SPAARx Issues Industry Letter to Inform Legislators and FDA About the Dissimilarity of Specialty Pharmacy vs. Compounding

FLORHAM PARK, NJ, Apr 02, 2013 (Marketwired via COMTEX) -- The Specialty Pharmacy Association of America (SPAARx), the largest national association representing the broad interests of the specialty pharmacy industry, today announced that it is launching a national advocacy initiative focused on pending federal and state legislation and regulation through agencies including the United States Food and Drug Administration (FDA) related to Compounding. The Association believes that a clear understanding of the differentiation between specialty pharmacy and compounding is critical to avoid unintended consequences.

Numerous media reports over recent weeks, including lead articles by The New York Times, The Wall Street Journal, The Boston Globe, The Washington Post, and others, have used the terms 'Specialty Pharmacy' and 'Compounding' interchangeably, which is inaccurate, misleading to the public and to legislators and regulators as they consider actions that could affect pharmacies that create compounded drugs, but specialty pharmacies as well.

In response, SPAARx is sending a letter to appropriate House and Senate Committees, the FDA Commissioner, and state legislators, that differentiates specialty pharmacy from compounding to help inform decision making. The Association supports the accreditation of compounding pharmacies by nationally recognized agencies with the necessary expertise to assess and confirm ongoing compliance with the highest standards for quality compounding. Most importantly, the Association wishes to inform the public that services provided by compounding pharmacies are poles apart from those services provided by specialty pharmacies.

"SPAARx believes that specialty pharmacy and the art and science of extemporaneous compounding are dissimilar," said Bill Sullivan, Interim Executive Director of the Specialty Pharmacy Association of America. Sullivan continued, "Specialty pharmacies dispense FDA approved and commercially available medications requiring patient-specific prescriptions. By comparison, compounding-only pharmacies prepare medications from FDA approved chemical ingredients and commercially available medications which may not require a patient-specific prescription at the time of formulation. New laws and / or regulations should take into account these significant dissimilarities and focus such actions on compounding as appropriate."

Earlier this year the Specialty Pharmacy Association of America endorsed a comprehensive Definition of Specialty Pharmacy in which no mention is made of the practice of compounding. The definition may be downloaded at: http://www.spaarx.org/documents/SPAARx Specialty Pharmacy - Definition.doc

About Specialty Pharmacy Association of America (SPAARx) SPAARx is the largest national Association solely dedicated to the interests of all individuals in the specialty pharmacy segment of healthcare. SPAARx is managed and governed by a board of directors comprised of executives from a diverse group of specialty pharmacies. This association is vendor-neutral and fully-aligned with the interests of all industry stakeholders. SPAARx is setting the standards, leading in advocacy and promoting the value of specialty pharmacy. The association's goal is to protect and promote common industry interests along with fostering professional growth within specialty pharmacy. To learn more about SPAARX or join today, please visit www.spaarx.org\

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Question of the Day: 4/1/2013 In increasing regulations and inspections to rein in bad compounders how do we keep from running off the good compounders who are so essential in both human and animal medicine?

ASHP Continues Efforts to Address Pharmacy Compounding

4/1/2013

The outbreak of meningitis caused by contaminated methylprednisolone acetate compounded by the New England Compounding Center last fall put the spotlight on sterile products outsourcing. In the aftermath of the incident, ASHP has workedwith policymakers, practitioners, and nationally recognized experts in compounding and manufacturing to develop new approaches to protect patients from preventable harm, and to give practitioners and organizations confidence that compounding outsourcers are appropriately regulated and inspected, and that the products they produce are safe.

Working with Experts

In February, ASHP partnered with The Pew Charitable Trusts, and the American Hospital Association to hold a Summit that explored the scope of pharmacy sterile compounding and the associated risk factors, the differences between sterile production expectations under Current Good Manufacturing Practices and United States Pharmacopeia <Chapter 797>, and oversight roles for states and the federal government. Recommendations from the Summit will be released in April.

 

Educating PolicymakersASHP has worked to educate policymakers and others about what distinguishes patient-care driven hospital and health-system based IV admixture services from commercial sterile compounding outsourcing.  ASHP has also advocated to preserve the important role that credible compounding outsourcers’ play to help supply hospitals and health systems with sterile products that are in short supply, customized dosage forms, high-risk level sterile preparations, and repackaged medications from FDA-approved products.

 

The Society has urged the Food and Drug Administration (FDA) to requirecompounding service providers that operate at the scale and scope of manufacturers to register with the agency, share details about their operations, and submit to routine inspections. Current discussions center on the FDA oversight of a “third category” of vendors—companies that prepare sterile preparations without patient-specific prescriptions and ship them across state lines. FDA is exploring what criteria must be met for these entities to be under the FDA's jurisdiction versus traditional state pharmacy scope of practice laws.

 

ASHP continues to work with Congress on strategies to address the regulatory gaps with respect to sterile preparations that are mass produced and often shipped to customers across state lines.  Much of the discussion thus far has focused on the third category of vendors and how broadly the category needs to be defined. Further, discussion has focused on ensuring there are no unintended consequences that would enable a large sterile preparation entity to bypass the New Drug Application and Abbreviated New Drug Application requirements set forth for manufacturers.

 

The Society is also collaborating with state affiliates to monitor activity in state legislatures and boards of pharmacy. California, Maryland, Massachusetts, New Jersey, South Carolina, Tennessee, and Virginia are among the numerous states taking action on compounding.

 

To support ASHP's continued advocacy efforts, a member survey is being conducted to gain information on sterile compounding and the use of outsourcing vendors by health systems.

Resources for Members

ASHP continues to provide members with up-to-date information on the compounding issue, including timely notification of compounded product recalls via the online Sterile Compounding Resource Center, news capsules, and ASHP Connect. The Society is also continuing its efforts to address drug shortages, which may play a role in the decision to obtain products from an outsourcing supplier. The Society continues to work closely with officials in the FDA’s Drug Shortages Program to help assess the situation and provide perspectives on the impact of shortages on patients and providers.

Read More• Experts Seek Strategies to Ensure Quality in Sterile Compounding• ASHP Makes Recommendations on Oversight of Pharmacy Compounding• ASHP Testifies to Senate Committee on Compounding• ASHP Provides Tools for Members to Deal with Aftermath of Compounding Incident

Quoted from here

Clark v. New England Compounding Pharmacy, Inc. et al

Clark v. New England Compounding Pharmacy, Inc. et al

Regulators scrutinize compounding pharmacies in Tennessee, nation (with video) by Kate Harrison

Compounding pharmacies see renewed attention after meningitis outbreak

Chattanooga-area compounding pharmacies have seen renewed attention from both customers and the Tennessee Legislature after a deadly meningitis outbreak that stemmed from a Massachusetts pharmacy. Access Family Pharmacy, which fills about 60 compounding prescriptions per day, has specialized in compounding prescriptions since 1962.

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Compounding pharmacies long have been able to fill the gap between mass-produced drugs and highly personal medical needs.

These pharmacies can customize a drug product into a liquid or a gas for patients who can't swallow pills. They can make a medication without specific allergens. They can flavor a medicine with mint or tropical fruit to be more palatable. And they can compound drugs that are on back order -- such as Tamiflu for children.

"Maybe [the patient] can't take something that's commercially made because it's one-size-fits all. Or it's something that's not commercially made and they've got to have it," explains pharmacist Phil Smith at Access Pharmacy, which has been compounding drugs in the Hixson store for more than 50 years.

But over the last few months, state and federal officials have said the gap that compounding pharmacies have filled has been far too unregulated, leading to abuse by certain pharmacies.

"It has been a crazy few months for compounding," said Smith. "We have been letting our customers know that our chemicals are tested, our manufacturers are FDA tested and approved. Things like that let people know what our quality standards are."

A deadly meningitis outbreak prompted heightened scrutiny from both state and federal regulators. Just last month, there were two more recalls of sterile compounded and repackaged drug products, first from a New Jersey compounding pharmacy after fungal contamination was found at a hospital. Days later, a compounding pharmacy in Martinez, Ga., recalled syringes of the drug Avastin after it received reports of eye infections among patients.

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