National take-back days have allowed participating agencies to take more than 4.1 million pounds of unwanted or expired prescription medications out of circulation since DEA

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.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Comply with OSHA’s Electronic Recordkeeping Requirements

    Collect relevant incident data and generate accurate OSHA 300, 300A, and 301 regulatory reports, including 300A CSV files for easy electronic submission to OSHA.

  • Complete Online Safety Training Courses

    Deliver state-of-the art, online safety training courses to your organization with IndustrySafe Training Management Software. Generate reports to track training compliance and automatically notify learners of upcoming or overdue classes.

  • Easy to Use Safety Inspection App

    Conduct inspections on the go with IndustrySafe’s mobile app. Complete safety audits at job sites and remote locations—with or without web access.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus
Live From Safety