Drug Shortages


Supply Chain Risk and Data Management Poised to Take a Leap Forward

In a complete supply chain, one site’s lag measure is another site’s lead measure.  As important as data integrity is to product quality decisions at the site, data risks in the supply chain can affect availability of product to patients.  As mentioned in a previous Lachman blog (here), drug shortages are the preeminent risk for […]

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FDA Updates Draft Guidance on Required Notification of Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020.  As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide […]

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As Ibuprofen Shortage Rages On, FDA Revises Recently Issued Guidance

On February 9, 2023, the FDA issued a revised guidance (here) on the compounding of Ibuprofen oral suspension products for outsourcing facilities.  We previously posted about the original document (here) and discussed the basic factors that caused the Agency to issue the guidance without public comment to meet the needs of a drug shortage that […]

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Expiration Date Extensions for Critical Drugs on the Shortage List

FDA has worked with companies to support expiration date extensions for “critical” drugs on the FDA’s drug shortage list.  The current list (here) contains 343 entries  Most products have had their expiration dates extended by one year from the labeled expiration date. The list provides information to providers to verify that the firm had submitted […]

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Coronavirus Readiness

  As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]

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Drug Shortages Report Provides Look Forward Image

Drug Shortages Report Provides Look Forward

Drug shortages have been in the headlines for years but getting them under control has proved to be a complex, multifaceted problem.  Reports of critical shortages for chemotherapeutic agents, saline solutions, other injectables, and oral medications have lead healthcare providers oft times to seek other options for therapy.  There has even been one firm created […]

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