lines, but are slower to consider more comprehensive regulatory powers for compounding centers.
When lawmakers return from their late (and long) summer break they are hopefully will pass this bill. But we are still left with many questions about the FDA’s ability to provide the necessary regulation of compounding pharmacies in a timely fashion. For now, the FDA is not commenting on the Texas incident.
quoted from here
According to the timeline reported in the story, the FDA inspected Specialty Compounding, near Austin, Texas in March of this year. This was a thorough inspection that took four days. And though it was reported to have found significant problems with the facility the FDA has yet to issue an alert or a recall. In fact it was early August, four months later, when the FDA filed its report with the Texas Department of State Health Services.
According to the FDA inspection report, employees were not preventing possible contaminations and were cited with a number of infractions which included picking up items on the floor while wearing gloves and then not changing the gloves.
“The FDA knew there was a serious problem here but didn’t use its existing legal authority to take prompt, aggressive enforcement action against the company. That exposed patients to unnecessary risk and might have contributed to 15 people being infected,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in a press release. “What’s the purpose of inspecting a facility if you’re not going to take appropriate action when you find conditions that pose a safety threat to patients?” (MedPage Today, 8/14/13)
Congress is still debating legislation that would give the FDA more power to oversee compounding pharmacies in the wake of the recent New England Compounding Center problem. Legislators seem willing to give greater oversight when medications are shipped across state lines, but are slower to consider more comprehensive regulatory powers for compounding centers.
When lawmakers return from their late (and long) summer break they are hopefully will pass this bill. But we are still left with many questions about the FDA’s ability to provide the necessary regulation of compounding pharmacies in a timely fashion. For now, the FDA is not commenting on the Texas incident.
quoted from here
8/23/13 - Griffith bill addresses meningitis outbreak that killed 2, sickened dozens in Southwest Virginia [The Roanoke Times, Va.]
| Aug. 22Nearly a year after a meningitis outbreak killed two people and sickened dozens in Southwest Virginia, a local lawmaker is drafting legislation as Congress starts to address the issue. U.S. Rep. Morgan Griffith, R-Salem, said he hopes to file a bill next month that will clarify how the Food and Drug Administration regulates facilities like the one linked to the outbreak. New England Compounding Center, a so-called compounding pharmacy in Massachusetts, has been blamed in lawsuits for mass-producing tainted steroids that made their way to the Roanoke Valley, where patients who received injections of the drug for back pain came down with fungal meningitis. At issue is whether facilities such as NECC are pharmacies, which fall under state control, or manufacturers, which are regulated by the FDA. The way Griffith sees it, the FDA had authority under current law to step in and stop problems with contamination at NECC and possibly prevent the outbreak. "In my opinion, the FDA dropped the ball," Griffith said this week. With a bill that he hopes will gain bipartisan support, Griffith plans to set out in greater detail how a facility like NECC is actually a drug manufacturer subject to FDA oversight. The congressman is being pushed at every turn by Ben Foutz, whose 16-year-old son, Zac, became seriously ill after receiving an injection of the tainted drug at a Roanoke clinic. Foutz is "very frustrated, and I don't blame him," Griffith said. "His son's life has been dramatically altered by what I would consider the culpable behavior of NECC, and by the negligent behavior of the cop on the beat, and that would be the FDA." To Foutz, one of the biggest frustrations in the slow pace of Congress, which is currently taking a summer break from a session that has produced more partisan bickering than legislation. "It's been almost a year [since the outbreak] and they still haven't got anything passed," Foutz said. "I'm not trying to make this a Democrat-Republican issue, I'm just trying to say, why can't Democrats and Republicans come together?" The stakes extend far beyond Southwest Virginia. Since the outbreak began, there have been 749 confirmed cases of meningitis and 63 deaths in 20 states, according to the U.S. Centers for Disease Control and Prevention. Lawsuits filed in Roanoke have alleged that methylprednisolone acetate, an epidural steroid injection produced by NECC, was contaminated at its Framingham, Mass, facility, possibly by debris from a trash dump located next door. The trail of culpability extends to Roanoke, the lawsuits allege, where Insight Imaging administered more than 600 doses of the drug with little concern for its safety. A $25 million lawsuit filed by the family of a Salem man who died from taking the contaminated drug accuses the clinic of systematically misrepresenting the steroid telling patients that it was an FDA-approved drug made by pharmaceutical giant Pfizer , while overbilling them for the cheaper and high-risk knockoff. While the lawsuits wind through court, Congress is attempting to find a way to tighten federal regulation. Compounding pharmacies are generally small operations that mix or compound drugs for specific patients, pursuant to doctors' prescriptions. Because they typically make drugs in forms that are not commercially available, compounding pharmacies have not routinely been regulated by the FDA. Critics contend that federal authorities have known for years that NECC was stretching the definition of a compounding pharmacy, mass producing drugs and distributing them across the country. "Unfortunately, the NECC tragedy is not an isolated incident," said Sarah Sellers of the Working Group on Pharmaceutical Safety, an advocacy group that is pushing for legislative reform. In May, another meningitis outbreak was linked to a compounding pharmacy in Tennessee, the group said in a June news release announcing its formation. FDA Commissioner Margaret Hamburg wrote in a blog post in April that a stronger law is needed for the agency to do its job. "It may surprise some people to know that, even in light of the recent tragic events, some of the firms we inspect still challenge our authority to conduct full inspections of their facilities," Hamburg wrote. Earlier this summer, a measure in the Senate was voted out of committee. The bill would create a special category of compounding pharmacies that will fall under FDA authority. Griffith is taking a different approach, crafting legislation that will more clearly put facilities like NECC in the manufacturing category.
-
|
State Tries to Regulate Compound Medications; Pharmacies Warn Proposed Law Will Cause Price Spikes
State tries to regulate compound medications
Pharmacies warn proposed law will cause price spikes
By Anna Bitong
Pharmacies that sell sterile compounded drugs in California may soon have to meet stricter standards following nationwide reports of injury and death from contaminated medications. Opponents say the regulations would drive up costs and hurt consumers.Sterile compounded drugs may be injected, inhaled or dropped into the eye. Unlike non-sterile compounded medications, which can be swallowed or applied to the skin, sterile drugs pose an increased risk for harm to patients because of how and where they are administered.
Compounded products accounted for up to 3 percent of the $320 billion spent on prescription drugs in the United States in 2011, according to a report from the California State Board of Pharmacy.
Licensed pharmacies may compound, or mix, both sterile and non-sterile drugs to customize prescribed medications by adjusting dosage strength, ingredients and formula to meet individual patient needs. They may also compound existing formulas to reproduce medications that are in short supply from manufacturers.
But the process of sterile compounding has produced some frightening results.
In October 2012, for example, the Massachusetts-based New England Compounding Center shipped tainted epidural steroid injections used to treat pain to 75 medical facilities in 23 states, including California.
The treatments were later linked to cases of fungal meningitis and other infections.
As of last month, of the 14,000 patients who received the injections, 61 people died and about 700 became ill.
Compounded products accounted for up to 3 percent of the $320 billion spent on prescription drugs in the United States in 2011, according to a report from the California State Board of Pharmacy.
Licensed pharmacies may compound, or mix, both sterile and non-sterile drugs to customize prescribed medications by adjusting dosage strength, ingredients and formula to meet individual patient needs. They may also compound existing formulas to reproduce medications that are in short supply from manufacturers.
But the process of sterile compounding has produced some frightening results.
In October 2012, for example, the Massachusetts-based New England Compounding Center shipped tainted epidural steroid injections used to treat pain to 75 medical facilities in 23 states, including California.
The treatments were later linked to cases of fungal meningitis and other infections.
As of last month, of the 14,000 patients who received the injections, 61 people died and about 700 became ill.
Thursday, August 22, 2013
Texas State Board of Pharmacy 2013 Summer Newsletter
| ||
Illegally Operating Wholesaler in Virginia Posed as Canadian Distributor, Owners Indicted
US Department of Justice (DOJ) officials indicted 11 people on 17 different charges related to the illegal importation and distribution of non-Food and Drug Administration (FDA)-approved drugs into the US. These individuals operated or worked for Gallant Pharma International Inc., an entity with headquarters in Virginia that represented itself as a Canadian company and “told potential customers that it sold drugs from Canada,” indicates a DOJ news release. The company allegedly imported drugs from India, Turkey, and Switzerland and mislabeled the contents of the packages to lessen scrutiny by US Customs and Border Protection, explains DOJ. The DOJ indictment indicates that the company was not licensed to distribute drugs in the US; however, it allegedly sold drugs to doctors, hospitals, and medical offices throughout the country. The scheme began in August 2009 and netted more than $8.6 million over three years. Of the 11 indicted, seven were arrested.
FDA advises that health care providers should purchase prescription drugs either directly from the manufacturer or from wholesale drug distributors licensed in the US and provides a list of state agencies for assistance in verifying licensure. Another way that pharmacies can be assured of the legitimacy of a wholesale distributor is to look for NABP’s Verified-Accredited Wholesale Distributors® (VAWD®) Seal. Those wholesale distributors that achieve VAWD accreditation are in compliance with state and federal laws and NABP's VAWD criteria. Wholesale distributers that display the VAWD Seal as part of their accreditation have undergone a criteria compliance review, including a rigorous review of their operating policies and procedures, licensure verification, survey of facility and operations, background checks, and screening through the NABP Clearinghouse. Accredited facilities are reviewed annually and undergo an on-site survey every three years. Created in 2004, the accreditation program plays a pivotal role in preventing counterfeit drugs from entering the US drug supply.
quoted from NABP
UPS First Package Delivery Company to Join CSIP in Fight against Rogue Internet Drug Outlets
United Parcel Service (UPS) has become the first global package delivery organization to join the Center for Safe Internet Pharmacies (CSIP) as a strategic partner and board member. CSIP is a nonprofit organization that was established to educate the public and to take voluntary enforcement action against illegal Internet drug sellers and its board of directors includes executives from American Express, Discover, Visa, MasterCard, eNom, GoDaddy, Google, Microsoft, Neustar, PayPal, Facebook, and Yahoo!
In a press release, CSIP Executive Director Marjorie Clifton said, “The participation of shippers represents an important addition to our membership which currently includes search engine advertisers, social media, registries and registrars, and payment processors. With UPS on board, our members now represent all areas of the online sales and delivery ecosystem. Together we aim to set a global precedent and call on other companies similar to our membership to take action.”
quoted from NABP
Risks of Buying Prescription Drugs from Illegal Online Sellers Highlighted in NBC Connecticut Report
Topics: Counterfeit drugs and Buying medicine online
The risks of ordering medications online and of receiving dangerous counterfeit products are highlighted in a recent NBC Connecticut report. In the segment, NBC Connecticut’s investigative troubleshooting team, along with global pharmaceutical security experts from Pfizer explain that many counterfeit drugs contain dangerous ingredients, are created in unsanitary environments, and may not even contain the active ingredient of the drug the consumer intended to buy. The Pfizer security experts report finding ingredients such as boric acid, sheet rock, road paint, and talc in counterfeit drugs, and emphasize that ordering from a rogue site is like playing Russian Roulette because, “you don’t know what you’re getting or where” the product is coming from.The news segment also highlighted information from the NABP Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: July 2013 (PDF) and cited the Association’s finding that of more than 10,000 Web sites selling prescription medications nearly 97% operate out of compliance with pharmacy laws and practice standards which have been established to protect public health in the United States and many other developed countries. The news program also recommended that consumers consult the list of recommended sites that have been accredited by the NABP Verified Internet Pharmacy Practice SitesCM (VIPPS®) accreditation program. The list of VIPPS-accredited sites is available at www.AWARErx.ORG.
quoted from NABP
Georgia Implements Prescription Monitoring Program
Topics: Prescription monitoring program
The state of Georgia became the second-to-last state to implement a prescription monitoring program (PMP), which allows pharmacists and physicians to submit and check patient controlled substance prescription medication history in order to help them make the most appropriate treatment decisions. The Augusta Chronicle reports that nearly 2,000 pharmacists and prescribers have already signed up for the program since it was started in May.PMPs are important tools in the fight against prescription drug abuse. Thanks to these programs, health care providers are able to watch for signs of prescription drug abuse such as a patient visiting multiple doctors in order to get access to more prescription drugs. Georgia officials hope to cut down on the rates of prescription drug abuse and on overdose deaths, which have dramatically increased in the state since 1999.
quoted from NABP
SPAARx Letter to HHS Seeks Clarification of HI-TECH Provisions
New Regulations Impede Standard of Care
On July 25th, the Specialty Pharmacy Association of America (SPAARx) sent a letter to The Office of Civil Rights, the department responsible for enforcing the U.S. Department of Health and Human Services' (HHS) newly issued revisions to HIPAA regulations implementing the HI-TECH Act [78 Fed. Reg. 5566 (Jan. 25,20l3) ("final rule')]. In the letter to Susan McAndrew, Deputy Director for Health Information Privacy, SPAARx cites several issues that the Association believes are confusing, and unduly restrictive to specialty pharmacies' ability to deliver the Standard of Care as defined in the SPAARx Definition of Specialty Pharmacy...Read More SPAARx Appeals for Congressional Action on Compounding Legislation
URGENT!!! FDA Advisory Regarding Front Range Laboratories, Inc. In Loveland, CO, a testing lab used by more than 100 pharmacies in 32 states--mostly compounding!
U.S. Food and Drug Administration Advisory Notice
August 22, 2013 | Industry News.
Dear Colleagues,
The U.S. Food and Drug Administration is advising pharmacies of concerns about the adequacy of testing performed by Front Range Laboratories, Inc., in Loveland, Colo., a testing laboratory used by more than 100 pharmacies in 32 states, to verify quality, sterility, and expiration dating.
In a recent inspection, FDA investigators observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time.
Front Range Labs is an independent laboratory performing quality control testing primarily for compounding pharmacies. FDA is working with Front Range to notify its customers and to determine if certain drugs should be removed from the market due to safety concerns. The FDA will update the public as new information becomes available or if products are being recalled. Here’s a link to the statement issued: http://www.fda.gov/Drugs/DrugSafety/ucm365920.htm.
We thank you for your continued support of our mission.
Best regards,
Anna
Anna M. Fine, PharmD, MS
Director, Health Professional Liaison Program
Office of Health and Constituent Affairs
Office of External Affairs/Office of the Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Anna.Fine@fda.hhs.gov
The U.S. Food and Drug Administration is advising pharmacies of concerns about the adequacy of testing performed by Front Range Laboratories, Inc., in Loveland, Colo., a testing laboratory used by more than 100 pharmacies in 32 states, to verify quality, sterility, and expiration dating.
In a recent inspection, FDA investigators observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time.
Front Range Labs is an independent laboratory performing quality control testing primarily for compounding pharmacies. FDA is working with Front Range to notify its customers and to determine if certain drugs should be removed from the market due to safety concerns. The FDA will update the public as new information becomes available or if products are being recalled. Here’s a link to the statement issued: http://www.fda.gov/Drugs/DrugSafety/ucm365920.htm.
We thank you for your continued support of our mission.
Best regards,
Anna
Anna M. Fine, PharmD, MS
Director, Health Professional Liaison Program
Office of Health and Constituent Affairs
Office of External Affairs/Office of the Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Anna.Fine@fda.hhs.gov
After Deadly Outbreak, FDA To Regulate Compounding Pharmacies; Increased regulation could bring an end to small compounding pharmacies in the era of Big Pharma.
After a deadly meningitis outbreak traced to a New England compounding pharmacy killed at least 50 Americans last year, the U.S. government is poised to step in and increase regulation of these niche facilities through the Food and Drug Administration (FDA). It could shake up an entire industry struggling to recover from a string of safety and health concerns after increased inspections.
Introduced in May, bill S. 959: The Pharmaceutical Quality, Security, and Accountability Act proposes federal oversight of an industry that allows pharmacists to create custom medications to suit specific patient needs. This includes combining, diluting or reconstituting an existing drug for patients who may have an allergy or sensitivity to commercially produced medications. The bill is still in committee and has not been put to a vote before the Senate or House.
The industry has functioned with few major incidents until the major meningitis outbreak last year. Here’s the latest on that story: CBS News reported earlier this month that the disaster began when 17,000 vials of a steroid were shipped to clinics and hospitals in 23 states last fall. The vials were contaminated with a fungus that killed at least 48 users and sent another 700 to seek treatment for persistent fungal infections.
It’s still unclear how the breakdown occurred, but it’s not the only incident that has patients concerned about the safety of the drugs produced in these facilities.
Since the fungal meningitis outbreak, the FDA has increased inspections at compounding facilities, finding a number of violations at pharmacies across the U.S.
USA Today reports that the FDA announced a voluntary nationwide recall of all sterile products from a Texas compounding pharmacy this month after reports that 15 patients at two Texas hospitals have developed bacterial bloodstream infections after they received injections from Specialty Compounding from Cedar Park, Texas.
This incident follows a report from The Salt Lake Tribune claiming that an inspection at the University Pharmacy Inc. in Salt Lake City was found to have multiple sanitation violations during safety inspections earlier this year.
The pharmacy was visited five times in February by FDA inspectors, who reported finding equipment and utensils used to mix injectable drugs were not sanitized frequently enough to prevent contamination.
“Spills and splatters of amber and white colored residue were observed in and around the equipment,” their inspection report says.
But opponents of the increased federal regulation say that states that are already tasked with regulating these facilities can handle the safe administration of compounding pharmacies. Toward this end, the Boston Globe reports that the state of Massachusetts Department of Health recently closed two compounding pharmacies, in Quincy and Norwood, after a surprise inspection revealed multiple safety violations.
“The Department of Public Health has made great strides to enhance oversight of the pharmacy industry in Massachusetts since last fall,” Roach said. “The Governor provided more than $1 million in new funding in this year’s budget to enable the Board to hire additional staff to enhance inspections of pharmacies.”
Some critics also believe that increased federal regulation could bring an end to the small “mom and pop” compounding pharmacies that are clinging to business in an era dominated by big drug manufacturers.
“The bill, S. 959, would subject mom and pop compounding pharmacies to many of the same regulations as the big drug manufacturers. If it were to pass, the result would be many small mom and pop businesses shutting their doors permanently,” writes Glenn Jacobs of the Daily Caller.quoted from here
Morgan Griffith to introduce compound pharmacy bill
August 22, 2013
SALEM -
When the U.S. Senate's Health, Education, Labor, and Pension Committee released it's November 2012 investigation of the fungal meningitis outbreak, it openly questioned how state and federal enforcement agencies let New England Compounding Center (NECC) continue to operate.
Photos from an onsite investigation in December revealed a poorly maintained facility, complete with a garbage dump directly outside.
The NECC was investigated on and off for more than a decade, but it wasn't until the meningitis outbreak that the company stopped producing and distributing compound drugs.
The Senate report detailed regulation and enforcement failures by the both the Food and Drug Administration and the Massachusetts Board of Pharmacy.
The NECC eventually recalled all of its drugs after multiple inspections by the FDA.
"They're now taking the action that I think they could have taken before, they just weren't paying attention to the warning signs," said Congressman Morgan Griffith (R-Salem).
He plans on introducing a bill next month that would give regulation authority for compound pharmacies to the FDA.
It's a move the agency has lobbied for and groups like the Government Accountability Office (GAO) are recommending.
"We're going to reign in these compounders that are really manufacturers and we're going to make it clear to the FDA they have the authority," Griffith said.
In a statement to WSLS 10, a spokesperson with the FDA said the new legislation is needed.
"(The) FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations."
Griffith said the bill will be bipartisan.
He expects it could be signed into law by the end of the year.
quoted from here
SALEM -
When the U.S. Senate's Health, Education, Labor, and Pension Committee released it's November 2012 investigation of the fungal meningitis outbreak, it openly questioned how state and federal enforcement agencies let New England Compounding Center (NECC) continue to operate.
Photos from an onsite investigation in December revealed a poorly maintained facility, complete with a garbage dump directly outside.
The NECC was investigated on and off for more than a decade, but it wasn't until the meningitis outbreak that the company stopped producing and distributing compound drugs.
The Senate report detailed regulation and enforcement failures by the both the Food and Drug Administration and the Massachusetts Board of Pharmacy.
The NECC eventually recalled all of its drugs after multiple inspections by the FDA.
"They're now taking the action that I think they could have taken before, they just weren't paying attention to the warning signs," said Congressman Morgan Griffith (R-Salem).
He plans on introducing a bill next month that would give regulation authority for compound pharmacies to the FDA.
It's a move the agency has lobbied for and groups like the Government Accountability Office (GAO) are recommending.
"We're going to reign in these compounders that are really manufacturers and we're going to make it clear to the FDA they have the authority," Griffith said.
In a statement to WSLS 10, a spokesperson with the FDA said the new legislation is needed.
"(The) FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations."
Griffith said the bill will be bipartisan.
He expects it could be signed into law by the end of the year.
quoted from here
Thu Aug 22, 2013 at 06:47 AM PDT. Texas mom claims pharmacy's dosage error killed her daughter
Like many kids with sickle cell anemia, Jadalyn Allen had to deal with a lot of pain. It got so bad at times that she had to take morphine. But back in March, Jadalyn died from a massive morphine overdose. Now her mom claims she died because of a dosage error at the pharmacy.
According to KTRK-TV in Houston, Allen initially sought $1 million in damages. While Texas tort reform caps the damages at $250,000, what she wants more is an apology.
continue to read here
Simone Allen says her 6-year-old daughter, Jadalyn, died after taking a dose of morphine 10 times higher than her prescription called for. Jadalyn had been taking the liquid painkiller off and on for sickle cell anemia.Jadalyn was originally prescribed 20 milligrams per 10 milliliters of morphine. But what she actually got was 20 milligrams per one milliliter--ten times the prescribed amount. The overdose was so massive that Simone was initially the target of a criminal investigation.
[snip]
Jadalyn died April 3, 2012, one day after taking the mega dosage, according to a lawsuit filed Tuesday in Harris County District Court against Cullen Care Pharmacy. The cause of Jadalyn's death was "morphine toxicity," according to the lawsuit. Allen's lawyer, Muhammad Aziz, said he had hoped to settle out of court, but negotiations "fell apart" when the pharmacy's insurance company blamed Jadalyn's death on her blood disorder instead of a pharmacy error.
"There's more than enough evidence to support our claim," said Aziz, citing what he says are facts established by the coroner's report, pharmacy records that reflect the dosage discrepancy and tests on the remaining contents of the morphine bottle. "Frankly, I'm surprised it had to come to this."
According to KTRK-TV in Houston, Allen initially sought $1 million in damages. While Texas tort reform caps the damages at $250,000, what she wants more is an apology.
continue to read here
Subscribe to:
Posts (Atom)