ORLANDO, FL--(Marketwired - Feb 17, 2015) - QmedRx, a compounding pharmacy servicing patients in all 50 states through in-home delivery, has concerns about the new US Food and Drug Administration (FDA) proposals for the pharmaceutical compounding industry.
Recently, the FDA proposed four guidance documents and one Memorandum of Understanding (MOU) that are meant to clarify the Drug Quality and Security Act (DQSA) enacted by Congress in 2012.
The proposed Memorandum of Understanding regarding states and their regulation of compound pharmacies is the most concerning to QmedRx. It would require compound pharmacies to be investigated and penalized if they distribute and dispense more than 30 percent of their prescriptions outside of the state in which they were compounded. If adopted, this regulation would greatly limit the quality of compound pharmaceuticals available to patients across the United States. Doctors would only be able to order compounds from pharmacies within their state lines instead of having the option to choose the pharmacy offering the best patient care. This proposal usurps State Board of Pharmacy Laws and Regulations while limiting free trade.
"QmedRx wants to ensure patient access across the United States," said QmedRx Chief Operating Officer Blake Powers. "If the FDA limits compound pharmaceutical companies' out-of-state distribution and dispensing, then it will negatively affect patients who rely on compound drugs to survive. I encourage you to submit comments to the FDA regarding these proposed documents and voice your concern about limiting patient access to necessary compound pharmaceuticals."
Compounding medications are an integral part of the practice of pharmacy and the demand for these customized medications is increasing every year. Compounded medications are prescriptions written by physicians, veterinarians and other legally authorized prescribers that are customized for an individual patient to meet special needs and requirements by a specially trained pharmacist.
QmedRx, Inc. is a Florida-based specialty pharmacy and healthcare service company that has been serving patients in their homes since 1990 through its PCAB® and ACHC-accredited pharmacy, Home Care Solutions. The pharmacy is proud to service patients in all 50 states, extending patient convenience for multi-state families and traveling situations. For more information, visit http://www.qmedrx.com/.