Comment period closes, standard in the making

Mark A. DeSorbo

WASHINGTON, DC—Public comment had slowed to a trickle by late August on the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) effort to hammer out standards to keep drugs and medical products virus- and bacteria-free.

In fact, CDER had received just one letter in early September, a little more than a month before the public comment period ended on Tuesday, October 13, says Andrea Masciale, regulatory counsel for CDER.

“What we anticipate is reviewing the public comments, drafting another document and then allowing the public to comment on the new document,” she adds.

The last letter to cross Masciale's desk was from David L. Laven, a nuclear pharmacist at the Kansas University Medical Center (Kansas City, KS). He raises many questions about the concept paper Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness—the basis for proposed FDA pharmacy practices and regulations.

In a letter dated September 8, Laven points out that the concept paper does not address radiopharmaceutical compounding, nor does the Food and Drug Administration Modernization Act of 1997.

“I believe, too, that we have not yet finished writing the chapters pertaining to radiopharmaceutical compounding, and so the issues that FDA raises in its Concept Paper reflect continuing philosophical beliefs that can have a negative impact on most any area of drug-compounding as we currently understand it today,” he writes.

The concept paper, which is largely based on Chapter 1206 of United States Pharmacopoeia, is also undergoing revision. It addresses numerous procedures for facilities, personnel and gowning, training, aseptic processing and cleaning and sanitizing. The paper, docket number 00N-1357, is the FDA's first attempt to establish a baseline for drug preparation standards. The effort 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.

Laven agrees with other industry professionals that Chapter 1206 and similar documents on drug compounding are not comprehensive enough when it comes to potency, purity and quality. “The FDA must recognize there are sources of expert opinion on matters of involving the compounding of sterile products, and not solely the content of information found in the 'standards in Chapter 1206,'” he writes.

Verbiage within the concept paper such as “sophisticated,” “variability,” “reproducibility,” “uniformly” and “specialized” can be “completely open ended in terms of interpretation and application, according to Laven. Calling it disturbing, he said the FDA's proposed interpretation of compounding does not make adequate differentiations of activities that involve mixing, reconstituting or other acts that are performed according to directions provided by the product manufacturer.

The FDA, Laven writes, is apparently negating the role of pharmacists and their level of compounding sterile products. As an example, he points out page 7 of the concept paper, where it states: “Each time a pharmacist removes the sterile product from its original container or reconstitutes a sterile product, a risk of compromising sterility of the product exists.”

“In this context, does [the] FDA truly intend to regulate acts of reconstitution according to manufacturers' instructions, as well as compounding? I sincerely hope this is not to be the case,” Laven says.

Although establishing a standard has its merits, he believes regulation of compounding should rest with state pharmacy boards, and not the FDA. “It would be appropriate for the FDA to offer guidance to state boards of pharmacy so that they could increase their regulatory oversight with regards to the practice of sterile compounding,” Laven writes. “Through such a cooperative effort, we may actually be able to move in a direction whereby the establishment of a national quality-assurance standard for the compounding of sterile drugs in any pharmacy practice setting.”

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. On the Web, log onto


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