Saturday, November 3, 2012

New legislation would help users identify source of a compounded drug

Friday, November 2, 2012
By Michael R. Cohen, R.Ph.
In response to the national outbreak of fungal meningitis, it makes sense for healthcare providers to seriously consider whether they have an ethical and legal obligation to inform end users when they dispense high risk sterile products prepared by a compounding pharmacy. To do that, doctors who inject these products need to be informed of the source.
While some physicians order compounded preparations directly from external compounding pharmacies, others simply prescribe the compounded medication and leave it up to the pharmacy or office staff to secure it from a reputable source. Thus, they may not know that a drug has been compounded from non-sterile ingredients or by an external pharmacy.

Continue reading here

New England Compounding Center Meningitis Outbreak Big Topic of the News WIth over 8000 Articles on Web About It and on Average 250 a Day

New England Compounding Center latest news

Pharmacy staff researching ways to meet long-term patient needs

A nationwide shortage of prescription drugs is growing and Blessing Hospital is feeling it.

The American Society of Health System Pharmacists has 261 medications on its shortage list this week. Blessing Hospital Pharmacy staff reviews this list daily to assess the impact on the hospital and determine how to address the needs.
Adding to the shortage situation, in late October the Food & Drug Administration (FDA) shut down a second major national drug compounding company that supplies medications to thousands of hospitals across the country. There have been no reports of injury from the products of Ameridose, however, the FDA shut down the company while improvements are made in its sterility testing processes.
“This closure further reduces the supply of medications available and places more demand on the remaining suppliers,” said Bob Miller, RPh, director, Blessing Hospital Pharmacy. “Hospitals across the country are trying to get medications from a smaller number of suppliers.”
Compounding companies purchase drugs from pharmaceutical companies in bulk sizes and, under the approval of the FDA, formulate the medications into products that may not be readily available or into smaller ready-to-use sizes more suited to particular patient needs.
The Blessing Hospital Pharmacy staff is researching ways to meet patient compounded medication needs in the long term. In the meantime, the Blessing Pharmacy staff will compound medications on-site to meet patient needs.
“We can do the same work as compounding companies, but we normally don’t because there is more waste when mixing medications for the patients of one hospital when compared to mixing medications for thousands of hospitals as national firms do and the medications we mix on-site have a shorter shelf life than those from national companies,” Miller stated.
“This may not be the preferred process due to the potential for waste,” said Maureen Kahn, president/chief executive officer Blessing Hospital, about compounding drugs at the Hospital. “But, right now, it is the safest process for our patients in light of national drug shortages and while the search for long term answers continues.”
Blessing Hospital provided information for this report.

Source found here

Some Questions About the Proposed Federal Compounding Legislation - jessevivian's pharmacy blog

Federal Compounding Legislation - jessevivian's pharmacy blog

Readers of This Blog: A List of the Countries of People Who Have Viewed the Blog

Algeria
Argentina

Australia

Austria

Bahamas

Bangladesh

Barbados

Belgium

Brazil

Bulgaria

Cayman Islands

Canada

China

Columbia

Croatia

Cyprus
Czech Republic
Denmark

Estonia

France

Gabon

Germany

Hong Kong

Hungary

India

Indonesia

Ireland

Israel

Italy

Kenya

Latvia

Macedonia

Malaysia

Mongolia
Morocco
Mexico

Netherlands

Netherlands Antilles

New Zealand

Nigeria

Pakistan

Panama

Philippines

Poland

Romania

Puerto Rico

Peru

Portugal

Russia

Singapore

Slovakia

Slovenia

South Africa

South Korea

Spain

Sweden

Switzerland

Thailand

Trinidad & Tobago

Turkey

Turks and Cacaos

Uganda

Ukraine

United Arab Emirates

United Kingdom

United States

Uruguay

Venezuela

Vietnam

Zimbabwe

1099 Employees and Marketing

What is All the Fuss About 1099 Employees and Marketing?

The thinking goes like this:
If you have a 1099 sales employee who gets a nominal base salary and also receives a commission or bonus on prescriptions generated from a specified number of doctors, there is a far greater likelihood that the sales person may be engaged in inappropriate behavior in order to generate a higher income. That might involve fiduciary incentives (direct payments/kickbacks, sports tickets, trips, anything that exceeds nominal financial value). For compounders who employ contracted sales people, it might also mean that they may make inappropriate or inaccurate claims about the compounded preparation, participate in communications which exceed their professional scope, or distribute marketing materials that would make the drug “misbranded” and therefore not eligible for coverage.
Many of the regulations and policies for sales and marketing employees and how their behavior can "cross the line" and generate significant legal trouble for a pharmacy appear in the Anti-KickBack Law (Stark) and the False Claims Act (FCA) language. Both laws are very broad. The Stark Law is more specific to health care and providers and what prohibitions exist which may result in payment by the federal government for Medicaid, Medicare and other health insurance programs funded with tax dollars. The FCA covers any transaction with the federal government including health care.
1099 employees are not prohibited by either law. It’s how they are compensated and a series of tests to assure that they are part of a regulatory provided "safe harbor" that an employer needs to establish. Included in that safe harbor provision are issues related to “fair market value” of their salaries vs. commissions or bonuses that are paid based upon generating specific business (e.g., more prescriptions, more dialysis machines, more lab tests) from providers who are subsequently billing CMS and the federal government for those services or products.
This is a particularly complicated issue but what every compounder who currently or is considering employing a contract sales person needs to know is that you, the employer, are directly accountable for the actions, statements and behavior of your sales person. To help you understand the complexities of these laws, IACP has scheduled an important and informative continuing education webinar on Thursday, September 27, 2012 at 1:00 pm. “Don’t Mess with Uncle Sam! How the Stark Law and the False Claims Act Impact Pharmacists” will be hosted by IACP Executive Vice President and CEO David G. Miller, RPh. Click here for more information.
Source found here

IACP Law Library-Compounding for Office Use Available for Purchase

As part of our ongoing development of tools, programs and materials that help our members improve their professional and business practice, IACP is launching its IACP Law Library. As conceived, this law library will provide pharmacists with a comprehensive analysis of state pharmacy law and regulation that affect many day-to-day decisions.

Our first installment in the new IACP Law Library—Compounding for Office-Use is now available for purchase! Click here for purchase information.

Overview of Results
The majority of the states (42) allows pharmacies to sell any non-controlled prescription drug and compounded drugs to practitioners for office use. Six states specifically prohibit that activity, and two states appear to be silent. Silent means the statutes and regulations do not specifically say whether it’s allowed. As our phone calls to the states Boards revealed, silent does not necessarily mean it is not allowed. Many of the states Boards confirmed that although the statutes or regulations don't say office use is specifically permitted, the Boards allow by broad interpretation, board policy, or by common practice covered by a pharmacy’s license the provision of office-use prescriptions.
For the most part, those states that do specifically prohibit office-use prescriptions provide for a “sales” process instead and require that in lieu of a prescription, orders from practitioners must be placed via an invoice. Several of these states limit the amount of product that a pharmacy can sell to a practitioner for office use to either 5% of the total annual sales or 5% of the total dosages in a consecutive 12-month period. This five percent figure appears in many of the states controlled substances laws and is being applied by the Boards to sales for office use in general.
The percentage limitation is from the federal DEA Controlled Substances Act and rules. The five percent language was placed into some of the states PDMA laws – which deal with wholesaler licensure -- where the allowing of sales for office use also is found in an exemption provided in the definition of wholesale drug distribution. In these states, sales to practitioners are not wholesale drug distribution and do not require a wholesaler license. Many of the states providing the exemption limit the sales to 5%. If sales exceed 5%, then a pharmacy would be required to obtain a wholesale drug distributor license.
Unanswered Questions
Even the best research has limitations. Three states did not respond to our numerous phone calls and emails for clarifications and additional information. They are: Georgia, Illinois, and New Jersey.

Based on our review of the statutes and regulations, Georgia allows the sale to practitioners for legend drugs but is not clear as to whether such is allowed for compounded products.
Illinois and New Jersey allow the sale of compounded products for office use but appear to be silent as to whether legend drugs may be sold to a practitioner for office use.

IACP members doing business in those states should confer with the Board of Pharmacy if they have any questions.

To read entire IACP statement click here

Friday, November 2, 2012

Why Presidents Don't Shape The FDA

Read this Forbes article here

Second Illness Infects Meningitis Sufferers

By DENISE GRADY

Published: November 2, 2012

Just when they might have thought they were in the clear, people recovering from meningitis in an outbreak caused by a contaminated steroid drug have been struck by a second illness.

The new problem, called an epidural abscess, is an infection near the spine at the site where the drug — contaminated by a fungus — was injected to treat back or neck pain. The abscesses are a localized infection, different from meningitis, which affects the membranes covering the brain and spinal cord. But in some cases, an untreated abscess can cause meningitis. The abscesses have formed even while patients were taking powerful antifungal medicines, putting them back in the hospital for more treatment, often with surgery.

The problem has just begun to emerge, so far mostly in Michigan, which has had more people sickened by the drug — 112 out of 404 nationwide — than any other state.

“We’re hearing about it in Michigan and other locations as well,” said Dr. Tom M. Chiller, the deputy chief of the mycotic diseases branch of the Centers for Disease Control and Prevention. “We don’t have a good handle on how many people are coming back.”

Continue reading New York Times article here

3 more suits filed in Roanoke Circuit Court over tainted shots

Three people from Alleghany County said they were sickened by tainted steroid injections.

By Neil Harvey981-3376

Related: Cave Spring athlete is latest to contract meningitis Three more lawsuits were filed this week in Roanoke Circuit Court by back-pain patients who claim they were made sick by tainted steroid injections.
Nine such suits have now been filed in Roanoke since a deadly national outbreak of fungal meningitis was announced Oct. 3. The outbreak has been linked to tainted steroid injections, and, as of Friday, is responsible for 386 illnesses and 28 deaths nationally. Two of those deaths, and 46 cases of sickness, have occurred in Virginia, according to the Centers for Disease Control and Prevention.
Friday's suits came from three patients in Alleghany County - Kimberly Brown, Forrest Linthicum and Denia Taliaferro - who said they received injections between August and September. They soon began to experience symptoms consistent with fungal meningitis, the suits said.
Each of the three lawsuits filed seeks $5 million in damages. All three name New England Compounding Center, the Massachusetts firm that produced the steroid, and Insight Imaging, the Roanoke outpatient clinic where the plaintiffs said they received the shots.
The nine lawsuits filed over the past two weeks seek between $5 million and $10 million apiece. All of them name New England Compounding, and all but one also name Insight Imaging. Spokespeople for both companies have declined to comment on the suits or the outbreak.
This outbreak of meningitis, an inflammation of the spinal cord and the lining of the brain, has sickened or killed people in more than a dozen states. Each victim had received a steroid shot, mostly for back pain. Federal health officials matched the shots produced by New England Compounding to the outbreak after finding a deadly fungus in more than 50 unopened vials there, but have not said how the shots were contaminated, according to the Associated Press
Source found here

Board extends closure in meningitis investigation | GazetteNet.com

Woman who lost husband to fungal meningitis fights for more regulation

GDUFA-style user fees provide one possible source of funding for FDA compounding regulations | Drug Store News

VALID Compounding Act to regulate compounding pharmacies is introduced

November 02, 2012

A new policy debate over drug regulation is emerging as the NECC scandal worsens

As promised, US Rep. Edward Markey (D-MA) has introduced legislation, provisionally called the Verifying Authority and Legality in Drug (VALID) Compounding Act, in an attempt to clarify the distinction between pharmacies that compound drugs for individual patients (a very common practice) and those that perform compounding on a scale that makes them, in effect, drug manufacturers. The bill is a response to the widening scandal over contaminated, compounded steroid preparation that has (as of Oct. 31) led to the deaths of 28 and meningitis infection of 377 patients. New England Compounding Center (Framingham, MA; the company is in Markey’s Congressional district) produced around 17,000 dosages of the drug, methylprednisolone acetate, in early summer; the three lots of the compounded drug have now been recalled (along with other products of NECC) and the plant is shuttered.

Meanwhile, the Massachusetts state government has issued emergency rules to require compounding pharmacies to report volumes of drugs so produced, and to report to the state when other states are investigating a pharmacy’s products. It has also set up a commission to develop a report to the governor by year-end. “The compounding industry has evolved, and in some ways it has outgrown the current regulatory framework, not just the state but the federal regulatory framework,” said Governor Deval Patrick, according to a Boston Globe report.

The VALID Act specifies that compounded drugs be labeled as such (and with the notation that the drug has not been approved by FDA), and clarifies, to some degree, the distinction between pharmacies compounding drugs for individual patients (which has been and will continue to be under state regulatory authority) and those who are effectively engaged in manufacturing. The Secretary of HHS is to provide a list of drugs that are not to be compounded; and to prohibit the copying of commercially available drugs. A set of waivers allowing production of compounded product without individual prescriptions, and of certain types of pharmacies (such as those at hospitals) is also specified.

It’s not clear to what extent Markey’s proposed legislation would change the existing circumstances, except perhaps that physicians and patients are better informed that a compounded product is being dispensed. But even in that case, would a patient reconsider taking a drug that a physician is recommending? FDA already has authority to regulate what it believes to be manufacturers—but that authority has been under steady attack by trade associations affiliated with compounding pharmacists. Finally, FDA itself authorized the compounding (or, to be precise, announced that it did “not intend to take enforcement action against pharmacies” involved in the activity) of hydroxyprogesterone caproate, when KV Pharmaceuticals won approval to market that compound as a branded product, Makena, in 2011. KV (which is now in bankruptcy proceedings) intended to sell the drug for roughly $1,500 per injection, while the compounded product had been available for around $20.

Several trends are going to drive this debate: the heightened focus on using generic drugs as a cost-saving measure by health systems; the twists and turns that “personalized” medicine is taking—including bringing consumer interests and preferences into drug-dispensing decisions; and the intensifying push by pharmacists’ business and professional associations to have a greater say in prescribing practices. The ongoing drug-shortage problem has also played into this growing debate, as there are indications that a backup for some drugs in short supply has been to compound the product to address immediate needs (Markey’s bill specifies a waiver for “when necessary to protect public health”).

Source found here

Meningitis outbreak nears 400 infected as lawmakers push for tougher regulation

More than 400 infections have now been tied to an outbreak linked to contaminated steroid shots from the New England Compounding Center, the Centers for Disease Control and Prevention announced Friday.

Is meningitis in your state?

As of Nov. 2, 395 people have developed fungal meningitis, including 29 deaths. Another nine patients have fungal joint infections from steroid injections they may have received in areas such as the knee, hip, shoulder and elbow.
The ongoing 19-state outbreak of fungal meningitis has been linked back to three lots of methylprednisolone acetate (MPA) steroid injections made by the Compounding Center of Framingham, Mass. The injections were shipped to 23 states and officials have said up to 14,000 patients may have received the contaminated shots, mostly for back pain treatments.

On Thursday, the Food and Drug Administration had announced that it found bacterial contamination in two other types of drugs made the New England Compounding Center, betamethasone - used to various skin conditions and inflammation - and cardioplegia solution, which is given during heart surgery. No illnesses however have been reported in people who used these drugs.
The agency said the findings bolster concerns about a lack of sterility at the now-closed company. Investigators there have already found standing water from a leaking boiler, filthy floor mats and records indicating drugs were shipped before sterility tests were returned.

Continue reading here

FDA IS Working to Offset Ameridose Impact on Drug Shortage

We’re Working to Offset Ameridose Impact

Posted on November 2, 2012 by FDA Voice

By Margaret A. Hamburg, M.D.
Drug shortages are two words that no one wants to hear—not patients, not health care professionals, and not me.

Continue reading here

Case Count: 404 States: 19 Deaths: 29

Meningitis-Related Pharmacy Recall Worsens Drug Shortage

By Anna Edney - Nov 2, 2012
The recall of hundreds of drugs by Ameridose LLC, a compounding pharmacy associated with the U.S. meningitis outbreak, may be exacerbating shortages of medicines used for surgery and heart failure, regulators said.

The Food and Drug Administration is working with other manufacturers to ramp up production and may consider foreign suppliers, Commissioner Margaret Hamburg said in a Web posting today. The drugs Westborough, Massachusetts-based Ameridose made were already in short supply and include local anesthesias, muscle relaxers to prevent movement during surgery and high-dose diuretics to remove fluids during congestive heart failure.

Continue Reading here

FDA: 2 More NECC Drugs Contaminated

ByDaniel J. DeNoon
WebMD Health NewsNov. 1, 2012 -- Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal.

The NECC is the Massachusetts compounding pharmacy whose drugs are the likely source of the ongoing outbreak of fungal meningitis. The FDA previously found fungus growing in unopened vials of the company's methylprednisolone injectable steroid.

Now the FDA has found bacteria in three lots of the NECC's betamethasone, another injectable steroid, and in cardioplegia solution, a drug used to stop the heart during transplant operations. It's not yet clear whether the drugs also carry fungal contamination or other kinds of bacteria.
Tests of each lot of the drugs found a different combination of bacteria:

Product and Lot Number	Microbial Identification
Betamethasone 08202012@141	Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp.
Betamethasone 07032012@22	Bacillus niabensis, Bacillus circulans
Betamethasone 07302012@52	Bacillus lentus, Bacillus circulans
Cardioplegia solution 09242012@55	Bacillus halmapalus, Brevibacillus choshinensis

Two of these bacteria -- Bacillus idriensis and Bacillus circulans -- have been linked to rare cases of human disease. The FDA says that for patients treated with these drugs, "the clinical significance of these results is not known."
All NECC drugs were recalled on Oct. 6. The FDA has not estimated how many patients were treated with the contaminated betamethasone or cardioplegia solution before that date.
So far, the CDC has not received any reports of laboratory-confirmed bacterial infections linked to these NECC products.
As of today, there have been 377 cases of fungal meningitis and nine cases of fungal joint infections in people who received NECC drugs. Twenty-eight of these people have died.
Source found here

Lawmakers want answers in meningitis outbreak

Lawmakers want answers in meningitis outbreak: TRIAD – Lawmakers on Capitol Hill want more details on the circumstances that led to a nationwide meningitis outbreak that killed 28 people, including a Denton woman, as a result of contaminated me...

House Dem writes bill tightening rules for drug compounders - Some Compounders Exempt

House Dem writes bill tightening rules for drug compounders - The Hill's Healthwatch

Ed Markey to Seek Stronger FDA Oversight of Compounding Pharmacies : Regulatory Netherlworld--Apply When Sale Across State Lines

Ed Markey to Seek Stronger FDA Oversight of Compounding Pharmacies : Roll Call News

Federal regulators said Thursday that they’ve found contamination in more drugs made by a pharmacy tied to a deadly meningitis outbreak.

By Associated Press,
Nov 02, 2012 12:33 AM EDT
AP Thursday, November 1, 7:33 PM

FRAMINGHAM, Mass. — Federal regulators said Thursday that they’ve found contamination in more drugs made by a pharmacy tied to a deadly meningitis outbreak.
The U.S. Food and Drug Administration said it doesn’t yet know the significance of the bacterial contamination discovered in recalled New England Compounding Center products. Some of the bacteria found are rarely cited as a cause of disease in humans. And no NECC products have been tied to reports of infection from the bacteria, the FDA said.
Continue reading here

Thursday, November 1, 2012

Bacteria found in more meds from Framingham pharmacy

Copy of New Emergency Regulations in Massachusetts

PHARMACY BOARD DRAFT EMERGENCY REGULATIONS
*all new language in bold; deleted language in strike-through
A. Existing Section; 2.00 Definitions - adds reference to specific definitions in new section 6.15
Additional definitions pertaining to:
(1) nuclear pharmacies are contained in 247 CMR 13.00;
(2) disciplinary proceedings are contained in 247 CMR 10.00;
(3) continuous quality improvement programs are contained in 247 CMR 15.00; and
(4) duty to report certain factors of pharmacy operations are contained in 247 CMR 6.15.
B. New Section 247 CMR 6.15 – Duty to Report Certain Factors of Pharmacy Operations
(1) Definitions:
(a) Accreditation means a process by which a professional association or non-governmental agency grants recognition to a pharmacy for demonstrated ability to meet certain pre-defined criteria.
(b) Disciplinary actions means actions including, but not limited to revocation, suspension, probation, censure, reprimand, or restriction of the license to operate a pharmacy or practice pharmacy, denial of application for renewal, denial or restriction of privileges or termination from Medicare or Medicaid programs including any adverse actions or fines imposed by a state or federal agency.

c) Federal agency means any U.S. Government agency that has regulatory purview over the clinical practice of pharmacy or of pharmacy operations, including, but not limited to, all agencies in the U.S. Department of Health and Human Services, the U.S. Occupational Safety and Health Administration, and the U.S. Department of Justice.
(d) State agency means any U.S. State or Territory that licenses or otherwise regulates pharmacies or pharmacist practice.

Compounding pharmacies must be better regulated

Published:

Thursday, November 1, 2012 12:03 PM EDT

As we come to the end of another Halloween season of ghouls and ghosts, we’re reminded that real life is much scarier than any imaginary villain we can concoct.

Few things are more frightening, in fact, than deadly threats against your health or the health of those you love. We have plenty of those types of diseases to deal with, most of which come into our lives unprovoked, which is why it’s particularly upsetting when another one slips through that could have been prevented.

In the case of the outbreak of fungal meningitis at a Massachusetts compounding pharmacy several weeks ago, the deadly component was a fungus in steroid injections that were concocted in a lab and administered to unknowing patients who were simply seeking some pain relief in their backs or joints.

The pharmacy, the New England Compounding Center of Framingham, Mass., recalled three lots consisting of a total of 17,676 single-dose vials of preservative-free methylprednisolone acetate, according to the Associated Press. The doses had been sent to 23 states and fungus was found in more than 50 unopened vials from the company.

More than 35 people in six states were infected with fungal meningitis linked to these shots. Twenty of those people have died as a result of the infection, and it appears that lack of oversight contributed to the deadly situation.

Compounding pharmacies like the one that made this injectable steroid are not regulated as closely as drug manufacturers, and their products are not subject to FDA approval for safety or effectiveness, according the AP report. Clearly, that needs to change.

This deadly meningitis outbreak is not the only problem that has arisen from such pharmacies, which create custom-mix solutions and medications in doses or forms that are not commercially available.

The AP reported that two people were blinded in Washington D.C., in 2005; three died in Virginia in 2006 and three more in Oregon the following year; 21 polo horses died in Florida in 2009; and earlier this year, 33 people in seven states developed fungal eye infections – all linked to drugs from compounding pharmacies.

When patients receive a drug of any kind from their doctor, they most likely believe that it has gone through FDA approval and the facility has been subject to rigorous inspection, so the drug is completely safe for their use. It’s shocking, frightening and enraging to find out that’s not the case.

The Massachusetts compounding pharmacy had been cited in the past for violations, and now inspectors believe they may have been operating beyond their license by making large batches of mixed drugs instead of customized prescriptions for specific patients. Everyone is looking for someone to blame in this incident and it’s certain that many lawsuits will be filed, particularly by those who lost family members to this disease.

Most importantly, however, this deadly incident offers an opportunity for regulators to take another look at their processes and try to improve the regulation of compounding pharmacies so such an incident can be avoided in the future. Of all the things we have to be afraid of, we shouldn’t have to fear our own medicines, the very thing we turn to for comfort when we’re already in pain.

• • •

Today’s editorial was written by Managing Editor Kristen Schulze Muszynski, representing the majority opinion of the Journal Tribune Editorial Board. Questions? Comments? Contact Kristen by calling 282-1535, Ext. 322, or via email at

Source found here

Massachusetts tightens rules for compounding pharmacies

BOSTON | Thu Nov 1, 2012 4:33pm EDT

BOSTON (Reuters) - Massachusetts adopted new regulations on Thursday that it said will allow it to keep a closer eye on compounding pharmacies, a class of drug supplier linked to the U.S. meningitis outbreak that has so far killed 29 people. The state, home to the New England Compounding Center that produced the injectable steroids at the heart of the outbreak, said the new rules give it the authority to track the volume and distribution of drugs that compounding pharmacies sell to determine if they are operating like manufacturers.
Compounding pharmacies - which are meant to assemble the raw ingredients of any medication one prescription at a time, not in industrial scale runs - had prior to this year's outbreak largely escaped the U.S. Food and Drug Administration's attention.
"Together with our federal partners, we will ensure that Massachusetts fulfills its responsibility in overseeing this transforming industry," said Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health.

Continue reading here

New rules set for compounding pharmacies

Mass. pharmacy board approves tougher rules for compounding pharmacies

The Patrick administration Thursday unveiled new emergency regulations to more tightly oversee compounding pharmacies like the Framingham facility linked to the national fungal meningitis outbreak.
The new rules, approved by the Massachusetts Board of Registration in Pharmacy, will for the first time allow the state to track the volume and distribution of drugs made by compounding pharmacies to determine whether they are operating more like a manufacturing facility subject to licensing by the US Food and Drug Administration.
Penalties are included for pharmacies that fail to comply with rules and regulations, and the rules give new powers to the pharmacy board to shut down operations of a compounding pharmacy and quarantine its products without having to first hold a hearing. The regulations also require pharmacies to report when they are the subject of an investigation by another state or federal authority.
At the same time, Massachusetts Congressman Ed Markey unveiled federal legislation Thursday to address what he called a “regulatory black hole” currently governing these pharmacies by giving the FDA new oversight authority. At least 28 people have died and 377 have been sickened after receiving injections of a contaminated steroid medication linked to the now-closed New England Compounding Center in Framingham.
“No one should live in fear that their medicine is unsafe, and these actions at the state and federal level will help ensure we’re at the forefront of efforts to protect public health,” interim state public health commissioner Dr. Lauren Smith said in a statement.
The Department of Public Health also announced Thursday that Christian A. Hartman, a specialist in pharmacy practice and patient safety, would chair a new Special Commission that will study potential changes to laws and regulations to fill the regulatory gray area between state and federal oversight.
Hartman is founder and president of the American Society of Medication Safety Officers, and previously served as medication safety officer at UMass Memorial Health System in Worcester and as a pharmacist at Brigham and Women’s Hospital in Boston, according to the Patrick administration.
State law requires compounders to have a patient prescription for each dose of medication produced, but officials have said New England Compounding was operating like a manufacturer, mass producing medications in violation of its state license. The FDA licenses drug manufacturers.
The new 10-member state commission will make its recommendations to the Patrick administration by Dec. 31, the statement said.

Source found here

Case Count: 386 States: 19 Deaths: 28* *Virginia is now reporting 2 deaths, instead of 3 deaths.

Description from Markey of Proposed Valid Compounding Act

The Verifying Authority and Legality In Drug (VALID) Compounding Act of 2012
The Verifying Authority and Legality In Drug (VALID) Compounding Act of 2012 builds on the
principles contained in the 1997 law that was later struck down, but without the provisions that
led to that legal outcome.
1. Preserves state regulatory authority for traditional small compounding pharmacy
activities. The VALID Compounding Act provides for an exemption from certain FDA
regulations if compounding pharmacies meet specific conditions, including:
• The drug must be compounded by a licensed pharmacist or physician for an identified
patient with a valid prescription;
• The drug must be compounded using safe and approved ingredients, and using good
manufacturing practices; and
• The drug cannot be a copy of a commercially-available drug.
2. Ensures that compounding pharmacies that are operating as drug manufacturers are
regulated by the FDA as drug manufacturers. The legislation requires compounding
pharmacies whose activities are classified by FDA as being more akin to drug manufacturing
(for example, because of the volumes of products they make) to register with the FDA as
manufacturers rather than pharmacies, and be subject to the same sorts of FDA inspection
authority as drug manufacturers are.
3. Allows some compounding pharmacies to request waivers to enable them to compound
drugs before the receipt of a valid prescription. The VALID Compounding Act requires
the FDA to define requirements (i.e. safety, testing, inspection, reporting or other
requirements) for types of compounding pharmacies that are not classified as drug
manufacturers, but that wish to compound drugs before receiving a valid prescription for an
identified patient. These types of compounding pharmacies could include hospital
pharmacies, community pharmacies that wish to make small batches of compounded drugs
for their regular customers, or compounding pharmacies that have small sterile compounding
facilities. The FDA also can delegate the authority for granting each type of waiver to state
regulatory authorities if the state authority has the resources to implement the waiver
program and oversee the facilities.
4. Allows the FDA to waive the requirement to compound drugs solely for individual
patients with valid prescriptions in the event of a drug shortage or to protect public
health. Waivers are for a period of one year, and extendable only if the drug shortage or
need to protect public health remains in effect.
5. Allows the FDA to waive the requirement to compound drugs only if they are not copies
of commercially-available drugs if doing so is necessary to protect public health or wellbeing.
Waivers are for a period of one year, and extendable only if the need to protect public
health or wellbeing remains in effect.
6. Increases transparency. FDA must create and maintain a “Do Not Compound” list of drugs
that are not safe or effective when compounded and make the list available to the public and
state regulators. The FDA is given clear authority to inspect any compounding pharmacy
that receives any waiver under the Act. Compounding pharmacies that become aware of
adverse reactions to compounded drugs or of potential safety problems with drugs they have
already distributed must report to the FDA. Compounded drugs must be labeled to ensure
that recipients are aware that FDA has not tested the drug for safety or effectiveness and to
provide a means to report serious adverse drug reactions.

What Proposed Federal Legislation IS Meant To Do?

VALID Compounding Act will give FDA authority it needs to ensure the safety of the compounding pharmacy sector nationwide

WASHINGTON, D.C. – Today, Congressman Edward J. Markey (D-Mass.) announced legislation he plans to introduce tomorrow that will strengthen federal regulations for compounding pharmacies. The New England Compounding Center (NECC), a compounding pharmacy located in Rep. Markey’s Congressional District, has been found to be the source of contaminated injectable steroids that have led to 28 deaths and 377 illnesses in 19 states. The Verifying Authority and Legality in Drug (VALID) Compounding Act will give the Food and Drug Administration (FDA) clear, new authority to oversee compounding pharmacy practices throughout the country.

“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” said Rep. Markey, senior member of the Energy and Commerce Committee. “The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies. I look forward to working with my colleagues in Congress on a bipartisan basis to move this legislation forward.”

A copy of the VALID Compounding Act can be found HERE. A one-page description of the legislation can be found HERE.

The VALID Compounding Act will:

Preserve state regulatory authority for traditional small compounding pharmacy activities;
Ensure that compounding pharmacies that are operating as drug manufacturers are regulated by the FDA as drug manufacturers;
Allow compounding pharmacies with a legitimate reason to compound drugs before the receipt of a valid prescription to request a waiver to enable them to do so;
Allow the FDA to waive the requirement to compound drugs solely for individual patients with valid prescriptions in the event of a drug shortage or to protect public health;
Allow the FDA to waive the requirement to compound drugs only if they are not copies of commercially-available drugs if doing so is necessary to protect public health or well- being; and
Increases transparency to the public by mandating that compounded drugs be labeled to ensure that recipients know that the drugs have not been tested for safety or effectiveness, publishing a “Do Not Compound” list of unsafe or ineffective drugs, and reporting of bad reactions to compounded drugs or any drug that poses a safety risk.

“This bill will save lives by ensuring that compounding pharmacies play by the rules that are essential to protect patients,” said Diana Zuckerman, PhD, president of the Cancer Prevention and Treatment Fund. “This month’s tragic meningitis outbreak from contaminated steroid injections was absolutely preventable. We call on Congress to work in a bipartisan manner to pass Congressman Markey’s legislation, which is necessary to protect our families from these predictable, preventable tragedies.”

The legislation has been endorsed by Cancer Prevention and Treatment Fund, Jacobs Institute for Women’s Health, National Consumers League, National Research Center for Women & Families, Our Bodies Ourselves, and Union of Concerned Scientists. A copy of the endorsement letter can be found HERE.

Earlier this week, Rep. Markey released the report “Compounding Pharmacies, Compounding Risk”, which revealed that even before the current outbreak, problems at compounding pharmacies led to at least 23 deaths and 86 illnesses in 34 states, and that state regulatory bodies typically focus on more non-safety related traditional pharmacy licensing activities. A timeline of Rep. Markey’s work on compounding pharmacies can be found HERE.

Source found here

Valid Compounding Act--To Be Introduced Into Federal Legislation Tomorrow

To view the proposed bill, click here

Markey's Legislation to Be Introduced Friday and To be FDA-Regulated if Large Producers

Under Markey’s legislation, to be introduced Friday, such pharmacies would be FDA-regulated, if they produce larger quantities of a drug for general distribution. Officials say that’s what the company appeared to be doing, though they were only permitted to produce patient-specific prescriptions.

The bill also requires pharmacies to label compounded drugs to show they haven’t been FDA-tested.

Source found here

Mass. lawmaker seeks greater pharmacy regulation

By JAY LINDSAY

Associated Press / November 1, 2012

FRAMINGHAM, Mass. (AP) — A Massachusetts lawmaker says he'll introduce legislation to increase federal oversight of specialty pharmacies like the one linked to a deadly meningitis outbreak.

Democratic U.S. Rep. Ed Markey made the announcement Thursday outside the now-closed New England Compounding Center in Framingham.

A tainted steroid made by the center caused a fungal meningitis outbreak linked to 28 deaths across the country.
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Pharmacy Compounding: Federal Law in Brief

by Jonathan J. Darrow

Until recently, most ordinary people had never heard of “pharmacy compounding.” Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis Outbreak, N.Y. Times, Oct. 6, 2012).

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FDA & Compounders: More Oversight Needed?

1 day ago by editor
By Ed Silverman

ver the past two years, compounded medications have figured in two highly controversial episodes. In one instance, Roche attempted to prevent ophthalmologists from using its older Avastin med for treating wet macular degeneration when its newer and more expensive Lucentis is the only approved treatment. The drugmaker has claimed that rejiggered vials of Avastin pose a safety risk (readhere and here).

In another, KV Pharmaceutical caused a huge ruckus by initially charging $1,500 for its Makena premature birth drug and trying to use its FDA approval under the Orphan Drug Act to prevent compounding pharmacies, which charged a fraction of the price, from competing. The move outraged physicians, among others, who maintained the compounded versions were safe and kept a lid on rising healthcare costs.

Now, an outbreak of meningitis that has been traced to a compounding pharmacy in Massachusetts has, once again, placed compounding in the spotlight, and renewed debate about the extent to which oversight is sufficient. The outbreak, which has left five people dead and another 30 in various stages of illness across six states, appears to have been caused by a compounded steroid drug contaminated by a fungus.

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The Sound of Silence

LINDA GREENHOUSE October 31, 2012, 9:00 PM

Reading about the belated scramble by Massachusetts regulators toinspect the compounding pharmacies in their state in the wake of the meningitis crisis left me wondering about the apparent lack of federal oversight of the $3 billion

Markey to unveil plan sparked by deaths linked to Framingham lab

Mass. to Hold Hearings on State Health Department

November 1st, 2012

BOSTON (AP) — Massachusetts lawmakers are planning to announce a series of public hearings looking into the state Department of Public Health’s handling of two recent crises.

The first hearing will look at the department’s oversight of pharmacies in Massachusetts.

The hearing comes in the wake of a deadly fungal meningitis outbreak linked to a compounding pharmacy in Framingham that has sickened 377 nationwide, 29 of whom have died.

The second public hearing will look at the department’s supervision of the state drug laboratory following the testing scandal at the drug lab.

A third public hearing will look at the state’s role in overseeing the department and the need for increased transparency at the department.

State Reps. Jeffrey Sßnchez, David Linsky, and Harold Naughton plan to announce the hearing schedule Thursday at the Statehouse.

Source found here

Huge Drug Recall Latest Fallout in Meningitis Outbreak

By Sharon Begley | November 1, 2012

Ameridose, a sister company of the U.S. pharmacy linked to a meningitis outbreak that has killed 29 people, announced on Wednesday a voluntary recall of all its products, a move to cooperate with regulators that could nevertheless create shortages of some drugs.

In particular, the U.S. Food and Drug Administration and a number of hospitals are concerned about the availability of several drugs for which Ameridose has been a major supplier, including those given as shots or intravenous drips or used during surgery.

The Westborough, Massachusetts-based company, which was closed on Oct. 10, said it had not received any reports of adverse reactions to the products it is recalling but that the FDA has asked it to improve its sterility testing processes.

“Ameridose and FDA agree that the use of injectable products that are not sterile can represent a serious hazard to health,” the company said in a statement, adding that it shipped its medications nationwide.

The company asked its customers to quarantine Ameridose drugs while they arrange to return them to the company.

Earlier in October, the FDA said, “The current production shutdown of Ameridose may impact supplies of certain drugs for some health care systems.”

The FDA “is aware that this recall might affect the availability of certain drugs,” Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, told Reuters. “This is a company that produces and ships a lot of sterile injectables. We are trying to mitigate the effects (of the Ameridose recall) on drug supplies.”

FILLING THE GAP

The FDA has already spoken with other manufacturers about filling the supply gap left by the shutdown of Ameridose and now the recall of its products, Woodcock said, including helping those whose manufacturing facilities have been curtailed by technical or other issues “get back into production.”