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

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.