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.
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Bacteria found in more meds from Framingham pharmacy

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

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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.

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New rules set for compounding pharmacies

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.

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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.