House Subcommittee on Health explores pharmacy compounding
WASHINGTON — Aftershocks from last year’s nationwide outbreak of fungal meningitis linked to a Massachusetts-based compounding pharmacy continued to be felt in a House subcommittee meeting Thursday.
The House Energy and Commerce Committee Subcommittee on Health convened a hearing to examine the state of pharmacy compounding in the United States and the current regulatory environment under which it operates.
Since last year, more than 50 people have died and nearly 700 have become sick with fungal meningitis and other fungal infections linked to contaminated injectable steroids shipped from the New England Compounding Center. Compounding consists of mixing or altering medical ingredients by a licensed pharmacist in response to a prescription for an individual patient and comprises two basic types, sterile and nonsterile. Nonsterile compounding is done for such medications as suppositories, mouthwashes and ointments and can involve pre-packaged ingredients in kits or changing an existing drug, such as the common practice of breaking open capsules of Genentech’s flu drug Tamiflu (oseltamivir) for administration as a drinkable liquid. Sterile compounding involves injectable pharmaceutical and biotech drugs, and must be done in clean rooms under strict adherence to sterile practices; this was the type of compounding that the NECC was doing.
In light of the NECC scandal, many people such as Food and Drug Administration commissioner Margaret Hamburg have called for increased federal scrutiny of compounding pharmacies, and Thursday’s meeting was one of a series of actions taken by the committee to determine how to prevent similar incidents in the future.
"Compounding is a backbone of pharmacy practice and, for many decades, independent community pharmacists have provided millions of adults, children and animals with access to safe effective and affordable medications through traditional compounding services," Arlington, Texas-based DFW Prescriptions owner Joseph Harmison said in testimony before the subcommittee on behalf of the National Community Pharmacists Association, a trade group representing independent pharmacies. "When manufactured drugs aren’t an option, independent community pharmacists provide traditional pharmacy compounding to prepare customized medications for patients in accordance with a doctor’s prescription based on the patient’s individual needs. Traditional compounding services also can help bridge the gaps during times of prescription-drug shortages."
Sometimes tragedies makes for bad laws. I hope they do not go too far to create barriers for pharmacies to provide services for thier patients.
Forest Labs to find new president, CEO before year’s end
NEW YORK — Forest Labs president and CEO Howard Solomon will retire at the end of 2013, the company said.
The drug maker announced that Solomon would still remain as chairman through the 2014 annual meeting, retaining the title of chairman emeritus after a replacement is elected. Solomon has served as CEO since 1977, chairman since 1998 and president since 2010.
An independent committee of the company’s board of directors is looking within and outside the company for candidates to replace Solomon and plans to announce a successor before the end of the year.
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Coty to purchase Southeast Asian distributor
NEW YORK — Coty Inc. has reached an agreement to acquire StarAsia, a distributor of beauty products in the markets of Southeast Asia — Cambodia, Hong Kong, Indonesia, Malaysia, Singapore, Taiwan and Vietnam — from Isibane Pte. Ltd.
Financial terms of the deal, which is expected to close in the summer, were not disclosed.
"The acquisition of StarAsia provides us with an established distribution platform to sell our mass brands in key developing markets in the Southeast Asia region," stated Michele Scannavini, CEO of Coty. "We are happy to welcome the StarAsia organization into the Coty family, and I am confident that the talented team there will fit in very well at Coty."
The existing management team of StarAsia will continue to lead the development of Coty`s business in the region.
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