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FDA Seeks Nominations for Bulk Drug Substance List

The Drug Quality and Security Act signed into law on Nov. 27 created a new category of "outsourcing facilities" that may compound drugs, either by or under the direct supervision of a licensed pharmacist.

The U.S. Food and Drug Administration is accepting nominations for a bulk drug substance list that is required by the newly enacted Drug Quality and Security Act. After the fungal meningitis outbreak of 2012 linked to the New England Compounding Center, this law was written to clarify FDA's authority to regulate compounded drugs and creates a new, voluntary program for FDA to regulate entities engaged in batch compounding so they can register with the agency.

A new section established by the act says outsourcing facilities may not compound using a bulk drug substance unless that substance is on the list established by the HHS secretary and identifying bulk drug substances for which there is a clinical need, or the drug compounded from such bulk drug substance appears on the drug shortage list in effect under section 506E of the FD&C Act at the time of compounding, distribution, and dispensing, along with two other possible ways substances may be used.

FDA's request for specific substance nominations say this information should be supplied:

  • Ingredient name
  • Chemical name
  • Common name(s)
  • Chemical grade or description of the strength, quality, and purity of the ingredient
  • Information about how the ingredient is supplied (e.g., powder, liquid
  • Information about recognition of the substance in foreign pharmacopeias and the status of its registration(s) in other countries, including whether information has been submitted to USP for consideration of monograph development
  • A bibliography of available safety and efficacy data,2 including any relevant peer-reviewed medical literature
  • An explanation of why there is a clinical need to compound from the bulk drug substance

For a compounded product, the necessary information is:

  • Information about the dosage form(s) into which the drug substance will be compounded (including formulations)
  • Information about the strength(s) of the compounded product(s)
  • Information about the anticipated route(s) of administration of the compounded product(s)
  • Information about the past and proposed use(s) of the compounded product(s), including the rationale for its use or why the compounded product(s), as opposed to an FDA-approved product, is necessary
  • Available stability data for the compounded product(s)

Submissions received must identify FDA and also Docket No. FDA-2013-N-1524. Check that number at www.regulations.gov for submitted substances/products.

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