The QMN Weekly Bulletin

FDA Adds 24 Entries to List of Drugs That Cannot Be Used in Compounding

Nov. 11, 2016

The FDA is revising the list of drug products that have been banned or removed from the market for safety or effectiveness reasons and so cannot be used in compounding.

The drugs on this list may not be compounded under exemptions provided by sections 503A and 503B of the Food, Drug, and Cosmetic Act. The revisions are necessary as new information has come to the agency’s attention. The agency is finalizing in part the proposed amendments published in the Federal Register in July 2014.

The new amendment adds 24 entries to the list of drugs and will modify the description of one drug product entry already on this list — bromfenac sodium — to allow an exception when the product is compounded under certain circumstances, as in the proposed rule.

At this time, FDA is not finalizing the entry in the proposed rule for all extended-release drug products containing oxycodone hydrochloride that have not been determined by FDA to have abuse-deterrent properties. An entry on the withdrawn or removed list for oxycodone hydrochloride remains under consideration by FDA.

The original list was created in March 1999. The amendment goes into effect in November.

What does the FDA take into consideration when reviewing nominated compounded substances? Safety concerns… efficiency of the evaluation process… nomination by multiple parties? Order the webinar CD Compounding Under Sections 503A and 503B: Distinctions, Limitation, Liabilities, and Compliance today and keep abreast of the rapidly changing rules and enforcement policies affecting compounding.

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