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Compounding Pharmacy Industry Has Outgrown Its Regulatory System, ASHP and FDA Say

[May 1, 2013, AJHP News]

Cheryl A. Thompson

BETHESDA, MD 11 Apr 2013—In the half year since a compounding pharmacy in Massachusetts announced a recall of all its products "due to the potential risk of contamination," two other pharmacies declared recalls "due to lack of sterility assurance."

And at least two additional compounding pharmacies have recalled their maybe-not-so-sterile products after FDA personnel inspected the facilities.

The human toll is real.

Five patients have been diagnosed with a serious eye infection after receiving bevacizumab that Clinical Specialties Compounding Pharmacy had repackaged into single-use syringes from the manufacturer’s vials, the Georgia pharmacy stated on March 20.

More than 50 patients have died and about 680 others in 20 states have been diagnosed with a fungal infection after receiving an injection of methylprednisolone acetate produced by the New England Compounding Center, according to the latest federal report.

A Connecticut hospital was more fortunate. Among the i.v. solutions received from Med Prep Consulting Inc. were five 50-mL bags of magnesium sulfate in 5% dextrose injection that turned out to contain mold, the New Jersey compounding pharmacy reported on March 16.

According to NBC News, a nurse at the hospital noticed "floating mold" in one of the bags and notified the pharmacy department.

Connecticut Senator Richard Blumenthal, in a letter to FDA’s chief, asserted that "gaps in current laws and FDA regulation" have allowed the "compounding pharmacy industry" to operate without sufficient oversight.

Need for better regulatory system. Kasey K. Thompson, an ASHP vice president, said hospital pharmacies, physician office practices, and other purchasers of products from the "large-scale compounding–manufacturing industry" would benefit from a better regulatory system.

"The original regulatory system hasn’t really kept up with changes in this industry," he said. "What we’re seeing now is that there isn’t a clear jurisdiction and oversight by the federal government and/or state boards of pharmacy over these large-scale manufacturing entities."

FDA Commissioner Margaret A. Hamburg recently blogged about her agency’s limited authorities over "this growing industry."

The agency, she wrote, needs legislation that establishes federal standards for companies that "compound sterile drug products in advance of or without a prescription and ship them interstate."

Thompson said these companies have justifiable reasons for operating at what seems to be the manufacturing level.

Oftentimes the companies "make up for deficits as a result of drug shortages," he said.

The companies also meet patient- and prescriber-specific needs for customized medications and help address general efficiency in the preparation of i.v. admixtures, he added.

Congressional promise. Hamburg and Thompson said a Senate committee has been working to improve the situation.

FDA, Hamburg wrote, wants legislation that makes "certain high-risk sterile compounding facilities" subject to federal oversight. And FDA wants funding, perhaps through fees, to support that oversight.

ASHP, Thompson said, has given the committee the Society’s ideas as to what should be addressed in that legislation.

In particular, the legislation should recognize that "there are distinctions between the various entities" that compound sterile drug preparations, he said.

For example, some companies repackage products in accordance with instructions in the FDA-approved labeling. Some companies prepare large amounts of products from bulk active pharmaceutical ingredients and sterilize those products.

The Senate committee may circulate a draft of the legislation as early as this summer, Thompson said.

Access for inspections. Nine years ago, an FDA official told a Senate committee that the agency had difficulty entering compounding pharmacies to determine whether they engaged in dangerous practices.

The pharmacies, the official testified, contended that they were not subject to regulation by FDA. Thus, FDA had to obtain a search warrant each time to enter the facilities and examine their records of compounding activities.

Hamburg in her March 22 blog said FDA’s lack of clear authority over pharmacies that produce medications in advance of or without a prescription and ship them out of state stymies inspections by the agency.

Not only have some inspectors been delayed in their work, she said, they have been denied full access to records at some of the facilities.

Nonetheless, FDA has managed to inspect more than 30 such facilities over the past two months, Hamburg said.

Reports from inspections at 24 of those facilities have been posted online by FDA.

In all of those reports, the entry for "Type of Establishment Inspected" was producer of sterile or injectable drug products.

FDA is helping to determine the root cause of the contamination found in the i.v. solutions from Med Prep Consulting, the New Jersey Division of Consumer Affairs announced March 22.

At the pharmacy’s website, Med Prep Consulting states that it is licensed as a "Central Fill IV Compounding Pharmacy" in New Jersey. The executive director of the state’s board of pharmacy did not respond to questions about this type of license.

Yale–New Haven Hospital, where a nurse found mold in an i.v. solution of magnesium sulfate, did not respond to a request for interview.

 

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