Navigation Links
PharMEDium Encourages Swift Action to Strengthen Federal Oversight of Advanced Sterile Compounding
Date:4/15/2013

WASHINGTON, April 15, 2013 /PRNewswire/ -- PharMEDium appreciates Congress' efforts to reexamine oversight of pharmacy compounding in the wake of the deadly meningitis outbreak. PharMEDium provides a valuable service on which hospitalized patients depend and feels strongly that oversight of the compounding pharmacy industry is in need of reform.

Today, the safety of patients depends on the patchwork of ambiguous federal jurisdiction and inconsistent state regulatory approaches. For example, the production of compounded sterile preparations (CSPs) in anticipation of a prescription is a difficult practice for states to oversee, especially when these preparations are shipped across state lines. Accordingly, PharMEDium believes Congress must move swiftly to clarify FDA's legal authority over the compounding pharmacy industry, distinguish it from the appropriate role of state boards of pharmacy, strengthen governing standards, and facilitate effective inspections and enforcement.

Many of the medications administered to hospitalized patients today are not manufactured by traditional pharmaceutical manufacturers in the specific composition and doses the modern practice of medicine requires. Many hospitals have determined it is simply more efficient and safe to outsource admixing CSPs in anticipation of the hospital pharmacy's dispensing these preparations to a patient. Forcing hospitals to make these sterile preparations would not improve the safety or quality of care, and could have the opposite effect. In a recent survey of hospitals, the HHS Office of Inspector General found that an abrupt shortage of CSPs from outside pharmacies would create "life-threatening major disruptions" in 11 percent of responding hospitals and would have "non-life-threatening but great impact" on an additional 48 percent.

PharMEDium believes that clear standards for compounding should enhance the safety of sterile compounding.  In addition to the standards established by the U.S. Pharmacopeia (USP), applicable good manufacturing practices (GMP) should be used by FDA to inspect facilities that perform this service. These standards would distinguish those compounding processes that begin with FDA-approved and inspected sterile ingredients and those that start with non-sterile active pharmaceutical ingredients (API, or bulk powders), which involve the highest level of risk.

In our years of experience as a registrant with the FDA, we have found that FDA alone has the expertise to apply appropriate GMP standards to oversee this sector of the industry. PharMEDium and other leading CSP hospital-outsourcers have benefitted from years of FDA inspections, leading to enhanced safety protocols and the development of best practices. While additional resources may be required to expand FDA oversight to all compounding pharmacies that engage in the interstate supply of compounded sterile preparations in anticipation of a prescription, patient safety is worth that investment.

PharMEDium stands ready to help Congress better understand this critical service and to work with Congress to prevent future incidents of patient harm by strengthening regulatory oversight through legislation that clarifies federal oversight of compounded sterile preparations.

Who we are: PharMEDium is one of the nation's leading providers of hospital pharmacy-outsourced, sterile admixture services with centers in four states and thousands of acute care hospital customers nationwide. Our qualified personnel and state-of-the-art centers are registered with the FDA, licensed by states as compounding pharmacies and governed by our own rigorous quality standards. We begin the compounding process with sterile FDA-approved drugs from FDA-approved drug manufacturers. It is our mission to be the preeminent provider of choice for hospital customers and to attain the highest degree of integrity in the compounding of sterile preparations.Contact:

Bob Szafranski Bob.Szafranski@edelman.com312-863-9135 (mobile)312-240-2687 (work)


'/>"/>
SOURCE PharMEDium
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. PharMEDium Highlights Enhanced Labeling for ICU Services at Critical Care Expo
2. CVS Caremark Encourages Heart Healthy Behavior During American Heart Month
3. Home Access Health Corp. encourages cholesterol testing during American Heart Month, beyond
4. BI-LO Offers Health Giveaways With Flu Vaccinations, Encourages Community To Shield Their Health This Flu Season
5. Faruqi & Faruqi, LLP Encourages Investors Who Suffered Substantial Losses Investing In American Oriental Bioengineering Inc. To Contact The Firm Regarding The August 22, 2012 Lead Plaintiff Deadline
6. EvergreenHealth Encourages Community to Use Free Microsoft Service to Store Personal Health Information for Emergencies
7. Terry Yon Encourages Higher Standards of Pharmaceutical Care
8. WAISMANN METHOD® Director Encourages Public to Participate in National Take-Back Day
9. Faruqi & Faruqi, LLP Encourages Investors Who Suffered Substantial Losses Investing in Chelsea Therapeutics International, Ltd. to Contact the Firm
10. Lung Cancer Alliance Congratulates 75 Medical Centers For Moving Swiftly And Responsibly On Lung Cancer Screening
11. Star Scientific, Inc. Issues Statement in Response to Two Plaintiffs Purported Class Action Law Suits and Multiple Press Releases Issued by Plaintiffs Law Firms Trolling for New Clients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/31/2016)... -- The global biomaterials market is driven by ... deaths from chronic diseases. According to research report, "Global Biomaterials ... and Forecasts (2016-2021) - (By Value; By Material Type - ... Care); By Region-North America, Europe , APAC, ... , Italy , Japan ...
(Date:5/31/2016)... , May 31, 2016 ... Health Assembly zur Eliminierung von viraler Hepatitis    ... eine historische Verpflichtung eingegangen, virale Hepatitis bis 2030 ... World Health Assembly haben sich die Staaten ... viraler Hepatitis (Global Viral Hepatitis Strategy) zu verabschieden, ...
(Date:5/30/2016)... India , May 30, 2016 /PRNewswire/ ... market research report "Healthcare Biometrics Market by ... (Signature, Voice)), Multifactor, Multimodal), Application (Workforce Management), ... Forecast to 2021", published by MarketsandMarkets, the ... Million by 2021 from USD 1,182.6 Million ...
Breaking Medicine Technology:
(Date:5/31/2016)... ... ... day, adults often find themselves reaching for a cup of coffee, an energy drink, or ... instead is a cup of Matcha green tea. Matcha is a premium green tea powder ... from early June to mid-July, when the leaves are the most tender. , ...
(Date:5/31/2016)... ... 31, 2016 , ... Twenty years ago it was revolutionary: enabling the people ... the voices they hear. But this approach has proven transformative, both for people who ... gained credibility and now is used around the world, but it still lags in ...
(Date:5/31/2016)... ... 31, 2016 , ... Spartan Bioscience today introduced the Spartan ... convenience. , The Cube is exceptionally small—it takes up the space of a ... into any space, whether in a hospital, doctor’s office, or pharmacy. , The ...
(Date:5/31/2016)... CA (PRWEB) , ... May 31, 2016 , ... WaterField ... for digital-minded professionals, announces the waxed-canvas and leather Duo Dopp Kit , the ... waxed canvas or ballistic nylon, the Duo is smartly designed for Dad’s ...
(Date:5/31/2016)... ... May 31, 2016 , ... Phynd Technologies, Inc. announced recently the signing of ... TX and Shore Medical Center – Somers Point, NJ. The new clients range in ... demonstrating the breadth of Phynd’s solution and its interoperability. , Houston Methodist is a ...
Breaking Medicine News(10 mins):