FDA PUBLIC MEETING DECEMBER 19, 2012, Framework for Pharmacy Compounding: State and Federal Roles

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1154]
Framework for Pharmacy Compounding: State and Federal Roles
AGENCY:  Food and Drug Administration, HHS.
ACTION:  Notice of public meeting; request for comments.
SUMMARY: The Food and Drug Administration (FDA) is announcing the following public
meeting entitled “Framework for Pharmacy Compounding: State and Federal Roles.”  At this
public meeting, FDA and State representatives will share their perspectives.
Date and Time:  The public meeting will be held on December 19, 2012, from 3 p.m. to
5 p.m.  Onsite registration will be on a first-come, first-served basis beginning at 2 p.m.
Location:  The public meeting will be held at the FDA White Oak Campus, 10903 New
Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993.  
Entrance for the public meeting participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking and security
information, please refer to
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInform
ation/ucm241740.htm.
If you need special accommodations due to a disability, please contact Steve Morin, FDA
Office of Special Health Issues, 301-796-0161, email: Steve.Morin@fda.hhs.gov no later than
December 14, 2012. 2
Contact Person: Patricia Kuntze, Food and Drug Administration, 10903 New H Ave.,
Bldg. 32, rm. 5322, Silver Spring, MD  20993; patricia.kuntze@fda.hhs.gov.
Streaming Webcast of the Meeting: This public meeting will also be Webcast.  Persons
interested in viewing the Webcast should use the access connection at
https://collaboration.fda.gov/pharmacycompounding/.  The Webcast will begin on December 19,
2012, at 3 p.m. ET.
If you have never attended a Connect Pro meeting before, test your connection at:
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. Get a quick overview
at: http://www.adobe.com/go/connectpro_overview.  Adobe, the Adobe logo, Acrobat and
Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated
in the United States and/or other countries.
If for some reason the test page does not work, that is not a definite indicating factor that
the actual Webcast will not work.  The test link sometimes appears to be broken on some
individuals’ computers. (FDA has verified the Web site addresses in this document, but FDA is
not responsible for any subsequent changes to the Web sites after this document publishes in the
Federal Register.)
This Webcast will be closed captioned.
Comments:  In order to obtain public comment, FDA is also soliciting either electronic or
written comments on the issues discussed in section II of this document.  The deadline for
submitting comments is January 18, 2013.
Regardless of attendance at the meeting, interested persons may submit either written
comments regarding this document to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or electronic 3
comments to http://www.regulations.gov. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the heading of this document.  In
addition, when submitting comments on issues as outlined in section II of this document, please
identify the issue you are addressing.  Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.
Transcripts:  Please be advised that as soon as a transcript is available, it will be
accessible at http://www.regulations.gov.  It may be viewed at the Division of Dockets
Management (see Comments).  A transcript will also be available in either hardcopy or on CDROM, after submission of a Freedom of Information request.  Written requests are to be sent to
the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD  20857.
SUPPLEMENTARY INFORMATION:
I.  Background
The recent outbreak of fungal meningitis associated with drugs produced and sold by
New England Compounding Center has raised serious questions about the regulation of
pharmacy compounding (Refs. 1 and 2).  Historically, regulation of pharmacy compounding has
focused on drawing a line between traditional pharmacy compounding and other manufacturing.
Generally, day-to-day oversight of traditional pharmacy compounding has been seen as the
primary responsibility of the States, which license pharmacies and regulate the practice of
pharmacy, while other manufacturing falls under the purview of FDA.  Going forward, FDA
believes the focus should be shifted from attempting to draw a bright line between traditional
pharmacy compounding and other manufacturing to clearly defining traditional pharmacy 4
compounding that should be primarily overseen by the States and higher risk non-traditional
pharmacy compounding that would require compliance with Federal standards.  In addition,
there are open questions about whether, and to what degree States should enforce Federal
standards, what that oversight should look like, and the appropriate level of communication and
coordination required to make the system of State and Federal oversight seamless and effective.
FDA recognizes that the States play a critical role in the oversight of traditional pharmacy
compounding, which can include compounding a customized medication in response to a
prescription by a licensed practitioner based on the identified medical need of a particular patient
for the compounded product.  However, a category of “non-traditional” compounding has
evolved in the last decade that FDA believes requires additional oversight.  The Agency is
working with Congress to consider new authorities regarding “non-traditional” compounding
pharmacies.  In recognition of the States’ role, FDA has also reached out to its State partners by
inviting representatives from all 50 States to an intergovernmental meeting.
II.  Questions for Comment
The intergovernmental meeting will be an opportunity for the State officials to discuss a
variety of issues regarding their views on the role of the FDA and the States in the oversight of
compounding including:
•  Given existing authorities and resources, are the States currently able to provide the needed
oversight of pharmacy compounding and consumer protection?
•  What should the Federal role be in regulating higher risk pharmacy compounding such as
compounding high-volumes of drugs for interstate distribution?  Is there a way to re-balance
Federal and State participation in the regulation of pharmacy compounding that would better 5
protect the public health? What strategies should be developed to further strengthen Federal/State
communications?
•  Do you see a role for the States in enforcing a Federal standard for “non-traditional”
compounding?  If so, what role?  What factors would affect a decision by your State to take on
such responsibility?
The public meeting announced in this document will be held after the intergovernmental
meeting described above.  FDA is holding this public meeting to share the results of the
intergovernmental meeting with interested stakeholders.  At the public meeting, FDA
representatives and participants from the intergovernmental meeting will summarize the results
of the intergovernmental meeting.  
III.  References
The following references have been placed on display in the Division of Dockets
Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and
4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but is not responsible
for any subsequent changes to the Web sites after this document publishes in the Federal
Register.)
1.  The Fungal Meningitis Outbreak: Could It Have Been Prevented? Statement of
Margaret A. Hamburg, M.D., before the House Committee on Energy and Commerce,
Subcommittee on Oversight and Investigations
(http://www.fda.gov/NewsEvents/Testimony/ucm327664.htm), November 14, 2012.
2.  Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak:
Margaret A. Hamburg, M.D., before the Senate Committee on Health, Education, Labor, 6
and Pensions (http://www.fda.gov/NewsEvents/Testimony/ucm327667.htm), November
15, 2012.
Dated: November 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28786 Filed 11/27/2012 at 8:45 am; Publication Date: 11/28/2012]

Compounding Gold Standards and Compliance and Standards

Slides and Notes prepared by Alexander Pytlarz, PharmD, Keystone Consulting Rx on 12/1/2012, can be found here

State closes deadly drug shipment misbranding case

Published 2:00 p.m., Tuesday, November 27, 2012

AUSTIN, Texas (AP) — The Texas attorney general's office has resolved its case against a Dallas-based mail-order compounding pharmacy over a shipment of a misbranded drug ingredient blamed for three Pacific Northwest deaths.

An attorney general's office statement Tuesday says pharmacist Gary Osborn and his companies, Apothecure Inc. and SpectraPharm Inc., will pay $200,000 to the state, including $100,000 in civil penalties. They also agree to compound drugs to order and in a legal manner.

Osborn and ApotheCure received probation and $100,000 fines after pleading guilty to two misdemeanor criminal violations of the federal Food, Drug and Cosmetic Act.

The cases center on a February 2007 shipment of a gout drug containing some vials with dosages more than seven times stronger than shown on the label. Autopsies showed three Oregon patients suffered fatal overdoses.

Read more: http://www.sfgate.com/news/texas/article/State-closes-deadly-drug-shipment-misbranding-case-4071164.php#ixzz2DTGehD3Y

Could There Be Another Meningitis Outbreak?

Nov 26, 2012 Uncategorized, Updates

The recent fungal meningitis outbreak devastated the country’s confidence in the system of checks and balances that keep its healthcare system safe and effective. Caused by an improperly-sterilized batch of custom-made intravenous steroids, the outbreak has so far killed over 30 people and has afflicted nearly 500 others. It has also led to rounds of recrimination and soul-searching as the country’s healthcare watchdogs race to prevent another tragedy from occurring again. Unfortunately, there are indications that it may only be a matter of time before tainted vaccines, drugs or other supposedly-safe vehicles cause a similar outbreak.
It appears that the recent outbreak was caused by the collective failure of Massachusetts state health regulators and the FDA to recognize and halt a pattern of fraudulent and misleading activity at the company that manufactured the steroid cocktail responsible for the meningitis outbreak. Known as New England Compounding Center, the company may have been engaging in unsafe practices for a decade or more before the outbreak occurred. While both the FDA and the Massachusetts Pharmacy Board seemed to have been aware of systematic health violations at NECC’s main facility in Framingham, Massachusetts, neither took meaningful steps to correct the problem.
This seemingly unconscionable lack of oversight and accountability occurred partially by design. NECC was founded as as a compounding facility that existed to produce custom mixtures of prescription drugs on demand. The company was licensed as such and never cleared by any health regulators to operate as a direct-to-retail manufacturer of original drugs. The state and federal laws that govern the operation of compounding facilities are considerably more lax than those that govern the operation of pharmaceutical companies and drug manufacturers.
Unfortunately, it appears that NECC was operating as a de facto drug manufacturer. The company maintained agreements with doctors, hospitals and retailers in nearly every state and would regularly produce generic knockoffs of existing drugs and vaccines. It would also regularly produce made-to-order steroid mixtures like the batch that caused the outbreak.
Although the enormous scale on which this particular company distributed its products may have been unusual, many other compounding facilities continue to blur the line between custom compounding and wholesale manufacturing and distribution. In fact, a recent investigative report by NBC News found that over 7,000 compounding facilities regularly make mixtures of steroids and other drugs. About 3,000 adhere to sterile processing protocols designed to minimize the risk of the sort of cross-contamination that caused the NECC outbreak.
The FDA and the various state health regulators are now racing to come up with a framework for recognizing and punishing lapses in the production and sterilization processes used by these outfits. Since NECC was cited several times during the run-up to the outbreak without ever being ordered to halt its operations, it’s clear that regulators must put in place a stricter regime that immediately identifies and isolates problematic procedures. The task at hand is an urgent one: Every year, dozens of compounding facilities are cited by local health authorities for lapses resembling those that occurred at NECC.
It’s unclear whether regulators can update the safety protocols designed to prevent tainted drugs from reaching the market in time to prevent another outbreak. Bacteria, fungi and viruses suspended in improperly-sterilized compounds can continue to grow and avoid detection for long periods of time. It may ultimately fall to the FDA and other agencies to combine more sensitive testing procedures with more aggressive inspection schedules. Even so, this fungal meningitis debacle serves as a sobering reminder that medicine is an imperfect science.

Jesse Anderson has worked in the medical field, and knows how dangerous fungus and bacteria contamination can be for patients. If you believe that you have been infected by meningitis, seek help from a certified personal injury lawyer specializing in meningitis.

Dept. of Health cites Bayview Pharmacy for state law violation

November 26, 2012

By

MARIA SHANAHAN

mshanahan@ricentral.com

The Rhode Island Department of Health recently ordered the South Kingstown business to temporarily stop compounding certain medications.

SOUTH KINGSTOWN – The Rhode Island Department of Health recently found that Bayview Pharmacy on Tower Hill Road has been compounding medications in violation of state law and ordered it to stop doing so immediately.
When Bayview Pharmacy was unable to produce an environmental test result from its sterile room at a follow-up inspection Nov. 13, the Department of Health ordered Bayview to temporarily cease production of sterile medications until an outside company retests the sterile room and the Department of Health reviews the results.
Bayview Pharmacy produces both sterile medications, such as injectables or eye drops, and non-sterile medications, like capsules, and according to Ryan Dyer, owner and pharmacist at Bayview.
“That only accounts for about 1 or 2 percent of our business,” Dyer said of the production of sterile products. “The other 98 percent is non-sterile capsules, suspensions or suppositories.”
Compounding is defined by the Rhode Island Rules and Regulations Pertaining to Pharmacists as, “the act of combining two or more ingredients as a result of a practitioner’s prescription or medication order occurring in the course of professional practice based upon the individual needs of a patient and the relationship between the practitioner, patient and pharmacist. Compounding does not mean the routine preparation, mixing or assembly of drug products that are essentially copies of a commercially available product.”
On Tuesday, Bayview had an outside company in to re-test the sterility of the room in which they produce sterile medication. According to Dyer, the testing was completed Wednesday and Bayview will be recertified to produce sterile injectables by the end of the week.
The Department of Health did not order Bayview to cease production of non-sterile medication or to discontinue business. During the inspection, Bayview continued to produce non-sterile products without interruption.
Dyer admitted the missing environmental test results were an “oversight” but said that all of Bayview’s injectables are sent off site for sterility testing and said “every product that we’ve produced has always been sterilized to proper means we’ve had no reports in six years that our products are not sterile.”
None of Bayview’s medications, sterile or non-sterile, are being recalled.
The Department of Health also found that Bayview used expired powders on at least two occasions to compound a non-sterile topical preparation, and ordered the pharmacy to discontinue doing so.
Bayview also reportedly sent sterile injectables to practitioners in Indiana and other states, which is in violation of Rhode Island state law, according to the Department of Health findings. The department has ordered the pharmacy to cease doing so.
On Sept. 7, Department of Health inspectors observed bedding, food and water dishes for pets in the pharmacy, which have since been removed.
Ryan Dyer said he believes the Department of Health is acting out of early concern based on a recent meningitis outbreak. Nearly 500 people fell ill, including three in Rhode Island, after receiving steroid shots made by a compounding pharmacy in Massachusetts.
“We’ve provide to the [Rhode Island Board of Pharmacy] everything they’ve requested, we haven’t had to make any modifications to our facility,” Dyer said. “They’re doing this out industry concern and maybe to set an example.”
Dyer said Bayview does not produce spinal injectables, like those responsible for the meningitis outbreaks.
Despite the Department of Health’s findings, Dyer insists that Bayview Pharmacy has a reputation of cleanliness.
“We have the most state of the art compounding lab in Rhode Island, if not in New England,” he said. “We have had a company come in every six months for the past six years and they have certified that the sterile room is sterile; that’s 12 inspections and there was never an incident.”

Source

Southern Rhode Island Newspapers

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• The Narragansett Times 

Previous fungal meningitis outbreak a decade ago resulted in no oversight changes

By David Brown

First, David Brannon couldn’t believe it. Then he couldn’t stand hearing about it.
Hundreds of people were ill with fungal meningitis they had contracted after getting pain-killing injections made by a compounding pharmacy in Massachusetts. Dozens were dead, and the numbers were still rising.
“It’s quite painful to follow, actually,” said the 60-year-old North Carolina lawyer, recalling a similar outbreak that killed his mother, Mary Virginia Scyster, in 2002. “It took my mother 66 days to die.”
Scyster was a victim in an outbreak eerily similar to the one now unfolding. In both, a steroid called methylprednisolone acetate became contaminated with black fungus during production by compounding pharmacies making large quantities of the drug.

In 2002, at least seven people got sick and two died after being injected with a drug made by a South Carolina pharmacy. In thecurrent outbreak, 419 people have become ill and 30 have died.

Despite the much higher numbers, nothing much has changed. Mass production of high-risk medicines by local drug stores continues — not only in South Carolina but in most other states as well.
“There appear to be no lessons learned from our outbreak in terms of oversight and regulation of these pharmacies,” said Jeffrey Engel, a 58-year-old physician who as North Carolina’s state epidemiologist investigated the 2002 incident. All the cases occurred in North Carolina.
His view is shared by the infectious diseases expert who diagnosed Scyster’s rare infection.
“It’s déjà vu for sure,” said Srilatha Edupuganti, 44, who was at the University of North Carolina in Chapel Hill and is now at Emory University in Atlanta. “It’s painful that it’s happening again.”
In the earlier incident, health authorities recalled the drug made by Urgent Care Pharmacy of Spartanburg, S.C. South Carolina’s Board of Pharmacy found the pharmacy unsanitary and its sterilization practices inadequate. It suspended the pharmacist’s license for four years and fined him $10,000. Ultimately, the drug store closed and lawsuits were filed.
In the current outbreak, officials recalled tainted lots produced by New England Compounding Center of Framingham, Mass.
“I’m struck that this happened again,” said Engel, who now heads the Council of State and Territorial Epidemiologists in Atlanta. “There should be a cease and desist until safety can be guaranteed. Where is the next one happening?”
Traditional compounding involves a pharmacist making a drug only after getting a prescription with an individual patient’s name on it. Urgent Care Pharmacy and New England Compounding Center were involved in a different type of compounding, which involved the small-batch mass production of drugs — including the riskiest ones, “sterile injectables — by gowned technicians working in clean rooms with special ventilation.
This type of drug-making in pharmacies continues because 42 states permit some form of what’s known as “compounding for office use.” That allows pharmacists to prepare many doses of a drug without patient-specific prescriptions and to provide them to doctors’ offices and clinics based on those places’ regular need.
Compounding pharmacies are regulated by state boards of pharmacy and aren’t held to the same workplace standards and sterility requirements of pharmaceutical plants. Instead, most follow less strict standards — USP 797 — set by an organization called the United States Pharmacopeia. While the Food and Drug Administration can shut down any drug-making activity, in practice it gets involved with compounding pharmacies only if there are complaints of contamination or mislabeling — or after a disaster is underway.
The past outbreak
Mary Virginia Scyster and her husband, David, retired to Pinehurst, N.C., not only for the great golf courses but also because of the town’s reputation for excellent medical care.
In the spring of 2002, Scyster, who was 77, twisted her back while playing golf. The pain persisted and she went to a doctor, who injected the area with an anti-inflammatory steroid. When the drug’s effect wore off, she returned and got a second injection.
“Within two weeks, she was in bed with a headache that wouldn’t quit,” recalled her son, David Brannon. “She resisted going to the hospital, and finally my father just put her in the car and took her. She never came home again.”
Unbeknownst to her, between the first and second shots, the pain clinic at Moore Regional Hospital in Pinehurst had turned to a new source for methylprednisolone when its usual supplier, the drug company Pharmacia, temporarily stopped making it. Between May 6 and June 5, the pain clinic bought 557 vials of methylprednisolone from Urgent Care Pharmacy.
About 140 miles to the east, in Jacksonville, Johnston Pain Clinic also turned to Urgent Care, buying 525 vials of methylprednisolone over five months.
“I couldn’t get what I wanted from anybody else,” recalled anesthesiologist Scott Johnston, now 53. It was there that Vivian Conrad, a 71-year-old retired dispatcher for the sheriff’s department with arthritis, got an injection in her back on June 3.
For both women, weeks or months passed before their infections were fully diagnosed.
When Scyster didn’t improve after two weeks of therapy for bacterial meningitis, a second spinal tap was done. It showed microscopic fungus. She was immediately transferred to Duke University Medical Center, where a world authority on fungal meningitis worked. There, Exophiala dermatitidis, a species that sometimes darkens the tile of bathrooms, was identified.
“By the time she got to the hospital she was never out of pain,” recalled Brannon, her son. “She had a lot of visual hallucinations. It was very frightening for her. Sometimes she would realize what was going on and sometimes she wasn’t with us.”
She died on Aug. 25, 2002.
It gets worse
In the meantime, Vivian Conrad, who lived with her husband in the Atlantic Coast community of Emerald Isle, N.C., was baffling physicians.
“One particular weekend, I remember she was having bad headaches and had had them all week long,” recalled Conrad’s daughter, Chiquita Prestwood, a 63-year-old bookkeeper in Lenoir, N.C. “I asked where they were and she told me toward her neck. I said, ‘Mom, that sounds like meningitis. Why don’t you call your doctor?’ ”
When the weekend was over she did and was admitted to a hospital in Morehead City on July 8.
Her symptoms, however, resembled those of a stroke, and after eight days she was discharged home. Two weeks later, she was readmitted. She got no better. On Aug. 20, she was transferred to a hospital in Greenville, N.C. Fungal meningitis was diagnosed after that.
“They said her spinal fluid, which should be clear, was almost pure pus,” her daughter said.
What happened next is unclear. Either with a tip from a Greenville physician or by the observation of an infectious diseases physician at Duke, the cases of Scyster, now dead, and Conrad, still alive, were put together. Engel, the state epidemiologist, was notified and started to investigate.
On Sept. 27, the South Carolina Board of Pharmacy ordered Urgent Care to close. The pharmacy recalled the methylprednisolone, but it refused to recall other products, which had been shipped to 11 states. On Nov. 15, the FDA issued a nationwide alert against using them.

In early December, the Centers for Disease Control and Prevention described in its newsletter, Morbidity and Mortality Weekly Report, four cases of meningitis and one case of joint infection in North Carolina caused by Exophiala fungus.

Continue reading here

The 2012 fungal meningitis outbreak: Whose fault?

• HEALTH CARE
• NOVEMBER 23, 2012
• BY: SANDY DECHERT

To date, finger-pointing rather than action has resulted from the widespread occurrence offungal meningitis due to human error in the United States this summer and fall. A fracas at Wednesday's hearing of the House Committee on Energy and Commerce demonstrated both the intensity and some of the longstanding controversies underlying the situation.

"Let's not lose sight of the wrongdoer as we go around blaming the regulators," Rep. Henry Waxman, D-Calif., said in reacting to this fall's meningitis crisis. "The regulators deserve blame, but the primary blame, in my mind, is the company."

In the search for culprits, pharmacies, drug manufacturers, physicians, the U.S. Food and Drug Administration, state pharmacy boards, loose interstate-federal relations, loopholes in the law, and Congress itself have taken the heat for the unprecedented infections that have sickened and killed hundreds of patients receiving epidural steroid injections of 80mg/ml preservative-free methylprednisolone acetate in the latter half of this year.
Blame it on the doctors
For once, it's not the doctors' fault. Physicians throughout a 23-state region where the tainted drugs were shipped by the New England Compounding Center had no idea what was going on with the medications they prescribed. The warning about contamination did not become widely known until the beginning of October. For constant, severe back pain unresponsive to other therapies, primary care physicians and specialists followed protocol. They prescribed suffering patients a shot containing the steroid. Usually, a physician assistant or nurse would administer the shot right at the office, and the patient would return to normal life in greater comfort. Standard Operating Procedure.
Only this time, many injected patients started feeling ill, usually after a couple of weeks to a month. (Fungal infections are rare and slow to develop.) When the symptoms seemed like only flu or the effects of a heavy night out, some patients sought the simplest solution: ignore the problem and put off seeking medical help. While a few sufferers felt no symptoms at all, many of those affected developed fever, headache, a stiff neck, nausea and vomiting, slurred speech, photophobia (sensitivity to light), and altered mental status. And some of them started to die.
Blame it on big government
The 1938 Food Drug and Cosmetic Act established the U.S. Food and Drug Administration with a very broad mandate:

"FDA [an agency within the federal Department of Health and Human Services] is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation."

The devil is in the details, however. Under the nation's current drug policies, only companies that make large quantities of a drug are considered "manufacturers" and subject to federal regulation. "Compounders," including NECC, have vigorously backed the distinction for years.
Specialty pharmacies like NECC traditionally respond to individual requests from health careproviders by making drugs to order: compounding small quantities of needed medication (usually formulations or dosages unavailable from the larger companies that mass-produce). The United States has no central data bank on licensed pharmacies.
Because they typically operate on a smaller scale and technically by request only, compounding pharmacies do not have to observe FDA's standards on "manufactured" pharmaceuticals, even if their products are sold nationwide, as NECC's steroids were. Compounding pharmacies are only regulated on a state-by-state basis by the states in which they produce drugs.

"Large-scale pharmacy compounding has greatly expanded since the early 1990s," say New York Times reporters covering the NECC case, "partly because hospitals are increasingly outsourcing the making of the compounded drugs that they need and also because of widespread shortages of medicines made by the big drug manufacturers."

A question basic to this situation is whether NECC should have been, or whether similar companies should be, considered a compounder or a manufacturer. “This is the worst and most tragic case [of a compounder causing iatrogenic illness] and should be the last,” said FDA commissioner Margaret Hamburg of the human-caused meningitis outbreak. “It should be a wake-up call that there is a gap in regulatory oversight. We really need strong, clear, and appropriate legislation." She also said that different rules in different states are not sufficient to handle situations like this one.
Some point to FDA lack of follow-up in similar cases and lay the blame on weak federal enforcement. Those who take FDA to task are often the same legislators who deny funding and/or regulatory teeth to the agency. The Department of Health and Human Services oversees the FDA. This month, HHS publicly noted the agency's limited powers over compounders and urged Congress to strengthen FDA's authority.
Blame it on the state pharmacy board
So if the FDA was not responsible for the tragedy, was it the Commonwealth of Massachusetts? Certainly the Commonwealth possessed regulatory authority to inspect and shut down any compounder doing business there.

Continue reading here

Updated: 11/24/2012 9:55:47 AM EST Health Dept. Takes Action Against Pharmacy A compounding pharmacy in Tamarac has been suspended, following a less than glowing inspection.

by Alan McBride

Florida Department of Health issued an Emergency Suspension Order of People's Choice Pharmacy, a compounding pharmacy located in Tamarac.

The order immediately suspended People's from operating as a community, sterile products, and special compounding pharmacy in the state of Florida.

The order comes after the department had conducted a routine pharmacy inspection of People's Choice Pharmacy in mid-October.

The inspection revealed that the pharmacy lacked quality assurance in high-risk sterile compounding.

It was also found that the pharmacy's use of unlicensed personnel for high-risk sterile compounding endangered the public.

The Department found further that People's Choice Pharmacy's failure to maintain adequate sanitation increased the likelihood that the medications compounded at this facility may become contaminated.

The issues inspectors reported finding gain substantially more public attention in the wake of a scandal involving tainted steroidal compounds.

the company NECC has been all but shuttered after medicine it compounded was traced to cases of fungal meningitis.

There have been three deaths in Florida as a result of fungal meningitis.

Emergency suspension or restriction orders are not considered final agency action but are imposed when the subject's actions pose an immediate serious danger to public health, as specified by section 456.074, Florida Statutes.

The subject is entitled to a hearing before final action is taken by a regulatory board or by DOH.

The suspension, however, will remain in effect until final disciplinary action is taken, the suspension is lifted, or the case is successfully appealed.

15 meningitis lawsuits filed in N.J. over tainted steroids

FRIDAY NOVEMBER 23, 2012, 11:03 PM

BY  LINDY WASHBURN

STAFF WRITER

THE RECORD

Fifteen lawsuits, including nine this week, have been filed in New Jersey by patients exposed to or sickened by fungal meningitis in the fatal nationwide outbreak caused by tainted steroid medication.

The lawsuits in Superior Court in Cumberland County name New England Compounding Center in Massachusetts, as well as the doctors and health care facilities that provided the injections to treat chronic pain. They include South Jersey Regional Medical Center in Vineland and Premier Orthopaedic Associates of Southern New Jersey, which has offices in Vineland and Elmer.

Several of the patients who filed suit were hospitalized for treatment of fungal meningitis, including Jose A. Ramos, a 35-year-old Millville resident who received an injection for back pain in August. He “has suffered with headaches, visual disturbances and neck stiffness,” the lawsuit said, noting that “he will continue to take oral anti-fungal medication and pain medication … continue to receive blood testing to monitor his liver function; [and] also follow-up with CDC physicians.”

Others described severe nausea, headaches, neck pain, increased back pain, sensitivity to light, and dizziness in their suits. After the recall, one woman underwent two failed spinal taps to confirm her diagnosis before being hospitalized to undergo a third. The original reason for her injection in June was to treat back pain.

Continue reading here

Patients say their cases ignored in meningitis outbreak

Developments last week indicate that the scope of the meningitis outbreak could be wider than previously believed.

5:07PM EST November 24. 2012 - NASHVILLE -- After being treated with drugs from New England Compounding Center, 52-year-old Bret Moody was told he has fungal meningitis. He's infected with Aspergillus, the first contaminant found in a national outbreak of illness tied to tainted medication.

But when health officials count the nearly 500 people sickened by the moldy drugs, they don't include Moody and others like him who fail to match the profile of most victims.

Moody, who also has been diagnosed with leukemia, is one of many patients nationwide who question whether health officials are undercounting the victims of the crisis.

Some got the spinal steroid, methylprednisolone acetate, blamed for the meningitis outbreak that has killed at least 34 nationwide. Some, like Moody, got other drugs from the Massachusetts firm. But if their symptoms are not already linked to the outbreak, they say, medical professionals aren't taking their illnesses seriously.

Health officials say they are watching closely and haven't yet confirmed any illnesses related to other drugs from New England Compounding or its sister company, Ameridose, both of which recalled all products amid sterility concerns.

Developments last week, however, indicate that the scope of the outbreak could be wider than previously believed. The U.S. Food and Drug Administration reported finding a new batch of bacterial and fungal contaminants in drugs from New England Compounding. Meanwhile, the U.S. Centers for Disease Control and Prevention reported a surge in epidural abscesses and bone infections among patients treated with three suspect lots of methylprednisolone acetate. Previously, the dominant infection had been fungal meningitis.

Dr. Diana Zuckerman, president of the patient advocacy organization National Research Center for Women & Families, said she believes more illnesses caused by contaminated drugs may be under the radar.

"This is the tip of the iceberg," Zuckerman said.

Questions about infection

Molds such as Aspergillus are common in the environment and have been known to sicken patients with weakened immune systems in rare instances. But Moody and his wife, Joy, are convinced that his fungal infections were triggered by the drugs he was given through a port.

Like hundreds of others across the country, Bret Moody got a letter telling him that during a recent hospital stay, he was treated with drugs from New England Compounding.

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