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Stokes Pharmacy Earns FDA 503B Registration As An Outsourcing Facility

October 2, 2018

MOUNT LAUREL, N.J.--(BUSINESS WIRE)--Oct 2, 2018--Stokes Pharmacy, a respected compounding pharmacy that has formulated medications for humans and pets nationwide for over 40 years, has earned registration from the U.S. Food and Drug Administration (FDA) as a 503B Outsourcing Facility which will operate under the name “Stokes Healthcare, Inc.” Stokes is one of the only compounding pharmacies in the veterinary industry to achieve 503B registration.

Now, not only can Stokes prepare compounded medications prescribed for individual patients nationwide—which the pharmacy has done since its founding in 1975—but is now also qualified to produce medication under the FDA 503B registration for use by doctors and veterinarians in their hospital/office.

To be registered as a 503B outsourcing facility by the FDA, a pharmacy must meet stringent rules and regulations to ensure the consistent quality and integrity of their compounded medications from batch to batch. Referred to as current good manufacturing practices (cGMPs), these rules and regulations are the same as those followed by the traditional pharmaceutical manufacturing industry.

The FDA Commissioner has stated that all hospitals should order compounded medication from an FDA 503B Registered Outsourcing Facility. Connecticut is the first state that is requiring this in the context of veterinary medicine. It is expected that many other states will follow suit. Read more here.

“Many veterinarians think that all compounded medications are the same, but nothing could be further from the truth,” said Stokes President and Owner Michael Tursi, MBA. “503B registration ensures a level of precision that translates into consistent concentrations of medication in every batch, reliable sterility, and purity, which leads to optimal patient outcomes. As a result, hospitals that purchase compounded medications from a 503B manufacturer working under FDA oversight can significantly decrease their liability.”

“Further, all 50 states allow practices unlimited administration of drugs from a 503B outsourcing facility,” he adds. “This helps ensure that animal hospitals have the supply they need in the face of shortages or emergency situations and deliver the best possible care.” To learn more, download the Stokes Report: The Importance of cGMP (503B) Compounded Drugs.

About Stokes Pharmacy

For more than 40 years, Stokes Pharmacy has been preparing compounded prescriptions nationwide for human and animal patients. Unlike medications dispensed at a traditional retail pharmacy, compounded medications can vary from pharmacy to pharmacy. Regulations pertaining to compounding pharmacies vary from state to state. That’s why Stokes adheres to strict quality standards, to ensure that medications are precisely and consistently formulated, every single time. For more information, visit stokespharmacy.com, or call (800) 754-5222.

View source version on businesswire.com:https://www.businesswire.com/news/home/20181002005017/en/

CONTACT: Stokes Pharmacy

Stacy Milazzo, 856-272-7466

smilazzo@stokespharmacy.com

KEYWORD: UNITED STATES NORTH AMERICA NEW JERSEY

INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL FDA VETERINARY GENERAL HEALTH

SOURCE: Stokes Pharmacy

Copyright Business Wire 2018.

PUB: 10/02/2018 07:00 AM/DISC: 10/02/2018 07:00 AM

http://www.businesswire.com/news/home/20181002005017/en

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