Since our last update, the Senate has confirmed Dr. Robert Califf as Commissioner of the United States Food and Drug Administration. The FDA has resumed domestic and foreign inspections. The agency also released a proposed rule to update current device good manufacturing practice requirements related to the Quality System (QS) Regulations and continued development of national standards for drug distributors. wholesale and third party logistics providers. The Office of Pharmaceutical Quality has also published its annual report.

Please see details of these and other supply chain developments below:

• On February 7, the FDA resumed planning and conducting nationwide surveillance inspections. The agency also continues to conduct mission-critical inspections overseas and at home, as well as remote assessments. The FDA is continuing to conduct previously scheduled overseas surveillance inspections in countries that have received clearance from the country and are in compliance with the Centers for Disease Control and Prevention’s Tier 1 or Tier 2 COVID-19 travel recommendations. The FDA reports that planning for additional foreign surveillance inspections is underway, with a planned goal of conducting priority foreign inspections beginning in April.
• On February 3, the FDA announced the availability of a proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” under the Drug Supply Chain Security Act. . The proposed rule would set standards for all state and federal licenses issued. Comments are due by June 6, 2022.
• On February 17, Dr. Robert Califf was sworn in as commissioner of the FDA. Califf, a cardiologist by training, previously served as commissioner under President Barack Obama.
• On February 22, the Biden-Harris administration met with stakeholders to discuss plans for major investment in the national minerals and materials supply chain. These plans include sustainable and recyclable lithium mining, element and mineral recovery projects, updating mining rules and regulations, and strengthening the mineral stockpile. The implementation of the programs should also create more national jobs.
• On February 22, the FDA’s Office of Pharmaceutical Quality (OPQ) released its “2021 Annual Report.” In 2021, the OPQ conducted 47 pre-approval inspections and 21 critical inspections and, using alternative tools such as remote interactive assessments, reduced the number of facilities requiring a pre-approval inspection by 52%.
• On February 23, the FDA released a proposed rule that would modify the current Good Manufacturing Practice requirements for devices in the Quality System (QS) Regulations to more closely align with the International Consensus Standard for Devices. incorporating by reference the 2016 edition of the International Organization for Standardization (ISO) 13485. ISO 13485 is an international standard specific to device quality management systems. Comments on the proposed rule are expected by May 24, 2022.
• On March 3, the FDA issued final guidance to industry, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which addresses preparations that companies in a “distribution chain, including including manufacturers and distributors, should consider doing to establish recall initiation procedures; to ensure the timely identification and response to product problems that could result in a recall; and to promptly issue communications of recall and press releases or other public notices. It also discusses the preparations companies in the supply chain should consider making to ensure prompt responses to a recall communication. With few exceptions, the guidance is apply to all FDA-regulated products. The guidelines also provide information on how entities can use the FDA to assist them in their recall efforts.

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