FDA and Pharmacy Weekly Digest - July 16

Alerts / July 16, 2019
Food/Dietary Supplements

FDA Issues Information for Food Producers Affected by Tropical Storm Barry – The FDA encouraged food producers to utilize established FDA guidance on evaluating the safety of flood-affected food crops. The FDA issued a reminder to “harvesters that generally, if the edible portion of a crop is exposed to contaminated flood waters, it is considered ‘adulterated’ under the Federal, Food, Drug and Cosmetic Act and should not enter the human food supply.

FDA Extends Comment Period for Potassium Chloride Draft Guidance – The FDA announced that it would extend the comment period for the draft guidance “The Use of an Alternate Name for Potassium Chloride in Food Labeling” for 60 days. The new comment period ends Sept. 17, 2019. The draft guidance was issued to “advise food manufacturers of its intent to exercise enforcement discretion for the name ‘potassium chloride salt’ in the ingredient statement on food labels as an alternative to the common or usual name ‘potassium chloride.’”


FDA Releases Commentary on Opioid Medications – The FDA published information on opioids stating, “One of the highest priorities of the FDA is advancing efforts to address the crisis of misuse and abuse of opioid drugs harming families. Opioids are claiming lives at a staggering rate, and overdoses from prescription opioids are reducing life expectancy in the United States.” It also published its plans on decreasing exposure and preventing new addiction.

FDA Updates REMS Guidance – The FDA published an update to its guidance “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry.” The guidance is intended to provide “information on how the FDA defines the types of changes to approved risk evaluation and mitigation strategies (REMS), how application holders should submit changes to an approved REMS, and how the FDA will process submissions from application holders for changes to REMS.”

FDA Publishes Inactive Ingredient Database Guidance – The FDA released a draft guidance titled “Using the Inactive Ingredient Database Guidance for Industry.” The draft “describes the Food and Drug Administration’s (FDA’s) Inactive Ingredient Database (IID) and provides recommendations for how to use the IID in the development of drug products. The guidance also describes how the IID can be used in evaluating excipient safety, which can affect application filing and scientific review.”

Medical Devices

FDA Publishes Information About Ethylene Oxide Sterilization for Medical Devices – This information was published in response to the March closure of a medical device sterilization facility. Included in this information is the announcement of the FDA’s sponsorship of two public innovation challenges to help encourage new developments in medical device sterilization.


FDA Comments on Court Ruling Relating to Application Submission Deadlines for Tobacco Products – The FDA made a statement that a judge in the U.S. District Court in Maryland decided that “makers and importers of e-cigarettes and other electronic nicotine delivery systems (ENDS) and certain other tobacco products like cigars, pipe tobacco and hookah” are required to submit applications for their marketed products to the FDA within 10 months. In response to the decision, the FDA stated, “The FDA stands ready to accelerate the review of e-cigarettes and other new tobacco products. And we remain committed to tackling the epidemic of youth vaping using all available regulatory tools at our disposal.”

FDA Posts Large Number of Tobacco Warning Letters – The FDA made seven warning letters available on the same day, alleging violations of the Family Smoking Prevention and Tobacco Control Act. One of the allegations against all of the companies is that they engaged in the practice of sales to minors.


Recall of Ophthalmic Products Sold at Pharmacies – A manufacturer has issued recalls for ophthalmic products sold at CVS, Walgreens and other retailers. The over-the-counter products are being recalled “due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility.”

FDA Issues Warning Letter to 503A Pharmacy – The FDA sent a warning letter to a pharmacy alleging that “drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated.” The letter further notes that “section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A.”

NAIC to Tackle PBM Issues – The National Association of Insurance Commissioners announced that the Pharmacy Benefit Manager Regulatory Issues (B) Subgroup will “[c]onsider developing a new NAIC model to establish a licensing or registration process for pharmacy benefit managers (PBMs). The Subgroup may consider including in the new NAIC model provisions on PBM prescription drug pricing and cost transparency.”

Federal Judge Vacates Drug Price Advertising Regulation – A federal judge vacated the federal regulation that would have required the disclosure of drug prices in television advertising.

Authorship Credit: Lindsay P. Holmes

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