FDA sets sights on sterile products standard

Mark A. DeSorbo

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has begun to compile public comments on the concept paper Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness in an effort to establish and regulate pharmacy practices.

The paper, which is largely based on Chapter 1206 of United States Pharmacopoeia, stems from a statute in the FDA Modernization Act of 1997 that mandates drugs and sterile products may be prepared if they are not identified by the FDA in regulation as a drug product that presents difficulties when compounding, causing adverse affects on safety and effectiveness.

“Our intent is to set some standards that would keep products free of hospital borne viruses and bacteria,” says Andrea C. Masciale, regulatory counsel for CDER. “The lack of any standard, be it in a hospital or local pharmacy, could lead to non-sterile products and harm to patients.”

Masciale says the concept paper, docket number 00N-1357, is the center's first attempt to establish a baseline for drug preparation standards, hailing Chapter 1206, which is also undergoing revision, as its foundation. The chapter addresses numerous protocols for facilities, personnel and gowning, training, aseptic processing and cleaning and sanitizing. The pharmaceutical community had until Tuesday, August 15 to comment on the concept, but Masciale says there will be at least one more opportunity for industry professionals to comment.

“We are not saying people cannot compound sterile products, we want standards in place to ensure the quality and sterility of products,” she adds. “If [pharmaceutical professionals] think USP 1206 is not the best set of standards, we want to hear that.”

In a letter to the FDA regarding the concept paper, Hank Rahe, a member of the CleanRooms Editorial Advisory Board, says he agrees that there is a need for a consistent minimum standard for compounding sterile products, but Chapter 1206 and similar guidelines from the American Society of Health-System Pharmacists (ASHP) is, at best, theoretical.

Open to interpretation

Chapter 1206 and ASHP guidelines, Rahe believes, are open to interpretation by personnel who may not be familiar with the requirements, in terms of facilities, training and quality assurance necessary to produce safe and effective sterile products.

“Both are, therefore, in need of improvement,” he wrote, pointing out “shortcomings” of USP 1206.

Rahe pointed out what he thought were deficiencies in facilities, personnel and gowning, training, and validation, testing and quality assurance.

“Guidance provided in USP 1206 is inadequate to assure compliance with FDA goals of providing safe and effective compounding of sterile products in hospital, home care, outpatient clinics or physicians' offices,” he writes. “To achieve this goal, specific minimum requirements… must be written in such a manner as to be easily understood by those expected to implement the changes.”

Equally important is communication and training aspects of the new requirements. Rahe says with the right support, the ASHP can meet the need, while FDA partnerships with industries it regulates has yielded “workable guidance documents that communicate expectations in clear and complete terms.

“ASP is in the best position to coordinate the preparation of such a document by utilizing the expertise of its membership as well as the USP and pharmaceutical industry resources,” Rahe writes. “This document could be ready for FDA review in less than six months.”

For more information on the concept paper Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness, contact Andrea Masciale, regulatory counsel for CDER, at (301) 594-2041, or write to Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, and reference Docket Number 00N-1357.


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