Tuesday, August 27, 2013

Not A Compounder but Nonetheless--Justice Department Sues South Dakota Drug Manufacturer for Improperly Producing Sterile Eye Drops August 26, 2013

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The Medicine Store closes up shop---It had already stopped compounding injectables and sterile eye drops-- Will More Compounding Pharmacies Start to Close their Doors With Increased Regulations?

HYANNIS — Richard "Rick" Gregg celebrated his pharmacy's 30th year in business last Thursday. On Monday, he closed up shop for good.
The Medicine Store, located on West Main Street, closed on Monday. Starting today, customers calling the shop are redirected to the nearby West Main Street Rite Aid, which bought the independent pharmacy.
Gregg, a pharmacist for 40 years, has retired. One of his pharmacists and two technicians will likely be working at the Rite Aid, he said. Three part-time pharmacists will focus on their full-time jobs elsewhere, he said.
Customers can get their prescriptions at the nearby Rite Aid store, Gregg said.
The pharmacist started alerting customers last week about the impending closure.
"It's my time," Gregg said about retiring.
Gregg bought the Medicine Shoppe on Seaboard Lane in 1983 as a franchise. He moved to the current spot on West Main Street in 1992. When his contract as a franchise business ran out 10 years ago, he renamed it the Medicine Store.
The shop's pharmacists would compound drugs for patients on an individual basis. It stopped compounding injectables and sterile eye drops last fall after the state enforced new guidelines for the industry. The increased oversight came after New England Compounding Center in Framingham made medicines linked to the 2012 fatal outbreak of fungal meningitis.
The Medicine Store continued to compound non-sterile products like hormone creams and pediatric products, Gregg said. Many pharmacies in the state take orders online for these compounds.
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FDA/CDER Statement: FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories

Drug Safety and Availability CDER Statement: FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories

Recalls, Market Withdrawals, & Safety Alerts Park Pharmacy & Compounding Center is Issuing a Voluntary Recall of Two Compounded Sterile Preparations. The Recall is Due to a Lack of Sterility Assurance

Recalls, Market Withdrawals, & Safety Alerts Park Pharmacy & Compounding Center is Issuing a Voluntary Recall of Two Compounded Sterile Preparations. The Recall is Due to a Lack of Sterility Assurance

Find Out the Safety of Compounded Drugs Before You Use Them--great tips in this blog post about questions to ask and things to look for

Are compounded medications safe? Well, it depends. It depends on which pharmacy you choose. It depends on the collaboration between you, your physician and your pharmacist. It also depends on your health condition and how you react to certain components in the medications. This is why it is even more important to plan the use of compounded drugs with your physician and pharmacist before you begin to use it.
Does the Food and Drug Administration (FDA) approve these drugs? The FDA has not approved these drugs but they do acknowledge the usefulness of these alternatives to the regular commercially manufactured drugs. Their website says, “FDA believes that pharmacists engaging in traditional pharmacy compounding provide a valuable medical service that is important to patient health.”

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Compounding Pharmacies Should Not Be Operating as Pharmaceutical Manufacturers

Robert G. Bell, Ph.D., is president and owner of Drug and Biotechnology Development LLC.

On October 26, 2012, the FDA issued a Form 483 with five observations to the New England Compounding Center, the company at the center of the storm of the fungal meningitis outbreak associated with more than 400 cases reported in almost 20 states with 29 deaths. During the inspection, the FDA observed contaminated products and listed a number of deficiencies regarding conditions in the clean rooms, environmental controls, and quality procedures. You can view the complete FDA Form 483 here.

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Another Job in Compounding Pharmacy Sales

Pharmaceutical/Compounding Pharmacy Sales Rep (Orlando)
We are looking for Pharmacy Sales Reps in the South Florida Area. Experience is desired but not required. Offering Both Full Time and Part Time positions. 100% Commission with average Sales Rep making 200K. Please reply with you resume attached or Fax 866-625-1709
  • Location: Orlando
  • Compensation: Average 200K per year - 100% commission
  • This is a contract job.
  • Principals only. Recruiters, please don't contact this job poster.
  • Please do not contact job poster about other services, products or commercial interests.
Posting ID: 4026975739
Posted: 2013-08-26, 1:58PM EDT
Updated: 2013-08-26, 1:58PM EDT

Fungal Meningitis Outbreak: Who Oversees a Compounding Pharmacy?

Since the fungal meningitis outbreak last fall, more than 50 people have died, and roughly 700 are being treated for “persistent fungal infections”
August 26, 2013 -- About 17,000 vials of unregulated injectable corticosteroids were shipped to clinics and hospitals in the fall of 2012 from a pharmacy “clean room” found at the New England Compounding Center (NECC) - a “clean room” that harbored fungal contamination, as reported by CBS News 60 Minutes.

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