Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Friday, January 4, 2013
Patrick announces legislation overhauling pharmacy board
1/04/2013 1:53 PM
By Kay Lazar and Chelsea Conaboy, Globe Staff
By Kay Lazar and Chelsea Conaboy, Globe Staff
Governor Deval Patrick announced on Friday planned legislation to reorganize the state board of pharmacy to add professionals from other fields and to give the board the authority to regulate out-of-state compounding pharmacies that distribute drugs in Massachusetts.
The state board has been scrutinized following a national outbreak of fungal meningitis that has killed at least 40 people and has been blamed on tainted steroids produced at New England Compounding Center in Framingham. The Globe reported that regulators knew about problems at the facility but repeatedly failed to take concerted action requiring improvements.
Continue reading here
Phil Woodward, Executive Director of Oklahoma Pharmacists Association Comments on Compounders
Phil Woodward, BSPharm, Pharm.D , Eecutive Director of Oklahoma Pharmacists Association has recently, 1/3/13, writen One Step Ahead of the Curve, arguing that Oklahoma remains ahead of the curve in protecting the safety of our citizens and will continue to work with state and federal officials to insure the strength, quality and purity of all medications. To read the entire article click here
DEA Proposes New Regulations to Dispose of Unwanted Prescription Drugs
http://ncadd-middlesex.blogspot.com/ is reporting the following:
The Drug Enforcement Administration (DEA) has proposed new regulations to give the public more options for disposing of unwanted prescription drugs, such as painkillers and sedatives. The new rules are designed to reduce the amount of highly abused prescription drugs on the streets, the Orlando Sentinel reports. The DEA wants law enforcement agencies and pharmacies to maintain collection boxes for certain medications. The agency also recommends implementing mail-back programs to safely dispose of the drugs. Under the proposed rules, for the first time, groups outside of law enforcement would be allowed to collect unused drugs for disposal, the article notes. According to a DEA news release, the proposal would allow authorized retail pharmacies to voluntarily maintain collection boxes at long-term care facilities. The DEA also calls for continued use of prescription drug “take-back” events. The public can comment on the proposed regulations until February 19. Congress subsequently will vote on the measure.
The Drug Enforcement Administration (DEA) has proposed new regulations to give the public more options for disposing of unwanted prescription drugs, such as painkillers and sedatives. The new rules are designed to reduce the amount of highly abused prescription drugs on the streets, the Orlando Sentinel reports. The DEA wants law enforcement agencies and pharmacies to maintain collection boxes for certain medications. The agency also recommends implementing mail-back programs to safely dispose of the drugs. Under the proposed rules, for the first time, groups outside of law enforcement would be allowed to collect unused drugs for disposal, the article notes. According to a DEA news release, the proposal would allow authorized retail pharmacies to voluntarily maintain collection boxes at long-term care facilities. The DEA also calls for continued use of prescription drug “take-back” events. The public can comment on the proposed regulations until February 19. Congress subsequently will vote on the measure.
Mass. pharmacy blames cleaning company for meningitis outbreak
The Associated Press
BOSTON — The Massachusetts compounding pharmacy linked to a nationwide meningitis outbreak that has been blamed for 39 deaths and hundreds of illnesses is blaming its cleaning contractor.
The Boston Globe reports that attorneys for New England Compounding Center sent a letter to UniFirst Corp. demanding that it take legal responsibility for claims against the pharmacy.
UniFirst acknowledged that a subsidiary helped clean portions of the pharmacy's cleanroom facility in Framingham, but maintained its cleaning services were limited and it was not responsible for the contaminated drugs. A spokesman called the claims "unfounded and without merit."
Federal investigators found widespread evidence of mold and other contamination when they visited the pharmacy in October.
UniFirst received the letter last week and disclosed it in a filing Thursday with the Securities and Exchange Commission.
Source found here
Mass. Gov. Proposes New Compounding Pharmacy Rules
BOSTON (AP) — Gov. Deval Patrick is proposing tighter regulations on compounding pharmacies following last year's deadly meningitis outbreak linked to a Massachusetts company.
Patrick said Friday he's filing a bill that would require compounding pharmacies obtain a special state license, create whistleblower protections for pharmacy workers, hire more inspectors and enforce new fines and penalties for compounding pharmacies that break the rules.
Continue reading here
Thursday, January 3, 2013
What is the Role of Compounding Pharmacies?
April Pettit, MD, an infectious disease specialist at Vanderbilt University in Nashville, Tenn., was the first physician to identify the unthinkable. One of her patients—an immunocompetent 50-year-old male—had contracted fungal meningitis in September 2012, weeks after receiving an epidural injection of methylprednisolone for low back pain. Twenty-two days after he was admitted to the hospital, the patient was dead.
Continue reading here
Continue reading here
Oregon Board of Pharmacy and LegitScript
The National Association of Board of Pharmacy announces:
In December 2012, the Oregon State Board of Pharmacy took actions that will prevent a rogue Internet drug outlet from distributing products to customers in Oregon, while LegitScript helped to shut down a large scale marketing portal facilitating rogue sites. The Oregon Board fined Hayden Hamilton, owner of ProgressiveRX.com, $50,000 for operating without an Oregon pharmacy license as well as other violations. Hamilton agreed to no longer distribute drug products to customers in Oregon, reportsPharmacy Choice.
Legitscript announced the shut down of Myrxcash.com, an Internet marketing affiliate site that provided tools to help establish rogue Internet drug outlets. The entity was linked to hundreds of Web sites identified as illegal online drug sellers, reports Pharmacy Choice. LegitScript indicates in a blog articlethat the entity subsequently set up shop under a new Web site address, but that LegitScript intends to assist in shutting down this site also, and will focus on “denying the network’s ability to process payments.”
Legitscript announced the shut down of Myrxcash.com, an Internet marketing affiliate site that provided tools to help establish rogue Internet drug outlets. The entity was linked to hundreds of Web sites identified as illegal online drug sellers, reports Pharmacy Choice. LegitScript indicates in a blog articlethat the entity subsequently set up shop under a new Web site address, but that LegitScript intends to assist in shutting down this site also, and will focus on “denying the network’s ability to process payments.”
Quotation found here
In the CapeCodeToday News dated 12/31/12, Massachusetts lawmakers began pursuing changes in state laws governing pharmacies. The following summary appears:
4) COMPOUNDED DRUGS, COMPOUNDING PROBLEMS
A nationwide outbreak of fungal meningitis landed on the doorstep of public health regulators in Massachusetts after the source of the infections was traced to the Framingham-based New England Compounding Center that had been manufacturing injectable steroids for widespread distribution in violation of its state pharmacy license. To date, the contaminated steroids have led to 620 cases of infection in 19 states, contributing to 39 deaths, according to the Centers for Disease Control. Though no one in Massachusetts was treated with the contaminated drugs, the public health crisis exposed wide gaps in the federal and state regulatory structure for compounding pharmacies and led to the issuance of emergency regulations by Gov. Deval Patrick to improve reporting and start more random spot checks of pharmacies located in Massachusetts. The Board of Registration in Pharmacy also got an overhaul in its membership, and state lawmakers embarked on a series of oversight hearings to explore the reasons why NECC was able to operate undetected as a compounded drug manufacturer in violation its state license. The stage is now set for lawmakers to pursue changes in state laws governing pharmacies in the session that starts on Wednesday.
Quotation appears here
4) COMPOUNDED DRUGS, COMPOUNDING PROBLEMS
A nationwide outbreak of fungal meningitis landed on the doorstep of public health regulators in Massachusetts after the source of the infections was traced to the Framingham-based New England Compounding Center that had been manufacturing injectable steroids for widespread distribution in violation of its state pharmacy license. To date, the contaminated steroids have led to 620 cases of infection in 19 states, contributing to 39 deaths, according to the Centers for Disease Control. Though no one in Massachusetts was treated with the contaminated drugs, the public health crisis exposed wide gaps in the federal and state regulatory structure for compounding pharmacies and led to the issuance of emergency regulations by Gov. Deval Patrick to improve reporting and start more random spot checks of pharmacies located in Massachusetts. The Board of Registration in Pharmacy also got an overhaul in its membership, and state lawmakers embarked on a series of oversight hearings to explore the reasons why NECC was able to operate undetected as a compounded drug manufacturer in violation its state license. The stage is now set for lawmakers to pursue changes in state laws governing pharmacies in the session that starts on Wednesday.
Quotation appears here
Subscribe to:
Posts (Atom)