Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- As part of the FDA’s efforts to help ensure Americans have access to compounded medicines when a patient’s medical needs cannot be met by an FDA-approved drug, the FDA has added the first four bulk drug substances to the list of bulk drug substances that may be used in compounding by outsourcing facilities (503B Bulks List). The bulk drug substances include: diphenylcyclopropenone (DPCP) for topical use, glycolic acid for topical use in concentrations up to 70 percent, squaric acid dibutyl ester (SADBE) for topical use and trichloroacetic acid (TCA) for topical use. These bulk drug substances are not components of any currently FDA-approved drugs. The FDA also determined that eight bulk drug substances will not be added to the list at this time. The FDA will continue to balance patient protection and access to compounded drugs for patients who need them.
- On Jan. 27, the FDA published an FDA Voices article by Center for Tobacco Products Director Mitch Zeller discussing the agency’s commitment toward advancing two proposed tobacco product standards—one prohibiting menthol as a characterizing flavor in cigarettes and another prohibiting all characterizing flavors (including menthol) in cigars. The FDA Voices highlights how these product standards would be a significant step in addressing tobacco-related health disparities and reducing tobacco-related disease and death. The FDA remains on track to advance the proposed product standards in the spring.
- On Jan. 26, the FDA published several guidances focused on generic drug application submissions, labeling and review. These guidances are part of the FDA’s continued efforts to bring greater efficiency and transparency to the generic drug review process, which helps spur competition and improves consumer access to the medicines they need at affordable prices. Bringing more competition to the market and addressing the high costs of medicines are top agency priorities. These guidances support the FDA’s Drug Competition Action Plan, which encourages robust and timely market competition for generic drugs. Offering clarified, up-to-date guidance for industry demonstrates the FDA’s commitment to bringing more high-quality, safe, effective and affordable generic medicines to all consumers.
- On Jan. 26, the FDA issued a constituent update to remind produce stakeholders of a prior statement regarding enforcement discretion for the agricultural water compliance dates. This includes exercising enforcement discretion related to the Jan. 26, 2022 compliance date for the pre-harvest, harvest and post-harvest agricultural water requirements in the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule for the large covered farms.
- On Jan. 26, the FDA provided an update related to the recall of certain Philips Respironics ventilators. In December 2021, Philips Respironics initiated a recall of certain Trilogy Evo ventilators distributed between April 15, 2021 and May 24, 2021 with specific serial numbers. The FDA classified this recall as a Class I recall in January 2022. These devices were not included in the June 2021 recall of Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines. As noted during a recent FDA inspection, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators with specific serial numbers. The foam was determined to be PE-PUR foam, the same foam used in Philips Respironics devices previously recalled in June 2021.
- COVID-19 testing updates:
- As of today, 423 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 molecular tests and sample collection devices, 87 antibody and other immune response tests and 45 antigen tests. There are 69 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 26 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 794 revisions to EUA authorizations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.