Lincare Pharmacy Faces Injunction, Spurs Regulatory Action

Kansas City, Mo. Med 4 Home — a compounding pharmacy that allegedly failed to comply with Missouri rules regarding the recall of contaminated drugs — has spurred regulatory activity that could threaten the viability of small compounding pharmacies throughout the state, according to the International Academy of Compounding Pharmacists.

The story became public March 10, when the Missouri Board of Pharmacy asked a judge to issue a temporary restraining order against Med 4 Home, a subsidiary of Clearwater, Fla.-based Lincare.

“Board investigators determined that Med 4 Home had not followed proper recall and notification procedures for a batch of albuterol/ipratropium solution it had compounded,” said Kevin Kinkade, the board’s executive director. “Quality assurance tests conducted by the pharmacy revealed contamination in at least two lots of the product.”

However, Med 4 Home recalled only partial batches of the product and did not explain to patients the reason for the recall, Kinkade explained. “They did not tell [patients] they had potentially contaminated products — only that it was a quality assurance problem,” he said.

Responding to the board’s findings, state officials last week renewed their focus on enacting a rule that governs the way compounding pharmacies operate, the Kansas City Star reported. The proposed rule, which could take effect as early as this summer, would require pharmacies to:

• ensure the sterile compounding of certain drugs;
• notify the state board every time they issue a drug;
• maintain better records of complaints; and
• log the amounts of drug ingredients they use, by volume.

But IACP called the rule’s approach to sterile compounding “fundamentally flawed.”

Because it places emphasis on end-product testing, the rule “is inefficient, extremely expensive and only partially effective for assuring product quality,” IACP said. “With millions of dollars at stake for both pharmacies and patients, IACP recommends that the Missouri Board of Pharmacy consider an alternative approach to the regulation of sterile products — the implementation of systematic process controls.”

In a Jan. 31, 2003, letter to the Missouri Board of Pharmacy, IACP requested that the board not issue compounding standards hastily. “The implications and impact of the proposed regulations on Missouri pharmacies warrant provision of additional time for discussion, research, evaluation and revision.”

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