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
Thursday, October 31, 2013
State Senate compounding bill exempts hospital pharmacies By Chelsea Conaboy | GLOBE STAFF OCTOBER 31, 2013
The state Senate passed a bill Wednesday requiring compounding pharmacies that custom-mix sterile drugs to obtain a special license from the state pharmacy board, submit to annual inspections, and report more information about their operations. But, unlike the plan approved last month by the House, it temporarily exempts a large segment of the industry: hospital pharmacies.
Instead, the bill would create a commission to review oversight of hospital pharmacies and make recommendations by July 2015. If no change is made by then, the hospitals would become subject to the same rules as other compounding pharmacies.
“A hospital is a very different setting from a manufacturer's setting,” said Anuj Goel, vice president of legal and regulatory affairs at the Massachusetts Hospital Association. He noted that hospitals monitor their drug quality and are subject to outside reviews conducted by accreditation boards and the Centers for Medicare & Medicaid Services, which are not done at wholesale drugmakers. “Hospitals have always been and continue to be regulated.”
But federal site visits to hospital pharmacies happen irregularly, and state inspections are done as part of overall hospital licensing. The state pharmacy board now has no role in inspecting the hospital pharmacies, though it does license their pharmacists.
continue to read here
Senate has adjoined; Schedule for Monday November 4, 2013
We prepare a Daily Summary with each day's expected Senate schedule.
Senate Floor Schedule for Monday, November 4, 2013
The Senate stands adjourned until 2:00pm on Monday, November 4, 2013. Following any Leader remarks, the Senate will resume consideration of the motion to proceed to S.815, the Employee Non-Discrimination Act. During Thursday’s session of the Senate, cloture was filed on the motion to proceed to S.815. At 5:00pm, the Senate will proceed ...
November 4, 2013
The Senate stands adjourned until 2:00pm on Monday, November 4, 2013. Following any Leader remarks, the Senate will resume consideration of the motion to proceed to S.815, the Employee Non-Discrimination Act. During Thursday’s session of the Senate, cloture was filed on the motion to proceed to S.815. At 5:00pm, the Senate will proceed ...
November 4, 2013
FDA outlines plan to combat drug shortages Toni ClarkeReuters Facebook Twitter LinkedIn GooglePlus Email 41 minutes ago
The Food and Drug Administration released a strategic plan for preventing drug shortages Thursday and proposed a rule to require drug and biotechnology companies to promptly notify the agency of potential disruptions to the supply of medically important drugs.
The plan and proposal come in response to a 2011 order from President Barack Obama to solve the problem of drug shortages. Between 2005 and 2011 the number of new shortages quadrupled to 251. That figure declined to 117 in 2012 but there were still more than 300 ongoing shortages at the end of the year.
The 2012 Food and Drug Administration Safety and Innovation Act called for the FDA to improve its response to imminent or existing drug shortages and to address the underlying causes. The act also gave the FDA new authority to require drug manufacturers to notify it of potential supply disruptions.
KUDOS to Michigan AG: Home Metro Michigan October 31, 2013 at 10:41 am Michigan AG seeks license suspension for South Lyon pharmacy Lauren Abdel-Razzaq The Detroit News
The Michigan Attorney General’s Office is seeking a license suspension for a South Lyon pharmacy recently linked to the distribution of tainted injections.
An administrative complaint was filed Tuesday against pharmacist Kenny R. Walkup Jr., and his operation Specialty Medicine Compounding Pharmacy. Attorney General Bill Schuette filed the complaint in conjunction with Steve Arwood, the director of the Department of Licensing and Regulatory Affairs.
Schuette also moved to suspend Walkup’s controlled substance license.
According to the complaint, Henry Ford Hospital notified the Food and Drug Administration on Oct. 17 after they found multiple vials of unexpired dextrose injections, which were a green and brown color. Tests showed the injections contained two types of mold and fungus.
“There is the potential that products received by Michigan facilities have been contaminated,” the complaint says. “Respondent allowed an adulterated product to be shipped to Michigan health facilities leading to an imminent public health threat in the State of Michigan as it is unknown how many products were contaminated and administered to patients.”
Because of the amount of the drug produced, it is believed Walkup was producing the drugs before his manufacturing license had been approved, court documents say. The complaint also questions whether Walkup’s facility is a sterile environment.
Walkup issued a voluntary recall of the tainted products on Oct. 19. The products were distributed to hospitals and individual consumers across the state beginning July 1. For a complete list of the recalled products, visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts.
“Michigan citizens trust pharmacists to follow the laws designed to keep consumers safe,” Schuette said in a statement. “As soon as the tainted drugs were reported, we moved swiftly to protect public safety and welfare, and we have launched an official investigation to determine whether additional civil or criminal action is warranted.”
The complaints come amid a massive review of state regulations for compounding pharmacies after a meningitis outbreak linked to New England Compounding Center in Massachusetts.
The pharmacy is alleged to be behind 264 infections and 19 deaths in Michigan, according to the most recent data available from the Centers for Disease Control and Prevention and the Michigan Department of Community Health.
lrazzaq@detroitnews.com
(313) 222-2127
(313) 222-2127
From The Detroit News: http://www.detroitnews.com/article/20131031/METRO06/310310091#ixzz2jK7k3cWW
AG calls for suspension of compounding pharmacy's license : Specialty Medicine Compounding Pharmacy Oct. 31, 2013 11:19 A
State Attorney General Bill Schuette is calling for the suspension of a South Lyon compounding pharmacy's license following a precautionary recall of the pharmacy's injected products.
Schuette announced this morning he was filing a complaint against Specialty Medicine Compounding Pharmacy seeking the suspension of the pharmacy's license, as well as the suspension of pharmacist-owner Kenny Walkup Jr.’s pharmacist and controlled- substance licenses.
The Department of Licensing and Regulatory Affairs has confiscated all controlled substances at the facility in South Lyon, and Specialty Medicine Compounding Pharmacy has been forced to cease operations.
continue to read here
Subscribe to:
Posts (Atom)