FDA and Pharmacy Weekly Digest - August 20, 2020

Alerts / August 20, 2020

FDA Released Final Rule on Gluten-Free Labeling – The final rule establishes compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, that use the “gluten-free” claim. Foods subject to the final rule include yogurt, sauerkraut, pickles, cheese, green olives, beers, wines, and hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces, and seasonings. The rule does not change the definition of gluten free. The Food and Drug Administration (FDA) will determine compliance based on records kept by the manufacturer of fermented or hydrolyzed foods.

FDA Announced Qualified Health Claim for Certain Cranberry Products and Urinary Tract Infections – In a letter of enforcement discretion, the FDA outlined that it does not intend to object to the use of certain qualified health claims regarding consumption of certain cranberry products and a reduced risk of recurrent urinary tract infection in healthy women.

FDA Investigating Salmonella Newport Outbreak – This outbreak has caused recalls of red, yellow, white and sweet yellow onions. The FDA investigation is ongoing. The FDA is collecting and analyzing product, water and environmental samples as part of the root cause investigation.


FDA Published Guidance on Inspections During COVID-19 Public Health Emergency – In Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers, the FDA responds to common questions regarding on-site inspections and the manufacturing supply chain.

FDA Issued Guidance on Marketing Status Notifications for NDA and ANDA Holders – NDA and ANDA holders must notify the FDA prior to withdrawal of an approved drug from sale or when a drug will not be available within 180 days of the date of approval, and must submit one-time marketing reports. This final guidance identifies the required content for these marketing status notifications, the recommended format for submitting these notifications to the FDA and the timelines for submission.

Medical Devices

FDA Updates Recognized Consensus Standards Database – The database provides the most up-to-date list of voluntary consensus standards to which the FDA will accept a Declaration of Conformity. Declarations of Conformity are used by medical device manufacturers to demonstrate that they have met relevant statutory requirements.


FDA Warns E-Cigarette and E-Liquid Product Manufacturers – The FDA issued warning letters notifying 10 companies to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization. Additional warning letters notified manufacturers of flavored disposable e-cigarettes that advertising which fails to include the required nicotine warning statement is misbranded. These new actions show the FDA’s ongoing aggressive enforcement in the tobacco space.


FDA Issued Final Guidance on Clinical Trial Reporting Violations – The Final Guidance, Civil Money Penalties Relating to the Data Bank, addresses several questions regarding civil money penalties under section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act. That section authorizes the FDA to assess civil money penalties against responsible parties and/or submitters of certain applications and submissions to the FDA regarding drug products, biological products and device products who violate the requirement to submit registration and/or results information to the data bank and/or certain certifications to the FDA.

FDA Updated the Purple Book – This update to the Purple Book: Database of FDA-Licensed Biological Products added information on all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER). Additional updates include exclusivity information and a glossary to help provide real-time information to users about terms and other information in the Purple Book Database.

D.C. Circuit Upholds 340B Reduction – On July 31, the U.S. Court of Appeals for the D.C. Circuit ruled that HHS had the legal authority to reduce payments by 28.5 percent for drugs purchased under the 340B discount program by hospital outpatient departments, reversing a decision by the lower court.

503B Bulks List Is Getting FDA’s Attention – The FDA proposed to include four bulk drug substances on the list of bulk drug substances that outsourcing facilities may use in drug compounding. The FDA also identified 19 bulk drug substances that the agency proposed not to include on the 503B bulks list. The FDA is seeking public comment on this proposal before finalizing its decision. Additionally, the FDA updated the list of Categories of Substances Nominated for the 503B Bulk Drug Substances List and added 19 bulk drug substances to category 1 for which FDA does not intend to take action against an outsourcing facility for compounding drugs using bulk drug substances.

HHS Authorizes Pharmacists to Administer Vaccines to Children – HHS issued a third amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act to authorize state-licensed pharmacists to order and administer vaccines to individuals ages 3 through 18 years.

Authorship Credit: Marc Wagner

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