Olympia Compounding Pharmacy Announces FDA Outsourcing Facility Registration
ORLANDO, Fla. - April 8, 2014 - PRLog -- Olympia Compounding Pharmacy announced today it has voluntarily registered with the FDA as an outsourcing facility. This new designation was created in November 2013, when President Obama signed Title 1 of the Drug Quality and Security Act, referred to as the Compounding Quality Act, into law. As a registered outsourcing facility, Olympia will be on the FDA’s list of compounding pharmacies that are subject to Section 503B of the Food, Drug, and Cosmetic Act. Olympia will therefore be able to compound and distribute medications to hospitals and clinics without patient-specific prescriptions, provided that all requirements of Section 503B are met. With this new designation, Olympia is implementing guidelines provided under Current Good Manufacturing Practice (CGMP) regulations. The CGMP standards help ensure higher quality and safety for compounded medications. To facilitate this transition, Olympia has enlisted the help of Kymanox, a leading CGMP services firm with expertise in regulatory compliance, aseptic manufacturing, validation, and quality systems.
Compounding pharmacies play a vital role in the health and well-being of millions of patients across the United States. Compounding is the practice of creating customized medications for patients in need of a drug that is not readily available through traditional means.
Prior to the passage of the new Compounding Quality Act, USP was the primary regulation used to govern sterile compounding pharmacies, and guidance was provided mainly by state boards of pharmacy. After the fungal meningitis outbreak in October 2012, caused by poor sterility assurance at New England Compounding Center in Massachusetts, federal legislators passed the new law, which greatly expanded the role of the FDA in providing guidance for compounding pharmacies.
Under current guidelines, registration with the FDA is not mandatory. However, compounding pharmacies who do not register as an outsourcing facility will no longer be able to supply “office use” medications to hospitals, clinics, or physician offices. Olympia has elected to be one of the pioneering compounders to voluntarily register as an outsourcing facility and is committed to working together with the FDA and state authorities to supply patients with safe and high-quality drug products. Valeria Baker, Olympia’s Quality Manager, stated, “We have always held ourselves to our own high expectations as a leader in the compounding world. This was an easy decision for our team. We will be a better compounder because of it, and the patients and physicians we service can rest assured they are getting the safest and highest quality medications available.”
About Olympia Compounding Pharmacy
Olympia is a full service pharmacy located near Universal Studios in Orlando, Florida. Specializing in bio-identical hormone replacement, men’s health medications, women’s health medications, anti-aging, weight loss, and veterinary drugs, Olympia has over 35 years of combined compounding experience. For more information on the Olympia Difference Click Here
Page Updated Last on: Apr 09, 2014