BakerHostetler FDA and Pharmacy Weekly Digest - December 17, 2018

Alerts / December 17, 2018
Food/Dietary Supplements

FDA Investigates Salmonella Concord Outbreak – FDA continues to investigate a multistate outbreak of Salmonella Concord linked to imported tahini products.

FDA Investigates E. coli O157:H7 Infections – FDA continues to investigate a multistate outbreak of E. coli linked to romaine lettuce in California.


FDA Makes Final Data Integrity Guidance Available – FDA issued the final version of its guidance titled “Data Integrity and Compliance with Drug CGMP: Questions and Answers.” The purpose “is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.”

FDA Commissioner Addresses Compounded Drugs – Commissioner Gottlieb and Deputy Commissioner Abram announced efforts to address quality of compounded drugs with a revised draft guidance on CGMP. The FDA indicated that the guidance contains “recommendations for protecting patients from the risk of contaminated or otherwise substandard products produced by outsourcing facilities. The aim is to outline practices for drugs produced under CGMP requirements by outsourcing facilities.”

FDA Announces Two Guidance Documents on Biosimilars – FDA announced the availability of two guidance documents to further the Biosimilars Action Plan released in July 2018. The guidance documents are “to facilitate implementation of the ‘deemed to be a license’ provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), as well as a proposed rule that provides FDA’s interpretation of the terms ‘protein’ and ‘chemically synthesized polypeptide’ in the statutory definition of ‘biological product.’”

FDA Warns Against Using Certain Sterile Products – FDA issued a warning to health care professionals and patients to avoid drug products purporting to be sterile because they “were produced in an inadequate designed processing room.”

FDA Seeks to Modernize Generic Drug Labels – FDA announced it is withdrawing a 2013 proposed rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” However, FDA also announced that it is “taking important steps to update the labels on certain generic cancer drugs with modern safety and efficacy information. This effort will help make sure that prescribers and patients have the most up-to-date information to guide treatment decisions and will broaden patient access to generic medicines.”

Medical Devices

FDA Announces Public Meeting on Devices – FDA released a notice announcing a public meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. The meeting will be held on February 12, 2019, and FDA has established a docket for public comment.

FDA Releases Final Rule on Medical Device Classification – FDA announced the availability of its final rule entitled “Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures.” The FDA’s announcement indicates that “[t]he purpose of this rulemaking is to implement the FDA Safety and Innovation Act (FDASIA) modifications and to update and clarify the Part 860 regulations without making substantive changes to existing practices for the classification and reclassification of medical devices. The FDA believes stakeholders, particularly regulated entities, will benefit from the finalization of this rule because it provides more clarity about the procedures for classifying and reclassifying medical devices.”

FDA Issues Draft Guidance on Radiation Control Regulations – FDA released a draft guidance relating to radiation control regulations titled “Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.” The draft guidance clarifies the regulations “relate to diagnostic X-ray systems and their major components.”


FDA Issues Warnings About E-liquids – FDA published an alert to consumers not to purchase two types of e-liquids because they “contain undeclared prescription drugs tadalafil and/or sildenafil.” FDA indicates that “[t]hese undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.”

Recently Posted Warning Letters

FDA issued a warning letter to an active pharmaceutical ingredient (API) manufacturer producing the API found in valsartan. The FDA announcement indicates, “The letter outlines several manufacturing violations at [the] … facility, including impurity control, change control and cross contamination from one manufacturing process line to another.” The warning letter is another step forward in the ongoing investigation. The agency is still looking into the root cause of the impurity.


President Expected to Sign Farm Bill – Congress issued a final version of the 2018 Farm Bill (Agricultural Improvement Act of 2018). The Farm Bill proposes to modify the status of certain hemp-derived products under the Controlled Substance Act.

Authorship Credit: Lindsay P. Holmes

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