FDA and Pharmacy Weekly Digest - June 17

Alerts / June 17, 2019
Food/Dietary Supplements

FDA Requests Seizure of Dietary Supplements – Per the FDA’s request, more than 300,000 containers of dietary supplements were seized from a manufacturer. The seizure was supported by a court finding that “determined there was probable cause that the company prepared, packed, and/or held dietary supplements under conditions that do not conform to the dietary supplement current good manufacturing practice (CGMP) requirements.”

FDA Releases Statement on Per- and Polyfluoroalkyl Substances (PFAS) in Foods – The FDA stated that it “has been working to develop new methods to quantify certain per- and polyfluoroalkyl substances (PFAS) in foods. We have employed these new methods to test samples of foods Americans typically consume for certain types of PFAS, and today we are making available recently analyzed data from these initial testing initiatives.”


FDA to Hold Listening Session for Outsourcing Facilities – On June 18, the FDA will hold a listening session on drug compounding for outsourcing facilities. This session will cover bulk drug substances, current good manufacturing practices, essential copies and adverse event reporting.

FDA Finalizes Guidance on ANDA Submissions – The FDA released a final guidance titled “ANDA Submissions – Content and Format of Abbreviated New Drug Applications.” The guidance outlines “the information that should be provided in each section of the common technical document (CTD) format for human pharmaceutical product applications and identifies supporting guidance documents and recommendations issued by the FDA to assist applicants in preparing their ANDA submission.”

FDA Appoints New Director of Division of Compounded Drugs – The FDA announced the appointment of Gail Bormel as the new director of the Division of Compounded Drugs.

Medical Devices

FDA Publishes Draft Guidance on Biotin Interference – The FDA issued a draft guidance titled “Testing for Biotin Interference in In Vitro Diagnostic Devices.” Its purpose is to “help device developers and clinicians understand how the FDA recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians.”

FDA Drafts Guidance on Conducting Mouse Embryo Assay – The draft guidance outlines “recommendations on conducting the mouse embryo assay (MEA) to support premarket submissions and lot release of assisted reproduction technology (ART) devices.”


FDA Releases Final ENDS Guidance – The FDA issued a final guidance titled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS).” The guidance outlines recommendations for individuals submitting premarket tobacco product applications for ENDS products. Acting Commissioner Sharpless stated, “FDA’s ongoing oversight of e-cigarettes and other ENDS products is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related disease and death. The FDA is committed to providing a solid, science-based regulatory foundation to ensure that ENDS products authorized for marketing are appropriate for the protection of public health. The final guidance issued today provides companies seeking to market e-cigarette and ENDS products with recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product.”

FDA Issues a Draft Guidance for New Tobacco Products – The FDA published a draft guidance titled “Applications for Premarket Review of New Tobacco Products” that provides recommendation about when and how to submit an application for a new tobacco product, as well as the information that should be included in that application.

FDA Extends Comment Period for Proposed Rule on Substantial Equivalence – The FDA announced a 30-day extension to the comment period for its proposed rule on the content and format of substantial equivalence reports. The comment period is extended through July 17.


OIG Releases Report on Compounded Drugs – Office of Inspector General (OIG) report titled “Most Hospitals Obtain Compounded Drugs From Outsourcing Facilities, Which Must Meet FDA Quality Standards” found that “89 percent of hospitals that obtained non-patient-specific compounded drugs did so exclusively from outsourcing facilities.” Based on its findings, “OIG recommends that FDA further communicate with hospitals about the importance of obtaining their non-patient-specific compounded drugs from outsourcing facilities. We also recommend that FDA take appropriate followup actions with the unregistered compounding facilities on the list that we provided; these facilities may not be in compliance with Federal law. FDA’s followup could include for-cause inspections and any advisory or enforcement actions that are warranted.”

Florida to Allow Drug Importation From Canada – Florida’s governor signed a bill “establish[ing] the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the state.”

Authorship Credit: Lindsay P. Holmes

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