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Capitol Connections Article [Bloomberg News Story] [5/03/2013]
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Bloomberg News: Draft Senate Bill Aims to Clarify FDA Role In Regulating Compounding Pharmacies

By Brian Broderick | April 26, 2013 05:13PM ET

(BNA) -- Senators' Draft Bill on Compounding Pharmacy Safety

Key Development: HELP Committee Chairman Harkin and other senators offer draft bill on improving safety of pharmacies that custom-make drugs.

Input Sought: Senators ask stakeholders for responses about the bill, and how to improve it, by May 3. A Senate draft bill is designed to improve the safety of compounded drugs by making clear the federal and state oversight roles for compounding pharmacies, the chairman of the Senate Health, Education, Labor, and Pensions Committee and other lawmakers said April 26.

“This legislation is a significant step forward in protecting the public from unsafe compounded products,” HELP Committee Chairman Tom Harkin (D-Iowa) said in a statement. “By clarifying [Food and Drug Administration] authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak.” The deadly outbreak, linked to a compounding pharmacy in Massachusetts, has prompted concerns about the adequacy of the existing oversight structure for such pharmacies. Harkin and the other senators, including committee ranking member Lamar Alexander (R-Tenn.), asked stakeholders to provide feedback on the policy merits, potential unintended consequences, and opportunities to improve the legislative language. Comments are due May 3 and should be sent to

Clear Boundaries, Fees on Pharmacies
A summary said the draft bill “establishes a clear boundary between traditional compounders and compounding manufacturers,” adding that such manufacturers “make sterile products without or in advance of a prescription and sell those products across state lines.”

However, materials on the committee's website said that “interstate shipment within a hospital system will not cause a hospital pharmacy to be considered a compounding manufacturer.”

The draft defines FDA's role in oversight of compounding manufacturers. It calls on compounding manufacturers to register with FDA and tell the agency what products they have made, the summary said. “Our goal with this bill is to put an end to FDA inaction and make it clear who is on the flagpole—who is in charge and accountable for oversight of these pharmacies and manufacturers,” Alexander said in a statement. The states' role in regulating traditional pharmacies would be preserved, according to the summary from Senate HELP. In addition, the draft encourages communication among the states and increases the communication between states and FDA, the summary said.

The committee's summary added that a compounding manufacturer would have to pay an annual establishment fee to defray the cost of compounding oversight and would cover FDA's costs for any needed reinspections. The fee is $15,000 per year with an inflation adjustment.

However, small businesses, defined as compounding manufacturers with 25 or fewer employees, would pay one-third of that fee, according to the Senate panel's website. Those fees can be used only for the inspection and regulation of compounding manufacturers.

FDA may promulgate a regulation that designates drugs that may not be compounded “due to the demonstrable difficulty of safely compounding these drugs, such as certain complex dosage forms and biologics,” according to the HELP Committee's website. Until such a rule is final, FDA can designate products by notice following a 30-day comment period.

A compounding manufacturer would have to label products with a statement identifying the products as compounded drugs and other specified information about the drugs.

Pharmacists See Need for Refinement
The International Academy of Compounding Pharmacists said it is reviewing the draft. “We applaud the steps the Committee and the U.S. Senate are taking to ensure that compounded medications are as safe as they can be. IACP believes that the safety of patients must always be the first consideration of any pharmacy-oriented public policy,” the group said in a statement.

IACP said that, from a preliminary review, “we see that there are some aspects of the draft that will need further discussion and refinement, and we intend to work with the Committee on these.” The group added that the draft does not contain any provisions “that speak directly to standards aimed at raising the quality of compounded medications.”

IACP said it is “gravely concerned that compounding pharmacies located in hospitals and health systems have been exempted from many of the proposed changes. Such an exemption denies patients and their families the assurance, regardless of where they receive their medications, of the quality and safety that they deserve.”

In addition, the group said it is concerned “that some provisions may reduce patient and physician access to customized medications, the very services that compounding pharmacists provide.” IACP stressed that “state boards of pharmacy are responsible for the licensing and oversight of compounding pharmacies and the FDA is responsible for overseeing and regulating pharmaceutical manufacturers. We think the term ‘compounding manufacturer’ and several of the definitions of that new category create more confusion and further blur the jurisdictional authority of regulators.”

IACP said it will recommend improvements in the draft language to make the proposed categories more clear.

Good Manufacturing Practice Standards
Attorney Greg Levine, with Ropes & Gray LLP, in Washington, D.C., told BNA April 26 that pharmaceutical manufacturers are likely to welcome the bill, which they may view as creating a “more level playing field” between manufacturers and the large-scale compounders that do not meet the criteria for traditional compounding.

He said a key aspect of the bill that would impose a burden on the new category of compounding manufacturers is requiring compliance with FDA's current good manufacturing practice (cGMP) standards, rather than the guidelines from the U.S. Pharmacopeia that have governed compounding of sterile medications.

The traditional compounders would remain exempt from cGMP, he noted, and may consider the legislation helpful because it would clarify the exemption. There is an analogous exemption in the current statute, but FDA has questioned its validity following a series of conflicting appellate court rulings, he added. Levine also noted that there may be debate over the definition of a traditional compounder. Some compounders that repackage medications into sterile, single-dose vials, but that otherwise meet the traditional compounding definition, might be surprised to find themselves swept into the new category of a compounding manufacturer under the draft bill, he said.

For More Information
Click here for the text of the bill.
Click here for the summary.

The above story appeared in:
Daily Report for Executives
Health Care Daily Report
Pharma. Law & Industry Report
Product Safety & Liability Rep















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