Seminar on the DQSA by Microtest Laboratories

 

The Impact of the Drug Quality and Security Act on Compounding Pharmacies Is the Subject of May 13th Seminar in Boston      

AGAWAM, MASS. — April 29, 2014 — A seminar focusing on the impact of HR3204 — the Drug Quality and Security Act — on compound pharmacies and manufacturers is the subject of a seminar set for May 13, 2014 in Dedham, Mass., near Boston.

Meeting the new guidelines will require substantial changes for many compounders. The seminar is designed to explain the stepping stones needed to comply with the new legislation as well as review USP <797> in its current state.

The seminar will provide pharmacies and compounders that do business as compounding manufacturers and outsourcing facilities with the knowledge they need to know about how the new regulatory expectations will affect their businesses.

Seminar topics will include:

·         Becoming a compounding manufacturer

·         Manufacturing under cGMP requirements

·         Meeting current USP <797> requirements

The seminar will be presented by Microtest Laboratories, a leader in testing services for the medical device, pharmaceutical, and biotechnology industries, on Tuesday, May 13, 2014, from 9 a.m. to 3 p.m. at the Endicott House in Dedham, Mass., just outside Boston. Registration is at 8:30 a.m. A continental breakfast, break refreshments, and a luncheon are included.

To register, visit http://www.microtestlabs.com/seminar or contact Julie Adamski 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com. Advance registration is $149.

 

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AHLA In-House Counsel Program and Annual Meeting June 29-June 2, 2014 in NYC to Including Laura A. Carpenter Speaking on Compounding

Pharmacy Compounding: What Hospitals Need to Know when Purchasing

Compounded Preparations from Specialty Pharmacies (not repeated)

Laura A. Carpenter

Pharmacy compounding serves an important health need when a patient needs a

product that is not commercially available. This program will address:

❯❯ The risk factors involved in outsourcing pharmacy compounding

❯❯ The difference between manufactured drugs and compounded preparations

❯❯ The United States Pharmacopoeia (USP) standards for compounding and monographs.

❯❯ The FDA’s position on when a drug is “compounded” or “manufactured”

❯❯ The impact of the federal Compounding Quality Act, which was enacted in

November 2013

❯❯ Different state law scenarios for regulating compounding preparations and purchasing

them by hospitals, clinics, outpatient treatment centers, and physician offices

more information found here

State legislation would tighten controls on compounding pharmacies

Compounding pharmacies in Michigan may soon operate under a system of tighter controls and regulations, and employees could face felony charges and prison sentences if patients are injured or die because the new rules are not followed.
The aim behind Senate bills 704 and 904, sponsored by Sen. Joe Hune, R-Hamburg, is to prevent the kind of injuries and deaths suffered in the state two years ago when the Framingham, Mass.-based New England Compounding Center allegedly sent tainted medicine to clinics around the country.

Michigan was the hardest hit when the tainted steroids were delivered to clinics in the state, resulting in 264 infections and 19 deaths. Nationwide, the death count hit 64 with 751 cases of fungal infections or meningitis, according to the Centers for Disease Control and Prevention.

"Hearing from constituents that have been so adversely impacted by these tainted steroids, it's the least we can do," Hune said.

Compounding pharmacies mix and assemble pharmaceuticals to create a drug or form of medicine needed by a patient.

Hune's bills would add a series of requirements for these businesses, including that accurate records of its procedures are maintained, that the pharmacies are subject to a physical state inspection once every two years and that all compounding pharmacies designate a "pharmacist-in-charge" responsible for making sure the business follows the state regulations.

The criminal penalties for violating the rules that result in personal injury include a maximum of a four-year prison sentence. A violation that resulted in a patient death would carry a maximum 15-year sentence.

The legislation would also give the state the ability to immediately suspend the pharmacy license of the business if notice was received by the CDC or the Food and Drug Administration of imminent risk to public health or safety.

Attorney General Bill Schuette's office has been working with Hune on the bill, and supports the legislation he says will protect patients and hold pharmacists accountable
continue to read here

Pharmacist Pleads To Fraud Charge

OLD FORGE — A pharmacist from Lackawanna County is facing insurance fraud charges.
Authorities say Peter Capitano, owner of Capitano’s Pharmacy on South Main Street in Old Forge, submitted false insurance claims for fake prescriptions between 2007 and August of 2013.
According to federal investigators, a plea agreement has been filed requiring Capitano to pay back as much as $200,000.

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Florida Board of Pharmacy Conference Call Agenda for May 1, 2014 Regarding Compounding Rule

10:00a.m. Conference Call Meet Me # 1(888) 670 - Florida ...

floridaspharmacy.gov/Meetings/Agendas/.../050114-board-agenda.pdf‎

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13 hours ago - legally distributed in the State of Florida by a drug manufacturer or wholesaler. (1) Compounding includes: (a) The preparation of drugs or devices in anticipation ...

States Raise Legal Issues With FDA's Compounding Info-Sharing Plan

FDA is weighing how to encourage state officials to enter information-sharing agreements for drug compounding oversight after state stakeholders expressed concerns that some agency requirements, such as those that conflict with some state sunshine laws, pose major legal hurdles, according to recently released minutes of an FDA meeting with state regulators and stakeholders.

How Hong Kong's On-Track Pharmacies Work

How Hong Kong's On-Track Pharmacies Work

In this video, David G. Miller, RPh, executive vice president and CEO of the International Academy of Compounding Pharmacists (IACP), discusses changes in insurance reimbursement for compounded medications.

view video here

PharMEDium Announces Updated Core Values

April 25, 2014

Our Core Values represent what the company is and where it is headed.  Please click here, or go to the About Section - Core Values Tab, to read more.                           

Oklahoma Legislators Want to Impeach Justices Who Suspended Death Sentences

The state of Oklahoma narrowly avoided a constitutional crisis over the death penalty on Wednesday evening, after the governor moved to defy a state Supreme Court order and legislators called for impeachment of several justices.
This constitutional stand-off began on Monday, when the court issued an order halting two executions. Gov. Mary Fallin (R) responded with an executive order saying the state might proceed with the executions, despite the court order. Rep. Mike Christian (R) ordered articles of impeachment drafted on Wednesday, claiming the justices engaged in a “willful neglect of duty” by halting the executions of Clayton Lockett and Charles Warner. After this pushback from the political branches, the court lifted its order on Wednesday and allowed the executions to proceed.

The court initially stopped the executions because the inmates had sued to find out the source of the state’s lethal drugs. Oklahoma law says, “The identity of all…persons who supply the drugs…for the execution shall be confidential.” The Oklahoma Supreme Court ultimately rejected the inmates’ argument that they needed this information to assert their right to avoid “cruel and unusual” punishment under the Eighth Amendment.

continue to read here