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Bloomberg BNA: Texas Drug Compounder to Resume Operations
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By Paul Stinson | April 13, 2016 5:13PM ET

April 13 (BNA) -- A Texas compounding pharmacy is rejecting an April 6 call for the suspension of its license and those of its pharmacists, telling Bloomberg BNA that a late March follow-up inspection by the state had concluded that a recall or halting of production of sterile products had been deemed unwarranted.

An April 6 letter from consumer group Public Citizen to the Texas State Board of Pharmacy “strongly urges” the state body “to suspend immediately the pharmacy license” of Austin, Texas-based I.V. Specialty and that of Pharmacist-in-Charge Carlos H. Garcia, citing a pair of “failed” Food and Drug Administration inspections over the past two years.

The Washington-based consumer group told the state board that “state regulatory actions are urgently needed to protect patients from potentially life-threatening infections,” adding that I.V. Specialty “recklessly refused” to follow the FDA's March 7 recommendations to discontinue production of injectable drugs and to recall all of its unexpired injectable drug products.


March Alert From FDA

The FDA on March 9 alerted health-care professionals and patients not to use sterile drug products originating from I.V. Specialty due to lack of sterility assurance, following an inspection carried out over the Jan. 25 to Feb. 5 period.

“We take the FDA's recommendation seriously and have implemented corrective actions to rectify the deficiencies pointed out,” Garcia told Bloomberg BNA April 6.

Gay Dodson, executive director of the Texas State Board of Pharmacy, told Bloomberg BNA April 11 that although a March 24 inspection conducted by the board had resulted in a warning notice in light of “conditions that needed to be fixed, ” the state official said a shutdown wasn't called for.

“[I]t didn't rise to the level of needing to do a temporary suspension hearing which is what we'd have to do to close them down,” Dodson said.

 

Pharmacy: Services to Resume Following Recertification

Garcia said that the state board “just completed a follow up inspection on March 24th, and while they did issue a warning letter for a few minor deficiencies which will be taken care of during the renovation, they did not find egregious issues to warrant disciplinary action against the pharmacy.”

“Following the completion of upgrading our facilities and subsequent recertification we will continue current services provided,” Garcia said. The recertification results, he added, will then be forwarded to the federal agency and the state board to show the company's compliance following the renovation.

As part of attending to the FDA warning, cleanroom renovations were completed April 10, Garcia confirmed to Bloomberg BNA in an April 12 e-mail, adding that “the recertification of the cleanroom has taken place and certificates are being issued.”

 

Compounding Association

Offering comment, a top compounding pharmacy association official affirmed patient safety as the highest priority, but said the federal agency had gone too far.

“[W]e feel the FDA has grossly overstepped their responsibility provided by Federal law,” John Voliva, executive vice president at the International Academy of Compounding Pharmacists (IACP), told Bloomberg BNA April 8.

“FDA performed two inspections of the pharmacy and appears to attempt to erroneously hold the pharmacy to current Good Manufacturing Standards (which Outsourcing Facilities must comply with) and not State or Federal law as it pertains to compounding,” he said. Under a 2013 federal law, an entity that compounds sterile drugs can register as an outsourcing facility.

It is the IACP's position, Voliva said, that the State Board of Pharmacy has the primary responsibility for the oversight of pharmacies and to ensure compliance with state and federal law, adding that if a pharmacy is found to be in violation of any part of federal law, responsibility falls to the state board to inform the federal agency of those violations.

“If the Texas Board of Pharmacy performed a follow-up inspection of the licensed pharmacy and they found no violations of Federal law, then we feel this issue should be closed, especially since the FDA admits they have no knowledge of any adverse events related to the preparations I.V. Specialty compounds,” Voliva said.

Responding to Public Citizen's April 6 release, the IACP also took issue with the organization's characterization of an order by the Alabama State Board of Pharmacy directed toward a compounding pharmacy to cease production of sterile drugs, because of a situation “remarkably similar to I.V. Specialty.”

Voliva said that in the absence of details of the federal and state inspections incurred by both pharmacies, “it is erroneous and problematic” that the consumer group would label the two situations as being remarkable in their similarity.

“We call on Public Citizen to retract this statement, unless they have intimate knowledge of both situations,” Voliva said.

“We do, however, fully support Public Citizen's call to increase the communication and coordination between the FDA and the State Boards of Pharmacy,” Voliva said, noting that language was included within the Drug Quality and Security Act that expresses congressional intent to increase communication between the state boards and the FDA.

“Both entities serve a similar goal—to protect patient health and well-being,” he said.

To contact the reporter on this story: Paul Stinson in Austin, Texas, at pstinson@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

The FDA's March 9 alert is at http://www.fda.gov/Drugs/DrugSafety/ucm489951.htm.

An undated statement from the pharmacy is at http://src.bna.com/d0k.

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