Tuesday, May 28, 2013
Congressional Consensus on Compounding Reform Stuck in Neutral After three hearings on the pressing issue, House lawmakers have not reached a consensus on how to reform federal oversight of compounding pharmacies, casting doubt on whether Congress will be able to pass legislation the FDA says it wants. Drug Industry Daily
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A NEW SPIN ON THE PROPOSED LEGISLATION--MUST READ: Proposed legislation compounds pharmacy risks If passed, the bill to reform compounding medicines could create opportunities to some pharmacies. By AlphaVN.com 9 hours ago
The pharmacy industry is likely to undergo a number of changes over the next few years with the implementation of the Affordable Care Act. The industry has had to deal with a number of major legal issues surrounding prescription security for opioids like Oxycontin. This issue has still not been fully addressed. Another issue relates to compounded medicines.
Just last week news broke of yet another contamination scare of compounded steroids made at a pharmacy in Tennessee that sickened patients. Last year, a breakout of fungal meningitis was linked to the same compounded steroid. And now, a bill to change compounding practices is heading to the Senate floor. This could create risks as well as opportunities to companies in the industry.
Pharmaceutical compounding is the customization of medications to fit a particular patient's needs. These meds, often manufactured by compounding companies on which the U.S. Food and Drug Administration has only limited oversight.
All of the major pharmacy chains like Walgreen (WAG -1.06%) and CVS Caremark (CVS +1.71%) offer compounding services. Walgreen recently inked a partnership with major drug compounding companyAmeriSourceBergen (ABC -0.13%) in what looks like a move that anticipates these legislative changes. Walgreens Specialty Pharmacy, LLC. is a subsidiary of Walgreen that carries out this part of the business. It generated $419 million in revenue in 2012.
The proposed legislation, which has made it out of the Senate committee, is up for a vote some time this summer. The bill will expand the FDA's oversight of the entire compounding supply chain and likely result in the closing of a number of small compounding pharmacies. Legislation like this, if passed by Congress, will almost certainly raise the costs of compounding. Larger companies like Walgreen will benefit directly from these changes in a classic barrier to entry effect, further rolling up revenue of prescription drug distribution to large chain pharmacies and away from independent ones.
Between this scare over quality of compounding medicines and the increased need for prescription chain-of-custody security for highly-demanded street drugs, pharmacies, especially independent ones, will have to specialize if they want to find opportunities for growth as the major chains move into more traditional roles of community or local pharmacies.
The effect of the proposed compounding legislation and other drug-oversight legislation at the state level will create new niches for pharmacies to fill and from which to build client lists. For niches like these it makes more sense for the major players to partner with local service providers rather than compete directly with them. However, we see this drive to greater legislative oversight continuing, and the risks associated with that for small companies quite high.
quoted from here
TN lists clinics that received suspect steroids May 28, 2013 5:16 PM
A Middle Tennessee clinic is among seven health facilities that received drugs from a compounding drug company suspected of being responsible for a cluster of infections in patients injected with a steroid, the state health department disclosed today.
At this time, the department is not certain of the number of patients who may have received injections, said agency spokesman Woody McMillin, adding the department was also not aware of any adverse events among Tennessee patients who received the suspect medications.
continue to read here
Outbreak Pharmacy Had Been in Trouble Before
Florida authorities are tracing the steroids that were shipped into the state from a Tennessee-based compounding pharmacy thought to be responsible for seven infections. The pharmacy had been in trouble before, but Florida and a dozen other states were still allowing it to ship in high-risk drugs.
Tennessee health inspectors cited Main Street Family Pharmacy of Newbern, Tenn., in 2011 and again in 2012 for violations of safety standards but did not shut it down, the Nashville Tennesseean reported Saturday.
Tennessee authorities had placed the pharmacy on probation, issued three consent agreements and fined it over $39,000, the newspaper reported. But they did not shut it down, so it continued to sell its drugs -- including high-risk sterile injectables -- to clinics and hospitals in other states.
It is not clear whether Florida's Department of Health was ever notified of the disciplinary actions in Tennessee. According to the Florida DOH license lookup site online, Florida's DOH and Board of Pharmacy have taken no disciplinary action against the Tennessee compounder.
Main Street Family Pharmacy sent out the steroids thought to have been contaminated in December, a few weeks after the Tennessee inspection that found many problems, the Tennesseean reported. The probation and major fines were imposed in March, long after the drugs were shipped.
The seven infections found so far were traced to injections from January and February, according to releases from the Food and Drug Administration and Tennessee health authorities.
A spokesman for Main Street Family Pharmacy sent the following statement on Tuesday: “As the FDA reported, an investigation into the exact source of the potential adverse effects from the methylprednisolone acetate is inconclusive and ongoing.
"The company is fully supportive and compliant with the FDA’s recommendation that a voluntarily recall take place and patients not be administered this compounded medicine until the investigation is complete.”
Florida DOH issued a release Friday evening that said at least three in-state facilities -- two in Melbourne and one in Chipley -- received the suspect drugs, Florida Department of Health said Friday evening.
DOH identified them as Family Health Care of Chipley, The B.A.C.K. Center of Melbourne and Dr. Parvesh Bansal, also in Melbourne.
The steroids in question are the same type that caused an outbreak last year that hurt 720 people and killed 48 -- including five in Florida.
"DOH has notified each of these facilities and is currently working with them to notify patients who may have been exposed," the agency said in its release.
Tennessee health officials said that Main Street has been cooperative in recalling all of its sterile products. Those are liquids that are injected or infused into a sterile space, such as the blood stream, spine, joint or eye.
Last year's outbreak, caused by contaminated steroid injections from the now-defunct New England Compounding Center in Massachusetts, triggered severe cases of fungal meningitis, as well strokes and other problems.
The patients in both outbreaks received injections of methylprednisolone acetate, according to the FDA. The drug is called MPA for short.
Five of the patients in the new outbreak, who got the shots at a primary care clinic in Herrin, Ill., developed skin infections at their injection sites on the hips and buttocks, CDC reported. At least one of two patients in North Carolina was reported to have a fungal infection.
Compounding pharmacies tailor-make drugs for particular patients who can't take brand-name manufactured drugs, and must do so under a doctor's prescription. However, as the Florida Board of Pharmacy has reported, many compounding pharmacies have become de facto manufacturers, producing drugs in bulk outside the regulatory reach of the FDA.
States are responsible for regulating pharmacies, but it has been difficult for them to ride herd on compounders, particularly those that are based in other states.
As Health News Florida reported in December, about half of Florida's 9,000 licensed pharmacies engage in compounding to some extent, and 950 of those are in the high-risk category because they make drugs that must be produced in ultra-clean facilities and kept sterile.
One-third of the high-risk compounders licensed in Florida are based in other states, shipping their products to hospitals and clinics.
--Health News Florida, www.HealthNewsFlorida.org, is published by WUSF Public Media. Editor Carol Gentry can be reached at 813-974-8629 (desk) or 727-410-3266 (cell) or by e-mail, cgentry@wusf.org.
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Question of the Day May 28, 2013 I have posted Ten Reasons (Actually 11 Reasons) Why the FDA Should Have Jurisdiction Over All Compounding. What are Ten Reasons Why This IS NOT A GOOD
IDEA? In Other Words What Are Ten Reasons It Would be Better To Have The Current System Proposed by the Senate HELP Committee?
ANH Says Compounding pharmacies, essential providers of medications used by alternative practitioners, threatened by legislation
The Alliance for Natural Health, a not-for-profit organization dedicated to political advocacy to ensure access to holistic medicine, serves an important role as watch dog and advocate for health freedoms. On May 7 the Alliance sent an action alert to its members advising of draft legislation by the Senate Committee on Health, Education, Labor and Pensions (HELP) that would act to eliminate important compounding medications. Examples of compounding medications commonly used in alternative health include DMSA (used to treat metal toxicity), Low Dose Naltrexone, bio-identical hormones and parasite medications. Due to an overwhelming response by interested citizens and support by Senator Tom Harkin (D-IA), who is a strong advocate for natural health, a second draft announced on May 17, removed much of the threatening language. The proposal still holds potential threats to compounding drugs such as the bio-identical hormone estriol, due to language that allows entire categories of compounding drugs to be banned by the FDA. A third draft will be announced May 20 and the committee will vote on May 22. For more information and to take action, see http://www.anh-usa.org
Learn more: http://www.naturalnews.com/040508_vaccines_parental_consent_medications.html#ixzz2UcBACqlU
Deja ve--FDA tracking down new outbreak tied to compounded drug May 28, 2013 | By Eric Palmer
Call it FDA déjà vu. While Congress continues to spar with the FDA over its oversight of compounding pharmacies, agency officials are running down yet another outbreak of possible infections tied to a potentially contaminated steroid manufactured by a compounding pharmacy.
The agency said in an alert that there have been 7 reports of adverse reactions after patients received injections of preservative-free methylprednisolone acetate, manufactured by Main Street Family Pharmacy, a compounding pharmacy in Newbern, TN. That is the same drug at the heart of the fungal meningitis outbreak that began last year and at last count had sickened 741 people, 55 fatally. The FDA is still figuring out what has caused the recent reactions but told providers to quarantine the drug because it is a "potentially contaminated medication."
State officials said there were reports of skin abscesses, NBC News reported. "Fortunately, we are aware of no serious events like meningitis, stroke or death in association with this cluster," Tennessee state health commissioner Dr. John Dreyzehner said in a news briefing NBC News reported. But the FDA said at least one of these adverse events appears to involve fungus.
The FDA continues to face criticism from some members of Congress for not taking a more aggressive attitude toward compounding pharmacies after the outbreak tied to the now-defunct New England Compounding Center cut a path of infection and death through much of the U.S. FDA Commissioner Margaret Hamburg has said the FDA's authority over compounders is ambiguous. They traditionally were overseen by state authorities. The agency nonetheless started a crash campaign to inspect the 30 largest compounding pharmacies in the U.S., many of whom have recalled drugs after the FDA said questionable sterility practices in their manufacturing might lead to contamination.
Hamburg has asked Congress to pass a law that gives the FDA clear authority to oversee the largest compounders. A bipartisan Senate bill making its way through Congress would establish a new category of large compounding pharmacies that would have to register with the FDA and report any adverse reactions tied to their drugs. It would not require the compounders to meet all of the strict regulations that drug manufacturers do, like getting preapproval of their products and labels. It would, however, prevent them from any longer making the most complex biologic drugs that are more easily contaminated. They also would not be allowed to make their own versions of FDA-approved drugs unless there was a shortage. And like manufacturers, they would have to kick in fees for the privilege of having FDA supervision.
quoted from --e: FDA tracking down new outbreak tied to compounded drug - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-tracking-down-new-outbreak-tied-compounded-drug/2013-05-28#ixzz2Uc0N29sV
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The agency said in an alert that there have been 7 reports of adverse reactions after patients received injections of preservative-free methylprednisolone acetate, manufactured by Main Street Family Pharmacy, a compounding pharmacy in Newbern, TN. That is the same drug at the heart of the fungal meningitis outbreak that began last year and at last count had sickened 741 people, 55 fatally. The FDA is still figuring out what has caused the recent reactions but told providers to quarantine the drug because it is a "potentially contaminated medication."
State officials said there were reports of skin abscesses, NBC News reported. "Fortunately, we are aware of no serious events like meningitis, stroke or death in association with this cluster," Tennessee state health commissioner Dr. John Dreyzehner said in a news briefing NBC News reported. But the FDA said at least one of these adverse events appears to involve fungus.
The FDA continues to face criticism from some members of Congress for not taking a more aggressive attitude toward compounding pharmacies after the outbreak tied to the now-defunct New England Compounding Center cut a path of infection and death through much of the U.S. FDA Commissioner Margaret Hamburg has said the FDA's authority over compounders is ambiguous. They traditionally were overseen by state authorities. The agency nonetheless started a crash campaign to inspect the 30 largest compounding pharmacies in the U.S., many of whom have recalled drugs after the FDA said questionable sterility practices in their manufacturing might lead to contamination.
Hamburg has asked Congress to pass a law that gives the FDA clear authority to oversee the largest compounders. A bipartisan Senate bill making its way through Congress would establish a new category of large compounding pharmacies that would have to register with the FDA and report any adverse reactions tied to their drugs. It would not require the compounders to meet all of the strict regulations that drug manufacturers do, like getting preapproval of their products and labels. It would, however, prevent them from any longer making the most complex biologic drugs that are more easily contaminated. They also would not be allowed to make their own versions of FDA-approved drugs unless there was a shortage. And like manufacturers, they would have to kick in fees for the privilege of having FDA supervision.
quoted from --e: FDA tracking down new outbreak tied to compounded drug - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-tracking-down-new-outbreak-tied-compounded-drug/2013-05-28#ixzz2Uc0N29sV
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You can now follow my tweets about the compounding world on Twitter at https://twitter.com/tuck_richmond or @tuck_richmond (aka lady lawyer).
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Report from California
Just one day before the FDA's new warning regarding Main Street Family products, the California Public Interest Research Group released a report stating that “last fall's fungal meningitis outbreak…was simply the latest and deadliest in a long line of errors and risky practices by compounding pharmacies.”
That report is available here.
Monday, May 27, 2013
Love 101: The Ring of Fire that Compounding Pharmacies and Pharmacists Have Created
I just finished watching Ring of Fire. I am watching it a second time. I have a fascination with or love of Johnny Cash and June Carter Cash and their love for each other. Having grown up with music all my life and a dad who played electric guitar on the radio and at numerous dances and events how could I not love music..it has always been a part of my life and always will be. I would be lost without music. What really amazes me about Johnny and June is June's love for Johnny despite his faults. In Ring of Fire it is about June's love for Johnny and what she will do for him at all cost. One of my favorite parts is where June says “I nursed him back from the grave,” she cries to the family’s counselor. “I hate him. I hate him. And that is just the truth of it. … I’m the one who has to stay strong and protect the kids and hold it all together. I want to ask God: What about me? I need help.” The counselor responds something like: You hate the disease; you love the man...that is what we all have in common here.
Love of anything whether it be a person, money, or a thing can cause a lot of people to do just about anything to hang on to that person, money or thing. It can cause people to do things they wouldn't normally do. It can cause people to cross lines they normally wouldn't cross. People fall into a Ring of Fire. I sense that is what has happened in the compounding world.
Consumers love compounded drugs...they work well for them when properly prepared. Consumers don't want to lose their right to purchase and use compounded medications. They fear losing this right if the federal government takes over the regulation of compounding. That fear is unfounded. Compounded drugs are needed and necessary. The federal government no matter what legislation it passes will not take away compounded drugs. Pharmacies and Pharmacists that compound drugs now may no longer be allowed or choose to compound medications. They may choose not to because they don't want to comply with the requirements of the federal government.
Love of anything whether it be a person, money, or a thing can cause a lot of people to do just about anything to hang on to that person, money or thing. It can cause people to do things they wouldn't normally do. It can cause people to cross lines they normally wouldn't cross. People fall into a Ring of Fire. I sense that is what has happened in the compounding world.
Consumers love compounded drugs...they work well for them when properly prepared. Consumers don't want to lose their right to purchase and use compounded medications. They fear losing this right if the federal government takes over the regulation of compounding. That fear is unfounded. Compounded drugs are needed and necessary. The federal government no matter what legislation it passes will not take away compounded drugs. Pharmacies and Pharmacists that compound drugs now may no longer be allowed or choose to compound medications. They may choose not to because they don't want to comply with the requirements of the federal government.
And the 11th and Maybe the Biggest Reason of All that the FDA Should have Jurisdiction Over All Compounding:
11. The Health Care Fraud Involved in this Industry is the main reason. It is a 5 Billion Dollar Business. Wonder how much of that was obtained by fraud and actually belongs to the Federal Government. The "manufacturing compounders" might be guilty of health care fraud but who has the ability and the means to go undetected in this area--the small --mom and pop compounders. True the federal government already has criminal laws and false claims already to rein these violators in giving the FDA authority over compounding would add one more layer of protection.
Ten Reasons Congress Needs to Give the FDA Jurisdiction Over All Compounding And They Need to Do It Now Not Later
May 27, 2013
by Sue Tuck Richmond
1. One set of rules makes more sense than piecemeal sets of rules from both the state and federal government.
2. Giving the FDA partial jurisdiction while leaving the states with partial jurisdiction will create much litigation in the state and federal courts and will most likely result in conflicting decisions that will take years to be decided and resolved--if ever--before another legislative fix will be needed.
3. States will most likely not (and in some cases cannot) provide the proper and essential funds need to enforce the rules and regulations they have regarding compounding especially if the past is any indication.
4. State boards are made up of pharmacists--like most professions--it protects its own--even when they are bad to the bone. The only way to get a handle on the compounding problem is to have oversight by someone other than pharmacists-who will continue to protect their own. This is when federal jurisdiction becomes critical in any situation that is out of control. Huge donations by compounders/pharmacist/pharmacies will be less likely to buy protection from the rules and regulations.
5. Creating a hodgepodge of jurisdiction means that compounders will find loopholes and ways around the federal jurisdiction; whereas, if the federal government has jurisdiction or the right to exercise that jurisdiction over all compounding--the loopholes are closed.
6. The FDA has shown that it is capable, ready and willing to get the compounding disaster under control; whereas, some states have made honest attempts to rein in bad compounders, a number of states including Texas have taken no action whatsoever since the NECC outbreak. Texas in fact has yet to publish any disciplinary action against any of the compounders such as NECC or Franck's etc.
7. The federal government via the FDA has the ability and resources to train, educate, oversee, maintain one mega database, and to civilly and criminally prosecute bad compounders in a consistent manner.
8. Giving the FDA the authority to exercise jurisdiction over all compounders-both human and animal--does not mean that the states will have no jurisdiction. The states would still be responsible for licensing pharmacists, overseeing that the states rules and regulations are met and could still civilly and criminally prosecute just as is done in the WAR ON DRUGS--with states and federal government working closely together.
9. With piecemeal jurisdiction for the FDA you still have the possibility of miscommunication and finger pointing rather than a joint effort to prevent the problems. The state will blame the FDA. The FDA will say it did not have jurisdiction or the proper information from the states. Giving the FDA the authority will nix this type of issue in the future.
10. Congress and states have tried the piecemeal litigation (although not with "manufacturing compounders" carved out) and it has simple not worked. People and animals have died. There continues to be misinformation, misunderstandings, bad compounds, and bad compounders...jurisdiction over just the worst of the worst compounders for the FDA will not ultimately solve the problem.
by Sue Tuck Richmond
1. One set of rules makes more sense than piecemeal sets of rules from both the state and federal government.
2. Giving the FDA partial jurisdiction while leaving the states with partial jurisdiction will create much litigation in the state and federal courts and will most likely result in conflicting decisions that will take years to be decided and resolved--if ever--before another legislative fix will be needed.
3. States will most likely not (and in some cases cannot) provide the proper and essential funds need to enforce the rules and regulations they have regarding compounding especially if the past is any indication.
4. State boards are made up of pharmacists--like most professions--it protects its own--even when they are bad to the bone. The only way to get a handle on the compounding problem is to have oversight by someone other than pharmacists-who will continue to protect their own. This is when federal jurisdiction becomes critical in any situation that is out of control. Huge donations by compounders/pharmacist/pharmacies will be less likely to buy protection from the rules and regulations.
5. Creating a hodgepodge of jurisdiction means that compounders will find loopholes and ways around the federal jurisdiction; whereas, if the federal government has jurisdiction or the right to exercise that jurisdiction over all compounding--the loopholes are closed.
6. The FDA has shown that it is capable, ready and willing to get the compounding disaster under control; whereas, some states have made honest attempts to rein in bad compounders, a number of states including Texas have taken no action whatsoever since the NECC outbreak. Texas in fact has yet to publish any disciplinary action against any of the compounders such as NECC or Franck's etc.
7. The federal government via the FDA has the ability and resources to train, educate, oversee, maintain one mega database, and to civilly and criminally prosecute bad compounders in a consistent manner.
8. Giving the FDA the authority to exercise jurisdiction over all compounders-both human and animal--does not mean that the states will have no jurisdiction. The states would still be responsible for licensing pharmacists, overseeing that the states rules and regulations are met and could still civilly and criminally prosecute just as is done in the WAR ON DRUGS--with states and federal government working closely together.
9. With piecemeal jurisdiction for the FDA you still have the possibility of miscommunication and finger pointing rather than a joint effort to prevent the problems. The state will blame the FDA. The FDA will say it did not have jurisdiction or the proper information from the states. Giving the FDA the authority will nix this type of issue in the future.
10. Congress and states have tried the piecemeal litigation (although not with "manufacturing compounders" carved out) and it has simple not worked. People and animals have died. There continues to be misinformation, misunderstandings, bad compounds, and bad compounders...jurisdiction over just the worst of the worst compounders for the FDA will not ultimately solve the problem.
Slaps on the Wrist Don't Work--
Excellent Comment from Dr. Woliner:
Slaps on the wrist don't stop these rogue pharmacies. Often, an unlicensed businessman will employ supervising pharmacists, paying them more than what they could working in a mill-like atmosphere of Walgreens-type pharmacies. Just as long as that pharmacist signs his name and license number, so this unlicensed manufacturer of drugs (disguised as a pharmacy), can make $ manufacturing and wholesaling drugs without the oversight and regulation a manufacturer needs to comply with. College Pharmacy in Colorado Springs, CO, is on probation for illegally importing and distributing contraband HGH from China. That doesn't stop them from manufacturing and wholesaling other drugs, even the silly "sublingual HCG" which, at 4.5 times larger than insulin, can't be absorbed sublingually (and has been disproven to have any effect on weight loss). These pharmacies are gambling that no one is going to take the time to file complaints, that the complaints won't be promptly investigated, and for " on A Tennessee compounding pharmacy--Main Street Family Pharmacy--Was On Probation in Tennessee!!
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A Dangerous Interplay: Rx Shortages and Med Errors
During two months starting in November 2010, more than 200 patients at seven hospitals in the MedStar Health system in the Maryland and Washington, D.C., region received double their prescribed concentration of potassium acetate.
In response to a shortage of the usual stock dose of the drug (2 mEq/mL), MedStar acted to fill the gap by procuring vials containing a 4-mEq/mL solution. The wrong concentration was entered into the IV compounder software, which then identified the new vials as containing the lower dose, and the drug was administered to patients receiving total parenteral nutrition. No patients experienced injuries or medical abnormalities, which is one reason why the mistake went undetected for so long.
continue reading here
5/27/2013: Metro: FDA found 392 drugs to be of poor quality last yr
MUMBAI: One out of a sample of 20 everyday drugs tested by the Food and Drug Administration (FDA) were found to be substandard and unfit for consumption. Although some of these substandard drugs may not aggravate the patient’s health condition, others...
Compounding Pharmacies Experiencing Crackdown By The FDA By Rebekah Marcarelli | May 27, 2013 01:15 PM EDT
Legislation is pending in congress to give the Food and Drug Administration more authority in regulating compounding pharmacies like the one that was linked to an outbreak that caused the deaths of more than 50 people last year, the Augusta Chronicle reported.
Since the outbreak, the FDA has cracked down on about 40 compounding pharmacies across the nation.
A group that represents compounding pharmacies complained that the FDA has imposed much more rigid expectations on sterility than pharmacies have ever had to deal with before.
continue reading here
Changes Eyed To Senate Compounding Bill Could Exempt Home Infusion Senators and stakeholders are considering potential changes to the upper chamber's drug compounding bill -- particularly the bill's current pooling and repackaging definitions that stakeholders worry could bring home infusion providers under the new regulatory category for compounding manufacturers and . . .
Unreleased FDA Compounding Guide Becomes Focus Of House Bill House Energy and Commerce Republicans signaled they may clarify FDA's authority over drug compounding -- particularly the much debated part of the statute that is subject to a circuit court split -- but they held steady on not giving the agency new powers.
Sunday, May 26, 2013
Louisiana among states that got suspect medicine from Tennessee firm May 26, 2013 9:57 AM
NASHVILLE, Tenn. -- Six months after state officials found multiple violations at a West Tennessee compounding pharmacy but did not shut it down, the pharmacy is the apparent source of infections in two states.
Main Street Family Pharmacy LLC in Newbern recalled all its sterile products, the U.S. Food and Drug Administration said Friday, after methylprednisolone acetate it made was linked to seven cases of injection site inflammation in Illinois and North Carolina. One of the cases appears to involve a fungus, the FDA said.
The drug is the same steroid blamed for an ongoing fungal meningitis outbreak that has killed 55 patients nationwide, including 15 in Tennessee.
Louisiana is among the states that received recalled shipments from Main Street Family Pharmacy LLC. The others are Alabama, Arkansas, California, Florida, Kentucky, Illinois, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.
State and federal health officials cautioned that they do not know the scope of the problem. The number of people exposed to the suspect medicine is not known.
State inspectors found issues at the pharmacy the month before the suspect medicine was shipped but allowed it to continue to operate.
“Fortunately, we are aware inueof no serious events like meningitis, stroke or death in association with this cluster, but still our hearts go out to those affected by this event,” said Tennessee Health Commissioner Dr. John Dreyzehner. “It is very important to note that based on everything we know right now, this situation does not approach the severity of the fungal infections outbreak we encountered in the fall of 2012.”
However, he noted that the information could change.
“This is very early in this rapidly evolving investigation,” Dreyzehner said. “We expect that we will receive additional facts that will be very important to this investigation.”
--Clients haven't been identified
The primary focus at this point is sequestering all the sterile products shipped by Main Street Family Pharmacy and to contact patients who might have received injections with the steroid — a common treatment for chronic pain.
continue reading here
FDA Could Oversee Some Compounds
By Jennifer Johnson Backer
A Senate panel on Wednesday, May 22, approved a bill that would tighten oversight of specialized compounding pharmacies and bring them under Food and Drug Administration control.
Compounding drugs, particularly sterile injectables, has fallen under the scrutiny of the FDA because of a string of recent health emergencies. In 2012, an outbreak of fungal meningitis was linked to an injectable steroid thatinfected hundreds of people across the U.S. The outbreak, which resulted in serious injuries and deaths, was tied to a firm in Framingham, Mass. In 2011, contaminated injectable eye medications also resulted in serious health problems.
The FDA does not approve drugs made by compounding pharmacies; instead, a compoundingpharmacy is licensed by its state’s board of pharmacy. Unlike traditional drug manufacturers, compounding pharmacies are not required to tell the FDA what drugs they are making.
The bill, the Pharmaceutical Compounding Quality and Accountability Act, was approved by the Senate Health, Education, Labor and Pensions Committee and will now head to the full Senate. The House has not yet drafted a bill, but a subcommittee held a hearing Thursday about state and federal compounding rules.
Senate Health, Education, Labor and Pensions Committee member Sen. Lamar Alexander, R-Tenn., said the legislation erases confusion over who regulates pharmacies and manufacturing facilities and clarifies who oversees each business.
“Putting one agency on the flagpole for each of these businesses will mean greater safety for American families so they don’t have to question whether the drugs they take are safe,” Lamar said in a prepared statement on May 15, the day he helped introduce the legislation.
While the Senate bill would establish a new category of FDA regulatory oversight for large-scale pharmacies that function more like manufacturers, traditional retail compounding pharmacies that do not ship across state lines would remain under state control. Currently, state laws vary widely, so a company that is considered a drug maker in one state could be classified as a retail compounding pharmacy in another state.
Most of the problems associated with drug compounding have been tied to the emergence of firms with pharmacy licenses making and distributing drugs in a way that’s outside the bounds of traditional pharmacy compounding. Many of those pharmacies mass produce injectables for hospitals and larger clients – which is different than traditional retail compounding pharmacies.
Already, the bill is under fire from consumer advocacy and public health groups, who say the legislation does not adequately address health risks from smaller retail compounding pharmacies. They also want the FDA to have oversight of compounding pharmacies that sell everything from oral drugs to topical creams.
Brett Wright, the owner of Benevere Pharmacy, a retail compounding pharmacy in Collierville, says he supports the new legislation and believes it would increase patient safety. Unlike large-scale pharmacies that function more like mass manufacturers, Wright’s pharmacy requires a physician’s prescription and does not produce sterile injectables or ship across state lines.
Most retail compounding pharmacies like Benevere Pharmacy specialize in custom-making medications that are tailored to meet the medical needs of an individual patient. Sometimes compounding is needed because a patient may be allergic to a certain dye, or an elderly patient may need a medicine in a liquid or suppository form that is not available. In other cases, compounding is necessary because a drug has been discontinued.
The number of drug shortages reported to the FDA gained 41 percent to 251 shortages in 2011, compared to 178 shortages reported in 2010. The agency says it continues to see an increasing number of shortages, including drugs used to treat cancer, anesthetics used for patients undergoing surgery, drugs needed for emergency medicine and injectable drugs. The FDA also has reported a spike in the number of medications that have been discontinued.
In its current form, the bill would not impact smaller retail compounding pharmacies like Benevere Pharmacy. Wright says he welcomes legislation that clarifies the rules, but wants to make sure any new legislation doesn’t restrict his ability to meet the needs of his customers, like a four-year-old patient who can’t swallow his seizure medication. Benevere Pharmacy compounds that medication into a liquid form.
“It’s not an overly complicated process, and it is life-saving for that patient,” he said.
A Senate panel has approved a bill that would tighten oversight of specialized compounding pharmacies and bring them under Food and Drug Administration control. The proposed bill would not impact smaller retail compounding pharmacies like Benevere Pharmacyof Collierville, pictured here, but it would affect large-scale pharmacies that function more like mass manufacturers.
(Daily News File Photo: Lance Murphey)
The FDA does not approve drugs made by compounding pharmacies; instead, a compounding
The bill, the Pharmaceutical Compounding Quality and Accountability Act, was approved by the Senate Health, Education, Labor and Pensions Committee and will now head to the full Senate. The House has not yet drafted a bill, but a subcommittee held a hearing Thursday about state and federal compounding rules.
Senate Health, Education, Labor and Pensions Committee member Sen. Lamar Alexander, R-Tenn., said the legislation erases confusion over who regulates pharmacies and manufacturing facilities and clarifies who oversees each business.
“Putting one agency on the flagpole for each of these businesses will mean greater safety for American families so they don’t have to question whether the drugs they take are safe,” Lamar said in a prepared statement on May 15, the day he helped introduce the legislation.
While the Senate bill would establish a new category of FDA regulatory oversight for large-scale pharmacies that function more like manufacturers, traditional retail compounding pharmacies that do not ship across state lines would remain under state control. Currently, state laws vary widely, so a company that is considered a drug maker in one state could be classified as a retail compounding pharmacy in another state.
Most of the problems associated with drug compounding have been tied to the emergence of firms with pharmacy licenses making and distributing drugs in a way that’s outside the bounds of traditional pharmacy compounding. Many of those pharmacies mass produce injectables for hospitals and larger clients – which is different than traditional retail compounding pharmacies.
Already, the bill is under fire from consumer advocacy and public health groups, who say the legislation does not adequately address health risks from smaller retail compounding pharmacies. They also want the FDA to have oversight of compounding pharmacies that sell everything from oral drugs to topical creams.
Brett Wright, the owner of Benevere Pharmacy, a retail compounding pharmacy in Collierville, says he supports the new legislation and believes it would increase patient safety. Unlike large-scale pharmacies that function more like mass manufacturers, Wright’s pharmacy requires a physician’s prescription and does not produce sterile injectables or ship across state lines.
Most retail compounding pharmacies like Benevere Pharmacy specialize in custom-making medications that are tailored to meet the medical needs of an individual patient. Sometimes compounding is needed because a patient may be allergic to a certain dye, or an elderly patient may need a medicine in a liquid or suppository form that is not available. In other cases, compounding is necessary because a drug has been discontinued.
The number of drug shortages reported to the FDA gained 41 percent to 251 shortages in 2011, compared to 178 shortages reported in 2010. The agency says it continues to see an increasing number of shortages, including drugs used to treat cancer, anesthetics used for patients undergoing surgery, drugs needed for emergency medicine and injectable drugs. The FDA also has reported a spike in the number of medications that have been discontinued.
In its current form, the bill would not impact smaller retail compounding pharmacies like Benevere Pharmacy. Wright says he welcomes legislation that clarifies the rules, but wants to make sure any new legislation doesn’t restrict his ability to meet the needs of his customers, like a four-year-old patient who can’t swallow his seizure medication. Benevere Pharmacy compounds that medication into a liquid form.
“It’s not an overly complicated process, and it is life-saving for that patient,” he said.
US State Rep. Griffith drafting compounding legislation
Compounding Legislation Remains Stuck On Definitions Even As House Budges / Rep. Griffith is drafting legislation based on the guidance FDA had in development before the NECC crisis struck, but the agency says it was not intended to fix its oversight problems, and FDA is also expressing dissatisfaction with the Senate’s bipartisan compounding bill. / “The Pink Sheet” DAILY May 23 2013 11:20 PM
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Arizona Board of Pharmacy Compounding Task Force May 1, 2013 Minutes
THE ARIZONA STATE BOARD OF PHARMACY
HELD A COMPOUNDING TASK FORCE MEETING ON MAY 1, 2013
MINUTES FOR COMPOUNDING TASK FORCE MEETING
Call to Order – May 1, 2013
Chairman John Musil convened the meeting at 10:00 A.M. and welcomed the audience to the
meeting.
Roll Call
The following Task Force Members were present: Chairman John Musil, Tom Van Hassel (via
telephone), Rich Monty (via telephone), Dana Reed-Kane (via telephone), Eric Bauer (via
telephone), Linda Carboni, Dennis Waggoner, Danielle Evans (via telephone), and Sandra
Sutcliffe.
Review of Rule R4-23-410 – Current Good Compounding Practices
Chairman Musil opened the discussion by stating that the task force would do a line by line
review of R4-23-410 that was revised by Ms. Sutcliffe and incorporated the recommendations
made by the task force at the last meeting.
R4-23-410 – Section A
The task force did not recommend any changes for Section A.
R4-23-410 – Section B - Component Selection
Mr. Musil stated that he had concerns about section 2 where it states that a certificate of analysis
(CofA) must be obtained for all components for compounding that do not meet the requirements
of subsection (1) (a). Mr. Musil stated that re-packagers often do not provide a certificate of
analysis because they do not do an analysis of the product. Mr. Musil stated in that case the
certificate of analysis would come from the point of origin.
Ms. Reed-Kane recommended that if the company does not provide a certificate of analysis then
the pharmacy would have to do their own analysis.Mr. Wand stated that the rule could be written to state that a certificate of analysis is obtained
and/or verified by the pharmacy.
The task force members recommended that Certificate of Analysis should be defined in the
definitions.
R4-23-410 – Section C- Training and Personnel
Mr. Musil stated that the rule reads that competency assessments must be maintained for two
years and questioned how long records should be kept for employees that have terminated their
employment.
Ms. Sutcliffe stated that the record retention requirements for employees that have terminated
employment are usually found in the policies and procedures of the individual pharmacy.
Mr. Van Hassel asked how long the compounding logs are kept. Ms. Sutcliffe stated that she
selected two years but the task force could change the requirement.
Ms. Sutcliffe stated that the records requirement could be changed to keep the records for three
years the same as other records are maintained. Ms. Sutcliffe recommended that the rule could
read that a pharmacy needs to maintain an ongoing record of all personnel compounding for
three years.
Ms. Reed- Kane asked if the record retention would include interns that were on rotation at the
pharmacy.
Mr. Musil replied yes that it would include anyone that compounded medications.
R4-23-410- Section D
Mr. Musil stated this section was changed to require both the permit holder and pharmacist in
charge to ensure the security, safety, and quality of a compounded pharmaceutical product.
R4-23-410 – Section E – Compounding Facilities
Mr. Musil stated that this section adds a minimum non-sterile pharmaceutical compounding area
of not less than 60 square feet except for pharmacies that been permitted or remodeled prior to
a specified date may continue to meet the previous requirements.
Ms. Reed- Kane asked about a pharmacy that has never remodeled their space. Ms. Sutcliffe
stated that the previous requirements would remain in place.
Mr. Van Hassel stated that he feels that this would have an economic impact on pharmacies.
Ms. Sutcliffe stated that this requirement would not affect pharmacies compounding simple or
moderate compounds. Ms. Sutcliffe stated that it would just affect pharmacies preparing complexpreparations.
Ms. Carboni asked if the pharmacy would be required to remodel their pharmacy. Ms. Sutcliffe
stated that they would need to remodel if they were compounding complex preparations.
Mr. Musil stated that he had some concerns because some hormone and antibiotic preparations
are considered to be simple and moderate compounds.
Mr. Musil stated that he had concerns about employee’s exposure to hormones.
Mr. Wand stated that certain preparations could be excluded in the definition of simple
compounds.
The task force members decided that the following products would be excluded from
simple and moderate compounds: hormones, antibiotics, chemotherapeutics, and cytotoxics.
The task force members decided to define the following compounding terms: simple, moderate,
and complex.
Ms. Sutcliffe asked if the compounding of hazardous compounds should be conducted in a
powder hood.
Mr. Musil stated that he felt that Narcotics should be compounded in a powder hood.
Mr. Musil stated that there were some concerns about the 60 square foot requirement for
a non-sterile compounding area. Mr. Musil stated that he feels that the area should be isolated
from the pharmacy dispensing area.
The task force members decided that Section E (2) (ii) should read is isolated from the
dispensing area instead of is isolated from other pharmacy functions.
Ms. Sutcliffe asked how the task force members would like to restrict entry or access.
Mr. Van Hassel stated that he feels that a designated area could be designated in the pharmacy
and a separate room would not be needed. Mr. Van Hassel stated that there would
have to be a designated room for sterile compounding and for non-sterile compounding a
designated area would be fine.
Mr. Wand asked if plastic strips could be used to restrict the area.
Mr. Musil stated that he would have no problem with the plastic strips as long as there is a
defined area.
Mr. Van Hassel stated that it should be 60 square feet of contiguous space.
The task force decided to add in Section E (2) (b) that the space provides a non-steriledesignated compounding area.
Mr. Van Hassel recommended that non-sterile compounding area be defined in definitions.
R4-23-410 – Section F – Compounding Equipment
The task force agreed to adding #2 which states that compounding of hazardous non-sterile
compounds must be made in a powder containment hood.
The task force decided to define hazardous non-sterile compound in definitions.
R4-23-410 – Section G
The task force did not recommend any changes for Section G.
R4-23-410 – Section H – Handling and Storage of Components, Containers, and
Closures
The task force did not recommend any changes for Section H.
R4-23-410 – Section I – Compounding Documentation
Ms. Sutcliffe stated that this section was changed to indicate that the documentation could be
either be in a written or electronic format.
Ms. Sutcliffe stated that the compounding record section was changed from initials or name of
the licensee to identity of the licensee.
R4-23-410- Section J – Quality Controls
Ms. Sutcliffe stated that changes were made to allow the procedures for documentation to be
kept in either written or electronic format.
Mr. Musil asked if there were any other testing for variability that should be added to #4.
Mr. Bauer stated that a final visual inspection should be added.
Mr. Musil suggested that final visual inspection should be added to both #2 and # 4 in that
section.
R4-23-410 – Section K - Re-packaging of powders
Mr. Musil stated that if repackaging the component into smaller containers the beyond use
date should be consistent.
R4-23-410 – Section L – Beyond use datesMr. Van Hassel asked if other sources could be used to determine the expiration date other
than official compendium.
Ms. Reed-Kane stated that PCAB allows the pharmacist to use their professional judgment in
determining the beyond use date. Ms. Reed-Kane stated that the pharmacist could use a
research paper or other documentation.
The task force decided to change the statement from in the absence of stability information to
in the absence of documented stability information.
Mr. Musil stated that they could use internal stability studies.
Mr. Bauer left the phone call at this time.
R4-23-410 – Section M – Labeling
The task force did not recommend any changes for Section M.
R4-23-410 – Section N
The task force did not recommend any changes for Section N.
R4-23-410 – Section O – Compounding in Excess of Prescription
Mr. Musil stated that he feels that to compound in excess there should be some kind of
documentation.
Mr. Van Hassel suggested that the statement should be changed from shall establish a
history of compounding valid prescriptions to shall establish a documented history of
compounding valid prescriptions.
Mr. Van Hassel stated that in #2 the label on the container should include the beyond use date
and storage information.
R4-23-410 – Section P
The task force did not recommend any changes for Section P.
R4-23-410 – Section Q – Compounding for Office Administration
Ms. Sutcliffe stated that Letter g was added to this section which states that the product is not for
resale or distribution.R4-23-410 – Section R
The task force did not recommend any changes for Section R.
R4-23-410 – Section S – Compounding Commercially Available Products
Mr. Musil stated that a product that is commercially available could not be compounded except
when there is documented shortages.
Mr. Musil stated that a documented clinical need should exist for compounding a commercially
available FDA product.
Ms. Sutcliffe asked if it should be a patient specific reason.
Mr. Musil stated that there should be a documented clinical need such as a clinically relevant
reason.
Mr. Musil summarized by stating that a like product could be compounded if there is a
documented clinical shortage or there is a documented clinical need for the patient.
Mr. Musil stated that office use medications should only be compounded for the same reasons.
It was recommended to move Section S before Section Q.
R4-23-410 – Section T
Mr. Musil recommended to change #4 to read written or electronic manual.
R4-23-410 – Section U
Ms. Sutcliffe stated that she could add each section in the rule to be required in the policies
and procedures.
R4-23-670 – Sterile Pharmaceutical Products
Mr. Musil stated that he would like to see ante room and sterile product compounding
area defined.
Mr. Musil stated that he feels that an ante room should be in addition to the square footage of the
compounding area.
Ms. Carboni asked if there should be a square footage requirement for the ante room.
Mr. Musil recommended that the ante room should meet ISO 7 requirements.
Mr. Van Hassel stated that ante room,sterile room, and storage room should be included in thedefinitions.
Mr. Musil stated that there should be a sink in the ante room and gowning area.
Mr. Musil was asked if an ante room would be required in all instances for example if a glove
box was in the use.
Mr. Musil stated that an ante room would be required.
Ms. Sutcliffe asked if 100 square feet would be required if someone was using a glove box.
Mr. Musil stated that the size of the room would remain the same no matter what type of hood
was being used.
Mr. Monty asked if a separate chemo room would be required.
Mr. Van Hassel recommended defining negative pressure in the definitions.
Ms. Carboni stated that some hospitals have a glove box in a separate room to do chemo.
Mr. Van Hassel stated that cytotoxic should be defined in the definitions.
Mr. Musil stated that the sterile preparation area should have a separate HVAC system from the
dispensing pharmacy.
In section C, it was recommended to add testing to #1.
Mr. Monty asked if the task force should specify criteria for who can certify the rooms.
Mr. Wand stated that the Board could approve a list of individuals who could certify the room.
Ms. Carboni asked about the daily monitoring of the temperature of the room.
Mr. Wand stated that the temperature could be monitored remotely.
The task force members decided to add temperature under #4 for supervisory controls and
verification procedures.
The task force members wanted “during excursion” added under #4 for supervisory controls and
verification procedures.
Ms. Sutcliffe asked if this was for both refrigerator and room temperatures.
The task force members decided to review risk in 797 and discuss at the next meeting.Call to the Public
Chairman Musil announced that interested parties have the opportunity at this time to address
issues of concern to the task force; however the task force may not discuss or resolve any issues
because the issues were not posted on the meeting agenda.
No one came forth.
Topics for next meeting
1. Concerns for Senate Health Draft
2. Office Use prescriptions – percentage
3. Interstate and intrastate compounding
Next Meeting
The Task Force will try to hold their next meeting prior to or at the Convention in June.
The meeting adjourned at 12:00 noon.
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