FDA and Pharmacy Weekly Digest - July 2020 #2



FDA Plans to Restart On-Site Inspections the Week of July 20 – Commissioner Hahn announced the goal of restarting inspections, which were halted due to COVID-19. The FDA has developed a COVID-19 Advisory Rating system to assist in determining when and where it is safest to conduct prioritized domestic inspections. Aside from retail tobacco inspections, for the foreseeable future, prioritized domestic inspections will be preannounced to FDA-regulated businesses.


FDA Unveiled the New Era of Smarter Food Safety Blueprint – The blueprint is centered around four core elements: 1) Tech-enabled Traceability, 2) Smarter Tools and Approaches for Prevention and Outbreak Response, 3) New Business Models and Retail Modernization, and 4) Food Safety Culture. This blueprint outlines the approach FDA will take over the next decade to usher in the “new era of smarter food safety.”

FDA Finalized Compliance Policy Guide for Use With the Seafood List – The FDA issued a final Compliance Policy Guide (CPG) titled “Use of the Seafood List to Determine Acceptable Seafood Names.” This CPG is intended for use with The Seafood List and is intended to provide consistency, accuracy and clarity for determining acceptable market names for seafood sold in interstate commerce.


FDA Releases Searchable List of Recalled Metformin Products – Weeks ago, the FDA announced that testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (known as 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. Several companies and counting have recalled products. The FDA has made available to patients and healthcare professionals a searchable list of recalled metformin products.

Medical Devices

FDA Seeks Comment on Draft Guidance for Devices Used to Treat Benign Prostatic Hyperplasia – The FDA is proposing select updates to the FDA guidance document “Guidance for the Non‐Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH),” issued in 2010. The existing guidance on devices used for the treatment of BPH remains in effect until the draft guidance is finalized. FDA intends to incorporate this draft guidance into one final guidance document after obtaining and considering public comment on select updates. Select updates include nonclinical testing, study endpoints and statistical analysis recommendations.


FDA’s Cigar Warnings Are Arbitrary and Capricious – The D.C. Circuit held that “Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act,” 81 Fed. Reg. 28,973 (May 10, 2016) (the Deeming Rule), violates the Tobacco Control Act and the Administrative Procedure Act. The Deeming Rule requires extensive health warnings on packaging and in advertising for cigars and pipe tobacco. The FDA concluded that these warnings would help communicate the health risks of smoking, but per the court it failed to consider how the warnings would likely affect the number of smokers, which is a requirement of the Tobacco Control Act. Thus, the FDA’s actions were arbitrary and capricious. The case was remanded to district court.


FDA Continues Compounding Quality Center of Excellence Training Program Remotely – The virtual, interactive training programs with live instruction target outsourcing facility staff and offer continuing education credits. The training is open to state regulators and pharmacy compounders if space is available. Topics include environmental monitoring, sterile drug compounding, cleanrooms, investigations, and corrective and preventive actions.

The National Academies of Science, Engineering, and Medicine (NASEM) Issued a Report on Compounded Hormone Therapy – In September 2018, the FDA asked NASEM to provide an independent assessment and evaluate scientific evidence relating to the safety and effectiveness of compounded bioidentical hormone therapy (cBHT) and discuss whether the available evidence supports use of cBHT products to treat patients. The NASEM Report was critical of the quality of evidence available on cBHT and the report included several recommendations. NASEM did note that that there is a clinical need for cBHT in certain circumstances. We expect to see increased activity around this report in the future as healthcare moves towards individualized, personalized medicine.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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