FDA and Pharmacy Weekly Digest - May 29

Alerts / May 29, 2020

FDA Published Report on 2019 E. Coli Outbreak in Romaine Lettuce – The report provides an overview of the investigation approach and factors that potentially contributed to the contamination of romaine lettuce with E. coli O157:H7 in two multistate and one single-state foodborne illness outbreaks in the fall of 2019. The report includes recommendations for risk mitigation strategies to reduce the potential for contamination of leafy greens from farm to fork.

FDA Extended Comment Period for Third Installment of the Draft Guidance for the Intentional Adulteration Rule – The comment period will be extended until August 14. The third installment of the draft guidance is designed to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule under the FDA Food Safety Modernization Act. The FDA released the third installment of the draft guidance in February 2020. This installment of the IA rule draft guidance covers topics focusing on food defense corrective actions, food defense verification, reanalysis of food defense plans and record-keeping; it also includes appendices on the FDA’s online Mitigation Strategies Database and how a business can determine whether it is a small or very small business under the rule. Comments can be submitted to docket FDA-2018-D-1398.


Carcinogen Found in Another Common Drug – The FDA announced that testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit in several lots of the extended-release formulation of metformin, a prescription drug used to control high blood sugar in patients with Type 2 diabetes. The FDA has already contacted five firms to recommend voluntary recalls of affected drug product. This announcement follows the finding of NDMA in other countries in late 2019 and the FDA’s previous investigation of NDMA in blood pressure, heart failure and heartburn medicines. The FDA is asking all manufacturers of metformin containing extended-release products to evaluate the risk of excessive NDMA in their products and to test each batch before it is released into the U.S. market. If testing shows NDMA above the acceptable intake limit, the manufacturer should inform the agency and should not release the batch to the U.S. market.

Registration Opened for Public Meeting on Reauthorizing the Prescription Drug User Fee Act – The FDA will hold a meeting virtually on July 23 to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2023 through 2027. PDUFA authorizes the FDA to collect user fees, which support the process for the review of human drugs. Public comments will be accepted through August 23, by submission to docket FDA-2010-N-0128, which will be published prior to the public meeting. Meeting attendees must register by June 23.

FDA Published Q&A Draft Guidance on Orange Book – The guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants and approved application holders) in utilizing the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book). Commonly asked questions regarding the Orange Book are answered in this guidance.

Medical Devices

FDA Revealed Upcoming Changes to the Electronic Medical Device Reporting System – The changes reflect updates to FDA Form 3500A and other system enhancements. FDA Form 3500A is used by manufacturers, distributors, importers and user facilities to report medical device adverse events. The updated FDA Form 3500A is available in paper form. These updates will allow the public to more easily analyze events in the FDA’s Manufacturer and User Facility Device Experience database. Updates include the ability to show whether a report represents a summary of multiple events (for example, Voluntary Malfunction Summary Reports), the number of events being summarized and patient gender.


Required Warnings for Cigarette Packages and Advertisements Postponed – The disruptive impacts of COVID-19 caused the U.S. District Court for the Eastern District of Texas to grant a joint motion in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al. to postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule by 120 days. The new required cigarette health warnings for cigarette packages and advertisements contain textual warnings and graphic images. The new effective date of the final rule is Oct. 16, 2021. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. The FDA has updated the “Required Warnings for Cigarette Packages and Advertisements” small-entity compliance guide and the “Submission of Plans for Cigarette Packages and Cigarette Advertisements” guidance to include the rule’s new effective date and update the recommended timing for submission of cigarette plans.

FDA Released New Webinars as Part of the Tobacco Compliance Webinar Series – The FDA’s Center for Tobacco Products hosts a series of webinars on federal tobacco regulations to provide compliance education and information to retailers and small-business manufacturers. Updates include webinars for importers, manufacturers and retailers.


The Comment Period for Draft Guidance on Compounding Animal Drugs From Bulk Is Closing – The deadline to submit comments is June 17. When finalized, this guidance will describe the circumstances in which the FDA does not intend to take action against drugs compounded from bulk drug substances. Under the draft guidance, only bulk drug substances on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals can be compounded into drugs for office stock or for antidotes for food-producing animals when no other medically appropriate treatment options exist.

Authorship Credit: Marc N. Wagner

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