PHARMACY COMPOUNDING OF BULK DRUG SUBSTANCES TO BE TOPIC OF FEDERAL REGISTER NOTICE, FDA SAYS; COMPOUNDING WORKING GROUP ASSEMBLING ADVISORY CMTE.

FDA will request advice about which bulk drug substances may be used in pharmacy compounding in an upcoming Federal Register notice, the agency said in a statement to industry posted on its Web site.

"The notice will describe the type of information -- such as safety data, efficacy data, and historical use in compounding -- that the agency will require in support of each nomination," FDA said. "At this time, the agency encourages interested groups and individuals to begin considering the drug substances they might want to nominate and the information they could submit to support their nominations."

FDA is directed to "promulgate regulations identifying drug substances that may be used for compounding...for which a monograph does not exist or which are not components of drug products approved by [FDA]," the FDA Modernization Act states. FDA "shall include in the regulation the criteria for such substances, which shall include historical use, reports on peer reviewed medical literature, or other criteria [FDA] may identify."

The FDAMA conference report recommends that FDA "develop the list of bulk drug substances...within one year from the date of enactment." The conferees intended "that the criteria used to develop the list of bulk drug substances and the list itself are to be developed in consultation with the U.S. Pharmacopoeia," according to the conference report. In addition, "the conferees intend that after this list is published, organizations may petition FDA for inclusion of additional substances on the aforementioned list."

The agency has assigned Center for Drug Evaluation & Research Associate Director for Policy Jane Axelrad and Prescription Drug Compliance and Surveillance Division Director Lana Ogram to direct the working group responsible for implementing the pharmacy compounding provisions in FDAMA.

Others on the working group include CDER Office of Compliance Adverse Drug Reaction & Compounding Team Leader Fred Richman and Associate Chief Counsel for Enforcement David Horowitz. Axelrad and Ogram have been designated the official agency contacts for the provisions.

FDA is directed to assemble an advisory committee made up of "representatives from the National Associations of Boards of Pharmacy, the U.S. Pharmacopoeia, pharmacy, physician, and consumer organizations, and other experts selected by [FDA]," FDAMA instructs. FDA will consult with the advisory committee in the development of the regulations. The working group is in the process of setting up the committee.

In addition, FDA is instructed to publish a list of drugs "that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective," FDAMA states. The agency also must issue regulations that define drug products "that present demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product."

The pharmacy compounding working group anticipates meeting the one-year recommendation by the conferees for the list of bulk drug substances. Following the publication of the Federal Register notice, the group will develop the list and will present it to the advisory committee. A regulation will be written following the advisory committee meeting. The working group similarly plans to present the list of products that have been withdrawn from the market to the committee. The development of the list of difficult-to-compound products will be done more collaboratively with the committee.

Unlike other FDAMA implementation working groups, such as the pharmacoeconomic group, which will have to define terms such as "competent and reliable scientific evidence" in its guidance to industry on those provisions, the pharmacy compounding group will not have to define the terms used in the provisions. The bill explicitly describes who would be allowed to compound drugs and under which circumstances ("The Pink Sheet" Nov. 17, 1997, p. 12).